Phase IIIb, Randomized, Study of Multiple Administration Regimens for Nivolumab Plus Ipilimumab in Subjects With Previously Untreated Unresectable or Metastatic Melanoma

Bristol-Myers Squibb11 sites in 4 countries106 target enrollmentOctober 27, 2016

ConditionsMelanoma

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Melanoma
Sponsor: Bristol-Myers Squibb
Enrollment: 106
Locations: 11
Primary Endpoint: Percentage of Participants Affected by Adverse Events (AEs) in the Broad Scope MedDRA Anaphylactic Reaction Standardized MedDRA Queries (SMQ)
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a safety and efficacy study of different administration regimens of nivolumab plus Ipilimumab in subjects with previously untreated, unresectable or metastatic melanoma.

Registry

clinicaltrials.gov

Start Date

October 27, 2016

End Date

October 25, 2019

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Bristol-Myers Squibb

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Males and Females, ages 15 years ≥ of age (Except where local regulations and/or institutional policies do not allow for subjects \< 18 years of age to participate)
•Subjects must have been diagnosed with stage III or/and stage IV histologically confirmed melanoma that is unresectable or metastatic
•Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
•Subjects have 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

Percentage of Participants Affected by Adverse Events (AEs) in the Broad Scope MedDRA Anaphylactic Reaction Standardized MedDRA Queries (SMQ)

Time Frame: Within 2 days from administration of any of the 4 doses in part 1 period (approximately 12 weeks)

This outcome describes the percentage of participants experiencing at least 1 AE in the MedDRA Anaphylactic Reaction broad scope SMQ. Such AEs include any acute systemic reaction characterized by a large list of terms, including (but not limited to) pruritus, urticaria, flushing, hypotension, respiratory distress, and vascular insufficiency. It also includes other signs and symptoms such as asthma, choking sensation, coughing, sneezing, and difficulty breathing due to laryngeal spasm and/or bronchospasm. Less frequent clinical presentations are also captured and include hyperventilation, sensation of foreign body, and ocular edema.

Secondary Outcomes

Percentage of Participants Affected by AEs in the Narrow Scope MedDRA Anaphylactic Reaction SMQ(Within 2 days from administration of any of the 4 doses in part 1 period (approximately 12 weeks))
Geometric Mean Trough Concentration of Ipilimumab(From Cycle 2, Day 1 to Cycle 4, Day 1 (approximately 6 weeks). Each cycle lasts 3 weeks.)
Objective Response Rate (ORR)(Week 12 following randomization, every 8 weeks for the first 12 months and then every 12 weeks until disease progression (approximately 20 months))
Progression Free Survival (PFS)(From the date of randomization to the first date of documented progression (approximately 26 months))
Percentage of Participants Affected by All Causality Grade 3 - 5 AEs(From initial dose of study treatment and within 30 days of the last dose of study treatment (approximately 25 months))
Geometric Mean Concentration of Nivolumab at End of Infusion (EOI)(From Cycle 1, Day 1 to Cycle 4, Day 1 (approximately 9 weeks). Each cycle lasts 3 weeks. Cycle 1 day 1, Cycle 2 day 1 and Cycle 4 day 1 values reported)
Geometric Mean Trough Concentration of Nivolumab(From Cycle 2, Day 1 to Cycle 4, Day 1 (approximately 6 weeks). Each cycle lasts 3 weeks.)
Percentage of Participants Affected by Hypersensitivity/Infusion Reaction Select AEs(Within 2 days from administration of any of the 4 doses in part 1 period (approximately 12 weeks))
Percentage of Participants Affected by Drug-related Grade 3 - 5 AEs(From initial dose of study treatment and within 30 days of the last dose of study treatment (approximately 25 months))
Geometric Mean Concentration of Ipilimumab at End of Infusion (EOI)(From Cycle 1, Day 1 to Cycle 4, Day 1 (approximately 9 weeks). Each cycle lasts 3 weeks. Cycle 1 day 1, Cycle 2 day 1 and Cycle 4 day 1 values reported.)