Trial Outcomes & Findings for IT-hu14.18-IL2 With Radiation, Nivolumab and Ipilimumab for Melanoma (NCT NCT03958383)
NCT ID: NCT03958383
Last Updated: 2026-06-03
Results Overview
The number and severity of toxicity incidents per (Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 will be summarized with frequency and proportion. The 95% confidence interval for the proportion of subjects with severe complications (grade 3 or higher toxicities) will be constructed.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
8 participants
Primary outcome timeframe
up to 2 years
Results posted on
2026-06-03
Participant Flow
Participant milestones
| Measure |
Phase IA
Participants receive hu14.18-IL2 fusion protein intratumorally (IT) once daily (QD) on days 1-3. Treatment repeats every 21 days for cycles 1-4. Participants who are eligible may continue to receive hu14.18-IL2 fusion protein maintenance therapy QD on days 1-3 beginning with cycle 5. Maintenance cycles repeat every 28 days for up to 13 cycles in the absence of disease progression or unacceptable toxicity. A total of 9-18 participants will be enrolled in 3 escalating dose levels to determine the Maximum Tolerated Dose (MTD)/Maximum Administered Dose (MAD) of hu14.18-IL2 in Phase IA.
|
Phase IB
Participants undergo palliative RT on days -8 to -4 of cycle 1 only. Participants also receive hu14.18-IL2 fusion protein IT as in phase IA. Treatment with hu14.18-IL2 repeats every 21 days for cycles 1-4. Participants who are eligible may continue to receive hu14.18-IL2 fusion protein maintenance therapy QD on days 1-3 beginning with cycle 5. Maintenance cycles repeat every 28 days for up to 13 cycles in the absence of disease progression or unacceptable toxicity. The MTD/MAD of IT-hu14.18-IL2 following palliative RT will be determined starting 1 dose level below the Phase IA determined MTD/MAD of IT-hu14.18-IL2 up to the Phase IA determined MTD/MAD.
|
Phase IC
Participants undergo palliative RT on days -8 to -4 of cycle 1 only. Nivolumab (3 mg/kg) is given every 2 weeks for up to 1 year with the initial dose given between day -7 and day -1 of cycle 1. Participants also receive hu14.18-IL2 fusion protein IT as in phase IA. Treatment with hu14.18-IL2 repeats every 21 days for cycles 1-4. Participants who are eligible may continue to receive hu14.18-IL2 fusion protein maintenance therapy QD on days 1-3 beginning with cycle 5. Maintenance cycles repeat every 28 days for up to 13 cycles in the absence of disease progression or unacceptable toxicity. The MTD/MAD of IT-hu14.18-IL2 following palliative RT in combination with nivolumab will be determined starting 1 dose level below the Phase IB determined MTD/MAD of IT-hu14.18-IL2 up to the Phase IB determined MTD/MAD.
|
Phase ID
Participants undergo palliative RT on days -8 to -4 of cycle 1 only. Nivolumab (1 mg/kg) in combination with ipilimumab (3 mg/kg) is given every 3 weeks for 4 cycles with the initial dose given between day -7 and day -1 of cycle 1. Following 4 cycles, no additional ipilimumab will be administered. Following cycle 4, maintenance nivolumab (3 mg/kg) can be given for up to one year. Participants also receive hu14.18-IL2 fusion protein IT as in phase IA. Treatment with hu14.18-IL2 repeats every 21 days for cycles 1-4. Participants who are eligible may continue to receive hu14.18-IL2 fusion protein maintenance therapy QD on days 1-3 beginning with cycle 5. Maintenance cycles repeat every 28 days for up to 13 cycles in the absence of disease progression or unacceptable toxicity. The MTD/MAD of IT-hu14.18-IL2 following palliative RT in combination with nivolumab and ipilimumab will be determined starting 1 dose level below the Phase IC determined MTD/MAD of IT-hu14.18-IL2 up to the Phase IC determined MTD/MAD. A total of 28 participants will be enrolled at the Phase ID MTD/MAD of IT-hu14.18-IL2.
