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SBRT for Kidney Cancer with Limited Progression on Immunotherapy

This study is for people with metastatic renal cell carcinoma (kidney cancer that has spread) who are currently receiving immune checkpoint inhibitors (a type of cancer treatment that helps your immune system fight cancer) but have a few spots of cancer that are growing. The study is testing if Stereotactic Body Radiation Therapy (SBRT), a focused type of radiation, can help control these growing spots. Researchers want to see how long people live without their cancer getting worse after SBRT. You can join if you are 18 or older and have kidney cancer that has spread, with 1 to 5 spots that are progressing while on immunotherapy. The study plans to enroll 30 participants. The current recruitment status is unclear.

Study design
This is a Phase II interventional study involving about 30 participants. It is designed to evaluate the effectiveness of Stereotactic Body Radiation Therapy.
What's involved
You would receive Stereotactic Body Radiation Therapy to 1-5 sites of progression, delivered in 1-5 sessions. You will also undergo imaging tests like CT, PET CT, or MRI to check your response to treatment.
Compensation
Not stated in the trial record.
Follow-up
Your progression-free survival will be measured at 6 months after treatment.

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NCT04974671

Trial Of Stereotactic Body Radiation Therapy (SBRT) for Oligoprogression on Immune Checkpoint Inhibitors (ICI) in Metastatic Renal Cell Carcinoma

Recruiting
PHASE2Ages 18+InterventionalTreatment
Yale University
~30 participants
Updated 2025-12-04 on ClinicalTrials.gov
What's tested:Stereotactic Body Radiation Therapy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression Free Survival
Measured over 6 Months

Conditions

Renal Cell Carcinoma
Metastatic Renal Cell Carcinoma
Oligoprogressive
Progression

Explore related trials

Renal Cell Carcinoma

Where it's being run

1 sites across 1 states
Connecticut1

Study leadership

  • Kimberly Johung, MD · PRINCIPAL_INVESTIGATOR · Yale University

Who to contact

Patricia Brand
[email protected]
(203) 738-9161
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

5 X ULN for subjects with liver metastases
Creatinine clearance should be calculated per institutional standard 10. Able to be treated with SBRT at a Yale radiation oncology facility 11. Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of SBRT. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. 12. Female subjects of childbearing must use an effective form of birth control during this study. Acceptable and highly effective birth control methods include intra-uterine hormone releasing system as well as other methods of birth control including consistent use of an approved oral contraceptive (birth control pill), an implantable contraceptive, an injectable contraceptive, a double-barrier method, or true abstinence. Oral, implantable, or injectable contraceptives are only considered effective if used properly and started at least 30 days prior to the screening visit and continue for 120 days after last dose of study drug. (Reference Section 5.7) 13. Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study therapy

What this trial measures

  • Progression Free Survival6 Months

    The primary objective of this study is to assess progression free survival after SBRT to all sites of progression and continuation of the same systemic regimen in patients with mRCC on ICI-containing systemic regimens with oligoprogression at 1-5 sites. Progression will be defined by RECIST criteria.