Combining radiotherapy with checkpoint inhibition for metastatic kidney cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of PULSAR radiotherapy combined with IMSA101 injectable for patients with metastatic renal cell carcinoma (mRCC) who have oligoprogressive disease. It aims to enroll 20 patients over a 3-4 year period, focusing on those with 1-3 lesions that have progressed after treatment with Anti-PD1/Anti-CTLA-4. Participants will receive a baseline biopsy and undergo a specific radiotherapy regimen followed by intratumoral injections of IMSA101. The study will also monitor disease progression through imaging and tissue/blood collections.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Texas Southwestern Medical Center
  Dallas, Texas, United States Recruiting

Study contacts

• Principal investigator: Raquibul Hannan, Md — University of Texas Southwestern Medical Center
• Study coordinator: Sarah Neufeld, Manager of Clinical Research, Ms, Mba
• Email: Sarah.Hardee@UTSouthwestern.edu
• Phone: 214 648 1836

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.