RecruitingPhase 2NCT04974671

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

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


Sponsor

Yale University

Enrollment

30 participants

Start Date

Dec 22, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether targeted radiation (Stereotactic Body Radiation Therapy, or SBRT) delivered to a small number of growing tumour spots can help people with metastatic kidney cancer stay on their current immunotherapy treatment for longer. **You may be eligible if...** - You are 18 years or older with confirmed metastatic renal cell carcinoma (kidney cancer that has spread) - Your most recent treatment is an immune checkpoint inhibitor (e.g., nivolumab, pembrolizumab), which you have been receiving for at least 3 months - You have developed "oligoprogression" — meaning only a small number of tumour spots (up to 5) have grown while the rest are stable or responding - Your general health is adequate (ECOG 0–2) and life expectancy is over 6 months **You may NOT be eligible if...** - More than 5 tumour sites are progressing at the same time - You are not currently on immunotherapy or it has been more than 3 months since your last dose - You have been on your current immunotherapy for less than 3 months - Your performance status or life expectancy is too low Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONStereotactic Body Radiation Therapy

1-5 fraction Stereotactic Body Radiation Therapy to all sites of progression


Locations(1)

Yale University

New Haven, Connecticut, United States

View Full Details on ClinicalTrials.gov

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NCT04974671


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