NCT05363631

Seleno-L Methionine (SLM)-Axitinib-Pembrolizumab

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)

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 55 (estimated)
• Sponsor: Mohammed Milhem · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Clear Cell Renal Cell Carcinoma
• Clear Cell Renal Cell Carcinoma Metastatic

Interventions

Type	Name	Description
DRUG	Selenomethionine (SLM)	Selenium (Se) is a natural element present in the earth's crust often in association with sulfur-containing compounds. Humans get their dietary requirements mainly from food. In this study Selenium will be administered in the chemical composition of selenomethionine (SLM)
DRUG	Axitinib	Axitinib is a small molecule tyrosine kinase inhibitor.
DRUG	Pembrolizumab	Pembrolizumab is a type of immunotherapy

Timeline

• Start date: 2022-09-19
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2022-05-06
• Last updated: 2025-12-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study