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Efficacy Study of Nivolumab Compared to Ipilimumab in Prevention of Recurrence of Melanoma After Complete Resection of Stage IIIb/c or Stage IV Melanoma (CheckMate 238)

Bristol-Myers Squibb (BMS) logo

Bristol-Myers Squibb (BMS)

Status and phase

Active, not recruiting
Phase 3

Conditions

Melanoma

Treatments

Drug: Nivolumab
Other: Placebo matching Nivolumab
Drug: Ipilimumab
Other: Placebo matching Ipilimumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT02388906
CA209-238
2014-002351-26 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment

906 patients

Sex

All

Ages

15+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

906 participants in 2 patient groups

Ipilimumab and Placebo matching Nivolumab
Experimental group
Treatment:
Drug: Ipilimumab
Other: Placebo matching Nivolumab
Nivolumab and Placebo matching Ipilimumab
Experimental group
Treatment:
Other: Placebo matching Ipilimumab
Drug: Nivolumab

Trial documents
2

Trial contacts and locations

136

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Data sourced from clinicaltrials.gov

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