Retifanlimab + Ruxolitinib for Kidney and Lung Cancer
(PRISM Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the safest dose of ruxolitinib, a JAK inhibitor, combined with retifanlimab, an immunotherapy drug, for treating advanced kidney and lung cancers. The researchers aim to determine if this combination can effectively aid those whose cancer has spread and who have not succeeded with other treatments. Participants will take ruxolitinib pills twice daily and receive retifanlimab infusions every four weeks at a clinic. Ideal candidates have kidney or lung cancer that has not responded to previous PD-1/PD-L1 therapies and lack better treatment options. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking cancer research.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you cannot have received systemic anti-cancer therapy within 3 weeks or small molecule kinase inhibitors within two weeks before enrolling. It's best to discuss your current medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that ruxolitinib and retifanlimab are being tested together to determine their safety for treating certain cancers, such as kidney and lung cancer. Ruxolitinib blocks proteins that can promote cancer growth, while retifanlimab enhances the immune system's ability to fight cancer cells.
In previous studies, ruxolitinib has been used alone and with other treatments. These studies indicate it is generally well-tolerated, though some patients might experience side effects like low blood cell counts or infections. Retifanlimab has also been used with other cancer treatments, showing some improvements in patient outcomes. However, it can sometimes cause side effects like tiredness and skin reactions.
This current trial aims to find the right dose of ruxolitinib when used with retifanlimab. While specific data for this combination is still being gathered, both drugs have been tested individually and are generally considered safe, with some manageable side effects.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the combination of Retifanlimab and Ruxolitinib for kidney and lung cancer because it introduces a dual approach to cancer treatment. Unlike the standard treatments that often target cancer cells directly, Retifanlimab works by blocking the programmed cell death protein-1 (PD-1), which helps the immune system recognize and attack cancer cells. Meanwhile, Ruxolitinib inhibits Janus kinase 1/2, which are enzymes involved in cancer cell growth and survival. This combo not only targets the cancer cells but also boosts the body's immune response, potentially leading to more effective and comprehensive treatment outcomes.
What evidence suggests that this trial's treatments could be effective for kidney and lung cancer?
This trial will evaluate the combination of retifanlimab and ruxolitinib for kidney and lung cancer. Studies have shown that retifanlimab, a drug that blocks a protein called PD-1, can extend the lives of patients with certain cancers, such as non-small cell lung cancer and kidney cancer. Ruxolitinib blocks proteins known as Janus kinases, reducing cancer-related inflammation. Using these treatments together might enhance the immune system's ability to fight cancer. Early research suggests this combination could be effective, but more evidence is needed to confirm its benefits for lung and kidney cancers. Initial results are promising, but researchers continue to study its effectiveness.12346
Who Is on the Research Team?
Rana McKay
Principal Investigator
University of California, San Diego
Are You a Good Fit for This Trial?
This trial is for patients with advanced kidney cancer or non-small cell lung cancer. Participants will take ruxolitinib daily and receive retifanlimab infusions every 4 weeks. They must keep a drug diary, attend clinic visits for checkups and tests.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive ruxolitinib twice daily and retifanlimab infusions every 4 weeks
Dose Escalation
Standard 3+3 dose escalation design to determine the recommended phase 2 dose
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Retifanlimab
- Ruxolitinib
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, San Diego
Lead Sponsor
Incyte Corporation
Industry Sponsor
Steven Stein
Incyte Corporation
Chief Medical Officer since 2015
MD from University of Witwatersrand
Hervé Hoppenot
Incyte Corporation
Chief Executive Officer since 2014
MBA from ESSEC Business School