Retifanlimab and Ruxolitinib In Solid Malignancies
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUniversity of California, San Diego
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
Pregnancy or lactation.
No prior treatment with Janus kinase inhibitors.
No more than one prior line of PD-1/PD-L1 therapy. No limit on prior lines of systemic therapy. PD-1/PD-L1 therapy does not need to be the most immediate prior line of therapy. Patients with progressive disease as best response to prior PD-1/PD-L1 therapy are not eligible. Need to have either stable disease, partial response, or complete response as best response using RECIST version 1.1 principles to prior PD-1/PD-L1 therapy.
Received systemic anti-cancer therapy within 3 weeks of enrollment or small molecule kinase inhibitors within two weeks or six elimination half-lives of enrollment, whichever is sooner.
Trial design
Treatments tested in this trial
- Ruxolitinib
- Retifanlimab
Treatment groups
40 Participants
are divided into 1 treatment groupSponsors and collaborators
University of California, San Diego
Lead sponsor
Incyte Corporation
Collaborator
Source ClinicalTrials.gov