RecruitingPhase 1Phase 2NCT03681561

Nivolumab With Ruxolitinib in Relapsed or Refractory Classical Hodgkin Lymphoma

Phase I/II Study of Nivolumab in Combination With Ruxolitinib in Relapsed or Refractory Classical Hodgkin Lymphoma


Sponsor

Veronika Bachanova

Enrollment

54 participants

Start Date

Sep 13, 2018

Study Type

INTERVENTIONAL

Conditions

Summary

This is a Phase I/II, multicenter, open-label, dose escalation/dose-expansion study to evaluate the tolerability, safety, and the maximum tolerated dose (MTD) of ruxolitinib when given with fixed dose nivolumab in patients with relapsed or refractory classical Hodgkin lymphoma (cHL).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether combining two drugs — nivolumab (an immune-boosting drug) and ruxolitinib (a drug that blocks certain inflammation signals) — can help treat Hodgkin lymphoma (a blood cancer) that has come back or stopped responding to treatment. **You may be eligible if...** - You are 18 or older - You have been diagnosed with classical Hodgkin lymphoma that came back or did not respond to treatment - You have already tried at least one prior treatment, including a checkpoint inhibitor drug (like nivolumab or pembrolizumab) - Your cancer can be seen and measured on scans - Your blood counts and organ function meet minimum health thresholds - You can swallow pills **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have a serious illness or organ dysfunction that makes the treatment too risky - You have an active autoimmune disease requiring ongoing immune-suppressing treatment - You have had certain types of prior organ or stem cell transplants - You have active hepatitis B or C, or HIV - You have uncontrolled heart rhythm problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRuxolitinib

Phase I: Ruxolitinib at assigned dose\* twice daily by mouth begin Day 1 and continuing daily until study treatment stop. * Dose Levels: 1. (starting) : 10mg twice daily 2: 15mg twice daily 3: 20mg: twice daily Phase II: Ruxolitinib 20mg twice daily by mouth begin Day 1 and continuing daily until study treatment stop.

DRUGNivolumab

Nivolumab 480 mg IV every 4 weeks (Day 1) Until disease progression, unacceptable toxicity, patient refusal or a maximum of 2 years


Locations(6)

University of Illinois Cancer Center

Chicago, Illinois, United States

Indiana Melvin and Bren Simon Comprehensive Cancer Center

Indianapolis, Indiana, United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

University of Minnesota

Minneapolis, Minnesota, United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

University of Wisconsin

Madison, Wisconsin, United States

View Full Details on ClinicalTrials.gov

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NCT03681561


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