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

Phase 3

Completed

• Conditions: Melanoma
• Interventions: Drug: Ipilimumab; Drug: Nivolumab; Other: Placebo matching Nivolumab; Other: Placebo matching Ipilimumab

• Registration Number: NCT02388906
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-03-10
• Study First Submitted QC: 2015-03-13
• Study Start: 2015-03-16
• Study First Posted: 2015-03-17
• Primary Completion: 2018-11-26
• Results First Submitted: 2021-04-16
• Results First Submitted QC: 2021-06-11
• Results First Posted: 2021-06-15
• Study Completion: 2024-10-16
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-04
• Last Update Posted: 2025-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 906

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ipilimumab and Placebo matching Nivolumab	Ipilimumab	-
Ipilimumab and Placebo matching Nivolumab	Placebo matching Nivolumab	-
Nivolumab and Placebo matching Ipilimumab	Nivolumab	-
Nivolumab and Placebo matching Ipilimumab	Placebo matching Ipilimumab	-

Primary Outcome Measures

Name	Time	Method
Recurrence-free Survival (RFS)	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

Name	Time	Method
Overall Survival (OS)	up to 106.6 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	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	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	reported between first dose and 30 to 100 days after last dose of study therapy	the safety and tolerability of Nivolumab and Ipilimumab was measured by the incidence of Deaths
The Safety and Tolerability of Nivolumab and Ipilimumab Measured by the Incidence of Laboratory Abnormalities	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	up to 106.6 months	Recurrence-free survival by PD-L1 Expression(5% tumor cell membrane expression)
Health Related Quality of Life (HRQoL) Evaluation	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.

Trial Locations

Locations (136)

Local Institution - 0036; 🇺🇸 Little Rock, Arkansas, United States

Local Institution - 0117; 🇺🇸 La Jolla, California, United States

Local Institution - 0189; 🇺🇸 Los Angeles, California, United States

Local Institution - 0021; 🇺🇸 San Francisco, California, United States

Local Institution - 0006; 🇺🇸 San Francisco, California, United States

Local Institution - 0010; 🇺🇸 Aurora, Colorado, United States

Local Institution - 0004; 🇺🇸 Washington, District of Columbia, United States

Local Institution - 0012; 🇺🇸 Jacksonville, Florida, United States

Local Institution - 0019; 🇺🇸 Miami Beach, Florida, United States

Local Institution - 0030; 🇺🇸 Orlando, Florida, United States

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