Trial Outcomes & Findings for Rintatolimod, Celecoxib and Interferon Alpha 2b With Pembrolizumab For the Treatment of Patients With Metastatic or Unresectable Triple Negative Breast Cancer (NCT NCT05756166)
NCT ID: NCT05756166
Last Updated: 2026-08-31
Results Overview
The dose limiting toxicities will be summarized by cohort using frequencies and relative frequencies.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
5 participants
Primary outcome timeframe
Up to 13 months
Results posted on
2026-08-31
Participant Flow
Participant milestones
| Measure |
Cohort I (CKM, Pembrolizumab)
Patients receive rintatolimod IV, celecoxib PO, interferon alpha-2b IV on days 0, 1, and 2 of week 1 and days 7, 8, and 9 of week 2 on study. Patients receive pembrolizumab IV on day 9 and then every 3 weeks after that for up to 4 doses on study. Patients also undergo CT scan or MRI at screening and follow-up and undergo blood sample collection during screening and on study.
Biospecimen Collection: Undergo blood sample collection
Celecoxib: Given PO
Computed Tomography: Undergo CT scan
Interferon Alpha-2: Given IV
Magnetic Resonance Imaging: Undergo MRI
Pembrolizumab: Given IV
Rintatolimod: Given IV
|
Cohort II (CMK, Early Pembrolizumab)
Patients receive rintatolimod IV, celecoxib PO, and interferon alpha-2b IV on days 0, 1, and 2 of week 1 and days 7, 8, and 9 of week 2 on study. Patients receive pembrolizumab IV on day 2 of week 1 and then every 3 weeks beginning in week 4 on study. Patients also undergo CT scan or MRI at screening and follow-up, undergo blood sample collection during screening and on study, and may undergo tumor biopsy at screening and follow-up.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Celecoxib: Given PO
Computed Tomography: Undergo CT scan
Interferon Alpha-2: Given IV
Magnetic Resonance Imaging: Undergo MRI
Pembrolizumab: Given IV
Rintatolimod: Given IV
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
2
|
|
Overall Study
COMPLETED
|
3
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Rintatolimod, Celecoxib and Interferon Alpha 2b With Pembrolizumab For the Treatment of Patients With Metastatic or Unresectable Triple Negative Breast Cancer
Baseline characteristics by cohort
| Measure |
Cohort I (CKM, Pembrolizumab)
n=3 Participants
Patients receive rintatolimod IV, celecoxib PO, interferon alpha-2b IV on days 0, 1, and 2 of week 1 and days 7, 8, and 9 of week 2 on study. Patients receive pembrolizumab IV on day 9 and then every 3 weeks after that for up to 4 doses on study. Patients also undergo CT scan or MRI at screening and follow-up and undergo blood sample collection during screening and on study.
Biospecimen Collection: Undergo blood sample collection
Celecoxib: Given PO
Computed Tomography: Undergo CT scan
Interferon Alpha-2: Given IV
Magnetic Resonance Imaging: Undergo MRI
Pembrolizumab: Given IV
Rintatolimod: Given IV
|
Cohort II (CMK, Early Pembrolizumab)
n=2 Participants
Patients receive rintatolimod IV, celecoxib PO, and interferon alpha-2b IV on days 0, 1, and 2 of week 1 and days 7, 8, and 9 of week 2 on study. Patients receive pembrolizumab IV on day 2 of week 1 and then every 3 weeks beginning in week 4 on study. Patients also undergo CT scan or MRI at screening and follow-up, undergo blood sample collection during screening and on study, and may undergo tumor biopsy at screening and follow-up.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Celecoxib: Given PO
Computed Tomography: Undergo CT scan
Interferon Alpha-2: Given IV
Magnetic Resonance Imaging: Undergo MRI
Pembrolizumab: Given IV
Rintatolimod: Given IV
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=14 Participants
|
2 Participants
n=36 Participants
|
4 Participants
n=324 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=324 Participants
|
|
Age, Continuous
|
56.5 years
STANDARD_DEVIATION 11.5 • n=14 Participants
|
48.8 years
STANDARD_DEVIATION 7.6 • n=36 Participants
|
53.4 years
STANDARD_DEVIATION 9.9 • n=324 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=14 Participants
|
2 Participants
n=36 Participants
|
5 Participants
n=324 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=14 Participants
|
1 Participants
n=36 Participants
|
1 Participants
n=324 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=14 Participants
|
1 Participants
n=36 Participants
|
4 Participants
n=324 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=14 Participants
|
2 participants
n=36 Participants
|
5 participants
n=324 Participants
|
PRIMARY outcome
Timeframe: Up to 13 monthsPopulation: All treated and eligible patients
The dose limiting toxicities will be summarized by cohort using frequencies and relative frequencies.