|
|---|---|---|---|---|
|
Phase 1A
STARTED
|
4
|
0
|
0
|
0
|
|
Phase 1A
Completed Treatment
|
4
|
0
|
0
|
0
|
|
Phase 1A
On Follow Up
|
2
|
0
|
0
|
0
|
|
Phase 1A
COMPLETED
|
2
|
0
|
0
|
0
|
|
Phase 1A
NOT COMPLETED
|
2
|
0
|
0
|
0
|
|
Phase IB
STARTED
|
0
|
4
|
0
|
0
|
|
Phase IB
Completed Treatment
|
0
|
3
|
0
|
0
|
|
Phase IB
COMPLETED
|
0
|
3
|
0
|
0
|
|
Phase IB
NOT COMPLETED
|
0
|
1
|
0
|
0
|
|
Phase IC
STARTED
|
0
|
0
|
0
|
0
|
|
Phase IC
COMPLETED
|
0
|
0
|
0
|
0
|
|
Phase IC
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Phase ID
STARTED
|
0
|
0
|
0
|
0
|
|
Phase ID
COMPLETED
|
0
|
0
|
0
|
0
|
|
Phase ID
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Phase IA
Participants receive hu14.18-IL2 fusion protein intratumorally (IT) once daily (QD) on days 1-3. Treatment repeats every 21 days for cycles 1-4. Participants who are eligible may continue to receive hu14.18-IL2 fusion protein maintenance therapy QD on days 1-3 beginning with cycle 5. Maintenance cycles repeat every 28 days for up to 13 cycles in the absence of disease progression or unacceptable toxicity. A total of 9-18 participants will be enrolled in 3 escalating dose levels to determine the Maximum Tolerated Dose (MTD)/Maximum Administered Dose (MAD) of hu14.18-IL2 in Phase IA.
|
Phase IB
Participants undergo palliative RT on days -8 to -4 of cycle 1 only. Participants also receive hu14.18-IL2 fusion protein IT as in phase IA. Treatment with hu14.18-IL2 repeats every 21 days for cycles 1-4. Participants who are eligible may continue to receive hu14.18-IL2 fusion protein maintenance therapy QD on days 1-3 beginning with cycle 5. Maintenance cycles repeat every 28 days for up to 13 cycles in the absence of disease progression or unacceptable toxicity. The MTD/MAD of IT-hu14.18-IL2 following palliative RT will be determined starting 1 dose level below the Phase IA determined MTD/MAD of IT-hu14.18-IL2 up to the Phase IA determined MTD/MAD.
|
Phase IC
Participants undergo palliative RT on days -8 to -4 of cycle 1 only. Nivolumab (3 mg/kg) is given every 2 weeks for up to 1 year with the initial dose given between day -7 and day -1 of cycle 1. Participants also receive hu14.18-IL2 fusion protein IT as in phase IA. Treatment with hu14.18-IL2 repeats every 21 days for cycles 1-4. Participants who are eligible may continue to receive hu14.18-IL2 fusion protein maintenance therapy QD on days 1-3 beginning with cycle 5. Maintenance cycles repeat every 28 days for up to 13 cycles in the absence of disease progression or unacceptable toxicity. The MTD/MAD of IT-hu14.18-IL2 following palliative RT in combination with nivolumab will be determined starting 1 dose level below the Phase IB determined MTD/MAD of IT-hu14.18-IL2 up to the Phase IB determined MTD/MAD.
|
Phase ID
Participants undergo palliative RT on days -8 to -4 of cycle 1 only. Nivolumab (1 mg/kg) in combination with ipilimumab (3 mg/kg) is given every 3 weeks for 4 cycles with the initial dose given between day -7 and day -1 of cycle 1. Following 4 cycles, no additional ipilimumab will be administered. Following cycle 4, maintenance nivolumab (3 mg/kg) can be given for up to one year. Participants also receive hu14.18-IL2 fusion protein IT as in phase IA. Treatment with hu14.18-IL2 repeats every 21 days for cycles 1-4. Participants who are eligible may continue to receive hu14.18-IL2 fusion protein maintenance therapy QD on days 1-3 beginning with cycle 5. Maintenance cycles repeat every 28 days for up to 13 cycles in the absence of disease progression or unacceptable toxicity. The MTD/MAD of IT-hu14.18-IL2 following palliative RT in combination with nivolumab and ipilimumab will be determined starting 1 dose level below the Phase IC determined MTD/MAD of IT-hu14.18-IL2 up to the Phase IC determined MTD/MAD. A total of 28 participants will be enrolled at the Phase ID MTD/MAD of IT-hu14.18-IL2.
