A Safety and Efficacy Study of Multiple Administration Regimens for Nivolumab Plus Ipilimumab in Subjects With Melanoma
Phase IIIb, Randomized, Study of Multiple Administration Regimens for Nivolumab Plus Ipilimumab in Subjects With Previously Untreated Unresectable or Metastatic Melanoma
2 other identifiers
interventional
106
4 countries
16
Brief Summary
This is a safety and efficacy study of different administration regimens of nivolumab plus Ipilimumab in subjects with previously untreated, unresectable or metastatic melanoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Oct 2016
Typical duration for phase_3
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 14, 2016
CompletedFirst Posted
Study publicly available on registry
September 19, 2016
CompletedStudy Start
First participant enrolled
October 27, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 23, 2017
CompletedResults Posted
Study results publicly available
January 8, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 25, 2019
CompletedDecember 17, 2020
November 1, 2020
12 months
September 14, 2016
October 23, 2018
November 19, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Affected by Adverse Events (AEs) in the Broad Scope MedDRA Anaphylactic Reaction Standardized MedDRA Queries (SMQ)
This outcome describes the percentage of participants experiencing at least 1 AE in the MedDRA Anaphylactic Reaction broad scope SMQ. Such AEs include any acute systemic reaction characterized by a large list of terms, including (but not limited to) pruritus, urticaria, flushing, hypotension, respiratory distress, and vascular insufficiency. It also includes other signs and symptoms such as asthma, choking sensation, coughing, sneezing, and difficulty breathing due to laryngeal spasm and/or bronchospasm. Less frequent clinical presentations are also captured and include hyperventilation, sensation of foreign body, and ocular edema.
Within 2 days from administration of any of the 4 doses in part 1 period (approximately 12 weeks)
Secondary Outcomes (10)
Percentage of Participants Affected by AEs in the Narrow Scope MedDRA Anaphylactic Reaction SMQ
Within 2 days from administration of any of the 4 doses in part 1 period (approximately 12 weeks)
Percentage of Participants Affected by Hypersensitivity/Infusion Reaction Select AEs
Within 2 days from administration of any of the 4 doses in part 1 period (approximately 12 weeks)
Percentage of Participants Affected by All Causality Grade 3 - 5 AEs
From initial dose of study treatment and within 30 days of the last dose of study treatment (approximately 25 months)
Percentage of Participants Affected by Drug-related Grade 3 - 5 AEs
From initial dose of study treatment and within 30 days of the last dose of study treatment (approximately 25 months)
Geometric Mean Concentration of Ipilimumab at End of Infusion (EOI)
From Cycle 1, Day 1 to Cycle 4, Day 1 (approximately 9 weeks). Each cycle lasts 3 weeks. Cycle 1 day 1, Cycle 2 day 1 and Cycle 4 day 1 values reported.
- +5 more secondary outcomes
Study Arms (2)
Nivolumab and Ipilimumab Concomitant Administration
EXPERIMENTALFollowed by Nivolumab monotherapy
Nivolumab and Ipilimumab Sequential Administration
EXPERIMENTALFollowed by Nivolumab monotherapy
Interventions
-Specified dose on specified days
-Specified dose on specified days
Eligibility Criteria
You may qualify if:
- Males and Females, ages 15 years ≥ of age (Except where local regulations and/or institutional policies do not allow for subjects \< 18 years of age to participate)
- Subjects must have been diagnosed with stage III or/and stage IV histologically confirmed melanoma that is unresectable or metastatic
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Subjects have not been treated by systemic anticancer therapy for unresectable or metastatic melanoma
You may not qualify if:
- Subjects with active brain metastases or leptomeningeal metastases
- Subjects with ocular melanoma
- Subjects with active, known or suspected autoimmune disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Melanoma Institute Australia
North Sydney, New South Wales, Australia
Greenslopes Private Hospital
Greenslopes, Queensland, Australia
Cabrini Hospital
Malvern, Victoria, Australia
Local Institution
Lyon, 69373, France
Hopital De La Timone
Marseille, 13385, France
Local Institution
Nantes, 44093, France
Hopital Saint Louis
Paris, 75475, France
Local Institution
Paris, 75679, France
Hopital Trousseau - Chru Tours
Tours, 37044, France
Istituto Nazionale Per La Ricerca Sul Cancro - Oncologia Med
Genova, 16128, Italy
Istituto Scientifico Romagnolo Per Lo Studio E Cura Tumori
Meldola (FC), 47014, Italy
Istituto Europeo Di Oncologia
Milan, 20141, Italy
Azienda Ospedaliera Citta della Salute e della Scienza
Torino, 10137, Italy
Local Institution
Barcelona, 08036, Spain
Local Institution
Madrid, 28007, Spain
Local Institution
Seville, 41071, Spain
Related Publications (1)
Menzies AM, Salman P, Frontera OA, Pook D, Hocking CM, Zakharia Y, Gurney H, Gedye C, Goh JC, Telivala B, Grob JJ, Lebbe C, de la Cruz Merino L, Machet L, Neidhardt EM, Qureshi A, Hosein F, Hamuro L, Simsek B, Amin A. Administration of nivolumab plus ipilimumab: Infusion of the fixed-ratio combination versus sequential infusions in two randomized controlled trials of metastatic melanoma (CheckMate 742) and renal cell carcinoma (CheckMate 800). Cancer. 2025 Jul 15;131(14):e35962. doi: 10.1002/cncr.35962.
PMID: 40614118DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bristol-Myers Squibb Study Director
- Organization
- Bristol-Myers Squibb
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 14, 2016
First Posted
September 19, 2016
Study Start
October 27, 2016
Primary Completion
October 23, 2017
Study Completion
October 25, 2019
Last Updated
December 17, 2020
Results First Posted
January 8, 2019
Record last verified: 2020-11