Outcome measures
| Measure |
Cohort I (CKM, Pembrolizumab)
n=3 Participants
Patients receive rintatolimod IV, celecoxib PO, interferon alpha-2b IV on days 0, 1, and 2 of week 1 and days 7, 8, and 9 of week 2 on study. Patients receive pembrolizumab IV on day 9 and then every 3 weeks after that for up to 4 doses on study. Patients also undergo CT scan or MRI at screening and follow-up and undergo blood sample collection during screening and on study.
Biospecimen Collection: Undergo blood sample collection
Celecoxib: Given PO
Computed Tomography: Undergo CT scan
Interferon Alpha-2: Given IV
Magnetic Resonance Imaging: Undergo MRI
Pembrolizumab: Given IV
Rintatolimod: Given IV
|
Cohort II (CMK, Early Pembrolizumab)
n=2 Participants
Patients receive rintatolimod IV, celecoxib PO, and interferon alpha-2b IV on days 0, 1, and 2 of week 1 and days 7, 8, and 9 of week 2 on study. Patients receive pembrolizumab IV on day 2 of week 1 and then every 3 weeks beginning in week 4 on study. Patients also undergo CT scan or MRI at screening and follow-up, undergo blood sample collection during screening and on study, and may undergo tumor biopsy at screening and follow-up.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Celecoxib: Given PO
Computed Tomography: Undergo CT scan
Interferon Alpha-2: Given IV
Magnetic Resonance Imaging: Undergo MRI
Pembrolizumab: Given IV
Rintatolimod: Given IV
|
|---|---|---|
|
Incidence of Dose Limiting Toxicities
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From the start of post-chemokine modulation (CKM) therapy therapy until disease progression, death, or lst follow-up, assessed up to 13 monthsPopulation: All treated and eligible patients
Will be summarized using standard Kaplan-Meier methods, with estimates of the median survival obtained with 90% confidence intervals.
Outcome measures
| Measure |
Cohort I (CKM, Pembrolizumab)
n=3 Participants
Patients receive rintatolimod IV, celecoxib PO, interferon alpha-2b IV on days 0, 1, and 2 of week 1 and days 7, 8, and 9 of week 2 on study. Patients receive pembrolizumab IV on day 9 and then every 3 weeks after that for up to 4 doses on study. Patients also undergo CT scan or MRI at screening and follow-up and undergo blood sample collection during screening and on study.
Biospecimen Collection: Undergo blood sample collection
Celecoxib: Given PO
Computed Tomography: Undergo CT scan
Interferon Alpha-2: Given IV
Magnetic Resonance Imaging: Undergo MRI
Pembrolizumab: Given IV
Rintatolimod: Given IV
|
Cohort II (CMK, Early Pembrolizumab)
n=2 Participants
Patients receive rintatolimod IV, celecoxib PO, and interferon alpha-2b IV on days 0, 1, and 2 of week 1 and days 7, 8, and 9 of week 2 on study. Patients receive pembrolizumab IV on day 2 of week 1 and then every 3 weeks beginning in week 4 on study. Patients also undergo CT scan or MRI at screening and follow-up, undergo blood sample collection during screening and on study, and may undergo tumor biopsy at screening and follow-up.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Celecoxib: Given PO
Computed Tomography: Undergo CT scan
Interferon Alpha-2: Given IV
Magnetic Resonance Imaging: Undergo MRI
Pembrolizumab: Given IV
Rintatolimod: Given IV
|
|---|---|---|
|
Median Progression-free Survival
|
2.3 months
Interval 1.2 to 2.5
|
1.3 months
Interval 0.5 to 2.1
|
SECONDARY outcome
Timeframe: From the start of study treatment until end of treatment or disease progression/recurrence, assessed up to 13 monthsPopulation: All treated and eligible patients
Evaluated using Immune Modulated Response Evaluation Criteria in Solid Tumors. Will be summarized using frequencies and relative frequencies, and obtained with 90% confidence intervals.