|
|---|---|---|---|---|
|
Phase 1A
Death
|
2
|
0
|
0
|
0
|
|
Phase IB
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
Baseline Characteristics
IT-hu14.18-IL2 With Radiation, Nivolumab and Ipilimumab for Melanoma
Baseline characteristics by cohort
| Measure |
Phase IA
n=4 Participants
As described above. Participants receive hu14.18-IL2 fusion protein intratumorally (IT).
|
Phase IB
n=4 Participants
As described above. Participants undergo palliative RT and hu14.18-IL2 fusion protein IT as in phase IA.
|
Phase IC
As described above. Participants undergo palliative RT, receive nivolumab, and hu14.18-IL2 fusion protein IT as in phase IA.
|
Phase ID
As described above. Participants undergo palliative RT, receive nivolumab in combination with ipilimumab, and hu14.18-IL2 fusion protein IT as in phase IA.
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
30 to 39 years
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=9 Participants
|
|
Age, Customized
40 to 49 years
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
|
Age, Customized
50 to 59 years
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=9 Participants
|
|
Age, Customized
60 to 69 years
|
1 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=9 Participants
|
|
Age, Customized
70 to 79 years
|
1 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=9 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
8 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
8 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=20 Participants
|
4 participants
n=20 Participants
|
—
|
—
|
8 participants
n=9 Participants
|
PRIMARY outcome
Timeframe: up to 2 yearsPopulation: Study was closed to enrollment early per Sponsor.
The number and severity of toxicity incidents per (Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 will be summarized with frequency and proportion. The 95% confidence interval for the proportion of subjects with severe complications (grade 3 or higher toxicities) will be constructed.
Outcome measures
| Measure |
Phase IC
Participants undergo palliative RT, receive nivolumab, and hu14.18-IL2 fusion protein IT as in phase IA. \[as described above\]
|
Phase ID
Participants undergo palliative RT, receive nivolumab in combination with ipilimumab, and hu14.18-IL2 fusion protein IT as in phase IA. \[as described above\]
|
Phase IA
n=1 events
Participants receive hu14.18-IL2 fusion protein intratumorally (IT) \[as described above\]
|
Phase IB
n=2 events
Participants undergo palliative RT and hu14.18-IL2 fusion protein IT as in phase IA. \[as described above\]
|
|---|---|---|---|---|
|
Incidence of Adverse Events
Grade 3
|
—
|
—
|
1 events
|
1 events
|
|
Incidence of Adverse Events
Grade 4
|
—
|
—
|
0 events
|
0 events
|
|
Incidence of Adverse Events
Grade 5
|
—
|
—
|
0 events
|
1 events
|
PRIMARY outcome
Timeframe: up to 21 daysPopulation: Study was closed to enrollment early per Sponsor (the company providing the investigational agent was sold to another company), Maximum Tolerated Dose was the Maximum Administered Dose, reported in another outcome.
The MTD is defined as the highest dose level at which less than 33% of the subjects experience a Dose Limiting Toxicity (DLT). DLT will be defined as grade 3 or 4 toxicity that is possibly, probably or definitely related to IT-hu14.18-IL2 graded according to CTCAE v. 5.0. A standard 3+3 design and descriptive statistics will primarily be generated to summarize the data.
Outcome measures
| Measure |
Phase IC
Participants undergo palliative RT, receive nivolumab, and hu14.18-IL2 fusion protein IT as in phase IA. \[as described above\]
|
Phase ID
Participants undergo palliative RT, receive nivolumab in combination with ipilimumab, and hu14.18-IL2 fusion protein IT as in phase IA. \[as described above\]
|
Phase IA
n=4 Participants
Participants receive hu14.18-IL2 fusion protein intratumorally (IT) \[as described above\]
|
Phase IB
n=4 Participants
Participants undergo palliative RT and hu14.18-IL2 fusion protein IT as in phase IA. \[as described above\]
|
|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD)
|
—
|
—
|
2 milligrams per meter squared
|
NA milligrams per meter squared
Maximum Tolerated Dose was not reached as study was closed early. Maximum Administered Dose is reported in another outcome.
|
PRIMARY outcome
Timeframe: up to 21 daysPopulation: Study was closed to enrollment early per Sponsor.
