Trial Outcomes & Findings for Trial of Combination Tumor Treating Fields (TTF; Optune), Nivolumab Plus/Minus Ipilimumab for Recurrent Glioblastoma (NCT NCT03430791)
NCT ID: NCT03430791
Last Updated: 2023-02-02
Results Overview
Objective response rate is the proportion of patients whose best overall response per modified immunotherapy response assessment in neuro-oncology (iRANO) criteria is complete (CR) or partial (PR) after at least 6 weeks from start of therapy
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
5 participants
Primary outcome timeframe
2 years
Results posted on
2023-02-02
Participant Flow
Participant milestones
| Measure |
Nivolumab Monotherapy
Nivolumab 240 mg IV every 2 weeks for maximum of 24 months. TTF (Optune) for max of 24 months
Nivolumab 240 mg IV: Nivolumab IV 240mg IV every 2 weeks for maximum of 24 months.
NovoTTF200A (Optune): A device to be worn continuously for a goal of 75% of the time, ranging from 18 hours daily nonstop or 22 hours daily with 2-3 days off monthly.
|
Nivolumab+Ipilimumab
Nivolumab 3 mg/kg IV with ipilimumab then 240 mg every 2 weeks for maximum of 24 months.
Ipilimumab 1 mg/kg IV every 6 weeks maximum of 4 times. NovoTTF200A (Optune) TTF for maximum 24 months
Nivolumab 240 mg IV: Nivolumab IV 240mg IV every 2 weeks for maximum of 24 months.
Nivolumab 3 mg/kg: Nivolumab IV 3mg/kg every 2 weeks for maximum of 24 months.
Ipilimumab 1 mg/kg: Ipilimumab IV 1 mg/kg every 6 weeks for maximum of 4 doses.
NovoTTF200A (Optune): A device to be worn continuously for a goal of 75% of the time, ranging from 18 hours daily nonstop or 22 hours daily with 2-3 days off monthly.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
0
|
|
Overall Study
COMPLETED
|
4
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trial of Combination Tumor Treating Fields (TTF; Optune), Nivolumab Plus/Minus Ipilimumab for Recurrent Glioblastoma
Baseline characteristics by cohort
| Measure |
Nivolumab Monotherapy
n=4 Participants
Nivolumab 240 mg IV every 2 weeks for maximum of 24 months. TTF (Optune) for max of 24 months
Nivolumab 240 mg IV: Nivolumab IV 240mg IV every 2 weeks for maximum of 24 months.
NovoTTF200A (Optune): A device to be worn continuously for a goal of 75% of the time, ranging from 18 hours daily nonstop or 22 hours daily with 2-3 days off monthly.
|
Nivolumab+Ipilimumab
Nivolumab 3 mg/kg IV with ipilimumab then 240 mg every 2 weeks for maximum of 24 months.
Ipilimumab 1 mg/kg IV every 6 weeks maximum of 4 times. NovoTTF200A (Optune) TTF for maximum 24 months
Nivolumab 240 mg IV: Nivolumab IV 240mg IV every 2 weeks for maximum of 24 months.
Nivolumab 3 mg/kg: Nivolumab IV 3mg/kg every 2 weeks for maximum of 24 months.
Ipilimumab 1 mg/kg: Ipilimumab IV 1 mg/kg every 6 weeks for maximum of 4 doses.
NovoTTF200A (Optune): A device to be worn continuously for a goal of 75% of the time, ranging from 18 hours daily nonstop or 22 hours daily with 2-3 days off monthly.
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65 Years
n=5 Participants
|
—
|
65 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: No participants met criteria for the Nivolumab+Ipilimumab arm, thus none were enrolled in that arm.
Objective response rate is the proportion of patients whose best overall response per modified immunotherapy response assessment in neuro-oncology (iRANO) criteria is complete (CR) or partial (PR) after at least 6 weeks from start of therapy
Outcome measures
| Measure |
Nivolumab Monotherapy
n=4 Participants
Nivolumab 240 mg IV every 2 weeks for maximum of 24 months. TTF (Optune) for max of 24 months
Nivolumab 240 mg IV: Nivolumab IV 240mg IV every 2 weeks for maximum of 24 months.
NovoTTF200A (Optune): A device to be worn continuously for a goal of 75% of the time, ranging from 18 hours daily nonstop or 22 hours daily with 2-3 days off monthly.
|
Nivolumab+Ipilimumab
Nivolumab 3 mg/kg IV with ipilimumab then 240 mg every 2 weeks for maximum of 24 months.