Outcome measures
| Measure |
Cohort I (CKM, Pembrolizumab)
n=3 Participants
Patients receive rintatolimod IV, celecoxib PO, interferon alpha-2b IV on days 0, 1, and 2 of week 1 and days 7, 8, and 9 of week 2 on study. Patients receive pembrolizumab IV on day 9 and then every 3 weeks after that for up to 4 doses on study. Patients also undergo CT scan or MRI at screening and follow-up and undergo blood sample collection during screening and on study.
Biospecimen Collection: Undergo blood sample collection
Celecoxib: Given PO
Computed Tomography: Undergo CT scan
Interferon Alpha-2: Given IV
Magnetic Resonance Imaging: Undergo MRI
Pembrolizumab: Given IV
Rintatolimod: Given IV
|
Cohort II (CMK, Early Pembrolizumab)
n=2 Participants
Patients receive rintatolimod IV, celecoxib PO, and interferon alpha-2b IV on days 0, 1, and 2 of week 1 and days 7, 8, and 9 of week 2 on study. Patients receive pembrolizumab IV on day 2 of week 1 and then every 3 weeks beginning in week 4 on study. Patients also undergo CT scan or MRI at screening and follow-up, undergo blood sample collection during screening and on study, and may undergo tumor biopsy at screening and follow-up.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Celecoxib: Given PO
Computed Tomography: Undergo CT scan
Interferon Alpha-2: Given IV
Magnetic Resonance Imaging: Undergo MRI
Pembrolizumab: Given IV
Rintatolimod: Given IV
|
|---|---|---|
|
Overall Response Rate
|
0 percentage of participants with response
Interval 0.0 to 0.44
|
0 percentage of participants with response
Interval 0.0 to 0.57
|
SECONDARY outcome
Timeframe: From the start of post-CKM therapy until death due to any cause or last follow up, assessed up to 13 monthsPopulation: All treated and eligible patients
Will be summarized using standard Kaplan-Meier methods, with estimates of the median survival obtained with 90% confidence intervals.
Outcome measures
| Measure |
Cohort I (CKM, Pembrolizumab)
n=3 Participants
Patients receive rintatolimod IV, celecoxib PO, interferon alpha-2b IV on days 0, 1, and 2 of week 1 and days 7, 8, and 9 of week 2 on study. Patients receive pembrolizumab IV on day 9 and then every 3 weeks after that for up to 4 doses on study. Patients also undergo CT scan or MRI at screening and follow-up and undergo blood sample collection during screening and on study.
Biospecimen Collection: Undergo blood sample collection
Celecoxib: Given PO
Computed Tomography: Undergo CT scan
Interferon Alpha-2: Given IV
Magnetic Resonance Imaging: Undergo MRI
Pembrolizumab: Given IV
Rintatolimod: Given IV
|
Cohort II (CMK, Early Pembrolizumab)
n=2 Participants
Patients receive rintatolimod IV, celecoxib PO, and interferon alpha-2b IV on days 0, 1, and 2 of week 1 and days 7, 8, and 9 of week 2 on study. Patients receive pembrolizumab IV on day 2 of week 1 and then every 3 weeks beginning in week 4 on study. Patients also undergo CT scan or MRI at screening and follow-up, undergo blood sample collection during screening and on study, and may undergo tumor biopsy at screening and follow-up.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Celecoxib: Given PO
Computed Tomography: Undergo CT scan
Interferon Alpha-2: Given IV
Magnetic Resonance Imaging: Undergo MRI
Pembrolizumab: Given IV
Rintatolimod: Given IV
|
|---|---|---|
|
Overall Survival
|
10.2 months
Interval 6.6 to 17.2
|
8.7 months
Interval 1.0 to 16.4
|
SECONDARY outcome
Timeframe: Up to 13 monthsPopulation: All treated and eligible patients
Will be summarized using frequencies and relative frequencies and obtained with 90% confidence intervals.
