NCT02714218CompletedPhase 3
Phase IIIb/IV, Randomized, Double Blinded, Study of Nivolumab 3 mg/kg in Combination With Ipilimumab 1 mg/kg vs Nivolumab 1 mg/kg in Combination With Ipilimumab 3 mg/kg in Subjects With Previously Untreated, Unresectable or Metastatic Melanoma
Bristol-Myers Squibb101 sites in 11 countries387 target enrollmentStarted: April 4, 2016Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 387
- Locations
- 101
- Primary Endpoint
- The Percentage of Participants With Drug-Related Grade 3 - 5 Adverse Events (AEs)
Study Overview
Brief Summary
The purpose of this study is to evaluate two different dose combinations of nivolumab and ipilimumab in the treatment of melanoma.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subject must have been diagnosed with stage III or/and stage IV histologically confirmed melanoma [per American Joint Committee on Cancer (AJCC) staging system] that is unresectable or metastatic
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- •Subject has not been treated by systemic anticancer therapy for unresectable or metastatic melanoma
Exclusion Criteria
- •Subjects with active brain metastases or leptomeningeal metastases
- •Subjects with ocular melanoma
- •Subjects with active, known or suspected autoimmune disease
- •Other protocol defined inclusion/exclusion criteria could apply
Outcomes
Primary Outcomes
The Percentage of Participants With Drug-Related Grade 3 - 5 Adverse Events (AEs)
Time Frame: From first dose of study treatment up to primary completion date 20-Apr-2017 (up to approximately 12 months)
The percentage of participants who experienced at least 1 AE of Grade 3 or higher, judged to be related to study drug by the investigator, and with onset on or after the first dose of study treatment and within 30 days of the last dose of study treatment. AE grade was defined using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0 criteria.
Secondary Outcomes
- Progression Free Survival (PFS)(From randomization to the first date of documented progression or death due to any cause, whichever occurs first (up to approximately 5 years))
- Objective Response Rate (ORR)(From date of randomization to date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (up to approximately 5 years))
- Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Role Functioning Scale(Weeks 7, 16, 20, 24, 28, 32, 36, 40)
- Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Social Functioning Scale(Weeks 7, 16, 20, 24, 28, 32, 36, 40)
- Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Global Health Status(Weeks 7, 16, 20, 24, 28, 32, 36, 40)
- Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Insomnia(Weeks 7, 16, 20, 24, 28, 32, 36, 40)
- Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Dyspnea(Weeks 7, 16, 20, 24, 28, 32, 36, 40)
- Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Appetite Loss(Weeks 7, 16, 20, 24, 28, 32, 36, 40)
- Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Constipation(Weeks 7, 16, 20, 24, 28, 32, 36, 40)
- Overall Survival (OS)(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first (up tp approximately 5 years))
- Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Physical Functioning Scale(Weeks 7, 16, 20, 24, 28, 32, 36, 40)
- Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Emotional Functioning Scale(Weeks 7, 16, 20, 24, 28, 32, 36, 40)
- Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Cognitive Functioning Scale(Weeks 7, 16, 20, 24, 28, 32, 36, 40)
- Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Diarrhea(Weeks 7, 16, 20, 24, 28, 32, 36, 40)
- Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Nausea and Vomiting(Weeks 7, 16, 20, 24, 28, 32, 36, 40)
- Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Fatigue(Weeks 7, 16, 20, 24, 28, 32, 36, 40)
- Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Financial Difficulties(Weeks 7, 16, 20, 24, 28, 32, 36, 40)
- Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Pain(Weeks 7, 16, 20, 24, 28, 32, 36, 40)
Investigators
Study Sites (101)
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