Ipilimumab 1 mg/kg IV every 6 weeks maximum of 4 times. NovoTTF200A (Optune) TTF for maximum 24 months
Nivolumab 240 mg IV: Nivolumab IV 240mg IV every 2 weeks for maximum of 24 months.
Nivolumab 3 mg/kg: Nivolumab IV 3mg/kg every 2 weeks for maximum of 24 months.
Ipilimumab 1 mg/kg: Ipilimumab IV 1 mg/kg every 6 weeks for maximum of 4 doses.
NovoTTF200A (Optune): A device to be worn continuously for a goal of 75% of the time, ranging from 18 hours daily nonstop or 22 hours daily with 2-3 days off monthly.
|
|---|---|---|
|
Objective Response Rate According to Modified iRANO Criteria
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: No participants met criteria for the Nivolumab+Ipilimumab arm, thus none were enrolled in that arm.
Objective response rate is the proportion of patients whose best overall response per response assessment in neuro-oncology (RANO) criteria is complete (CR) or partial (PR) after at least 6 weeks from start of therapy
Outcome measures
| Measure |
Nivolumab Monotherapy
n=4 Participants
Nivolumab 240 mg IV every 2 weeks for maximum of 24 months. TTF (Optune) for max of 24 months
Nivolumab 240 mg IV: Nivolumab IV 240mg IV every 2 weeks for maximum of 24 months.
NovoTTF200A (Optune): A device to be worn continuously for a goal of 75% of the time, ranging from 18 hours daily nonstop or 22 hours daily with 2-3 days off monthly.
|
Nivolumab+Ipilimumab
Nivolumab 3 mg/kg IV with ipilimumab then 240 mg every 2 weeks for maximum of 24 months.
Ipilimumab 1 mg/kg IV every 6 weeks maximum of 4 times. NovoTTF200A (Optune) TTF for maximum 24 months
Nivolumab 240 mg IV: Nivolumab IV 240mg IV every 2 weeks for maximum of 24 months.
Nivolumab 3 mg/kg: Nivolumab IV 3mg/kg every 2 weeks for maximum of 24 months.
Ipilimumab 1 mg/kg: Ipilimumab IV 1 mg/kg every 6 weeks for maximum of 4 doses.
NovoTTF200A (Optune): A device to be worn continuously for a goal of 75% of the time, ranging from 18 hours daily nonstop or 22 hours daily with 2-3 days off monthly.
|
|---|---|---|
|
Objective Response Rate (ORR) by Standard RANO Criteria
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: No participants met criteria for the Nivolumab+Ipilimumab arm, thus none were enrolled in that arm.
The length of time that a participant lives with the disease but it does not get worse.
Outcome measures
| Measure |
Nivolumab Monotherapy
n=4 Participants
Nivolumab 240 mg IV every 2 weeks for maximum of 24 months. TTF (Optune) for max of 24 months
Nivolumab 240 mg IV: Nivolumab IV 240mg IV every 2 weeks for maximum of 24 months.
NovoTTF200A (Optune): A device to be worn continuously for a goal of 75% of the time, ranging from 18 hours daily nonstop or 22 hours daily with 2-3 days off monthly.
|
Nivolumab+Ipilimumab
Nivolumab 3 mg/kg IV with ipilimumab then 240 mg every 2 weeks for maximum of 24 months.
Ipilimumab 1 mg/kg IV every 6 weeks maximum of 4 times. NovoTTF200A (Optune) TTF for maximum 24 months
Nivolumab 240 mg IV: Nivolumab IV 240mg IV every 2 weeks for maximum of 24 months.
Nivolumab 3 mg/kg: Nivolumab IV 3mg/kg every 2 weeks for maximum of 24 months.
Ipilimumab 1 mg/kg: Ipilimumab IV 1 mg/kg every 6 weeks for maximum of 4 doses.
NovoTTF200A (Optune): A device to be worn continuously for a goal of 75% of the time, ranging from 18 hours daily nonstop or 22 hours daily with 2-3 days off monthly.
|
|---|---|---|
|
Progression Free Survival (PFS)
|
62.5 days
Standard Deviation 16.1
|
—
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: No participants met criteria for the Nivolumab+Ipilimumab arm, thus none were enrolled in that arm.