The MAD is defined as the highest safely tolerated dose where less than 33% subjects experience a DLT but no higher dose level has been assessed. Descriptive statistics will primarily be generated to summarize the data.
Outcome measures
| Measure |
Phase IC
Participants undergo palliative RT, receive nivolumab, and hu14.18-IL2 fusion protein IT as in phase IA. \[as described above\]
|
Phase ID
Participants undergo palliative RT, receive nivolumab in combination with ipilimumab, and hu14.18-IL2 fusion protein IT as in phase IA. \[as described above\]
|
Phase IA
n=4 Participants
Participants receive hu14.18-IL2 fusion protein intratumorally (IT) \[as described above\]
|
Phase IB
n=4 Participants
Participants undergo palliative RT and hu14.18-IL2 fusion protein IT as in phase IA. \[as described above\]
|
|---|---|---|---|---|
|
Maximum Administered Dose (MAD)
|
—
|
—
|
2 milligrams per meter squared
|
1 milligrams per meter squared
|
SECONDARY outcome
Timeframe: Up to 5 yearsOR will be summarized using descriptive statistics. Furthermore, a point estimate along with the 95% confidence interval for the proportion of subjects with OR will be provided. Clinical outcome of OR will be summarized by dose level for Phase IC.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsThe length of time from the start of treatment until disease progression or death. Kaplan-Meier method will be used to estimate the survival distribution of progression-free survival for the Phase ID expansion cohort.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsThe length of time from the start of treatment until death from any cause. Kaplan-Meier method will be used to estimate the survival distribution of overall survival for the Phase ID expansion cohort.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Planned to be collected for up to 5 years, study closed early and this data was collected for approximately 8 monthsPopulation: 1 participant in Phase IB withdrew from study and 1 started a new treatment before disease assessment, study closed early per sponsor and no participants were enrolled to Phase IC or Phase ID.
The status of achieving complete response, partial response or stable disease in response to treatment.
Outcome measures
| Measure |
Phase IC
Participants undergo palliative RT, receive nivolumab, and hu14.18-IL2 fusion protein IT as in phase IA. \[as described above\]
|
Phase ID
Participants undergo palliative RT, receive nivolumab in combination with ipilimumab, and hu14.18-IL2 fusion protein IT as in phase IA. \[as described above\]
|
Phase IA
n=4 Participants
Participants receive hu14.18-IL2 fusion protein intratumorally (IT) \[as described above\]
|
Phase IB
n=2 Participants
Participants undergo palliative RT and hu14.18-IL2 fusion protein IT as in phase IA. \[as described above\]
|
|---|---|---|---|---|
|
Clinical Benefit (CB)
first assessment date, up to 3 months · Disease Progression
|
—
|
—
|
3 Participants
|
1 Participants
|
|
Clinical Benefit (CB)
first assessment date, up to 3 months · Mixed Response - Concern for Recurrence
|
—
|
—
|
0 Participants
|
0 Participants
|
|
Clinical Benefit (CB)
second assessment date, up to 8 months · Complete Response
|
—
|
—
|
0 Participants
|
0 Participants
|
|
Clinical Benefit (CB)
second assessment date, up to 8 months · Stable Disease
|
—
|
—
|
0 Participants
|
0 Participants
|
|
Clinical Benefit (CB)
second assessment date, up to 8 months · Disease Progression
|
—
|
—
|
1 Participants
|
0 Participants
|
|
Clinical Benefit (CB)
second assessment date, up to 8 months · Mixed Response - Concern for Recurrence
|
—
|
—
|
0 Participants
|
1 Participants
|
|
Clinical Benefit (CB)
first assessment date, up to 3 months · Complete Response
|
—
|
—
|
0 Participants
|
0 Participants
|
|
Clinical Benefit (CB)
first assessment date, up to 3 months · Stable Disease
|
—
|
—
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 5 yearsThe length of time from documentation of tumor response until disease progression. Kaplan-Meier method will be used to estimate the survival distribution for the Phase ID expansion cohort.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Cycle 3 day 1, Cycle 5 day 1, End of Treatment (up to 13 cycles) (cycles 1-4 are 21 days, 5+ are 28 days)Immunologic activation induced in vivo by intratumoral (IT)-hu14.18-IL2 fusion protein will be evaluated using both in vivo and in vitro analyses. Changes between assessment time points will be evaluated using a paired t-test or non-parametric Wilcoxon signed rank test, depending on the scale and distribution of the endpoint.