Retifanlimab + Ruxolitinib for Kidney and Lung Cancer

(PRISM Trial)

Age: Any Age
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: University of California, San Diego
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

Why 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?

RM

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

I have chosen not to undergo or there are no standard treatments available for my condition.
Measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1
Adequate organ and marrow function: Absolute neutrophil count ≥ 1.0×10^9/L, Platelet count ≥ 100×10^9/L, Hemoglobin level ≥ 8.5 g/dL without erythropoietin dependency and without packed red blood cell transfusion within the last 2 weeks, Serum creatinine ≤ 2 mg/dL or estimated creatinine clearance ≥ 30 mL/minute, Aspartate Aminotransferase and Alanine Aminotransferase ≤ 2.5 x upper limit of normal, Bilirubin ≤1.5 x upper limit of normal
See 4 more

Exclusion Criteria

Pregnancy or lactation
I have a serious heart condition.
I am not allergic to retifanlimab or ruxolitinib.
See 16 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ruxolitinib twice daily and retifanlimab infusions every 4 weeks

28 days
Clinic visits every 4 weeks for infusions and checkups

Dose Escalation

Standard 3+3 dose escalation design to determine the recommended phase 2 dose

Varies based on dose escalation process

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Retifanlimab
  • Ruxolitinib
Trial Overview The study is testing the highest safe dose of ruxolitinib when used with retifanlimab in treating metastatic renal cell carcinoma and non-small cell lung carcinoma. It's about finding the right balance between effectiveness and safety.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: ruxolitinib plus retifanlimabExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials
1,215
Recruited
1,593,000+

Incyte Corporation

Industry Sponsor

Trials
408
Recruited
66,800+
Steven Stein profile image

Steven Stein

Incyte Corporation

Chief Medical Officer since 2015

MD from University of Witwatersrand

Hervé Hoppenot profile image

Hervé Hoppenot

Incyte Corporation

Chief Executive Officer since 2014

MBA from ESSEC Business School

Citations

Retifanlimab and Ruxolitinib In Solid MalignanciesDespite significant improvements in survival outcomes, most patients eventually develop resistance to PD-1/PD-L1 blockade. The optimal approach ...
Retifanlimab + Ruxolitinib for Kidney and Lung CancerTrial Overview The study is testing the highest safe dose of ruxolitinib when used with retifanlimab in treating metastatic renal cell carcinoma ...
Transforming cancer immunotherapy: integration of distinct ...ICIs, for example, have significantly improved outcomes for patients with metastatic melanoma, non-small cell lung cancer (NSCLC), and renal ...
Comparison of real-world outcomes from combination ...A recent study compared the real world treatment outcomes for an immunotherapy combination, nivolumab plus ipilimumab, with two immunotherapy ...
Incyte's Cancer Drug Zynyz Shows Major Survival Benefit ...Patients in the retifanlimab and chemotherapy combination treatment group achieved a median overall survival (OS) of 18.1 months compared to ...
6.ucla.clinicaltrials.researcherprofiles.orgucla.clinicaltrials.researcherprofiles.org/neoplasm
UCLA Neoplasms Clinical Trials for 2025 — Los AngelesThis is an open-label, multicenter, non-randomized, Phase 2 study to determine the safety, tolerability and efficacy of encorafenib given in ...
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