Total number of toxicities as defined by AEs that attributed as probable or possibly related to the study drug across all study subjects.
Outcome measures
| Measure |
Nivolumab Monotherapy
n=4 Participants
Nivolumab 240 mg IV every 2 weeks for maximum of 24 months. TTF (Optune) for max of 24 months
Nivolumab 240 mg IV: Nivolumab IV 240mg IV every 2 weeks for maximum of 24 months.
NovoTTF200A (Optune): A device to be worn continuously for a goal of 75% of the time, ranging from 18 hours daily nonstop or 22 hours daily with 2-3 days off monthly.
|
Nivolumab+Ipilimumab
Nivolumab 3 mg/kg IV with ipilimumab then 240 mg every 2 weeks for maximum of 24 months.
Ipilimumab 1 mg/kg IV every 6 weeks maximum of 4 times. NovoTTF200A (Optune) TTF for maximum 24 months
Nivolumab 240 mg IV: Nivolumab IV 240mg IV every 2 weeks for maximum of 24 months.
Nivolumab 3 mg/kg: Nivolumab IV 3mg/kg every 2 weeks for maximum of 24 months.
Ipilimumab 1 mg/kg: Ipilimumab IV 1 mg/kg every 6 weeks for maximum of 4 doses.
NovoTTF200A (Optune): A device to be worn continuously for a goal of 75% of the time, ranging from 18 hours daily nonstop or 22 hours daily with 2-3 days off monthly.
|
|---|---|---|
|
Number of Toxicities
|
13 adverse events
|
—
|
SECONDARY outcome
Timeframe: Monthly for up to 2 yearsPopulation: No participants met criteria for the Nivolumab+Ipilimumab arm, thus none were enrolled in that arm.
Percent of participants who have a compliance rate above the 75% goal for tumor treating fields (TTFields) therapy via the NovoTTF200A (OptuneTM). Daily compliance rates for using the device are averaged (mean ± stdev) over the 28-31 days of the month.
Outcome measures
| Measure |
Nivolumab Monotherapy
n=4 Participants
Nivolumab 240 mg IV every 2 weeks for maximum of 24 months. TTF (Optune) for max of 24 months
Nivolumab 240 mg IV: Nivolumab IV 240mg IV every 2 weeks for maximum of 24 months.
NovoTTF200A (Optune): A device to be worn continuously for a goal of 75% of the time, ranging from 18 hours daily nonstop or 22 hours daily with 2-3 days off monthly.
|
Nivolumab+Ipilimumab
Nivolumab 3 mg/kg IV with ipilimumab then 240 mg every 2 weeks for maximum of 24 months.
Ipilimumab 1 mg/kg IV every 6 weeks maximum of 4 times. NovoTTF200A (Optune) TTF for maximum 24 months
Nivolumab 240 mg IV: Nivolumab IV 240mg IV every 2 weeks for maximum of 24 months.
Nivolumab 3 mg/kg: Nivolumab IV 3mg/kg every 2 weeks for maximum of 24 months.
Ipilimumab 1 mg/kg: Ipilimumab IV 1 mg/kg every 6 weeks for maximum of 4 doses.
NovoTTF200A (Optune): A device to be worn continuously for a goal of 75% of the time, ranging from 18 hours daily nonstop or 22 hours daily with 2-3 days off monthly.
|
|---|---|---|
|
Rate of Treatment Compliance
|
75 percent of participants compliant
Standard Deviation 12
|
—
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: No participants met criteria for the Nivolumab+Ipilimumab arm, thus none were enrolled in that arm.
Proportion of participants who discontinued therapy. Reasons for discontinuation also will be noted.
Outcome measures
| Measure |
Nivolumab Monotherapy
n=4 Participants
Nivolumab 240 mg IV every 2 weeks for maximum of 24 months. TTF (Optune) for max of 24 months
Nivolumab 240 mg IV: Nivolumab IV 240mg IV every 2 weeks for maximum of 24 months.
NovoTTF200A (Optune): A device to be worn continuously for a goal of 75% of the time, ranging from 18 hours daily nonstop or 22 hours daily with 2-3 days off monthly.
|
Nivolumab+Ipilimumab
Nivolumab 3 mg/kg IV with ipilimumab then 240 mg every 2 weeks for maximum of 24 months.
