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

Phase 1

Completed

• 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

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
• Primary Completion: 2025-02-19
• Study Completion: 2025-02-19
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-28
• Last Update Posted: 2025-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 229

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Number of Adverse Events (AEs)	Approximately 4 years
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 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 - 0006; 🇺🇸 Duarte, California, United States

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

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

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

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

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

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

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

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

Local Institution - 0015; 🇫🇷 Villejuif, France

Scroll for more (12 remaining)