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Cycle 3 day 1, Cycle 5 day 1, End of Treatment (up to 13 cycles) (cycles 1-4 are 21 days, 5+ are 28 days)Immunologic activation induced in vivo by intratumoral (IT)-hu14.18-IL2 fusion protein will be evaluated using both in vivo and in vitro analyses. Changes between assessment time points will be evaluated using a paired t-test or non-parametric Wilcoxon signed rank test, depending on the scale and distribution of the endpoint.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline; Cycle 1 days 1,4,8; Cycle 4 days 1,4,8; Cycle 7 days 1,4,8; Cycle 10 day 1,4,8 (cycles 1-4 are 21 days, 5+ are 28 days)Immunologic activation induced in vivo by intratumoral (IT)-hu14.18-IL2 fusion protein will be evaluated using both in vivo and in vitro analyses. Changes between assessment time points will be evaluated using a paired t-test or non-parametric Wilcoxon signed rank test, depending on the scale and distribution of the endpoint.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Cycle 1, Cycle 2, Cycle 4 (cycles 1-4 are 21 days)For the primary parameters to be assessed on the resected melanoma an objective scoring system will be established by a pathologist, grading each specimen with a score of 0, +, ++, +++. Changes in number of Necrotic Tumor Cells from baseline will be evaluated using a paired McNemar's test for binary outcomes. Quantitative assessment of necrosis of tumor cells will be measured and scored with a value ranging from 0% - 100% of tumor area.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Cycle 1, Cycle 2, Cycle 4 (cycle length is 21 days)For the primary parameters to be assessed on the resected melanoma an objective scoring system will be established by a pathologist, grading each specimen with a score of 0, +, ++, +++.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Cycle 1, Cycle 2, Cycle 4 (cycle length is 21 days)For the primary parameters to be assessed on the resected melanoma an objective scoring system will be established by a pathologist, grading each specimen with a score of 0, +, ++, +++.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Cycle 1, Cycle 2, Cycle 4 (cycle length is 21 days)Cellular phenotype of infiltrate within the tumor will be summarized by descriptive statistics. Changes from baseline will be evaluated using a paired McNemar's test for binary outcomes.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Cycle 1, Cycle 2, Cycle 4 (cycle length is 21 days)Presence hu14.18-IL2 within the tumor will be summarized by descriptive statistics. Changes from baseline will be evaluated using a paired McNemar's test for binary outcomes.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At baseline, course 1 day 5, and day 5 of courses 2 & 4 (cycle length is 21 days)Pharmacokinetic assessments will be performed on multiple serum specimens for each subject. The analysis of all PK parameters will be performed using the PK analysis population. The distribution half-life called alpha half-life (t1/2 alpha) will be summarized by dose level with simple summary statistics.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At baseline, course 1 day 5, and day 5 of courses 2 & 4 (cycle length is 21 days)Pharmacokinetic assessments will be performed on multiple serum specimens for each subject. The analysis of all PK parameters will be performed using the PK analysis population. The elimination half-life called beta half-life (t1/2 beta) will be summarized by dose level with simple summary statistics.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At baseline, course 1 day 5, and day 5 of courses 2 & 4 (cycle length is 21 days)Pharmacokinetic assessments will be performed on multiple serum specimens for each subject. The analysis of all PK parameters will be performed using the PK analysis population. AUC will be summarized by dose level with simple summary statistics.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At baseline, course 1 day 5, and day 5 of courses 2 & 4 (cycle length is 21 days)Pharmacokinetic assessments will be performed on multiple serum specimens for each subject. The analysis of all PK parameters will be performed using the PK analysis population. Clearance will be summarized by dose level with simple summary statistics.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At baseline, course 1 day 5, and day 5 of courses 2 & 4 (cycle length is 21 days)Scatterplots will be used to explore possible associations between the dose and area under the curve (AUC). The Jonckheere-Terpstra trend test will be performed to determine the significance of the association between increasing dose level and AUC.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At baseline, course 1 day 5, and day 5 of courses 2 & 4 (cycle length is 21 days)Logistic regression analyses will be performed to correlate PK parameters with toxicity (grade \>= 3 vs. grade 0-2) and response.