Ipilimumab 1 mg/kg IV every 6 weeks maximum of 4 times. NovoTTF200A (Optune) TTF for maximum 24 months
Nivolumab 240 mg IV: Nivolumab IV 240mg IV every 2 weeks for maximum of 24 months.
Nivolumab 3 mg/kg: Nivolumab IV 3mg/kg every 2 weeks for maximum of 24 months.
Ipilimumab 1 mg/kg: Ipilimumab IV 1 mg/kg every 6 weeks for maximum of 4 doses.
NovoTTF200A (Optune): A device to be worn continuously for a goal of 75% of the time, ranging from 18 hours daily nonstop or 22 hours daily with 2-3 days off monthly.
|
|---|---|---|
|
Discontinuation Rate of Any Component of Therapy
|
4 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: No participants met criteria for the Nivolumab+Ipilimumab arm, thus none were enrolled in that arm.
FACT-Br is a validated self-report tool measuring general quality of life (QOL) that assesses symptoms or problems associated with CNS tumors across 5 scales. FACT-Br yields data about total QOL, as well as dimensions of disease specific physical, social/family, emotional, and functional well-being. The tool contains 20 items using a 5-point Likert scale. A higher score indicates better QOL, ranging from 0 (lowest) to 92 (highest). Median percent change between first and last measurement provided, with negative percent change indicating a decline in function.
Outcome measures
| Measure |
Nivolumab Monotherapy
n=4 Participants
Nivolumab 240 mg IV every 2 weeks for maximum of 24 months. TTF (Optune) for max of 24 months
Nivolumab 240 mg IV: Nivolumab IV 240mg IV every 2 weeks for maximum of 24 months.
NovoTTF200A (Optune): A device to be worn continuously for a goal of 75% of the time, ranging from 18 hours daily nonstop or 22 hours daily with 2-3 days off monthly.
|
Nivolumab+Ipilimumab
Nivolumab 3 mg/kg IV with ipilimumab then 240 mg every 2 weeks for maximum of 24 months.
Ipilimumab 1 mg/kg IV every 6 weeks maximum of 4 times. NovoTTF200A (Optune) TTF for maximum 24 months
Nivolumab 240 mg IV: Nivolumab IV 240mg IV every 2 weeks for maximum of 24 months.
Nivolumab 3 mg/kg: Nivolumab IV 3mg/kg every 2 weeks for maximum of 24 months.
Ipilimumab 1 mg/kg: Ipilimumab IV 1 mg/kg every 6 weeks for maximum of 4 doses.
NovoTTF200A (Optune): A device to be worn continuously for a goal of 75% of the time, ranging from 18 hours daily nonstop or 22 hours daily with 2-3 days off monthly.
|
|---|---|---|
|
Change in Quality of Life From Baseline Using the Functional Assessment of Cancer Therapy-Brain (FACT-Br)
|
-22 percentage of change
Interval -25.0 to 3.0
|
—
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: No participants met criteria for the Nivolumab+Ipilimumab arm, thus none were enrolled in that arm.
FACT-G is a validated self-report tool measuring general quality of life (QOL) that assesses symptoms or problems associated with any tumors. The tool contains 33 items using a 5-point Likert scale. A higher score indicates better QOL, ranging from 0 (lowest) to 108 (highest). Median percent change between first and last measurement provided, with negative percent change indicating a decline in function.
Outcome measures
| Measure |
Nivolumab Monotherapy
n=4 Participants
Nivolumab 240 mg IV every 2 weeks for maximum of 24 months. TTF (Optune) for max of 24 months
Nivolumab 240 mg IV: Nivolumab IV 240mg IV every 2 weeks for maximum of 24 months.
NovoTTF200A (Optune): A device to be worn continuously for a goal of 75% of the time, ranging from 18 hours daily nonstop or 22 hours daily with 2-3 days off monthly.
|
Nivolumab+Ipilimumab
Nivolumab 3 mg/kg IV with ipilimumab then 240 mg every 2 weeks for maximum of 24 months.
Ipilimumab 1 mg/kg IV every 6 weeks maximum of 4 times. NovoTTF200A (Optune) TTF for maximum 24 months
Nivolumab 240 mg IV: Nivolumab IV 240mg IV every 2 weeks for maximum of 24 months.
Nivolumab 3 mg/kg: Nivolumab IV 3mg/kg every 2 weeks for maximum of 24 months.