Outcome measures
| Measure |
Cohort I (CKM, Pembrolizumab)
n=3 Participants
Patients receive rintatolimod IV, celecoxib PO, interferon alpha-2b IV on days 0, 1, and 2 of week 1 and days 7, 8, and 9 of week 2 on study. Patients receive pembrolizumab IV on day 9 and then every 3 weeks after that for up to 4 doses on study. Patients also undergo CT scan or MRI at screening and follow-up and undergo blood sample collection during screening and on study.
Biospecimen Collection: Undergo blood sample collection
Celecoxib: Given PO
Computed Tomography: Undergo CT scan
Interferon Alpha-2: Given IV
Magnetic Resonance Imaging: Undergo MRI
Pembrolizumab: Given IV
Rintatolimod: Given IV
|
Cohort II (CMK, Early Pembrolizumab)
n=2 Participants
Patients receive rintatolimod IV, celecoxib PO, and interferon alpha-2b IV on days 0, 1, and 2 of week 1 and days 7, 8, and 9 of week 2 on study. Patients receive pembrolizumab IV on day 2 of week 1 and then every 3 weeks beginning in week 4 on study. Patients also undergo CT scan or MRI at screening and follow-up, undergo blood sample collection during screening and on study, and may undergo tumor biopsy at screening and follow-up.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Celecoxib: Given PO
Computed Tomography: Undergo CT scan
Interferon Alpha-2: Given IV
Magnetic Resonance Imaging: Undergo MRI
Pembrolizumab: Given IV
Rintatolimod: Given IV
|
|---|---|---|
|
Disease Control Rate
|
0 percentage of participants
Interval 0.0 to 0.44
|
0 percentage of participants
Interval 0.0 to 0.57
|
Adverse Events
Cohort I (CKM, Pembrolizumab)
Serious events: 2 serious events
Other events: 3 other events
Deaths: 3 deaths
Cohort II (CMK, Early Pembrolizumab)
Serious events: 1 serious events
Other events: 2 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Cohort I (CKM, Pembrolizumab)
n=3 participants at risk
Patients receive rintatolimod IV, celecoxib PO, interferon alpha-2b IV on days 0, 1, and 2 of week 1 and days 7, 8, and 9 of week 2 on study. Patients receive pembrolizumab IV on day 9 and then every 3 weeks after that for up to 4 doses on study. Patients also undergo CT scan or MRI at screening and follow-up and undergo blood sample collection during screening and on study.
Biospecimen Collection: Undergo blood sample collection
Celecoxib: Given PO
Computed Tomography: Undergo CT scan
Interferon Alpha-2: Given IV
Magnetic Resonance Imaging: Undergo MRI
Pembrolizumab: Given IV
Rintatolimod: Given IV
|
Cohort II (CMK, Early Pembrolizumab)
n=2 participants at risk
Patients receive rintatolimod IV, celecoxib PO, and interferon alpha-2b IV on days 0, 1, and 2 of week 1 and days 7, 8, and 9 of week 2 on study. Patients receive pembrolizumab IV on day 2 of week 1 and then every 3 weeks beginning in week 4 on study. Patients also undergo CT scan or MRI at screening and follow-up, undergo blood sample collection during screening and on study, and may undergo tumor biopsy at screening and follow-up.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Celecoxib: Given PO
Computed Tomography: Undergo CT scan
Interferon Alpha-2: Given IV
Magnetic Resonance Imaging: Undergo MRI
Pembrolizumab: Given IV
Rintatolimod: Given IV
|
|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
33.3%
1/3 • Number of events 1 • Baseline, monthly up to 13 months.
|
0.00%
0/2 • Baseline, monthly up to 13 months.
