Actively Recruiting
Phase II Trial of Stereotactic Body Radiation Therapy for Oligoprogression on Immune Checkpoint Inhibitors in Metastatic Renal Cell Carcinoma
Led by Yale University · Updated on 2025-12-04
30
Participants Needed
1
Research Sites
65 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating progression-free survival in patients with metastatic renal cell carcinoma who have limited progression (1-5 lesions) while on immune checkpoint inhibitor-containing treatments. This Phase II trial focuses on patients who received their last systemic therapy dose within 3 months before joining the study. The study allows alternative local therapies to some lesions, but at least one lesion must be treated with Stereotactic Body Radiation Therapy (SBRT). Participants will receive SBRT, delivering 1 to 5 fractions on nonconsecutive days depending on the lesion location, as decided by their treating physician. Treatment to multiple sites may be done at the same time or one after another. Patients will continue their immune checkpoint inhibitor regimen during and after SBRT unless disease progression occurs. A multidisciplinary tumor board will review each case before enrollment. During the study, participants will have imaging tests such as CT scans, PET CT, or MRI to assess treatment response using RECIST criteria. Researchers will monitor side effects and toxicities both short and long term. The main outcome is progression-free survival at 6 months, with additional measures of recurrence, response rates, and overall survival tracked up to two years. Patients will be followed regularly to evaluate their health and treatment effects throughout the study period.
CONDITIONS
Brief Title
Trial Of Stereotactic Body Radiation Therapy (SBRT) for Oligoprogression on Immune Checkpoint Inhibitors (ICI) in Metastatic Renal Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide written informed consent
- Age 18 years or older
- Histologically confirmed metastatic renal cell carcinoma
- Performance status of 0, 1, or 2 on the ECOG scale
- Life expectancy greater than 6 months
- Last systemic therapy was an immune checkpoint inhibitor-containing regimen given for at least 3 months, with last dose within 3 months prior to enrollment
- Oligoprogression defined as progression in up to 5 lesions with no prior local therapy to those sites
- Adequate organ function based on laboratory values within 28 days before treatment
- Able to receive SBRT at a Yale radiation oncology facility
- Female participants of childbearing potential must have a negative pregnancy test and use effective birth control
- Male participants must agree to use adequate contraception during and for 6 months after treatment
You will not qualify if you...
- Radiation therapy within 2 weeks before first protocol treatment
- Brain-only oligoprogression
- Immunodeficiency or systemic steroid/immunosuppressive therapy within 2 weeks before treatment (low-dose steroids for chronic conditions allowed)
- Known additional progressing malignancy requiring active treatment (except certain skin cancers and treated cervical cancer)
- Active autoimmune disease requiring systemic treatment within 3 months or severe autoimmune history
- History of pneumonitis requiring steroids, current pneumonitis, or lung disease making patient ineligible
- Active infection requiring systemic therapy
- Pregnant or breastfeeding, or planning to conceive/father children during study and 120 days after last dose
- Active Hepatitis B or C infection
- Live vaccine received within 30 days before treatment
- Serious medical conditions precluding radiotherapy, including connective tissue diseases and Crohn's disease if GI tract will receive radiation
- Significant overlap with previously treated radiation area not meeting dose constraints; prior radiotherapy otherwise allowed if dose constraints met
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for consultation and eligibility assessment
Duration - Delivered in 1 to 5 fractions on nonconsecutive days depending on the treatment plan
Participants receive Stereotactic Body Radiation Therapy to 1-5 progressing lesions while continuing their immune checkpoint inhibitor regimen.
1 to 5 visits for radiation therapy sessions
Duration - Up to 2 years
Participants undergo response-assessment imaging and toxicity monitoring after treatment to evaluate progression and side effects.
Regular imaging and clinical visits as scheduled by the care team
Trial Site Locations
Total: 1 location
1
Yale University
New Haven, Connecticut, United States, 06520
Actively Recruiting
Research Team
P
Patricia Brand
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here