Actively Recruiting
Trial Of Stereotactic Body Radiation Therapy (SBRT) for Oligoprogression on Immune Checkpoint Inhibitors (ICI) in Metastatic Renal Cell Carcinoma
Led by Yale University · Updated on 2025-12-04
30
Participants Needed
1
Research Sites
223 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This Phase II trial will evaluate progression-free survival after Stereotactic Body Radiation Therapy to oligoprogressive (1-5) lesions in metastatic renal cell carcinoma patients on any immune checkpoint inhibitor-containing regimen with last dose of systemic therapy within 3 months prior to trial enrollment.
CONDITIONS
Official 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 for the trial
- 18 years of age or older
- Histologically confirmed metastatic renal cell carcinoma
- ECOG performance status of 0, 1, or 2
- Life expectancy greater than 6 months
- Received immune checkpoint inhibitor regimen for at least 3 months prior to developing oligoprogressive lesions with last dose within 3 months of enrollment
- Oligoprogression defined as progression in up to 5 lesions without prior local therapy to those sites
- No restriction on total number of metastases
- Adequate organ function based on laboratory values within 28 days prior to treatment
- Able to be treated with SBRT at a Yale radiation oncology facility
- Negative pregnancy test within 72 hours before first SBRT dose for females of childbearing potential
- Use of effective birth control during study for females of childbearing potential
- Male subjects agree to use contraception from first dose through 6 months after last dose
You will not qualify if you...
- Radiation therapy within 2 weeks prior to first protocol treatment
- Brain-only oligoprogression (brain and systemic progression allowed with brain treated per standard care)
- Immunodeficiency or systemic steroid/immunosuppressive therapy within 2 weeks prior to 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 past 3 months or history of severe autoimmune disease requiring systemic steroids or immunosuppressants
- History of pneumonitis requiring steroids, current pneumonitis, or lung disease making patient ineligible
- Active infection requiring systemic therapy
- Pregnancy, breastfeeding, or planning to conceive/father children during study through 120 days after last treatment
- Known active Hepatitis B or C infection
- Live vaccine received within 30 days prior to first treatment
- Serious medical conditions precluding radiotherapy, including connective tissue diseases or Crohn's disease if GI tract will receive radiation
- Significant overlap with previously treated radiation volume exceeding dose constraints
AI-Screening
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Trial Site Locations
Total: 1 location
1
Yale University
New Haven, Connecticut, United States, 06520
Actively Recruiting
Research Team
P
Patricia Brand
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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