|
|
Infections and infestations
Lung infection
|
33.3%
1/3 • Number of events 1 • Baseline, monthly up to 13 months.
|
0.00%
0/2 • Baseline, monthly up to 13 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
1/3 • Number of events 1 • Baseline, monthly up to 13 months.
|
0.00%
0/2 • Baseline, monthly up to 13 months.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/3 • Baseline, monthly up to 13 months.
|
50.0%
1/2 • Number of events 1 • Baseline, monthly up to 13 months.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/3 • Baseline, monthly up to 13 months.
|
50.0%
1/2 • Number of events 1 • Baseline, monthly up to 13 months.
|
|
Endocrine disorders
Hypothyroidism
|
33.3%
1/3 • Number of events 1 • Baseline, monthly up to 13 months.
|
0.00%
0/2 • Baseline, monthly up to 13 months.
|
Other adverse events
| Measure |
Cohort I (CKM, Pembrolizumab)
n=3 participants at risk
Patients receive rintatolimod IV, celecoxib PO, interferon alpha-2b IV on days 0, 1, and 2 of week 1 and days 7, 8, and 9 of week 2 on study. Patients receive pembrolizumab IV on day 9 and then every 3 weeks after that for up to 4 doses on study. Patients also undergo CT scan or MRI at screening and follow-up and undergo blood sample collection during screening and on study.
Biospecimen Collection: Undergo blood sample collection
Celecoxib: Given PO
Computed Tomography: Undergo CT scan
Interferon Alpha-2: Given IV
Magnetic Resonance Imaging: Undergo MRI
Pembrolizumab: Given IV
Rintatolimod: Given IV
|
Cohort II (CMK, Early Pembrolizumab)
n=2 participants at risk
Patients receive rintatolimod IV, celecoxib PO, and interferon alpha-2b IV on days 0, 1, and 2 of week 1 and days 7, 8, and 9 of week 2 on study. Patients receive pembrolizumab IV on day 2 of week 1 and then every 3 weeks beginning in week 4 on study. Patients also undergo CT scan or MRI at screening and follow-up, undergo blood sample collection during screening and on study, and may undergo tumor biopsy at screening and follow-up.
Biopsy: Undergo tumor biopsy
Biospecimen Collection: Undergo blood sample collection
Celecoxib: Given PO
Computed Tomography: Undergo CT scan
Interferon Alpha-2: Given IV
Magnetic Resonance Imaging: Undergo MRI
Pembrolizumab: Given IV
Rintatolimod: Given IV
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
66.7%
2/3 • Number of events 3 • Baseline, monthly up to 13 months.
|
50.0%
1/2 • Number of events 1 • Baseline, monthly up to 13 months.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • Baseline, monthly up to 13 months.
|
50.0%
1/2 • Number of events 1 • Baseline, monthly up to 13 months.
|
|
Gastrointestinal disorders
Dyspepsia
|
33.3%
1/3 • Number of events 2 • Baseline, monthly up to 13 months.
|
0.00%
0/2 • Baseline, monthly up to 13 months.
|
|
Gastrointestinal disorders
Mucositis oral
|
33.3%
1/3 • Number of events 1 • Baseline, monthly up to 13 months.
|
0.00%
0/2 • Baseline, monthly up to 13 months.
|
|
Gastrointestinal disorders
Nausea
|
100.0%
3/3 • Number of events 8 • Baseline, monthly up to 13 months.
|
0.00%
0/2 • Baseline, monthly up to 13 months.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • Number of events 4 • Baseline, monthly up to 13 months.
|
0.00%
0/2 • Baseline, monthly up to 13 months.
|
|
General disorders
Chills
|
33.3%
1/3 • Number of events 1 • Baseline, monthly up to 13 months.
|
50.0%
1/2 • Number of events 1 • Baseline, monthly up to 13 months.
|
|
General disorders
Fatigue
|
66.7%
2/3 • Number of events 4 • Baseline, monthly up to 13 months.
|
50.0%
1/2 • Number of events 1 • Baseline, monthly up to 13 months.
|
|
General disorders
Fever
|
33.3%
1/3 • Number of events 1 • Baseline, monthly up to 13 months.
