A Phase 3, Randomized, Double-blind Study of Adjuvant Immunotherapy With Nivolumab Versus Ipilimumab After Complete Resection of Stage IIIb/c or Stage IV Melanoma in Subjects Who Are at High Risk for Recurrence (CheckMate 238: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 238)

Bristol-Myers Squibb136 sites in 4 countries906 target enrollmentMarch 16, 2015

ConditionsMelanoma

InterventionsIpilimumab Placebo matching Nivolumab Nivolumab Placebo matching Ipilimumab

Overview

Phase: Phase 3
Intervention: Ipilimumab
Conditions: Melanoma
Sponsor: Bristol-Myers Squibb
Enrollment: 906
Locations: 136
Primary Endpoint: Recurrence-free Survival (RFS)
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to determine whether nivolumab is better than ipilimumab to prevent recurrence of melanoma.

Registry

clinicaltrials.gov

Start Date

March 16, 2015

End Date

October 16, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Bristol-Myers Squibb

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•At least 15 years of age Except: where local regulations and/or institutional policies do not allow for subjects \< 18 years of age (pediatric population) to participate. For those sites, the eligible subject population is ≥ 18 years of age
•Completely removed melanoma by surgery performed within 12 weeks of randomization
•Stage IIIb/C or Stage IV before complete resection
•No previous anti-cancer treatment

Exclusion Criteria

•Ocular or uveal melanoma
•History of carcinomatosis meningitis
•History of auto-immune disease
•Treatment directed against the resected melanoma that is administrated after the surgery
•Other protocol-defined inclusion/exclusion criteria apply

Arms & Interventions

Ipilimumab and Placebo matching Nivolumab

Intervention: Ipilimumab

Ipilimumab and Placebo matching Nivolumab

Intervention: Placebo matching Nivolumab

Nivolumab and Placebo matching Ipilimumab

Intervention: Nivolumab

Nivolumab and Placebo matching Ipilimumab

Intervention: Placebo matching Ipilimumab

Outcomes

Primary Outcomes

Recurrence-free Survival (RFS)

Time Frame: up to 36 months

RFS is defined as the time between the date of randomization and the date of first recurrence (local, regional or distant metastasis), new primary melanoma, or death (whatever the cause), whichever occurs first.

Secondary Outcomes

Overall Survival (OS)(up to 106.6 months)
The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Adverse Events(reported between first dose and 30 days after last dose of study therapy)
The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Serious Adverse Events(reported between the first dose and 30 days after last dose of study therapy)
the Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Deaths(reported between first dose and 30 to 100 days after last dose of study therapy)
The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Laboratory Abnormalities(reported after first dose and within 30 days of last dose of the study therapy)
Recurrence-free Survival by PD-L1 Expression(up to 106.6 months)
Health Related Quality of Life (HRQoL) Evaluation(up to 36 months)