A Randomized Trial of Maintenance Systemic Therapy After Radiation for Oligometastatic Renal Cell Carcinoma (ASTROs)
M.D. Anderson Cancer Center
Summary
To learn if adding 1 year of therapy with pembrolizumab can help to continue to control RCC after radiation therapy.
Description
Primary Objectives: * To evaluate PFS in patients randomized to definitive RT followed by pembrolizumab versus definitive RT followed by observation. Secondary Objectives: Secondary Objective #1: * To evaluate overall survival (OS) in patients randomized to definitive RT followed by maintenance pembrolizumab versus definitive RT followed by observation. Secondary Objective #2: * To evaluate time to next line systemic therapy (defined as systemic therapy given after pembrolizumab) in patients randomized to definitive RT followed by maintenance pembrolizumab versus definitive RT followed b…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 th…
Interventions
- DrugPembrolizumab
Given by vein (IV)
- RadiationRadiation therapy
Given by vein (IV)
Location
- M D Anderson Cancer CenterHouston, Texas