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

RecruitingPhase 2

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

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
Inclusion Criteria:

* Patients must have metastatic ccRCC.
* Patients must have oligoprogressive disease (up to 5 progressing lesions) on any ongoing or prior check-point inhibitor regimen that are all amenable to radiation including one lesion suitable for IMSA101 injection.
* Karnofsky Performance Status (KPS) of at least 50%.
* Life expectancy of at least 6 months.
* Age ≥ 18 years.
* Patients must have adequate organ and marrow function within 14 days prior to study entry.
* All IMDC risk categories are allowed.

Exclusion Criteria:

* Prior high-grade toxicity from check-point inhibitors deemed to place he patient at high risk for toxicity recurrence with re-challenge with check-point inhibitors.
* Prior STING agonist use.
* Any condition requiring systemic treatment with corticosteroids (\>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days prior to first dose of study drug. Inhaled steroids and adrenal replacement steroid doses up to 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
* Uncontrolled adrenal insufficiency.

About the study

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).

What is being tested

Sponsor: University of Texas Southwestern Medical Center · Participants: 15 · Started: Apr 1, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06601296

Locations in the U.S.

TexasUniversity of Texas Southwestern Medical Center, Dallas

Conditions

From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.