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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)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT02388906
First received: March 10, 2015
Last updated: April 17, 2017
Last verified: August 2016
  Purpose
The purpose of this study is to determine whether nivolumab is better than ipilimumab to prevent recurrence of melanoma.

Condition Intervention Phase
Melanoma Drug: Ipilimumab Drug: Nivolumab Other: Placebo matching Ipilimumab Other: Placebo matching Nivolumab Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official 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)

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Recurrence -free-survival [ Time Frame: Upto 36 months ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: Upto 48 months ]

Estimated Enrollment: 800
Study Start Date: March 2015
Estimated Study Completion Date: November 2019
Estimated Primary Completion Date: November 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ipilimumab and Placebo matching Nivolumab
Ipilimumab IV infusion and Placebo as specified
Drug: Ipilimumab Other: Placebo matching Nivolumab
Experimental: Nivolumab and Placebo matching Ipilimumab
Nivolumab IV infusion and Placebo as specified
Drug: Nivolumab Other: Placebo matching Ipilimumab

Detailed Description:
Italy, Greece, and Argentina: ≥ 18 years of age
  Eligibility

Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02388906

  Show 136 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02388906     History of Changes
Other Study ID Numbers: CA209-238
2014-002351-26 ( EudraCT Number )
Study First Received: March 10, 2015
Last Updated: April 17, 2017

Additional relevant MeSH terms:
Melanoma
Recurrence
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Disease Attributes
Pathologic Processes
Nivolumab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 24, 2017