Trial Outcomes & Findings for Optune Device - TT Field Plus Nivolumab and Ipilimumab for Melanoma With Brain Metastasis (NCT NCT03903640)
NCT ID: NCT03903640
Last Updated: 2022-06-07
Results Overview
* The PFS time will be calculated as the duration of time from the date of first dose of study treatment to the date of earliest intracranial progression or death, whichever occurs first. * Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
2 participants
Primary outcome timeframe
At 6 months (up to 184 days)
Results posted on
2022-06-07
Participant Flow
The study opened to enrollment on 07/01/2019 and closed to enrollment on 03/09/2022.
Participant milestones
| Measure |
Optune + Ipilimumab + Nivolumab
* Ipilimumab at 3 mg/kg IV over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.
* Nivolumab at 1 mg/kg IV over 30 minutes on Day 1 of each 21-day cycle for 4 cycles, then at 240 mg IV over 30 minutes on Days 1 and 15 of each 28-day cycle for up to 20 doses
* Within 2 weeks of the start of ipilimumab (before or after), treatment with Optune will begin. All patients will be required to shave their heads to initiate array placement and Optune therapy.
* Treatment may continue for up to 1 year
|
|---|---|
|
Overall Study
STARTED
|
2
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Optune Device - TT Field Plus Nivolumab and Ipilimumab for Melanoma With Brain Metastasis
Baseline characteristics by cohort
| Measure |
Optune + Ipilimumab + Nivolumab
n=2 Participants
* Ipilimumab at 3 mg/kg IV over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.
* Nivolumab at 1 mg/kg IV over 30 minutes on Day 1 of each 21-day cycle for 4 cycles, then at 240 mg IV over 30 minutes on Days 1 and 15 of each 28-day cycle for up to 20 doses
* Within 2 weeks of the start of ipilimumab (before or after), treatment with Optune will begin. All patients will be required to shave their heads to initiate array placement and Optune therapy.
* Treatment may continue for up to 1 year
|
|---|---|
|
Age, Continuous
|
59 years
n=39 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: At 6 months (up to 184 days)* The PFS time will be calculated as the duration of time from the date of first dose of study treatment to the date of earliest intracranial progression or death, whichever occurs first. * Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).
Outcome measures
| Measure |
Optune + Ipilimumab + Nivolumab
n=2 Participants
* Ipilimumab at 3 mg/kg IV over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.
* Nivolumab at 1 mg/kg IV over 30 minutes on Day 1 of each 21-day cycle for 4 cycles, then at 240 mg IV over 30 minutes on Days 1 and 15 of each 28-day cycle for up to 20 doses
* Within 2 weeks of the start of ipilimumab (before or after), treatment with Optune will begin. All patients will be required to shave their heads to initiate array placement and Optune therapy.
* Treatment may continue for up to 1 year
|
|---|---|
|
Intracranial Progression-free Survival
|
99.5 days
Interval 15.0 to 184.0
|
SECONDARY outcome
Timeframe: At 6 months (up to 184 days)-Defined as the duration of time from the date of first dose of study treatment to death from any cause.
Outcome measures
| Measure |
Optune + Ipilimumab + Nivolumab
n=2 Participants
* Ipilimumab at 3 mg/kg IV over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.
* Nivolumab at 1 mg/kg IV over 30 minutes on Day 1 of each 21-day cycle for 4 cycles, then at 240 mg IV over 30 minutes on Days 1 and 15 of each 28-day cycle for up to 20 doses
* Within 2 weeks of the start of ipilimumab (before or after), treatment with Optune will begin. All patients will be required to shave their heads to initiate array placement and Optune therapy.
* Treatment may continue for up to 1 year
|
|---|---|
|
Overall Survival
|
104.5 days
Interval 25.0 to 184.0
|
SECONDARY outcome
Timeframe: Until disease progression or death whichever comes first (median follow-up 53 days (full range 15-91 days))* Defined as the percentage of patients with a confirmed intracranial complete or partial response * Using modified RANO criteria
Outcome measures
| Measure |
Optune + Ipilimumab + Nivolumab
n=2 Participants
* Ipilimumab at 3 mg/kg IV over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.
* Nivolumab at 1 mg/kg IV over 30 minutes on Day 1 of each 21-day cycle for 4 cycles, then at 240 mg IV over 30 minutes on Days 1 and 15 of each 28-day cycle for up to 20 doses
* Within 2 weeks of the start of ipilimumab (before or after), treatment with Optune will begin. All patients will be required to shave their heads to initiate array placement and Optune therapy.
* Treatment may continue for up to 1 year
|
|---|---|
|
Best Intracranial Response Rate
|
0 Participants
|
SECONDARY outcome
Timeframe: Until disease progression or death whichever comes first (median follow-up 53 days (full range 15-91 days))* Defined as the percentage of patients with a confirmed extracranial complete or partial response * Using modified RANO criteria
Outcome measures
| Measure |
Optune + Ipilimumab + Nivolumab
n=2 Participants
* Ipilimumab at 3 mg/kg IV over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.