Ipilimumab 1 mg/kg: Ipilimumab IV 1 mg/kg every 6 weeks for maximum of 4 doses.
NovoTTF200A (Optune): A device to be worn continuously for a goal of 75% of the time, ranging from 18 hours daily nonstop or 22 hours daily with 2-3 days off monthly.
|
|---|---|---|
|
Change in Quality of Life From Baseline Using the Functional Assessment of Cancer Therapy-General (FACT-G)
|
-13 percentage of change
Interval -28.0 to 3.0
|
—
|
Adverse Events
Nivolumab Monotherapy
Serious events: 0 serious events
Other events: 4 other events
Deaths: 2 deaths
Nivolumab+Ipilimumab
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Nivolumab Monotherapy
n=4 participants at risk
Nivolumab 240 mg IV every 2 weeks for maximum of 24 months. TTF (Optune) for max of 24 months
Nivolumab 240 mg IV: Nivolumab IV 240mg IV every 2 weeks for maximum of 24 months.
NovoTTF200A (Optune): A device to be worn continuously for a goal of 75% of the time, ranging from 18 hours daily nonstop or 22 hours daily with 2-3 days off monthly.
|
Nivolumab+Ipilimumab
Nivolumab 3 mg/kg IV with ipilimumab then 240 mg every 2 weeks for maximum of 24 months.
Ipilimumab 1 mg/kg IV every 6 weeks maximum of 4 times. NovoTTF200A (Optune) TTF for maximum 24 months
Nivolumab 240 mg IV: Nivolumab IV 240mg IV every 2 weeks for maximum of 24 months.
Nivolumab 3 mg/kg: Nivolumab IV 3mg/kg every 2 weeks for maximum of 24 months.
Ipilimumab 1 mg/kg: Ipilimumab IV 1 mg/kg every 6 weeks for maximum of 4 doses.
NovoTTF200A (Optune): A device to be worn continuously for a goal of 75% of the time, ranging from 18 hours daily nonstop or 22 hours daily with 2-3 days off monthly.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Scalp rash
|
50.0%
2/4 • Number of events 3 • 18 months
No participants were accrued to the Nivolumab+Ipilimumab arm, thus the number at risk for SAE, all-cause mortality, and other events is 0 for that arm.
|
—
0/0 • 18 months
No participants were accrued to the Nivolumab+Ipilimumab arm, thus the number at risk for SAE, all-cause mortality, and other events is 0 for that arm.
|
|
Gastrointestinal disorders
Dry mouth
|
25.0%
1/4 • Number of events 1 • 18 months
No participants were accrued to the Nivolumab+Ipilimumab arm, thus the number at risk for SAE, all-cause mortality, and other events is 0 for that arm.
|
—
0/0 • 18 months
No participants were accrued to the Nivolumab+Ipilimumab arm, thus the number at risk for SAE, all-cause mortality, and other events is 0 for that arm.
|
|
General disorders
Fatigue
|
25.0%
1/4 • Number of events 2 • 18 months
No participants were accrued to the Nivolumab+Ipilimumab arm, thus the number at risk for SAE, all-cause mortality, and other events is 0 for that arm.
|
—
0/0 • 18 months
No participants were accrued to the Nivolumab+Ipilimumab arm, thus the number at risk for SAE, all-cause mortality, and other events is 0 for that arm.
|
|
Nervous system disorders
Dysarthria
|
25.0%
1/4 • Number of events 1 • 18 months
No participants were accrued to the Nivolumab+Ipilimumab arm, thus the number at risk for SAE, all-cause mortality, and other events is 0 for that arm.
|
—
0/0 • 18 months
No participants were accrued to the Nivolumab+Ipilimumab arm, thus the number at risk for SAE, all-cause mortality, and other events is 0 for that arm.
|
|
Injury, poisoning and procedural complications
Fall
|
25.0%
1/4 • Number of events 1 • 18 months
No participants were accrued to the Nivolumab+Ipilimumab arm, thus the number at risk for SAE, all-cause mortality, and other events is 0 for that arm.
|
—
0/0 • 18 months
No participants were accrued to the Nivolumab+Ipilimumab arm, thus the number at risk for SAE, all-cause mortality, and other events is 0 for that arm.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
25.0%
1/4 • Number of events 1 • 18 months
No participants were accrued to the Nivolumab+Ipilimumab arm, thus the number at risk for SAE, all-cause mortality, and other events is 0 for that arm.
