An Investigational Study of Immunotherapy Combinations in Participants With Solid Cancers That Are Advanced or Have Spread

Phase 1

Active, not recruiting

• Conditions: Advanced Cancer
• Interventions: Biological: Relatlimab; Biological: Nivolumab; Drug: BMS-986205; Biological: Ipilimumab

• Registration Number: NCT03459222
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The purpose of this study is to demonstrate the safety and preliminary activity with triple combinations of relatlimab in combination with nivolumab and BMS-986205, or in combination with nivolumab and ipilimumab in immunotherapy-naive and pretreated populations across select advanced tumor types.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-03-02
• Study First Submitted QC: 2018-03-02
• Study First Posted: 2018-03-08
• Study Start: 2018-05-30
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-20
• Primary Completion: 2026-11-10
• Study Completion: 2026-11-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 255

Inclusion Criteria

• Histologic or cytologic confirmation of select incurable solid malignancies that are advanced (metastatic and/or unresectable), with measurable disease per RECIST v1.1
• Available tumor tissue for biomarker analysis
• Eastern Cooperative Oncology Group Performance Status (ECOG) status of 0 or 1

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Exclusion Criteria

• Known or suspected central nervous system (CNS) metastases or with the CNS as the only site of active disease
• History of interstitial lung disease / pneumonitis
• Prior malignancy active within the previous 2 years except for locally curable cancers that have been cured, such as basal or squamous cell skin cancer
• Encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent

Other protocol-defined inclusion/exclusion criteria apply

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A	Nivolumab	Relatlimab + Nivolumab + BMS-986205
Arm A	BMS-986205	Relatlimab + Nivolumab + BMS-986205
Arm B	Nivolumab	Relatlimab + Nivolumab + Ipilimumab
Arm B	Ipilimumab	Relatlimab + Nivolumab + Ipilimumab
Arm A	Relatlimab	Relatlimab + Nivolumab + BMS-986205
Arm B	Relatlimab	Relatlimab + Nivolumab + Ipilimumab

Primary Outcome Measures

Name	Time	Method
Number of Serious Adverse Events (SAEs)	Approximately 4 years
Number of AEs meeting protocol defined dose-limiting toxicity (DLT) criteria	Up to 6 weeks
Number of AEs leading to discontinuation	Approximately 4 years
Number of clinical laboratory test abnormalities	Approximately 4 years
Number of Adverse Events (AEs)	Approximately 4 years
Number of AEs leading to death	Approximately 4 years
Objective Response Rate (ORR)	Approximately 4 years
Disease Control Rate (DCR)	Approximately 4 years
Median Duration of Response (mDOR)	Approximately 4 years

Secondary Outcome Measures

Name	Time	Method
Progression-Free Survival (PFS)	Up to 4 years

Trial Locations

Locations (22)

Local Institution - 0011; 🇦🇺 Nedlands, Western Australia, Australia

Local Institution - 0003; 🇺🇸 Aurora, Colorado, United States

Local Institution - 0023; 🇮🇹 Rome, Italy

Local Institution - 0006; 🇺🇸 Duarte, California, United States

Local Institution - 0004; 🇺🇸 Baltimore, Maryland, United States

Local Institution - 0005; 🇺🇸 Saint Louis, Missouri, United States

Local Institution - 0022; 🇪🇸 Málaga, Spain

Local Institution - 0012; 🇦🇺 Wollstonecraft, New South Wales, Australia

Local Institution - 0001; 🇺🇸 Germantown, Tennessee, United States

Local Institution - 0017; 🇫🇷 Marseille Cedex 5, France

Local Institution - 0016; 🇫🇷 Toulouse Cedex 9, France

Local Institution - 0020; 🇪🇸 Pamplona, Spain

Local Institution - 0015; 🇫🇷 Villejuif, France

Local Institution - 0010; 🇮🇹 Forlì, Italy

Local Institution - 0009; 🇮🇹 Napoli, Italy

Local Institution - 0019; 🇪🇸 Barcelona, Spain

Local Institution - 0021; 🇪🇸 Madrid, Spain

Local Institution - 0018; 🇪🇸 Madrid, Spain

Local Institution - 0014; 🇬🇧 Newcastle Upon Tyne, United Kingdom

Local Institution - 0013; 🇬🇧 Headington, United Kingdom

Local Institution - 0007; 🇨🇭 Zuerich, Switzerland

Local Institution - 0008; 🇨🇭 Lausanne, Switzerland