Trial purpose
Cancer treatment
Tumor type
Skin
Age
15+
Trial acronym
CheckMate 238
Clinical summary
Summary
Eligible participants will be randomly allocated to one of two treatments arms.
Arm A will receive Ipilimumab immunotherapy and a placebo that matches nivolumab.
Arm B will receive Nivolumab immunotherapy and a placebo that matches ipilimumab.
Conditions
This trial is treating people with melanoma which has been completely removed by surgery
Eligibility
Inclusion
- 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
- 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
Inclusion
- You have had a certain type of treatment or surgical procedure.
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have certain types of non-cancer medical conditions.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Bristol-Myers Squibb
Scientific Title
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)
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