PRISM: Phase 1b of Retifanlimab and Ruxolitinib In Solid Malignancies Progressing on Prior Checkpoint Inhibition
University of California, San Diego
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.
Description
The treatment landscape for renal cell carcinoma has evolved significantly with the use of immunotherapy. Immune checkpoint inhibitors are now used in both adjuvant and metastatic settings. Programmed cell death protein-1 (PD-1) inhibitors are utilized as adjuvant therapy following nephrectomy for high-risk disease, and in the metastatic setting as first-line treatment in combination with either cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibition or vascular endothelial growth factor (VEGF) pathway blockade. Despite improvements in overall survival with these approaches, the majori…
Eligibility
- Age range
- Not specified
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. 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). 2. Decline standard of care treatment or no available standard of care treatment. 3. Measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1. 4. Eastern Cooperative Oncology Group performance status of 0 or 1. 5. Adequate organ and marrow function: * Absolute neut…
Interventions
- DrugRuxolitinib
Janus kinase 1/2 inhibitor
- DrugRetifanlimab
Programmed cell death protein-1 blocker
Location
- University of California, San Diego Moores Cancer CenterLa Jolla, California