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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02388906
Recruitment Status : Active, not recruiting
First Posted : March 17, 2015
Results First Posted : June 15, 2021
Last Update Posted : June 15, 2021
Sponsor:
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb

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

Condition or disease Intervention/treatment Phase
Melanoma Drug: Ipilimumab Drug: Nivolumab Other: Placebo matching Ipilimumab Other: Placebo matching Nivolumab Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 906 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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)
Actual Study Start Date : March 16, 2015
Actual Primary Completion Date : November 26, 2018
Estimated Study Completion Date : December 12, 2025

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

Arm Intervention/treatment
Experimental: Ipilimumab and Placebo matching Nivolumab Drug: Ipilimumab
Specified dose on specified days

Other: Placebo matching Nivolumab
Specified dose on specified days

Experimental: Nivolumab and Placebo matching Ipilimumab Drug: Nivolumab
Specified dose on specified days

Other: Placebo matching Ipilimumab
Specified dose on specified days




Primary Outcome Measures :
  1. Recurrence-free Survival (RFS) [ Time Frame: up to 36 months ]
    RFS is defined as the time between the date of randomization and the date of first recurrence (local, regional or distant metastasis), new primary melanoma, or death (whatever the cause), whichever occurs first.


Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: up to 60 months ]
    OS is defined as as the time between the date of randomization and the date of death.

  2. The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Adverse Events [ Time Frame: reported between first dose and 30 days after last dose of study therapy ]
    the safety and tolerability of Nivolumab and Ipilimumab was measured by the incidence of adverse events

  3. The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Serious Adverse Events [ Time Frame: reported between the first dose and 30 days after last dose of study therapy ]
    The Safety and Tolerability of nivolumab and ipilimumab was measured by the incidence of serious adverse events

  4. the Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Deaths [ Time Frame: reported between first dose and 30 to 100 days after last dose of study therapy ]
    the safety and tolerability of Nivolumab and Ipilimumab wasmeasured by the incidence of Deaths

  5. The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Laboratory Abnormalities [ Time Frame: reported after first dose and within 30 days of last dose of the study therapy ]
    The Safety and Tolerability of Nivolumab and Ipilimumab measured by the incidence of Laboratory abnormalities.

  6. Recurrence-free Survival by PD-L1 Expression [ Time Frame: up to 36 months ]
    Recurrence-free survival by PD-L1 Expression(5% tumor cell membrane expression)

  7. Health Related Quality of Life (HRQoL) Evaluation [ Time Frame: up to 36 months ]

    HRQoL was measured by mean changes from baseline in EORTC-QLQ-C30 global health status/QoL composite scale and in remaining EORTC QLQ-C30 scales in all randomized participants.

    EORTC QLQ-C30 is the most commonly used QoL instrument in melanoma clinical studies, is a 30-item instrument that has gained wide acceptance in oncology clinical studies and comprises 5 functional scales (physical functioning, cognitive functioning, emotional functioning, social functioning and global quality of life) as well as nine symptom scales (fatigue, pain, nausea/vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Except for the overall health status and global quality of life items, responses for all items are 4 point categorical scales ranging from 1 (Not at all) to 4 (Very much). The overall health status/quality of life responses are 7-point Likert scales for which higher score reflects higher health status/quality of life for the 7-point Likert scale.




Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
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

Other protocol-defined inclusion/exclusion criteria apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02388906


Locations
Show Show 136 study locations
Sponsors and Collaborators
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  Study Documents (Full-Text)

Documents provided by Bristol-Myers Squibb:
Study Protocol  [PDF] October 14, 2020
Statistical Analysis Plan  [PDF] April 3, 2019

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02388906    
Other Study ID Numbers: CA209-238
2014-002351-26 ( EudraCT Number )
First Posted: March 17, 2015    Key Record Dates
Results First Posted: June 15, 2021
Last Update Posted: June 15, 2021
Last Verified: June 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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
Ipilimumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action