PRISM: Phase 1b of Retifanlimab and Ruxolitinib In Solid Malignancies Progressing on Prior Checkpoint Inhibition
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.
• Advanced or metastatic clear cell renal cell carcinoma or non-small cell lung carcinoma having progressed on prior PD-1/PD-L1 therapy (radiographic progression within 6 months of discontinuing immunotherapy; immunotherapy does not need to be the immediate line of preceding therapy).
• Decline standard of care treatment or no available standard of care treatment.
• Measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1.
• Eastern Cooperative Oncology Group performance status of 0 or 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; 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.
• Ability to take oral medication and be willing to adhere to the study intervention.
• Willingness to comply with all study procedures and availability for the duration of the study.