* Nivolumab at 1 mg/kg IV over 30 minutes on Day 1 of each 21-day cycle for 4 cycles, then at 240 mg IV over 30 minutes on Days 1 and 15 of each 28-day cycle for up to 20 doses
* Within 2 weeks of the start of ipilimumab (before or after), treatment with Optune will begin. All patients will be required to shave their heads to initiate array placement and Optune therapy.
* Treatment may continue for up to 1 year
|
|---|---|
|
Best Extracranial Response Rate
|
0 Participants
|
SECONDARY outcome
Timeframe: At 6 months* Defined as the duration of time from the date of first dose of study treatment to the date of earliest extracranial progression or death, whichever occurs first. Patients who neither progress nor die by the data cutoff date will be censored at the last follow up. * Using modified RANO criteria
Outcome measures
| Measure |
Optune + Ipilimumab + Nivolumab
n=2 Participants
* Ipilimumab at 3 mg/kg IV over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.
* Nivolumab at 1 mg/kg IV over 30 minutes on Day 1 of each 21-day cycle for 4 cycles, then at 240 mg IV over 30 minutes on Days 1 and 15 of each 28-day cycle for up to 20 doses
* Within 2 weeks of the start of ipilimumab (before or after), treatment with Optune will begin. All patients will be required to shave their heads to initiate array placement and Optune therapy.
* Treatment may continue for up to 1 year
|
|---|---|
|
Extracranial Progression-free Survival
|
58 days
Interval 25.0 to 91.0
|
SECONDARY outcome
Timeframe: Through 100 days after completion of treatment (median follow-up 107.5 days, full range (25 days-190 days)-The descriptions and grading scales found in CTCAE version 5.0.
Outcome measures
| Measure |
Optune + Ipilimumab + Nivolumab
n=2 Participants
* Ipilimumab at 3 mg/kg IV over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.
* Nivolumab at 1 mg/kg IV over 30 minutes on Day 1 of each 21-day cycle for 4 cycles, then at 240 mg IV over 30 minutes on Days 1 and 15 of each 28-day cycle for up to 20 doses
* Within 2 weeks of the start of ipilimumab (before or after), treatment with Optune will begin. All patients will be required to shave their heads to initiate array placement and Optune therapy.
* Treatment may continue for up to 1 year
|
|---|---|
|
Safety of the Treatment Regimen as Measured by Number of Participants With Treatment-related Grade 3 or Greater Adverse Events
|
0 Participants
|
SECONDARY outcome
Timeframe: Through 100 days after completion of treatment (median follow-up 107.5 days, full range (25 days-190 days)-The descriptions and grading scales found in CTCAE version 5.0.
Outcome measures
| Measure |
Optune + Ipilimumab + Nivolumab
n=2 Participants
* Ipilimumab at 3 mg/kg IV over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.
* Nivolumab at 1 mg/kg IV over 30 minutes on Day 1 of each 21-day cycle for 4 cycles, then at 240 mg IV over 30 minutes on Days 1 and 15 of each 28-day cycle for up to 20 doses
* Within 2 weeks of the start of ipilimumab (before or after), treatment with Optune will begin. All patients will be required to shave their heads to initiate array placement and Optune therapy.
* Treatment may continue for up to 1 year
|
|---|---|
|
Safety of the Treatment Regimen as Measured by Number of Participants With Discontinuations Due to Treatment Related Adverse Events.
|
0 Participants
|
Adverse Events
Optune + Ipilimumab + Nivolumab
Serious events: 1 serious events
Other events: 2 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Optune + Ipilimumab + Nivolumab
n=2 participants at risk
* Ipilimumab at 3 mg/kg IV over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.
* Nivolumab at 1 mg/kg IV over 30 minutes on Day 1 of each 21-day cycle for 4 cycles, then at 240 mg IV over 30 minutes on Days 1 and 15 of each 28-day cycle for up to 20 doses
* Within 2 weeks of the start of ipilimumab (before or after), treatment with Optune will begin. All patients will be required to shave their heads to initiate array placement and Optune therapy.
* Treatment may continue for up to 1 year
|
|---|---|
|
General disorders
Death NOS
|
50.0%
1/2 • Adverse events were followed from start of treatment until 100 days after last day of treatment (median follow-up 107.5 days, full range (25 days-190 days)). All-cause mortality was followed from time of enrollment until completion of follow-up (median follow-up 314.50 days (full range 25 days-604 days)
|
|
Vascular disorders
Deep vein thrombosis
|
50.0%
1/2 • Adverse events were followed from start of treatment until 100 days after last day of treatment (median follow-up 107.5 days, full range (25 days-190 days)). All-cause mortality was followed from time of enrollment until completion of follow-up (median follow-up 314.50 days (full range 25 days-604 days)
|
Other adverse events
| Measure |
Optune + Ipilimumab + Nivolumab
n=2 participants at risk
* Ipilimumab at 3 mg/kg IV over 90 minutes on Day 1 of each 21-day cycle for 4 cycles.
