Study on Retifanlimab and Ruxolitinib for Advanced Kidney and Lung Cancers
Sponsor: University of California, San Diego
ClinicalTrials ID:NCT07219576
This clinical trial is testing the safety and effectiveness of combining two drugs, retifanlimab and ruxolitinib, in treating advanced kidney and lung cancers. The study aims to find the highest safe dose of ruxolitinib that can be used with retifanlimab.
Patient Parameters
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Program Overview
The purpose of this study is to determine the safest dose of the drug ruxolitinib when used together with retifanlimab in patients with advanced kidney (renal cell carcinoma) and lung (non-small cell lung carcinoma) cancers. Participants will take ruxolitinib twice daily and keep a diary of their doses. They will also visit the clinic every four weeks for retifanlimab infusions and regular checkups and tests.
Description
This study focuses on advanced kidney and lung cancers that have not responded well to previous treatments. The combination of retifanlimab and ruxolitinib is being tested to see if it can help patients who have developed resistance to standard immunotherapy treatments.
Ruxolitinib is a drug that may help restore the immune system's ability to fight cancer, while retifanlimab is an immunotherapy drug that blocks a protein called PD-1, which can help cancer cells hide from the immune system. Previous studies have shown promising results with similar drug combinations, and this trial aims to build on those findings.
Participants will take ruxolitinib at home and visit the clinic for retifanlimab infusions every four weeks. The study will monitor the safety and effectiveness of this treatment combination, with the goal of finding the best dose of ruxolitinib to use with retifanlimab.
Eligibility Criteria
Inclusion Criteria
- Have advanced or metastatic kidney or lung cancer that has progressed after previous PD-1/PD-L1 therapy.
- Decline or have no available standard treatment options.
- Have measurable disease according to specific medical criteria.
- Be in good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Have adequate organ and bone marrow function, including:
- Neutrophil count of at least 1.0×10^9/L.
- Platelet count of at least 100×10^9/L.
- Hemoglobin level of at least 8.5 g/dL without recent blood transfusions.
- Serum creatinine of 2 mg/dL or less.
- Liver enzymes and bilirubin within specified limits.
- Be able to take oral medication and willing to follow the study procedures.
- Agree to participate in all study activities and be available for the study duration.
Exclusion Criteria
- Pregnant or breastfeeding women.
- Previous treatment with Janus kinase inhibitors.
- More than one prior line of PD-1/PD-L1 therapy.
- Recent systemic anti-cancer therapy or radiotherapy.
- Recent major surgery without adequate recovery.
- Unresolved side effects from previous immunotherapy.
- Active brain metastases or certain autoimmune diseases requiring treatment.
- Active infections or history of certain viral infections without control.
- Significant heart disease or other serious medical conditions.
- Known allergy to study drugs or their components.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of California, San Diego Moores Cancer Center | 92093 | La Jolla | California |
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