Seleno-L Methionine (SLM)-Axitinib-Pembrolizumab

Introduction

• Org Study ID: 202104398
• NTC ID: NCT05363631
• Lead Sponsor Name: University of Iowa
• Status: RECRUITING

Conditions

• Clear Cell Renal Cell Carcinoma

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).

Eligibility Criteria

Inclusion Criteria:

To be eligible to participate in this study, an individual must meet all the following criteria:

* Written and voluntary informed consent.
* Histologically and radiologically confirmed locally advanced or metastatic ccRCC. Locally advanced is defined as non resectable in the opinion of the treating providers. Participants must be treatment naïve in metastatic setting. Prior immunotherapy treatment in adjuvant setting is allowed.
* > 18 years of age
* At least one Response Evaluation Criteria in Solid Tumors (RECIST 1.1)-defined target lesion that has not been irradiated
* Eastern Cooperative Oncology Group performance status of 0 (fully active, able to carry on all pre-disease performance without restriction) or 1 (restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, such as light housework or office work).
* Renal function (creatinine level within normal institutional limit, or creatinine clearance >15 mL/min/1.73 m2 for patients with creatinine levels above institutional normal, calculated using the Cockcroft-Gault formula).
* Liver function (AST/ALT