RecruitingRenal Cell CarcinomaMetastatic Renal Cell CarcinomaOligoprogressive
Trial Of Stereotactic Body Radiation Therapy (SBRT) for Oligoprogression on Immune Checkpoint Inhibitors (ICI) in Metastatic Renal Cell Carcinoma
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: Yale University
You may qualify if…
- ✓ In order to be eligible for participation in this trial, the subject must:
- ✓ 1. Be willing and able to provide written informed consent/assent for the trial
- ✓ 2. Be ≥ 18 years of age on day of signing informed consent.
- ✓ 3. Have histologically confirmed renal cell carcinoma with metastatic disease detected on imaging. Biopsy of metastasis is preferred but not required
- ✓ 4. The subject has a performance status of 0, 1, or 2 on the ECOG Performance Scale
- ✓ 5. The life expectancy is \> 6 months
- ✓ 6. The most recent systemic therapy must be an ICI-containing regimen, delivered for at least 3 months prior to development of oligoprogressive lesions, with the last dose received within 3 months of trial enrollment.
- ✓ 7. Oligoprogression - defined as documented progression in up to 5 individual lesions with no previous local therapy to those sites using one of the following criteria:
You may not qualify if…
- ✕ The subject must be excluded from participating in the trial if the subject
- ✕ 1. Has had radiation therapy within 2 weeks of the first protocol treatment.
- ✕ 2. Has brain-only oligoprogression. subjects with brain and systemic oligoprogression can still be considered, however treatment of brain metastases will be per standard of care prior to receiving study SBRT.
- ✕ 3. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 2 weeks of the first protocol treatment. The use of lowdose steroids for management of chronic conditions is allowed (up to 12mg prednisone orally per day or the equivalent).
- ✕ 4. Has had prior radiation therapy within 2 weeks of the first protocol treatment.
- ✕ 5. Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.
- ✕ 6. Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Subjects with vitiligo or resolved childhood asthma/atopy would be an example of an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Those with a history of hypothyroidism who are now stable on hormone replacement will not be excluded. Those with Sjorgen's syndrome will not be excluded from the study.
- ✕ 7. Has a history of (non-infectious) pneumonitis that required steroids, current pneumonitis, or underlying lung disease that according to the treating physician makes the patient ineligible.
Where it's recruiting
Connecticut
New Haven
Source: ClinicalTrials.gov · NCT04974671 · last updated 2025-12-04