NCT05347212

Phase II Trial of Immunotherapy in Patients With Carcinomas Arising From the Renal Medulla

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To learn if the combination of nivolumab and relatlimab can help to control renal medullary carcinoma (RMC) that is locally advanced or metastatic (has spread).

Detailed description

OBJECTIVES Primary objective: To determine the objective response rate (ORR) of patients with locally advanced or metastatic RMC treated with combination nivolumab plus relatlimab. ORR is defined as the proportion of patients with a best response of complete response (CR) or partial response (PR) by the Response Evaluation Criteria. In Solid Tumors (RECIST 1.1) criteria recorded between Day 1 of the study and the date of objectively documented progression per RECIST 1.1 or the date of subsequent anti-cancer therapy, whichever occurs first. Our goal is to significantly improve the ORR compared with the historical ORR of 29% achieved in our institution using conventional cytotoxic chemotherapies. Secondary objectives: * To determine the efficacy and safety of the combination of nivolumab plus relatlimab in patients with RMC. Efficacy will be measured by overall survival (OS), progression-free survival (PFS), time to ORR, duration of response, and the disease control rate (DCR). * To evaluate potential biomarkers for patient stratification and treatment response, as well as tumor antigen-specific immune responses, such as antibody and T cell responses, as surrogates for anti-tumor activity.

Conditions

• Carcinomas
• Renal Medullary Carcinoma

Interventions

Type	Name	Description
DRUG	Nivolumab	Given by IV
DRUG	Relatlimab	Given by IV

Timeline

• Start date: 2022-09-22
• Primary completion: 2027-07-16
• Completion: 2027-07-16
• First posted: 2022-04-26
• Last updated: 2026-04-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study