Overview

This trial is active, not recruiting.

Condition unresectable or metastatic melanoma
Treatments nivolumab, ipilimumab, placebo matching with nivolumab
Phase phase 2
Targets CTLA-4, PD-1
Sponsor Bristol-Myers Squibb
Start date August 2013
End date July 2014
Trial size 150 participants
Trial identifier NCT01927419, 2013-002018-11, CA209-069

Summary

The primary purpose of this study is to compare the objective response rate (ORR) as determined by investigators, of Nivolumab combined with Ipilimumab versus Ipilimumab monotherapy in subjects with unresectable or metastatic melanoma

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Part I: Nivolumab 1 mg/kg solution and Ipilimumab 3 mg/kg solution intravenously every 3 weeks for 4 doses (4 Cycles) Part II: Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression due to toxicity, withdrawal of consent or the study ends
nivolumab BMS-936558
ipilimumab
(Experimental)
Part I: Placebo matching with Nivolumab 0 mg/kg solution and Ipilimumab 3 mg/kg solution intravenously every 3 weeks for 4 doses (4 Cycles) Part II: Placebo matching with Nivolumab 0 mg/kg solution intravenously every 2 weeks until documented disease progression due to toxicity, withdrawal of consent or the study ends After documented disease progression, subjects in Arm B will have the option to either start Nivolumab monotherapy on-study (3 mg/kg solution intravenously every 2 weeks) or proceed to follow-up phase of the protocol
ipilimumab
placebo matching with nivolumab

Primary Outcomes

Measure
Objective response rate (ORR) as assessed by the investigator
time frame: Until disease progression is documented (expected to be no more than 5 years)

Secondary Outcomes

Measure
Investigator assessed progression free survival (PFS) in BRAF WT subjects
time frame: Until disease progression is documented (expected to be no more than 5 years)
ORR and PFS in BRAF mutant subjects
time frame: Until disease progression is documented (expected to be no more than 5 years)
Mean changes from baseline in the EORTC-QLQ-C30 global health status/QoL composite scale
time frame: Every 6 weeks for the first 6 months

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: - Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 - Histologically confirmed unresectable Stage III or Stage IV melanoma, as per AJCC staging system - No prior systemic anticancer therapy for unresectable or metastatic melanoma. Note that prior adjuvant or neoadjuvant melanoma therapy is permitted if it was completed at least 6 weeks prior to date of first dose, and all related adverse events have either returned to baseline or stabilized - Tumor tissue obtained in the metastatic setting or from an unresectable site must be provided for biomarker analyses. In order to be randomized, tumor tissue should be received by the central laboratory. Biopsy should be excisional, incisional punch or core needle. Fine needle aspirates or other cytology samples are insufficient - Known BRAF V600 mutation status as determined by an FDA approval test. Subjects with either V600 wild-type or V600 mutation-positive melanoma are eligible Exclusion Criteria: - Active brain metastases or leptomeningeal metastases. Subjects with brain metastases are eligible if these have been treated and there is no magnetic resonance imaging (MRI) evidence of progression for at least 8 weeks after treatment is complete and within 28 days prior to first dose of study drug administration. There must also be no requirement for high doses of systemic corticosteroids that could result in immunosuppression (>10 mg/day prednisone equivalents) for at least 2 weeks prior to study drug administration - Ocular melanoma - Subjects with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll

Additional Information

Official title Phase 2, Randomized, Double Blinded, Study of Nivolumab (BMS-936558) in Combination With Ipilimumab vs Ipilimumab Alone in Subjects With Previously Untreated, Unresectable or Metastatic Melanoma
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by Bristol-Myers Squibb.