* Nivolumab at 1 mg/kg IV over 30 minutes on Day 1 of each 21-day cycle for 4 cycles, then at 240 mg IV over 30 minutes on Days 1 and 15 of each 28-day cycle for up to 20 doses
* Within 2 weeks of the start of ipilimumab (before or after), treatment with Optune will begin. All patients will be required to shave their heads to initiate array placement and Optune therapy.
* Treatment may continue for up to 1 year
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
1/2 • Adverse events were followed from start of treatment until 100 days after last day of treatment (median follow-up 107.5 days, full range (25 days-190 days)). All-cause mortality was followed from time of enrollment until completion of follow-up (median follow-up 314.50 days (full range 25 days-604 days)
|
|
Gastrointestinal disorders
Ascites
|
50.0%
1/2 • Adverse events were followed from start of treatment until 100 days after last day of treatment (median follow-up 107.5 days, full range (25 days-190 days)). All-cause mortality was followed from time of enrollment until completion of follow-up (median follow-up 314.50 days (full range 25 days-604 days)
|
|
General disorders
Fatigue
|
50.0%
1/2 • Adverse events were followed from start of treatment until 100 days after last day of treatment (median follow-up 107.5 days, full range (25 days-190 days)). All-cause mortality was followed from time of enrollment until completion of follow-up (median follow-up 314.50 days (full range 25 days-604 days)
|
|
Infections and infestations
Urinary tract infection
|
50.0%
1/2 • Adverse events were followed from start of treatment until 100 days after last day of treatment (median follow-up 107.5 days, full range (25 days-190 days)). All-cause mortality was followed from time of enrollment until completion of follow-up (median follow-up 314.50 days (full range 25 days-604 days)
|
|
Investigations
Creatinine increased
|
50.0%
1/2 • Adverse events were followed from start of treatment until 100 days after last day of treatment (median follow-up 107.5 days, full range (25 days-190 days)). All-cause mortality was followed from time of enrollment until completion of follow-up (median follow-up 314.50 days (full range 25 days-604 days)
|
|
Investigations
Platelet count decreased
|
50.0%
1/2 • Adverse events were followed from start of treatment until 100 days after last day of treatment (median follow-up 107.5 days, full range (25 days-190 days)). All-cause mortality was followed from time of enrollment until completion of follow-up (median follow-up 314.50 days (full range 25 days-604 days)
|
|
Metabolism and nutrition disorders
Anorexia
|
50.0%
1/2 • Adverse events were followed from start of treatment until 100 days after last day of treatment (median follow-up 107.5 days, full range (25 days-190 days)). All-cause mortality was followed from time of enrollment until completion of follow-up (median follow-up 314.50 days (full range 25 days-604 days)
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
50.0%
1/2 • Adverse events were followed from start of treatment until 100 days after last day of treatment (median follow-up 107.5 days, full range (25 days-190 days)). All-cause mortality was followed from time of enrollment until completion of follow-up (median follow-up 314.50 days (full range 25 days-604 days)
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
50.0%
1/2 • Adverse events were followed from start of treatment until 100 days after last day of treatment (median follow-up 107.5 days, full range (25 days-190 days)). All-cause mortality was followed from time of enrollment until completion of follow-up (median follow-up 314.50 days (full range 25 days-604 days)
|
|
Metabolism and nutrition disorders
Hyponatremia
|
50.0%
1/2 • Adverse events were followed from start of treatment until 100 days after last day of treatment (median follow-up 107.5 days, full range (25 days-190 days)). All-cause mortality was followed from time of enrollment until completion of follow-up (median follow-up 314.50 days (full range 25 days-604 days)
|
|
Metabolism and nutrition disorders
Lymphocyte count decreased
|
50.0%
1/2 • Adverse events were followed from start of treatment until 100 days after last day of treatment (median follow-up 107.5 days, full range (25 days-190 days)). All-cause mortality was followed from time of enrollment until completion of follow-up (median follow-up 314.50 days (full range 25 days-604 days)
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
50.0%
1/2 • Adverse events were followed from start of treatment until 100 days after last day of treatment (median follow-up 107.5 days, full range (25 days-190 days)). All-cause mortality was followed from time of enrollment until completion of follow-up (median follow-up 314.50 days (full range 25 days-604 days)
|
|
Psychiatric disorders
Confusion
|
50.0%
1/2 • Adverse events were followed from start of treatment until 100 days after last day of treatment (median follow-up 107.5 days, full range (25 days-190 days)). All-cause mortality was followed from time of enrollment until completion of follow-up (median follow-up 314.50 days (full range 25 days-604 days)
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
50.0%
1/2 • Adverse events were followed from start of treatment until 100 days after last day of treatment (median follow-up 107.5 days, full range (25 days-190 days)). All-cause mortality was followed from time of enrollment until completion of follow-up (median follow-up 314.50 days (full range 25 days-604 days)
|
Additional Information
Dr. George Ansstas
Washington University School of Medicine
Phone: 314-508-4426
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place