Trial Outcomes & Findings for Nivolumab and Ipilimumab in Treating Patients With Metastatic Uveal Melanoma (NCT NCT01585194)

NCT ID: NCT01585194

Last Updated: 2024-07-09

Results Overview

RECIST 1.1 response is defined as \>=30% reduction in sum of the longest diameter of target lesions

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 67 participants
• Primary outcome timeframe: Up to 2 years of treatment plus 60 days from last study dose
• Results posted on: 2024-07-09

Participant Flow

The accrual goal and dates were updated to match the new statistical design 10/2017.The enrollment changed to 39 participants. A total of 67 participants signed consent, 39 participants entered the study to participate in the trial in its current form w/combination metastatic therapy. 28 patients entered the study in its previous form when it was an adjuvant trial and then subsequently a monotherapy metastatic trial, and they are inevaluable for reporting results of the study in its current form

Participant milestones

Measure	Treatment (Nivolumab, Ipilimumab) INDUCTION PHASE: Patients receive nivolumab IV over 60 minutes and ipilimumab IV over 90 minutes during weeks 1, 4, 7, and 10. Treatment continues for 12 weeks in the absence of disease progression or unacceptable toxicity. MAINTENANCE PHASE: Patients not experiencing disease progression or unacceptable toxicity by week 12 of the induction phase receive nivolumab IV every 2 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Ipilimumab: Given IV Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV
Overall Study STARTED	39
Overall Study COMPLETED	35
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	Treatment (Nivolumab, Ipilimumab) INDUCTION PHASE: Patients receive nivolumab IV over 60 minutes and ipilimumab IV over 90 minutes during weeks 1, 4, 7, and 10. Treatment continues for 12 weeks in the absence of disease progression or unacceptable toxicity. MAINTENANCE PHASE: Patients not experiencing disease progression or unacceptable toxicity by week 12 of the induction phase receive nivolumab IV every 2 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Ipilimumab: Given IV Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV
Overall Study Withdrawal by Subject	1
Overall Study Physician Decision	2
Overall Study Lack of insurance	1

Baseline Characteristics

Nivolumab and Ipilimumab in Treating Patients With Metastatic Uveal Melanoma

Baseline characteristics by cohort

Measure	Treatment (Nivolumab, Ipilimumab) n=35 Participants INDUCTION PHASE: Patients receive nivolumab IV over 60 minutes and ipilimumab IV over 90 minutes during weeks 1, 4, 7, and 10. Treatment continues for 12 weeks in the absence of disease progression or unacceptable toxicity. MAINTENANCE PHASE: Patients not experiencing disease progression or unacceptable toxicity by week 12 of the induction phase receive nivolumab IV every 2 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Ipilimumab: Given IV Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	24 Participants n=5 Participants
Age, Categorical >=65 years	11 Participants n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	33 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	33 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	35 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 2 years of treatment plus 60 days from last study dose

Population: 5 patients not analyzed due to lack of follow-up efficacy imaging

RECIST 1.1 response is defined as >=30% reduction in sum of the longest diameter of target lesions

Outcome measures

Measure	Treatment (Nivolumab, Ipilimumab) n=35 Participants INDUCTION PHASE: Patients receive nivolumab IV over 60 minutes and ipilimumab IV over 90 minutes during weeks 1, 4, 7, and 10. Treatment continues for 12 weeks in the absence of disease progression or unacceptable toxicity. MAINTENANCE PHASE: Patients not experiencing disease progression or unacceptable toxicity by week 12 of the induction phase receive nivolumab IV every 2 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Ipilimumab: Given IV Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV
Overall Response Rate, Defined Per RECIST 1.1 Complete Response	1 Participants
Overall Response Rate, Defined Per RECIST 1.1 Partial Response	5 Participants
Overall Response Rate, Defined Per RECIST 1.1 Stable Disease	11 Participants
Overall Response Rate, Defined Per RECIST 1.1 Progressive Disease	16 Participants
Overall Response Rate, Defined Per RECIST 1.1 Unknown	2 Participants

SECONDARY outcome

Timeframe: From date of enrollment until the date of progressive disease or date of death from any cause, whichever came first, and assessed up to 60 days after completion of study treatment, a median of 13.0 months

Time from enrollment to progressive disease or death. Progressive disease is defined per RECIST 1.1 as >=20% increase in the sum of the longest diameter of target lesions from nadir, or a measurable increase in a non-target lesion, or the appearance of new lesions

Outcome measures

Measure

Treatment (Nivolumab, Ipilimumab) n=35 Participants INDUCTION PHASE: Patients receive nivolumab IV over 60 minutes and ipilimumab IV over 90 minutes during weeks 1, 4, 7, and 10. Treatment continues for 12 weeks in the absence of disease progression or unacceptable toxicity. MAINTENANCE PHASE: Patients not experiencing disease progression or unacceptable toxicity by week 12 of the induction phase receive nivolumab IV every 2 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Ipilimumab: Given IV Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV

Progression-Free Survival

5.5 Weeks Interval 3.4 to 9.5

SECONDARY outcome

Timeframe: From date of enrollment until the date of death from any cause, a median of 13.0 months

Measured from time of enrollment to death

Outcome measures

Measure

Treatment (Nivolumab, Ipilimumab) n=35 Participants INDUCTION PHASE: Patients receive nivolumab IV over 60 minutes and ipilimumab IV over 90 minutes during weeks 1, 4, 7, and 10. Treatment continues for 12 weeks in the absence of disease progression or unacceptable toxicity. MAINTENANCE PHASE: Patients not experiencing disease progression or unacceptable toxicity by week 12 of the induction phase receive nivolumab IV every 2 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Ipilimumab: Given IV Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV

Overall Survival

19.1 Weeks Interval 9.6 to The upper limit 95% Confidence Interval on Secondary Outcome Overall Survival as not enough "events" (deaths) have occurred past the median to calculate this upper limit of measure of dispersion.

