NCT06005818

Molecular Residual Disease (MRD) Guided Adjuvant ThErapy in Renal Cell Carcinoma (RCC)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this Clinical Study is to understand the outcomes by informing therapy choice for adjuvant treatment in clear cell renal cell carcinoma by using molecular residual disease. The main question\[s\] it aims to answer are: * what is the progression free survival of a cohort of high risk resected RCC patients when treated based on MRD * what is the overall survival of high risk resected RCC patients when treated based on MRD Participants will forgo adjuvant therapy with pembrolizumab if they have no detectable molecular residual disease. Participants will continue on with standard of care pembrolizumab if they do appear to have molecular residual disease.

Detailed description

This is a multicenter open label biomarker integral treatment de-escalation study, where patients with localized renal cell carcinoma who are otherwise eligible to receive standard of care pembrolizumab will be offered observation only, if they do not demonstrate presence of molecular residual disease. Primary Objective(s): Provide an estimate for the 1 year -Disease-Free Survival (DFS) Provide an estimate for overall Survival (OS) for patients treated based on MRD information. Estimate the safety of an MRD based strategy of adjuvant therapy in RCC Primary Endpoint(s) : i. Disease Free Survival (DFS) by Investigator's assessment as defined by RECIST 1.1 Secondary Endpoint: i. Overall Survival at 1 year from surgery ii. Safety as defined by incidence of adverse events per NCI CTCAE v5.0 100 patients with non-metastatic clear cell renal cell carcinoma who undergo surgery to remove tumor will be enrolled, patients will be adults (≥18 years), there are no gender, age, demographic group related constraints, the trial will be conducted at centers based in the United States.

Conditions

• Renal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Pembrolizumab injection	PD-1 antibody

Timeline

• Start date: 2024-01-01
• Primary completion: 2027-07-01
• Completion: 2028-09-01
• First posted: 2023-08-23
• Last updated: 2025-10-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study