Actively Recruiting
Retifanlimab and Ruxolitinib In Solid Malignancies
Led by University of California, San Diego · Updated on 2026-01-13
40
Participants Needed
1
Research Sites
203 weeks
Total Duration
On this page
Sponsors
U
University of California, San Diego
Lead Sponsor
I
Incyte Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Retifanlimab and Ruxolitinib In Solid Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Advanced or metastatic clear cell renal cell carcinoma or non-small cell lung carcinoma with progression on prior PD-1/PD-L1 therapy within 6 months of stopping immunotherapy
- Declined standard of care treatment or no available standard treatment options
- Measurable disease according to Response Evaluation Criteria in Solid Tumors version 1.1
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Adequate organ and marrow function, including neutrophil count 1.0 x 10^9/L, platelet count 100 x 10^9/L, hemoglobin level 8.5 g/dL without recent transfusion or erythropoietin dependence, serum creatinine 2 mg/dL or estimated creatinine clearance 30 mL/min, liver enzymes and bilirubin within specified limits
- Ability to take oral medication and willingness to adhere to study treatment
- Willingness to comply with all study procedures and be available for the entire study duration
You will not qualify if you...
- Pregnancy or breastfeeding
- No prior treatment with Janus kinase inhibitors
- More than one prior line of PD-1/PD-L1 therapy or progressive disease as best response to prior PD-1/PD-L1 therapy
- Recent systemic anti-cancer therapy within 3 weeks or kinase inhibitors within 2 weeks or six elimination half-lives before enrollment
- Radiotherapy within one week before enrollment
- Major surgery within two weeks before enrollment without adequate healing
- Unresolved immune-related adverse events greater than grade 1
- Active central nervous system metastases or carcinomatous meningitis (except stable treated brain metastases without steroids for 14 days)
- Active or history of autoimmune disease requiring steroids or immunosuppressive agents, with some exceptions for controlled conditions
- Immunodeficiency or use of systemic steroids or immunosuppressants within 7 days before treatment
- Active infections needing systemic antimicrobial treatment within 7 days before treatment
- Active tuberculosis
- HIV infection with detectable viral load
- Active hepatitis B or C infection without successful treatment and undetectable viral load
- Significant cardiovascular disease within recent months
- Additional progressing malignancies requiring treatment within 2 years, with some low-risk cancers allowed
- Inability to swallow oral medications or gastrointestinal disorders affecting absorption
- Other unstable or uncontrolled medical conditions
- Allergies to components of retifanlimab or ruxolitinib
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of California, San Diego Moores Cancer Center
La Jolla, California, United States, 92093
Actively Recruiting
Research Team
R
Rana McKay, MD
CONTACT
A
Alexandrea Cronin
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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