Retifanlimab and Ruxolitinib for Lung and Kidney Cancers

This study is testing a combination of two drugs, retifanlimab and ruxolitinib, for people with advanced non-small cell lung cancer or kidney cancer (renal cell carcinoma). These cancers must have gotten worse after previous immunotherapy treatment. The main goal is to find the safest and most effective dose of ruxolitinib when given with retifanlimab. Retifanlimab is a PD-1 blocker (a type of immunotherapy that helps your immune system fight cancer), and ruxolitinib is a Janus kinase 1/2 inhibitor (a drug that targets specific pathways in cancer cells). The study aims to enroll 40 participants, but its current status is unclear.

Study design
This is an interventional study with a planned enrollment of 40 participants. It is not specified if it is randomized or blinded.
What's involved
You will take ruxolitinib twice a day at home and keep a diary. You will visit the clinic for retifanlimab infusions every 4 weeks, and for regular checkups and tests.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, recommended phase 2 dose, is measured at 28 days.

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NCT07219576

Retifanlimab and Ruxolitinib In Solid Malignancies

Recruiting
PHASE1All AgesInterventionalTreatment
University of California, San Diego
~40 participants
Updated 2026-01-13 on ClinicalTrials.gov
What's tested:RuxolitinibRetifanlimab

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Recommended phase 2 dose
Measured over 28 days
Non Small Cell Lung Carcinoma
Renal Cell Carcinoma
1 sites across 1 states
California1
  • Rana McKay · PRINCIPAL_INVESTIGATOR · University of California, San Diego

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Eligibility criteria

Inclusion

Absolute neutrophil count ≥ 1.0×10\^9/L.
Platelet count ≥ 100×10\^9/L.
Hemoglobin level ≥ 8.5 g/dL; criteria must be met 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 calculated by the Cockcroft Gault or Modification of Diet in Renal Disease formulas).
Aspartate Aminotransferase and Alanine Aminotransferase ≤ 2.5 x upper limit of normal.
Bilirubin ≤1.5 x upper limit of normal. 6. Ability to take oral medication and be willing to adhere to the study intervention. 7. Willingness to comply with all study procedures and availability for the duration of the study.

Exclusion

Cerebral vascular accident/stroke or myocardial infarction (\<6 months prior to enrollment)
Unstable angina, congestive heart failure exacerbation (New York Heart Association Classification ≥ Class II), or unstable cardiac arrhythmia (\< 3 months prior to enrollment). Stable cardiac arrhythmia (such as atrial fibrillation, atrial flutter) controlled on or off medications is permitted. 16. Known additional malignancy that is progressing or has required active treatment within the past 2 years. Patients with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, low grade prostate cancer, carcinoma in situ (e.g., breast carcinoma in situ, bladder carcinoma in situ) that have undergone potentially curative therapy or are on active surveillance are not excluded. Patients with cancer not detectable on imaging, not receiving active treatment, and not expected to impact 5-year life expectancy are eligible to enroll. 17. Unable to swallow orally administered medication intact or has a history or current evidence of a gastrointestinal disorder (e.g., inflammatory bowel disease, Crohn's disease, ulcerative colitis, gastrectomy, partial bowel obstruction, malabsorption) or impaired liver function or diseases that in the opinion of the investigator may significantly alter the absorption and metabolism of oral medications. 18. History or evidence of any other clinically unstable/uncontrolled disorder, condition, or disease (including, but not limited to, cardiopulmonary, renal, metabolic, hematologic, or psychiatric) other than their primary malignancy, that in the opinion of the investigator would pose a risk to patient safety or interfere with study evaluations, procedures, or completion. 19. Known allergy or hypersensitivity to any component or formulation components of retifanlimab and ruxolitinib.
  • Recommended phase 2 dose28 days

    Determine the recommended phase 2 dose of ruxolitinib in combination with a fixed dose of retifanlimab. The recommended phase 2 dose will be determined by assessment of the dose limiting toxicities during the first cycle of treatment.