Study comparing nivolumab to ipilimumab in prevention of recurrence of melanoma after complete resection of stage IIIb/c or Stage IV melanoma

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 Pharmacogenetics Blood Sample Amendment 01 (site-specific)- dated 03-dec-2014 - CheckMate 238: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 238)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-002351-26-BE

Enrollment

1070

Registered

2015-01-22

Start date

2015-03-18

Completion date

Unknown

Last updated

2024-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High risk, completely resected Stage IIIb/c and IV melanoma subjects. MedDRA version: 21.1 Level: LLT Classification code 10053571 Term: Melanoma System Organ Class: 100000004864

Interventions

Product Name: Nivolumab Product Code: BMS-936558 Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: NIVOLUMAB CAS Number: 946414-94-4 Current Sponsor code: BMS-936558-01 Other d

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Man and woman, 15 years or older (in some countries, only subjects aged 18 years or older will be recruited) -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 -Adequate function of the blood, kidney, and liver Are the trial subjects under 18? yes Number of subjects for this age range: 10 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 870 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 190

Exclusion criteria

Exclusion criteria: -Ocular or uveal melanoma -History of carcinomatosis meningitis -History of auto-immune disease -Previous non-melanoma cancers unless complete remission since 3 years -Treatment directed against the resected melanoma that is administrated after the surgery -Postive testing for hepatitis B, hepatitis C, or known HIV

Design outcomes

Primary

Measure	Time frame
Main Objective: -To compare the efficacy, as measured by recurrence free survival (RFS), provided by nivolumab versus ipilimumab in subjects with completely resected Stage IIIb/c or Stage IV NED melanoma who are at high-risk for recurrence.;Secondary Objective: - To compare the overall survival of nivolumab vs ipilimumab in subjects with completely resected Stage IIIb/c or Stage IV NED melanoma who are at high risk for recurrence; - To assess the overall safety and tolerability of nivolumab and ipilimumab in subjects with completely resected Stage IIIb/c or Stage IV NED melanoma who are at high risk for recurrence; - To evaluate whether PD-L1 expression is a predictive biomarker for RFS; - To evaluate the Health Related Quality of Life (HRQoL) as assessed by European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30.;Primary end point(s): Recurrence-free-survival ;Timepoint(s) of evaluation of this end point: The final analysis of the primary endpoint will take place when all subjects have a minimum of 36 months of follow-up	—

Measure

Time frame

Main Objective: -To compare the efficacy, as measured by recurrence free survival (RFS), provided by nivolumab versus ipilimumab in subjects with completely resected Stage IIIb/c or Stage IV NED melanoma who are at high-risk for recurrence.;Secondary Objective: - To compare the overall survival of nivolumab vs ipilimumab in subjects with completely resected Stage IIIb/c or Stage IV NED melanoma who are at high risk for recurrence; - To assess the overall safety and tolerability of nivolumab and ipilimumab in subjects with completely resected Stage IIIb/c or Stage IV NED melanoma who are at high risk for recurrence; - To evaluate whether PD-L1 expression is a predictive biomarker for RFS; - To evaluate the Health Related Quality of Life (HRQoL) as assessed by European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30.;Primary end point(s): Recurrence-free-survival ;Timepoint(s) of evaluation of this end point: The final analysis of the primary endpoint will take place when all subjects have a minimum of 36 months of follow-up

—

Secondary

Measure	Time frame
Secondary end point(s): Overall survival;Timepoint(s) of evaluation of this end point: The final analysis of overall survival will take place when all subjects have a minimum follow-up of 48 months.	—

Countries

Argentina, Australia, Austria, Belgium, Brazil, Canada, Czechia, Czech Republic, Finland, France, Greece, Hungary, Ireland, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Norway, Poland, Romania, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, United States

Contacts

Public ContactGCT-SU

Bristol-Myers Squibb International Corporation

clinical.trials@bms.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026