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)
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| ClinicalTrials.gov Identifier: NCT02388906 |
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Recruitment Status :
Active, not recruiting
First Posted : March 17, 2015
Results First Posted : June 15, 2021
Last Update Posted : January 10, 2024
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Melanoma | Drug: Ipilimumab Drug: Nivolumab Other: Placebo matching Ipilimumab Other: Placebo matching Nivolumab | Phase 3 |
| 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 19, 2015 |
| Actual Primary Completion Date : | November 26, 2018 |
| Estimated Study Completion Date : | October 6, 2024 |
| 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 |
- 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.
- 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.
- 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
- 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
- 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
- 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.
- 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)
- 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.
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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 |
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
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
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| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Documents provided by Bristol-Myers Squibb:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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: | January 10, 2024 |
| Last Verified: | January 2024 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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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 Skin Neoplasms |
Neoplasms by Site Skin Diseases Disease Attributes Pathologic Processes Nivolumab Ipilimumab Antineoplastic Agents, Immunological Antineoplastic Agents Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action |