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Nivolumab and Relatlimab in Treating Participants With Advanced Chordoma

Chordoma Clinical Trial

Official title:
A Signal Finding Phase 2 Study of Nivolumab (Anti-PD-1; BMS-936558; ONO-4538) and Relatlimab (Anti-LAG-3 Monoclonal Antibody; BMS-986016) in Patients With Advanced Chordoma

Clinical Trial Summary

This phase II trial studies how well nivolumab and relatlimab work in treating participants with chordoma that has spread to other places in the body. Monoclonal antibodies, such as nivolumab and relatlimab, may interfere with the ability of tumor cells to grow and spread.

Clinical Trial Description

PRIMARY OBJECTIVES: I. To assess the clinical benefit of the combination of nivolumab and relatlimab in patients with advanced chordomas by objective response rate (ORR). SECONDARY OBJECTIVES: I. Ascertain the safety of nivolumab in combination with relatlimab in subjects with metastatic or locally advanced/unresectable chordoma by the frequency of adverse events (AEs). II. Assess the clinical benefit of the combination of nivolumab and relatlimab in patients with advanced chordomas by progression free survival (PFS). EXPLORATORY OBJECTIVES: I. Compare response rate (RR) and clinical benefit rate (CBR) in patients whose tumors are PD-L1+ and PD-L1- at baseline. II. Compare RR and CBR in patients whose tumors are LAG-3+ and LAG-3- at baseline. III. In the patients who are PD-L1 positive, compare RR and CBR in patients with 1% and 5% tumor membrane staining. III. Determine the response to treatment based on the baseline mutation load. IV. Determine the ORR and CBR via Choi criteria. OUTLINE: Participants receive nivolumab intravenously (IV) over 60 minutes and relatlimab via infusion over 60 minutes on day 1. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. After completion of study treatment, participants are followed up within 100 days. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03623854
Study type Interventional
Source Jonsson Comprehensive Cancer Center
Contact
Status Completed
Phase Phase 2
Start date April 3, 2019
Completion date September 28, 2023
View Details
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