RecruitingPhase 1Phase 2NCT07219576

Retifanlimab and Ruxolitinib In Solid Malignancies

PRISM: Phase 1b of Retifanlimab and Ruxolitinib In Solid Malignancies Progressing on Prior Checkpoint Inhibition


Sponsor

University of California, San Diego

Enrollment

40 participants

Start Date

Jan 8, 2026

Study Type

INTERVENTIONAL

Summary

The goal of this clinical trial is to learn what dose of ruxolitinib can be given safely together with retifanlimab in patients with metastatic renal cell carcinoma and non-small cell lung carcinoma. The main question it aims to answer is: What is the maximum dose of ruxolitinib that can be used safely in patients with metastatic renal cell carcinoma and non-small cell lung carcinoma, and will it work? Participants will: Take drug ruxolitinib twice a day and keep a diary of when they take ruxolitinib at home; visit the clinic for infusions of retifanlimab every 4 weeks; visit the clinic for checkups and tests.


Eligibility

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two drugs — retifanlimab (an immunotherapy that helps the immune system fight cancer) and ruxolitinib (a drug that blocks certain signals that help cancer evade the immune system) — in people with advanced kidney cancer (clear cell renal cell carcinoma) or non-small cell lung cancer whose cancer progressed after prior immunotherapy. **You may be eligible if...** - You have advanced clear cell renal cell carcinoma (kidney cancer) or non-small cell lung cancer (NSCLC) that progressed on or after prior PD-1/PD-L1 immunotherapy treatment - Your cancer can be measured on a scan - You are generally well enough for treatment (ECOG performance status 0 or 1) - You have adequate organ function (kidney, liver, and blood counts within safe ranges) - You are willing to take oral medication and comply with the study **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have not previously been treated with a PD-1/PD-L1 immunotherapy - You have already received more than one prior line of immunotherapy - You have not received any Janus kinase (JAK) inhibitor treatment previously (as prior JAK inhibitor use is required) 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

DRUGRuxolitinib

Janus kinase 1/2 inhibitor

DRUGRetifanlimab

Programmed cell death protein-1 blocker


Locations(1)

University of California, San Diego Moores Cancer Center

La Jolla, California, United States

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NCT07219576