|
100.0%
2/2 • Number of events 2 • Baseline, monthly up to 13 months.
|
|
Nervous system disorders
Paresthesia
|
33.3%
1/3 • Number of events 1 • Baseline, monthly up to 13 months.
|
100.0%
2/2 • Number of events 2 • Baseline, monthly up to 13 months.
|
|
Vascular disorders
Hypertension
|
66.7%
2/3 • Number of events 7 • Baseline, monthly up to 13 months.
|
0.00%
0/2 • Baseline, monthly up to 13 months.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
66.7%
2/3 • Number of events 2 • Baseline, monthly up to 13 months.
|
0.00%
0/2 • Baseline, monthly up to 13 months.
|
|
Nervous system disorders
Tremor
|
33.3%
1/3 • Number of events 1 • Baseline, monthly up to 13 months.
|
0.00%
0/2 • Baseline, monthly up to 13 months.
|
|
Psychiatric disorders
Anxiety
|
33.3%
1/3 • Number of events 1 • Baseline, monthly up to 13 months.
|
0.00%
0/2 • Baseline, monthly up to 13 months.
|
|
Vascular disorders
Lymphedema
|
33.3%
1/3 • Number of events 1 • Baseline, monthly up to 13 months.
|
0.00%
0/2 • Baseline, monthly up to 13 months.
|
|
Reproductive system and breast disorders
Breast pain
|
33.3%
1/3 • Number of events 1 • Baseline, monthly up to 13 months.
|
0.00%
0/2 • Baseline, monthly up to 13 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
33.3%
1/3 • Number of events 1 • Baseline, monthly up to 13 months.
|
0.00%
0/2 • Baseline, monthly up to 13 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
33.3%
1/3 • Number of events 1 • Baseline, monthly up to 13 months.
|
0.00%
0/2 • Baseline, monthly up to 13 months.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
33.3%
1/3 • Number of events 1 • Baseline, monthly up to 13 months.
|
0.00%
0/2 • Baseline, monthly up to 13 months.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
0.00%
0/3 • Baseline, monthly up to 13 months.
|
50.0%
1/2 • Number of events 1 • Baseline, monthly up to 13 months.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
33.3%
1/3 • Number of events 1 • Baseline, monthly up to 13 months.
|
50.0%
1/2 • Number of events 1 • Baseline, monthly up to 13 months.
|
|
Skin and subcutaneous tissue disorders
Bullous dermatitis
|
33.3%
1/3 • Number of events 1 • Baseline, monthly up to 13 months.
|
0.00%
0/2 • Baseline, monthly up to 13 months.
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
33.3%
1/3 • Number of events 1 • Baseline, monthly up to 13 months.
|
0.00%
0/2 • Baseline, monthly up to 13 months.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
66.7%
2/3 • Number of events 4 • Baseline, monthly up to 13 months.
|
0.00%
0/2 • Baseline, monthly up to 13 months.
|
|
General disorders
Infusion site extravasation
|
33.3%
1/3 • Number of events 1 • Baseline, monthly up to 13 months.
|
0.00%
0/2 • Baseline, monthly up to 13 months.
|
|
General disorders
Localized edema
|
33.3%
1/3 • Number of events 1 • Baseline, monthly up to 13 months.
|
0.00%
0/2 • Baseline, monthly up to 13 months.
|
|
General disorders
Malaise
|
33.3%
1/3 • Number of events 1 • Baseline, monthly up to 13 months.
|
0.00%
0/2 • Baseline, monthly up to 13 months.
|
|
General disorders
Non-cardiac chest pain
|
66.7%
2/3 • Number of events 4 • Baseline, monthly up to 13 months.
|
0.00%
0/2 • Baseline, monthly up to 13 months.
|
|
General disorders
Pain
|
66.7%
2/3 • Number of events 2 • Baseline, monthly up to 13 months.
|
50.0%
1/2 • Number of events 1 • Baseline, monthly up to 13 months.
