Actively Recruiting
A Randomized Trial of Maintenance Systemic Therapy After Radiation for Oligometastatic Renal Cell Carcinoma (ASTROs)
Led by M.D. Anderson Cancer Center · Updated on 2026-01-14
144
Participants Needed
1
Research Sites
269 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
To learn if adding 1 year of therapy with pembrolizumab can help to continue to control RCC after radiation therapy.
CONDITIONS
Official Title
A Randomized Trial of Maintenance Systemic Therapy After Radiation for Oligometastatic Renal Cell Carcinoma (ASTROs)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent for the trial
- Have pathologically confirmed renal cell carcinoma with a clear cell component
- Be willing and able to undergo biopsy of a lesion planned for definitive radiation therapy, or have an existing biopsy available
- Be 18 years of age or older at the time of consent
- Have an ECOG performance status of 0-1 (able to walk or use a wheelchair)
- Have measurable disease based on RECIST 1.1 criteria
- Have 5 or fewer metastatic lesions at study entry; lung lesions under 1 cm and lymph nodes under 1.5 cm may not be counted
- Have adequate organ function as defined by specified laboratory values
- Have at least one site suitable for definitive radiation therapy and biopsy
- Hepatitis B positive participants must have received antiviral therapy for at least 4 weeks with undetectable viral load
- Hepatitis C participants must have undetectable viral load and completed antiviral therapy at least 4 weeks prior to randomization
You will not qualify if you...
- Received last dose of immunotherapy within 24 weeks before starting radiation or last dose of other systemic therapy within 4 weeks
- Have immunocompromising conditions such as HIV, primary immunodeficiency, or organ transplant
- Have used immunosuppressive medication within 7 days before study treatment, except low dose corticosteroids
- Have psychiatric or substance abuse disorders interfering with study compliance
- History of severe immune-related adverse events from checkpoint inhibitors, except controlled endocrine events
- Received live or live-attenuated vaccine within 30 days before study intervention
- Cognitive impairments preventing informed consent or participation
- Diffuse metastatic disease not treatable with definitive radiation
- Pregnant, breastfeeding, or planning pregnancy during the study period
- Women of childbearing potential must follow contraception guidance and have negative pregnancy tests prior to enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
C
Chad Tang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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