Spots Global Cancer Trial Database for Seleno-L Methionine (SLM)-Axitinib-Pembrolizumab

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Trial Identification

Brief Title: Seleno-L Methionine (SLM)-Axitinib-Pembrolizumab

Official Title: Phase I/II Study of Seleno-L Methionine (SLM) in Sequential Combination With Fixed Doses and Schedules of Axitinib and Pembrolizumab (SAP) in Locally Advanced and Metastatic Clear Cell Renal Cell Carcinoma (ccRCC)

Study ID: NCT05363631

Conditions

Clear Cell Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma Metastatic

Interventions

Selenomethionine (SLM)

Axitinib

Pembrolizumab

Study Description

Brief Summary: The purpose of this research study is to test the safety and effectiveness of Seleno-L Methionine (SLM) when combined with the standard dose and schedule of Axitinib and Pembrolizumab in patients who have locally advanced or metastatic clear cell renal cell carcinoma (ccRCC).

Detailed Description: The proposed study is a single arm, open-label Phase I/II trial of Seleno-L Methionine (SLM) in sequential combination with the standard dose and schedule of Axitinib and Pembrolizumab in previously untreated patients with advanced ccRCC. The hypothesis is that adding SLM to the Pembrolizumab and Axitinib combination will improve efficacy without added toxicity. This is a two-part study: * Escalation Part 1: The study will begin with a dose-escalation study to find the maximum tolerated dose (MTD) of study drug, SLM. * Expansion Part 2: Once the appropriate dose of SLM is determined, the second part of the study will begin.