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 5 yearsClinical outcomes such as OR, duration of response, CB, PFS, and OS will be analyzed separately among subjects who were resistant to prior treatment with anti-CTLA-4 and/or anti-PD1/PD-L1 antibodies and those who lacked resistance in a subgroup analysis. This comparison is by necessity exploratory in nature and hypothesis generating.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 5 yearsClinical outcomes such as OR, duration of response, CB, PFS, and OS will be analyzed separately among subjects who were resistant to prior treatment with anti-CTLA-4 and/or anti-PD1/PD-L1 antibodies and those who lacked resistance in a subgroup analysis. This comparison is by necessity exploratory in nature and hypothesis generating.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 5 yearsClinical outcomes such as OR, duration of response, CB, PFS, and OS will be analyzed separately among subjects who were resistant to prior treatment with anti-CTLA-4 and/or anti-PD1/PD-L1 antibodies and those who lacked resistance in a subgroup analysis. This comparison is by necessity exploratory in nature and hypothesis generating.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 5 yearsClinical outcomes such as OR, duration of response, CB, PFS, and OS will be analyzed separately among subjects who were resistant to prior treatment with anti-CTLA-4 and/or anti-PD1/PD-L1 antibodies and those who lacked resistance in a subgroup analysis. This comparison is by necessity exploratory in nature and hypothesis generating.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 5 yearsClinical outcomes such as OR, duration of response, CB, PFS, and OS will be analyzed separately among subjects who were resistant to prior treatment with anti-CTLA-4 and/or anti-PD1/PD-L1 antibodies and those who lacked resistance in a subgroup analysis. This comparison is by necessity exploratory in nature and hypothesis generating.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 5 yearsClinical outcomes such as OR, duration of response, CB, PFS and OS and treatment associated selected biologic effects will be analyzed separately among patients who are GD2+ and those who are GD2- in a subgroup analysis. These outcome measures will be compared using two-sample t-test, log rank test and chi-square/Fisher's exact test between the two groups of patients who are GD2+ and who are GD2-.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 5 yearsClinical outcomes such as OR, duration of response, CB, PFS and OS and treatment associated selected biologic effects will be analyzed separately among patients who are GD2+ and those who are GD2- in a subgroup analysis. These outcome measures will be compared using two-sample t-test, log rank test and chi-square/Fisher's exact test between the two groups of patients who are GD2+ and who are GD2-.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 5 yearsClinical outcomes such as OR, duration of response, CB, PFS and OS and treatment associated selected biologic effects will be analyzed separately among patients who are GD2+ and those who are GD2- in a subgroup analysis. These outcome measures will be compared using two-sample t-test, log rank test and chi-square/Fisher's exact test between the two groups of patients who are GD2+ and who are GD2-.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 5 yearsClinical outcomes such as OR, duration of response, CB, PFS and OS and treatment associated selected biologic effects will be analyzed separately among patients who are GD2+ and those who are GD2- in a subgroup analysis. These outcome measures will be compared using two-sample t-test, log rank test and chi-square/Fisher's exact test between the two groups of patients who are GD2+ and who are GD2-.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 5 yearsClinical outcomes such as OR, duration of response, CB, PFS and OS and treatment associated selected biologic effects will be analyzed separately among patients who are GD2+ and those who are GD2- in a subgroup analysis. These outcome measures will be compared using two-sample t-test, log rank test and chi-square/Fisher's exact test between the two groups of patients who are GD2+ and who are GD2-.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 5 yearsPD-L1 expression level will be compared between baseline and after initiation of treatment using linear mixed effects model after suitable transformation of PD-L1 expression level. Clinical outcomes such as OR, duration of response, CB, PFS and OS and treatment associated selected biologic effects will be analyzed separately among patients who are PDL1+ and those who are PD-L1- in a subgroup analysis. In addition, these outcome measures will be compared using two-sample t-test, log rank test and chi-square/Fisher's exact test between the two groups of patients who are PD-L1+ and who are PD-L1-.
