Retifanlimab and Ruxolitinib In Solid Malignancies

Part of paid clinical trials in La Jolla, California.

Sponsor
University of California, San Diego
Study ID
NCT07219576
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Jan 8, 2026
Status verified
Jan 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2029

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: ruxolitinib plus retifanlimab
    Combination of the Janus kinase 1/2 inhibitor ruxolitinib plus the programmed cell death protein-1 blocker retifanlimab. The study utilizes a standard 3+3 dose escalation design evaluating 2 dose escalation levels (15 mg and 20 mg orally twice daily) and 2 dose de-escalation levels (10 mg and 5 mg orally twice daily, if necessary) of ruxolitinib with fixed dose retifanlimab (500 mg intravenously every 4 weeks), followed by an expansion cohort at the recommended phase 2 dose.

Primary Outcome Measure

Recommended phase 2 dose [ Time Frame: 28 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San Diego Moores Cancer CenterLa JollaCalifornia92093
Alexandrea Cronin
[email protected]
(858) 822-5354
Rana McKay, MD (PRINCIPAL_INVESTIGATOR)

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