Overview

This trial is active, not recruiting.

Condition advanced or metastatic melanoma
Treatments nivolumab, ipilimumab
Phase phase 2
Targets CTLA-4, PD-1
Sponsor Bristol-Myers Squibb
Start date April 2013
End date April 2015
Trial size 140 participants
Trial identifier NCT01783938, CA209-064

Summary

The purpose of this study is to evaluate the safety and efficacy of a sequential combination therapy of Nivolumab and Ipilimumab

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Nivolumab 3 mg/kg solution intravenously every 2 weeks up to 6 doses in Induction period and 3 mg/kg solution intravenously every 2 weeks until disease progression, unacceptable toxicity, or withdrawal of consent in Continuation period for a maximum of 2 years from 1st study treatment in Induction Period 1 Ipilimumab 3 mg/kg solution intravenously every 3 weeks up to 4 doses in Induction period
nivolumab BMS-936558
ipilimumab Yervoy
(Experimental)
Ipilimumab 3 mg/kg solution intravenously every 3 weeks up to 4 doses in Induction period Nivolumab 3 mg/kg solution intravenously every 2 weeks up to 6 doses in Induction period and 3 mg/kg solution intravenously every 2 weeks until disease progression, unacceptable toxicity, or withdrawal of consent in Continuation period for a maximum of 2 years from 1st study treatment in Induction Period 1
nivolumab BMS-936558
ipilimumab Yervoy

Primary Outcomes

Measure
Incidence of treatment-related grade 3-5 adverse events (AEs) during the induction period
time frame: Up to Week 24

Secondary Outcomes

Measure
Response rate
time frame: Baseline (Day 1), Week 25 and Week 33
Progression rates
time frame: Baseline (Day 1), Week 13 and Week 25

Eligibility Criteria

Male or female participants at least 18 years old.

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Histologically confirmed unresectable Stage III or IV melanoma - Treatment-naive or experienced disease recurrence or progression during or after one prior systemic regimen for advanced disease - Measurable disease by Computed Tomography/Magnetic resonance imaging (CT/MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria - Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 - Known BRAF V600 mutation status or consent to BRAF V600 mutation testing - Sufficient tumor tissue accessible for baseline and post-treatment biopsies. Exclusion Criteria: - Active central nervous system (CNS) metastases - Carcinomatous meningitis - Active, known or suspected autoimmune disease - Condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization - Prior therapy with anti-Programmed Death-1 (PD1), anti-Programmed Death-Ligand 1 (PD-L1), anti-PD-L2, anti-CD137, or anti-CTLA-4 (cytotoxic T lymphocyte antigen 4) antibody - Prior treatment with other immunotherapies - Prior therapy with BRAF inhibitor within 6 weeks of enrollment

Additional Information

Official title An Open-Label, Randomized, Phase 2 Study of Nivolumab Given Sequentially With Ipilimumab in Subjects With Advanced or Metastatic Melanoma
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Bristol-Myers Squibb.