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
33.3%
1/3 • Number of events 1 • Baseline, monthly up to 13 months.
|
0.00%
0/2 • Baseline, monthly up to 13 months.
|
|
Infections and infestations
Skin infection
|
33.3%
1/3 • Number of events 1 • Baseline, monthly up to 13 months.
|
0.00%
0/2 • Baseline, monthly up to 13 months.
|
|
Infections and infestations
Thrush
|
33.3%
1/3 • Number of events 1 • Baseline, monthly up to 13 months.
|
0.00%
0/2 • Baseline, monthly up to 13 months.
|
|
Injury, poisoning and procedural complications
Bruising
|
33.3%
1/3 • Number of events 1 • Baseline, monthly up to 13 months.
|
0.00%
0/2 • Baseline, monthly up to 13 months.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3 • Baseline, monthly up to 13 months.
|
100.0%
2/2 • Number of events 2 • Baseline, monthly up to 13 months.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • Baseline, monthly up to 13 months.
|
50.0%
1/2 • Number of events 1 • Baseline, monthly up to 13 months.
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • Baseline, monthly up to 13 months.
|
50.0%
1/2 • Number of events 1 • Baseline, monthly up to 13 months.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/3 • Baseline, monthly up to 13 months.
|
50.0%
1/2 • Number of events 1 • Baseline, monthly up to 13 months.
|
|
Vascular disorders
Hot flashes
|
33.3%
1/3 • Number of events 1 • Baseline, monthly up to 13 months.
|
0.00%
0/2 • Baseline, monthly up to 13 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
1/3 • Number of events 2 • Baseline, monthly up to 13 months.
|
0.00%
0/2 • Baseline, monthly up to 13 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
0.00%
0/3 • Baseline, monthly up to 13 months.
|
50.0%
1/2 • Number of events 1 • Baseline, monthly up to 13 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
33.3%
1/3 • Number of events 1 • Baseline, monthly up to 13 months.
|
50.0%
1/2 • Number of events 3 • Baseline, monthly up to 13 months.
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other, specify
|
33.3%
1/3 • Number of events 1 • Baseline, monthly up to 13 months.
|
0.00%
0/2 • Baseline, monthly up to 13 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • Number of events 1 • Baseline, monthly up to 13 months.
|
0.00%
0/2 • Baseline, monthly up to 13 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
33.3%
1/3 • Number of events 1 • Baseline, monthly up to 13 months.
|
0.00%
0/2 • Baseline, monthly up to 13 months.
|
|
Nervous system disorders
Dizziness
|
33.3%
1/3 • Number of events 1 • Baseline, monthly up to 13 months.
|
0.00%
0/2 • Baseline, monthly up to 13 months.
|
|
Nervous system disorders
Dysgeusia
|
33.3%
1/3 • Number of events 1 • Baseline, monthly up to 13 months.
|
0.00%
0/2 • Baseline, monthly up to 13 months.
|
|
Nervous system disorders
Headache
|
66.7%
2/3 • Number of events 2 • Baseline, monthly up to 13 months.
|
0.00%
0/2 • Baseline, monthly up to 13 months.
|
|
Eye disorders
Eye disorders - Other, specify
|
33.3%
1/3 • Number of events 1 • Baseline, monthly up to 13 months.
|
0.00%
0/2 • Baseline, monthly up to 13 months.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Number of events 1 • Baseline, monthly up to 13 months.
|
50.0%
1/2 • Number of events 1 • Baseline, monthly up to 13 months.
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
33.3%
1/3 • Number of events 1 • Baseline, monthly up to 13 months.
|
0.00%
0/2 • Baseline, monthly up to 13 months.
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify
|
33.3%
1/3 • Number of events 1 • Baseline, monthly up to 13 months.
|
0.00%
0/2 • Baseline, monthly up to 13 months.
|
|
Endocrine disorders
Hypothyroidism
|
33.3%
1/3 • Number of events 1 • Baseline, monthly up to 13 months.
|
0.00%
0/2 • Baseline, monthly up to 13 months.
|
Additional Information
Senior Administrator, Compliance - Clinical Research Services
Roswell Park Comprehensive Cancer Center
Phone: Ellis Levine
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place