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Recruiting Phase 2 NCT06004336

A Randomized Trial of Maintenance Systemic Therapy After Radiation for Oligometastatic Renal Cell Carcinoma (ASTROs)

Trial Parameters

Condition Oligometastatic Renal Cell Carcinoma
Sponsor M.D. Anderson Cancer Center
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 144
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2023-10-31
Completion 2029-01-01
Interventions
PembrolizumabRadiation therapy

Brief Summary

To learn if adding 1 year of therapy with pembrolizumab can help to continue to control RCC after radiation therapy.

Eligibility Criteria

Inclusion Criteria: In order to be eligible for trial participation, patients must have: 1. The participant provides written informed consent for the trial. 2. Pathologically confirmed diagnosis of RCC with a clear cell component. 3. Be willing and able to undergo biopsy of a lesion planned for definitive RT. If a lesion amenable to SBRT was biopsied prior to enrollment, this material can be used in lieu of a planned biopsy if the tissue is available for review at MD Anderson. 1. Patients may be allowed on this trial without a biopsy if they are deemed medically unfit for biopsy or if the biopsy poses undue risk in the opinion of the treating physician(s). 4. Be ≥18 years of age on the day of signing informed consent. 5. ECOG performance status 0-1. NOTE: If subject is unable to walk due to paralysis, but is mobile in a wheelchair, subject is ambulatory for the purpose of assessing their performance status. 1. Have measurable disease based on RECIST 1.1. Lesions situated in a previousl

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