Outcome measures
Outcome data not reported
Adverse Events
Phase IA
Serious events: 1 serious events
Other events: 4 other events
Deaths: 2 deaths
Phase IB
Serious events: 2 serious events
Other events: 3 other events
Deaths: 3 deaths
Phase IC
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase ID
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase IA
n=4 participants at risk
As described above. Participants receive hu14.18-IL2 fusion protein intratumorally (IT).
|
Phase IB
n=4 participants at risk
As described above. Participants undergo palliative RT and hu14.18-IL2 fusion protein IT as in phase IA.
|
Phase IC
As described above. Participants undergo palliative RT, receive nivolumab, and hu14.18-IL2 fusion protein IT as in phase IA.
|
Phase ID
As described above. Participants undergo palliative RT, receive nivolumab in combination with ipilimumab, and hu14.18-IL2 fusion protein IT as in phase IA.
|
|---|---|---|---|---|
|
General disorders
Injection Site Reaction
|
25.0%
1/4 • Number of events 1 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
0.00%
0/4 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
25.0%
1/4 • Number of events 1 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
|
Hepatobiliary disorders
Disease Progression
|
0.00%
0/4 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
25.0%
1/4 • Number of events 1 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
Other adverse events
| Measure |
Phase IA
n=4 participants at risk
As described above. Participants receive hu14.18-IL2 fusion protein intratumorally (IT).
|
Phase IB
n=4 participants at risk
As described above. Participants undergo palliative RT and hu14.18-IL2 fusion protein IT as in phase IA.
|
Phase IC
As described above. Participants undergo palliative RT, receive nivolumab, and hu14.18-IL2 fusion protein IT as in phase IA.
|
Phase ID
As described above. Participants undergo palliative RT, receive nivolumab in combination with ipilimumab, and hu14.18-IL2 fusion protein IT as in phase IA.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
75.0%
3/4 • Number of events 12 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
75.0%
3/4 • Number of events 8 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
2/4 • Number of events 2 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
50.0%
2/4 • Number of events 4 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
1/4 • Number of events 1 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
25.0%
1/4 • Number of events 2 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
1/4 • Number of events 1 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
25.0%
1/4 • Number of events 1 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
|
Gastrointestinal disorders
Dyspepsia
|
25.0%
1/4 • Number of events 1 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
25.0%
1/4 • Number of events 2 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
|
Gastrointestinal disorders
Constipation
|
25.0%
1/4 • Number of events 1 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
0.00%
0/4 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
|
Gastrointestinal disorders
Oral pain
|
25.0%
1/4 • Number of events 3 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
0.00%
0/4 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
|
General disorders
Chills
|
100.0%
4/4 • Number of events 10 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
50.0%
2/4 • Number of events 3 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
|
General disorders
Fatigue
|
50.0%
2/4 • Number of events 3 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
75.0%
3/4 • Number of events 5 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
|
General disorders
Injection site reaction
|
75.0%
3/4 • Number of events 11 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
50.0%
2/4 • Number of events 2 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
|
General disorders
Fever
|
50.0%
2/4 • Number of events 4 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
25.0%
1/4 • Number of events 1 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
|
General disorders
Flu like symptoms
|
25.0%
1/4 • Number of events 2 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
25.0%
1/4 • Number of events 1 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
|
General disorders
Non-cardiac chest pain
|
50.0%
2/4 • Number of events 3 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
0.00%
0/4 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
|
General disorders
Pain
|
25.0%
1/4 • Number of events 1 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
25.0%
1/4 • Number of events 1 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
|
General disorders
Localized edema
|
25.0%
1/4 • Number of events 1 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
0.00%
0/4 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
|
Vascular disorders
Hypotension
|
75.0%
3/4 • Number of events 3 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
75.0%
3/4 • Number of events 7 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
|
Vascular disorders
Hot flashes
|
25.0%
1/4 • Number of events 5 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
25.0%
1/4 • Number of events 1 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
|
Vascular disorders
Hypertension
|
25.0%
1/4 • Number of events 1 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
25.0%
1/4 • Number of events 1 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
|
Investigations
Lymphocyte count decreased
|
100.0%
4/4 • Number of events 11 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
50.0%
2/4 • Number of events 5 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
|
Investigations
Aspartate aminotransferase increased
|
50.0%
2/4 • Number of events 4 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
50.0%
2/4 • Number of events 4 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
|
Investigations
Alanine aminotransferase increased
|
25.0%
1/4 • Number of events 3 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
50.0%
2/4 • Number of events 4 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
|
Investigations
Alkaline phosphatase increased
|
25.0%
1/4 • Number of events 1 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
50.0%
2/4 • Number of events 3 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
|
Investigations
White blood cell decreased
|
25.0%
1/4 • Number of events 1 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
25.0%
1/4 • Number of events 1 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
|
