RecruitingPhase 2NCT06601296

Radiotherapy in Combination With Checkpoint Inhibition for Patients With Metastatic Kidney Cancer

STING Agonist and Personalized Ultra-fractionated Stereotactic Adaptive Radiotherapy in Combination With Checkpoint Inhibition for Patients With Metastatic Kidney Cancer.


Sponsor

University of Texas Southwestern Medical Center

Enrollment

15 participants

Start Date

Apr 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

To evaluate the impact of combining innate immune system activation (with IMSA101) with antigen release (through SAbR/PULSAR) on limited progressing lesions during ongoing adaptive immune system activation (with maintenance Nivo).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether combining targeted radiation therapy with a checkpoint inhibitor immunotherapy drug (IMSA101) can improve outcomes for people with metastatic kidney cancer (clear cell renal cell carcinoma) that is progressing in only a small number of sites (called oligoprogression). **You may be eligible if...** - You have metastatic clear cell renal cell carcinoma (the most common type of kidney cancer) - Your cancer is progressing in 5 or fewer sites (oligoprogression) - All progressing tumour sites can be safely treated with radiation - You have at least one tumour site that can safely receive an injection of IMSA101 - You are 18 or older and have a reasonable performance level (Karnofsky score at least 50%) - Your organ and blood function are adequate **You may NOT be eligible if...** - You have tumours that are progressing in an area near the central airways of the chest that is too dangerous to radiate Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIMSA101

All enrolled patients to undergo the following treatment: SOC treatment: Nivolumab 480mg monthly PULSAR: 36 Gy in 3 fractions, Q4weeks IMSA101: three intra-tumoral injections of one of the progressive lesions at 1200 mcg (C1D1, C2D1, C3D1)


Locations(1)

University of Texas Southwestern Medical Center

Dallas, Texas, United States

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NCT06601296


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