An Investigational Immuno-therapy Study to Assess the Safety, Tolerability and Effectiveness of Anti-LAG-3 With and Without Anti-PD-1 in the Treatment of Solid Tumors

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Neoplasms by Site

Treatments: Biological: BMS-986213; Biological: Relatlimab; Biological: Nivolumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01968109

2023-508067-70 (Registry Identifier)

CA224-020

Details and patient eligibility

About

The purpose of the study is to assess the safety, tolerability and effectiveness of experimental medication BMS-986016 administered alone and in combination with nivolumab in patients with solid tumors that have spread and/or cannot be removed by surgery.

The following tumor types are included in this study:

Non-Small Cell Lung Cancer (NSCLC), gastric cancer, hepatocellular carcinoma, renal cell carcinoma, bladder cancer, squamous cell carcinoma of the head and neck, and melanoma, that have NOT previously been treated with immunotherapy. NSCLC and melanoma that HAVE previously been treated with immunotherapy.

Enrollment: 1,482 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• For Dose escalation: subjects with cervical, ovarian, bladder and colorectal cancer (CRC), head and neck, gastric and hepatocellular cancer naive to immuno-oncology agents; 1st line melanoma and 1st line/2nd line NSCLC; Renal Cell Carcinoma naive to IO; NSCLC progressing while on or after therapy with anti-PD1/anti-PDL-1 and melanoma subjects progressed while-on or after treatment with anti-PD1 or anti-PDL1 with or without anti-CTLA-4.
• For Dose Expansion: all of the above in escalation except for cervical, ovarian, and CRC
• Progressed, or been intolerant to, at least one standard treatment regimen, except for participants in 1st line cohorts.
• ECOG performance status between 0 and 2
• At least 1 lesion with measurable disease at baseline
• Availability of an existing tumor biopsy sample (and consent to allow pre-treatment tumor biopsy)

Exclusion criteria

• Primary central nervous system (CNS) tumors or solid tumors with CNS metastases as the only site of active disease
• Autoimmune disease
• Encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent
• Uncontrolled CNS metastases

Other protocol defined inclusion/exclusion criteria could apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,482 participants in 3 patient groups

Relatlimab

Experimental group

Description:

Relatlimab (BMS-986016) specified dose on specified days

Treatment:

Biological: Relatlimab

Relatlimab + Nivolumab

Experimental group

Description:

Relatlimab (BMS-986016) + Nivolumab (BMS-936558) specified dose on specified days

Treatment:

Biological: Nivolumab

Biological: Relatlimab

BMS-986213

Experimental group

Description:

Relatlimab (BMS-986016) + Nivolumab (BMS-936558)

Treatment:

Biological: BMS-986213