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New treatment option for Non Small Cell Lung Carcinoma
Official title Retifanlimab and Ruxolitinib In Solid Malignancies
ClinicalTrials.gov ID: NCT07219576
What this study is testing
What is Ruxolitinib?
Ruxolitinib is an investigational medicine, given as a twice-daily infusion into a vein, being studied as a potential treatment for non small cell lung carcinoma.
Also referred to as Jakafi, Jakavi.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join if
- Advanced or metastatic clear cell renal cell carcinoma or non-small cell lung carcinoma having progressed on prior PD-1/PD-L1 therapy (radiographic...
- 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.
- Adequate organ and marrow function:
You likely can't join if
- 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...
- Received systemic anti-cancer therapy within 3 weeks of enrollment or small molecule kinase inhibitors within two weeks or six elimination half-lives...
- Has received prior radiotherapy within one week before enrollment.
- Has had history of major surgery less than two weeks before enrollment. Adequate wound healing after major surgery must be assessed clinically.
See the full eligibility criteria
Who can join
- 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...
- 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.
- Adequate organ and marrow function:
- Absolute neutrophil count ≥ 1.0×10\^9/L.
- Platelet count ≥ 100×10\^9/L.
- Hemoglobin level ≥ 8.5 g/dL; criteria must be met without erythropoietin dependency and without packed red blood cell transfusion within the last 2 weeks.
- Serum creatinine ≤ 2 mg/dL (or estimated creatinine clearance ≥ 30 mL/minute calculated by the Cockcroft Gault or Modification of Diet in Renal Disease formulas).
- Aspartate Aminotransferase and Alanine Aminotransferase ≤ 2.5 x upper limit of normal.
- Bilirubin ≤1.5 x upper limit of normal.
- Ability to take oral medication and be willing to adhere to the study intervention.
- Willingness to comply with all study procedures and availability for the duration of the study.
What rules you out
- 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...
- 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.
- Has received prior radiotherapy within one week before enrollment.
- Has had history of major surgery less than two weeks before enrollment. Adequate wound healing after major surgery must be assessed clinically.
- Failure to recover from any immune related adverse event from prior immunotherapy to Common Terminology Criteria in Adverse Event grade ≤ 1 (participants with grade ≤ 2 sensory neuropathy, endocrinopathies controlled by...
- Known active central nervous system metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate, provided they are clinically stable and without the requirement of...
- Known active or history of autoimmune disease that requires steroids or immunosuppressive agents. Patients are allowed in the study if they have vitiligo, type 1 diabetes mellitus, controlled asthma; residual hypo- or...
- Diagnosis of immunodeficiency or receiving systemic steroid therapy (equivalent of prednisone \> 10 mg daily) or any other form of immunosuppressive therapy within seven days prior to the first dose of study treatment...
- Active infections requiring systemic antibiotics or antifungal or antiviral treatment within 7 days before first dose of study treatment.
- Active tuberculosis.
- Active immunodeficiency virus (HIV) infection. To be enrolled, patients with history of HIV must have an undetectable viral load at screening.
- Active hepatitis B or hepatitis C virus infections. To be enrolled, patients with a history of these infections must have been treated and cured with undetectable viral load at screening.
- Have clinically significant cardiovascular disease defined as:
- Cerebral vascular accident/stroke or myocardial infarction (\<6 months prior to enrollment)
- Unstable angina, congestive heart failure exacerbation (New York Heart Association Classification ≥ Class II), or unstable cardiac arrhythmia (\< 3 months prior to enrollment). Stable cardiac arrhythmia (such as atrial...
- Known additional malignancy that is progressing or has required active treatment within the past 2 years. Patients with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, low grade prostate cancer...
- Unable to swallow orally administered medication intact or has a history or current evidence of a gastrointestinal disorder (e.g., inflammatory bowel disease, Crohn's disease, ulcerative colitis, gastrectomy, partial...
- History or evidence of any other clinically unstable/uncontrolled disorder, condition, or disease (including, but not limited to, cardiopulmonary, renal, metabolic, hematologic, or psychiatric) other than their primary...
- Known allergy or hypersensitivity to any component or formulation components of retifanlimab and ruxolitinib.
The study team makes the final eligibility decision.
Where it's taking place
- La Jolla, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include La Jolla, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.