Investigations
Blood bicarbonate decreased
|
25.0%
1/4 • Number of events 1 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
0.00%
0/4 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/4 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
25.0%
1/4 • Number of events 1 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/4 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
25.0%
1/4 • Number of events 2 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
|
Investigations
Creatinine increased
|
25.0%
1/4 • Number of events 4 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
0.00%
0/4 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/4 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
25.0%
1/4 • Number of events 1 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
|
Investigations
Platelet count decreased
|
25.0%
1/4 • Number of events 3 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
0.00%
0/4 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
50.0%
2/4 • Number of events 5 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
50.0%
2/4 • Number of events 5 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
50.0%
2/4 • Number of events 2 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
50.0%
2/4 • Number of events 5 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
50.0%
2/4 • Number of events 2 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
50.0%
2/4 • Number of events 2 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
|
Metabolism and nutrition disorders
Anorexia
|
25.0%
1/4 • Number of events 1 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
50.0%
2/4 • Number of events 2 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
|
Metabolism and nutrition disorders
Dehydration
|
25.0%
1/4 • Number of events 2 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
0.00%
0/4 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/4 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
25.0%
1/4 • Number of events 3 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
25.0%
1/4 • Number of events 1 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
0.00%
0/4 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
2/4 • Number of events 4 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
50.0%
2/4 • Number of events 4 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
50.0%
2/4 • Number of events 2 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
50.0%
2/4 • Number of events 5 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
25.0%
1/4 • Number of events 1 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
0.00%
0/4 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
25.0%
1/4 • Number of events 1 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
0.00%
0/4 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
|
Nervous system disorders
Headache
|
50.0%
2/4 • Number of events 5 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
50.0%
2/4 • Number of events 3 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
25.0%
1/4 • Number of events 2 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
|
Nervous system disorders
Paresthesia
|
25.0%
1/4 • Number of events 1 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
0.00%
0/4 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
|
Cardiac disorders
Sinus tachycardia
|
25.0%
1/4 • Number of events 1 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
50.0%
2/4 • Number of events 2 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
|
Cardiac disorders
Sinus bradycardia
|
25.0%
1/4 • Number of events 1 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
0.00%
0/4 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
25.0%
1/4 • Number of events 1 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
25.0%
1/4 • Number of events 4 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/4 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
25.0%
1/4 • Number of events 1 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
25.0%
1/4 • Number of events 1 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
0.00%
0/4 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/4 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
25.0%
1/4 • Number of events 1 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
1/4 • Number of events 2 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
50.0%
2/4 • Number of events 2 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/4 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
25.0%
1/4 • Number of events 1 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/4 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
25.0%
1/4 • Number of events 1 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
|
Immune system disorders
Allergic reaction
|
50.0%
2/4 • Number of events 2 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
0.00%
0/4 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
50.0%
2/4 • Number of events 9 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
0.00%
0/4 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.0%
1/4 • Number of events 2 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
0.00%
0/4 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
25.0%
1/4 • Number of events 1 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
25.0%
1/4 • Number of events 1 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
|
Infections and infestations
Wound Infection
|
25.0%
1/4 • Number of events 1 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
0.00%
0/4 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
|
Psychiatric disorders
Confusion
|
25.0%
1/4 • Number of events 1 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
0.00%
0/4 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/4 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
25.0%
1/4 • Number of events 1 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/4 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
25.0%
1/4 • Number of events 1 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
—
0/0 • up to 2 years
Participants will be monitored for at least 90 days after completion of study treatment for late toxicities associated with any component of therapy (RT, IT-hu14.18-IL2, nivolumab, ipilimumab). Potential sub-acute and late toxicities due to palliate radiation therapy will be monitored for 12 months following the radiation therapy. Following the required monitoring periods all adverse events will be followed until they resolve to baseline or less than Grade 2, or are deemed irreversible.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place