Testing Nivolumab and BMS-986016 (Relatlimab) as Potentially Targeting Treatment in Cancers That Are LAG-3+ and Have Mismatch Repair Deficiency (MATCH - Subprotocol Z1M)

Refractory Multiple Myeloma Clinical Trial

Official title: MATCH Treatment Subprotocol Z1M: Phase 2 Study of Nivolumab and BMS-986016 (Relatlimab) in Patients With LAG-3+ Tumors With Mismatch Repair Deficiency (MMR-d) After Progression on Anti-PD-1/PD-L1 Therapy

Status Withdrawn

Clinical Trial Summary

This phase II MATCH treatment trial tests how well nivolumab and BMS-986016 (relatlimab) works in treating patients with cancer that has certain genetic changes called LAG-3 mutations with mismatch repair deficiency. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as nivolumab and BMS-986016 (relatlimab), may help the body's immune system attack the cancer, and may interfere with the ability of cancer cells to grow and spread.

Clinical Trial Description

PRIMARY OBJECTIVE:

I. To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas/multiple myeloma.

SECONDARY OBJECTIVES:

I. To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas/multiple myeloma.

II. To evaluate time until death or disease progression. III. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, ribonucleic acid (RNA), protein and imaging-based assessment platforms.

IV. To assess whether radiomic phenotypes obtained from pre-treatment imaging and changes from pre- through post-therapy imaging can predict objective response and progression free survival and to evaluate the association between pre-treatment radiomic phenotypes and targeted gene mutation patterns of tumor biopsy specimens.

OUTLINE:

Patients receive nivolumab intravenously (IV) over 30 minutes on day 1 and BMS-986016 (relatlimab) over 30 minutes on day 1 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo computed tomography (CT) or magnetic resonance imaging (MRI) during screening and on study, as well as during follow-up as clinically necessary. Patients also undergo echocardiography (ECHO) during screening as clinically indicated. Patients undergo a biopsy during screening and blood sample collection during screening and on study.

After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 1 year. ;

Related Conditions & MeSH terms

• Advanced Lymphoma
• Advanced Malignant Solid Neoplasm
• Lymphoma
• Multiple Myeloma
• Neoplasms
• Refractory Lymphoma
• Refractory Malignant Solid Neoplasm
• Refractory Multiple Myeloma

• NCT number: NCT06400264
• Study type: Interventional
• Source: National Cancer Institute (NCI)
• Status: Withdrawn
• Phase: Phase 2
• Start date: February 22, 2022
• Completion date: January 17, 2023