|
—
0/0 • 18 months
No participants were accrued to the Nivolumab+Ipilimumab arm, thus the number at risk for SAE, all-cause mortality, and other events is 0 for that arm.
|
|
Nervous system disorders
Hemiplegia
|
25.0%
1/4 • Number of events 1 • 18 months
No participants were accrued to the Nivolumab+Ipilimumab arm, thus the number at risk for SAE, all-cause mortality, and other events is 0 for that arm.
|
—
0/0 • 18 months
No participants were accrued to the Nivolumab+Ipilimumab arm, thus the number at risk for SAE, all-cause mortality, and other events is 0 for that arm.
|
|
Endocrine disorders
Hyperthyroid
|
25.0%
1/4 • Number of events 1 • 18 months
No participants were accrued to the Nivolumab+Ipilimumab arm, thus the number at risk for SAE, all-cause mortality, and other events is 0 for that arm.
|
—
0/0 • 18 months
No participants were accrued to the Nivolumab+Ipilimumab arm, thus the number at risk for SAE, all-cause mortality, and other events is 0 for that arm.
|
|
Endocrine disorders
Pituitary disorder
|
25.0%
1/4 • Number of events 1 • 18 months
No participants were accrued to the Nivolumab+Ipilimumab arm, thus the number at risk for SAE, all-cause mortality, and other events is 0 for that arm.
|
—
0/0 • 18 months
No participants were accrued to the Nivolumab+Ipilimumab arm, thus the number at risk for SAE, all-cause mortality, and other events is 0 for that arm.
|
|
Nervous system disorders
Seizure
|
25.0%
1/4 • Number of events 1 • 18 months
No participants were accrued to the Nivolumab+Ipilimumab arm, thus the number at risk for SAE, all-cause mortality, and other events is 0 for that arm.
|
—
0/0 • 18 months
No participants were accrued to the Nivolumab+Ipilimumab arm, thus the number at risk for SAE, all-cause mortality, and other events is 0 for that arm.
|
|
Gastrointestinal disorders
Stomach pain
|
25.0%
1/4 • Number of events 3 • 18 months
No participants were accrued to the Nivolumab+Ipilimumab arm, thus the number at risk for SAE, all-cause mortality, and other events is 0 for that arm.
|
—
0/0 • 18 months
No participants were accrued to the Nivolumab+Ipilimumab arm, thus the number at risk for SAE, all-cause mortality, and other events is 0 for that arm.
|
|
Skin and subcutaneous tissue disorders
Toenail avulsion
|
25.0%
1/4 • Number of events 1 • 18 months
No participants were accrued to the Nivolumab+Ipilimumab arm, thus the number at risk for SAE, all-cause mortality, and other events is 0 for that arm.
|
—
0/0 • 18 months
No participants were accrued to the Nivolumab+Ipilimumab arm, thus the number at risk for SAE, all-cause mortality, and other events is 0 for that arm.
|
|
General disorders
Weakness
|
50.0%
2/4 • Number of events 2 • 18 months
No participants were accrued to the Nivolumab+Ipilimumab arm, thus the number at risk for SAE, all-cause mortality, and other events is 0 for that arm.
|
—
0/0 • 18 months
No participants were accrued to the Nivolumab+Ipilimumab arm, thus the number at risk for SAE, all-cause mortality, and other events is 0 for that arm.
|
|
Infections and infestations
Urinary tract infection
|
25.0%
1/4 • Number of events 1 • 18 months
No participants were accrued to the Nivolumab+Ipilimumab arm, thus the number at risk for SAE, all-cause mortality, and other events is 0 for that arm.
|
—
0/0 • 18 months
No participants were accrued to the Nivolumab+Ipilimumab arm, thus the number at risk for SAE, all-cause mortality, and other events is 0 for that arm.
|
|
Infections and infestations
Worsening herpes zoster infection
|
25.0%
1/4 • Number of events 1 • 18 months
No participants were accrued to the Nivolumab+Ipilimumab arm, thus the number at risk for SAE, all-cause mortality, and other events is 0 for that arm.
|
—
0/0 • 18 months
No participants were accrued to the Nivolumab+Ipilimumab arm, thus the number at risk for SAE, all-cause mortality, and other events is 0 for that arm.
|
Additional Information
Yazmin Odia
Miami Cancer Institute at Baptist Health, Inc.
Phone: 786-596-2000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place