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CheckMate 238: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 238

A Phase 3, Randomized, Double-blind Study of Adjuvant Immunotherapy With Nivolumab Versus Ipilimumab After Complete Resection of Stage 3b/c or Stage 4 Melanoma in Subjects Who Are at High Risk for Recurrence (CheckMate 238: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 238)

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080222893
Enrollment
800
Registered
2015-06-19
Start date
2015-08-04
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Melanoma

Interventions

Sponsors

Bristol-Myers Squibb K.K.
Lead Sponsor
ONO PHARMACEUTICAL CO., LTD.
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: At least 15 years of age Except: where local regulations and/or institutional policies do not allow for subjects less than 18 years of age (pediatric population) to participate. For those sites, the eligible subject population is at least 18 years of age. Completely removed melanoma by surgery performed within 12 weeks of randomization. Stage 3b/C or Stage 4 before complete resection. No previous anti-cancer treatment.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Recurrence -free-survival.

Secondary

MeasureTime frame
Overall survival.

Countries

Argentina, Australia, Austria, Belgium, Canada, Czech Republic, Finland, France, Greece, Hungary, Ireland, Italy, Netherlands, Norway, Poland, Romania, South Africa, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026