Spots Global Cancer Trial Database for Phase II Trial of Immunotherapy in Patients With Carcinomas Arising From the Renal Medulla

Study Description

Brief 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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