SECONDARY outcome

Timeframe: Baseline up to 1 year

Measured as percentage of patients alive at 1 year from enrollment

Outcome measures

Measure

Treatment (Nivolumab, Ipilimumab) n=35 Participants INDUCTION PHASE: Patients receive nivolumab IV over 60 minutes and ipilimumab IV over 90 minutes during weeks 1, 4, 7, and 10. Treatment continues for 12 weeks in the absence of disease progression or unacceptable toxicity. MAINTENANCE PHASE: Patients not experiencing disease progression or unacceptable toxicity by week 12 of the induction phase receive nivolumab IV every 2 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Ipilimumab: Given IV Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV

1-year Overall Survival

19 Participants

Adverse Events

Treatment (Nivolumab, Ipilimumab)

Serious events: 2 serious events

Other events: 32 other events

Deaths: 16 deaths

Serious adverse events

Measure	Treatment (Nivolumab, Ipilimumab) n=35 participants at risk INDUCTION PHASE: Patients receive nivolumab IV over 60 minutes and ipilimumab IV over 90 minutes during weeks 1, 4, 7, and 10. Treatment continues for 12 weeks in the absence of disease progression or unacceptable toxicity. MAINTENANCE PHASE: Patients not experiencing disease progression or unacceptable toxicity by week 12 of the induction phase receive nivolumab IV every 2 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Ipilimumab: Given IV Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV
Cardiac disorders Death	2.9% 1/35 • Number of events 1 • From baseline to 60 days after last dose of study drug, a median of 13.0 months From baseline to 60 days after last dose of drug, a median of 13.0 months
Endocrine disorders Adrenal insufficiency	2.9% 1/35 • Number of events 1 • From baseline to 60 days after last dose of study drug, a median of 13.0 months From baseline to 60 days after last dose of drug, a median of 13.0 months

Other adverse events

Measure	Treatment (Nivolumab, Ipilimumab) n=35 participants at risk INDUCTION PHASE: Patients receive nivolumab IV over 60 minutes and ipilimumab IV over 90 minutes during weeks 1, 4, 7, and 10. Treatment continues for 12 weeks in the absence of disease progression or unacceptable toxicity. MAINTENANCE PHASE: Patients not experiencing disease progression or unacceptable toxicity by week 12 of the induction phase receive nivolumab IV every 2 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Ipilimumab: Given IV Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV
Gastrointestinal disorders Diarrhea	60.0% 21/35 • From baseline to 60 days after last dose of study drug, a median of 13.0 months From baseline to 60 days after last dose of drug, a median of 13.0 months
Hepatobiliary disorders Increased ALT	48.6% 17/35 • From baseline to 60 days after last dose of study drug, a median of 13.0 months From baseline to 60 days after last dose of drug, a median of 13.0 months
Hepatobiliary disorders Increased AST	40.0% 14/35 • From baseline to 60 days after last dose of study drug, a median of 13.0 months From baseline to 60 days after last dose of drug, a median of 13.0 months
Skin and subcutaneous tissue disorders Pruritus	40.0% 14/35 • From baseline to 60 days after last dose of study drug, a median of 13.0 months From baseline to 60 days after last dose of drug, a median of 13.0 months
Endocrine disorders Hypothyroidism	37.1% 13/35 • From baseline to 60 days after last dose of study drug, a median of 13.0 months From baseline to 60 days after last dose of drug, a median of 13.0 months
Skin and subcutaneous tissue disorders Rash	31.4% 11/35 • From baseline to 60 days after last dose of study drug, a median of 13.0 months From baseline to 60 days after last dose of drug, a median of 13.0 months
General disorders Pyrexia	22.9% 8/35 • From baseline to 60 days after last dose of study drug, a median of 13.0 months From baseline to 60 days after last dose of drug, a median of 13.0 months
Musculoskeletal and connective tissue disorders Arthralgia	14.3% 5/35 • From baseline to 60 days after last dose of study drug, a median of 13.0 months From baseline to 60 days after last dose of drug, a median of 13.0 months
Endocrine disorders Adrenal insufficiency	11.4% 4/35 • From baseline to 60 days after last dose of study drug, a median of 13.0 months From baseline to 60 days after last dose of drug, a median of 13.0 months
Eye disorders Eye disorder	8.6% 3/35 • From baseline to 60 days after last dose of study drug, a median of 13.0 months From baseline to 60 days after last dose of drug, a median of 13.0 months

Additional Information

Dr. Sapna P. Patel/Associate Professor, Melanoma Medical Oncology

MD Anderson Cancer Center

Phone: 713-792-2921

Email: sppatel@mdanderson.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place