Nivolumab + Ruxolitinib for Hodgkin's Lymphoma
What You Need to Know Before You Apply
What is the purpose of this trial?
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).
Will I have to stop taking my current medications?
The trial requires a 1-week washout period (time without taking certain medications) for those currently on strong CYP3A4 inhibitors or Fluconazole over 200 mg/day. Other medications are not specifically mentioned, so it's best to discuss your current medications with the trial team.
Is the combination of Nivolumab and Ruxolitinib safe for treating Hodgkin's Lymphoma?
Nivolumab, used alone or with other treatments, has shown a generally acceptable safety profile in patients with Hodgkin's Lymphoma, with common side effects including fatigue, rash, and thyroid issues. Serious side effects like pneumonitis (lung inflammation) and neutropenia (low white blood cell count) can occur, but they are less common. Ruxolitinib's safety in combination with Nivolumab specifically for Hodgkin's Lymphoma isn't detailed here, but both drugs have been used safely in other contexts.12345
How is the drug combination of Nivolumab and Ruxolitinib unique for treating Hodgkin's Lymphoma?
The combination of Nivolumab and Ruxolitinib is unique because Nivolumab is an immune checkpoint inhibitor that helps the immune system attack cancer cells, while Ruxolitinib is a JAK inhibitor that can reduce inflammation and potentially enhance the immune response. This combination may offer a novel approach by targeting different pathways compared to standard treatments.678910
What data supports the effectiveness of the drug Nivolumab for Hodgkin's Lymphoma?
Nivolumab has shown effectiveness in treating relapsed or refractory Hodgkin lymphoma, with studies indicating frequent and durable responses. It is approved in the USA for this condition, and its combination with other treatments like brentuximab vedotin has been explored for enhanced efficacy.6891112
Who Is on the Research Team?
Veronkia Bachanova
Principal Investigator
University of Minnesota
Are You a Good Fit for This Trial?
Adults over 18 with classical Hodgkin lymphoma that's come back or hasn't responded to treatment, including checkpoint inhibitors. They must have measurable disease, be in fair health (ECOG 0-2), and have normal organ function tests. Participants need prior treatments like chemotherapy and possibly a transplant but should be recovered from these treatments. Women of childbearing age must test negative for pregnancy, and sexually active participants must use contraception.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Phase I
Participants receive ruxolitinib at their assigned dose taken orally twice daily on a 28-day cycle combined with nivolumab 480 mg IV administered every 4 weeks until disease progression, unacceptable toxicity, or for a maximum of 2 years.
Treatment Phase II
Participants receive ruxolitinib at 20mg orally twice daily on a 28-day cycle combined with nivolumab 480 mg IV administered every 4 weeks until disease progression, unacceptable toxicity, or for a maximum of 2 years.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Nivolumab
- Ruxolitinib
Nivolumab is already approved in United States, European Union, Canada, Switzerland for the following indications:
- Advanced or metastatic gastric cancer
- Gastroesophageal junction cancer
- Esophageal adenocarcinoma
- Melanoma
- Non-small cell lung cancer
- Renal cell carcinoma
- Hodgkin lymphoma
- Head and neck squamous cell carcinoma
- Urothelial carcinoma
- Colorectal cancer
- Hepatocellular carcinoma
- Esophageal squamous cell carcinoma
- Melanoma
- Non-small cell lung cancer
- Renal cell carcinoma
- Hodgkin lymphoma
- Head and neck squamous cell carcinoma
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Gastroesophageal junction cancer
- Esophageal adenocarcinoma
- Melanoma
- Non-small cell lung cancer
- Renal cell carcinoma
- Hodgkin lymphoma
- Head and neck squamous cell carcinoma
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Gastroesophageal junction cancer
- Esophageal adenocarcinoma
- Melanoma
- Non-small cell lung cancer
- Renal cell carcinoma
- Hodgkin lymphoma
- Head and neck squamous cell carcinoma
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Gastroesophageal junction cancer
- Esophageal adenocarcinoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Veronika Bachanova
Lead Sponsor
Incyte Corporation
Industry Sponsor
Steven Stein
Incyte Corporation
Chief Medical Officer since 2015
MD from University of Witwatersrand
Hervé Hoppenot
Incyte Corporation
Chief Executive Officer since 2014
MBA from ESSEC Business School
Bristol-Myers Squibb
Industry Sponsor
Christopher Boerner
Bristol-Myers Squibb
Chief Executive Officer since 2023
PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis
Deepak L. Bhatt
Bristol-Myers Squibb
Chief Medical Officer since 2024
MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania