54 Participants Needed

Nivolumab + Ruxolitinib for Hodgkin's Lymphoma

Recruiting at 2 trial locations
VB
RL
AL
Overseen ByAhran Lee
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

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?

VB

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

I've had treatment with checkpoint inhibitors and my cancer either got worse, stayed the same, or partially improved.
I have tried at least 2 treatments including chemotherapy and transplantation without success.
Written informed consent and HIPAA authorization for release of personal health information
See 13 more

Exclusion Criteria

My lymphoma affects my brain or spinal cord.
I have heart problems that are not well-managed.
I am currently taking immunosuppressive drugs, including steroids.
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

Up to 24 months
Monthly visits for IV administration

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.

Up to 24 months
Monthly visits for IV administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

What Are the Treatments Tested in This Trial?

Interventions

  • Nivolumab
  • Ruxolitinib
Trial Overview The trial is testing the combination of Ruxolitinib with Nivolumab to find the highest dose patients can take without severe side effects (MTD). It's an early-phase study where everyone gets both drugs at varying doses to see how well they work together against relapsed or refractory classical Hodgkin lymphoma.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Phase II: Ruxolitinib and NivolumabExperimental Treatment2 Interventions
Participants will receive ruxolitinib at 20mg orally twice daily on a 28-day cycle combined with nivolumab 480 mg IV administered every 4 weeks (i.e. on Day 1 of a 28-day cycle) until disease progression, unacceptable toxicity, or for a maximum of 2 years.
Group II: Phase I:Ruxolitinib and NivolumabExperimental Treatment2 Interventions
Participants will 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 (i.e. on Day 1 of a 28-day cycle) until disease progression, unacceptable toxicity, or for a maximum of 2 years.

Nivolumab is already approved in United States, European Union, Canada, Switzerland for the following indications:

🇺🇸
Approved in United States as Opdivo for:
  • 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
🇪🇺
Approved in European Union as Opdivo for:
  • 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
🇨🇦
Approved in Canada as Opdivo for:
  • 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
🇨🇭
Approved in Switzerland as Opdivo for:
  • 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

Trials
1
Recruited
50+

Incyte Corporation

Industry Sponsor

Trials
408
Recruited
66,800+
Steven Stein profile image

Steven Stein

Incyte Corporation

Chief Medical Officer since 2015

MD from University of Witwatersrand

Hervé Hoppenot profile image

Hervé Hoppenot

Incyte Corporation

Chief Executive Officer since 2014

MBA from ESSEC Business School

Bristol-Myers Squibb

Industry Sponsor

Trials
2,731
Recruited
4,127,000+
Headquarters
New York City, USA
Known For
Oncology & Cardiovascular
Top Products
Eliquis, Opdivo, Revlimid, Orencia
Christopher Boerner profile image

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 profile image

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania

Published Research Related to This Trial

Nivolumab is an effective immune checkpoint inhibitor for treating various cancers, including melanoma and non-small-cell lung cancer, and its efficacy may be linked to the expression of PD-L1 in tumors.
In comparing two antibodies for detecting PD-L1, the 28-8 antibody showed superior detection capabilities over E1L3N, highlighting the importance of antibody choice and detection methods in assessing PD-L1 expression for predicting treatment outcomes.
An Analytical Comparison of Dako 28-8 PharmDx Assay and an E1L3N Laboratory-Developed Test in the Immunohistochemical Detection of Programmed Death-Ligand 1.Cogswell, J., Inzunza, HD., Wu, Q., et al.[2021]
Brentuximab vedotin (BV) and nivolumab (NV) have shown high response rates as monotherapies for refractory or relapsed classical Hodgkin lymphoma (RRHL), although there is still a risk of disease progression.
Combining BV or NV with chemotherapy may enhance treatment effectiveness and serve as a bridge to hematopoietic stem cell transplantation, potentially leading to better survival rates for patients with RRHL.
Efficacy of Brentuximab Vedotin and Nivolumab in Refractory or Relapsed Hodgkin Lymphoma: A Systematic Review.Macapagal, SC., Lee, H., Abdul Jabbar, J., et al.[2022]
In a study of 21 patients with relapsed and refractory classic Hodgkin lymphoma who had previously failed nivolumab treatment, the combination of nivolumab and brentuximab vedotin showed a promising overall response rate of 57%.
The treatment was found to be relatively safe, with 63% of patients experiencing any grade adverse events, and only 10% experiencing severe (grade 3-4) adverse events, suggesting that this combination therapy could be a viable option for patients after PD-1 inhibitor failure.
Efficacy and safety of nivolumab combined with brentuximab vedotin after nivolumab monotherapy failure in patients with relapsed and refractory classic Hodgkin lymphoma.Fedorova, LV., Lepik, KV., Volkov, NP., et al.[2023]

Citations

An Analytical Comparison of Dako 28-8 PharmDx Assay and an E1L3N Laboratory-Developed Test in the Immunohistochemical Detection of Programmed Death-Ligand 1. [2021]
Efficacy of Brentuximab Vedotin and Nivolumab in Refractory or Relapsed Hodgkin Lymphoma: A Systematic Review. [2022]
Efficacy and safety of nivolumab combined with brentuximab vedotin after nivolumab monotherapy failure in patients with relapsed and refractory classic Hodgkin lymphoma. [2023]
Nivolumab for Newly Diagnosed Advanced-Stage Classic Hodgkin Lymphoma: Safety and Efficacy in the Phase II CheckMate 205 Study. [2021]
Ipilimumab, nivolumab, and brentuximab vedotin combination therapies in patients with relapsed or refractory Hodgkin lymphoma: phase 1 results of an open-label, multicentre, phase 1/2 trial. [2021]
Safety and Efficacy of Anti-PD-1 Monoclonal Antibodies in Patients With Relapsed or Refractory Lymphoma: A Meta-Analysis of Prospective Clinic Trails. [2020]
A real-world analysis of PD1 blockade from the Rete Ematologica Pugliese (REP) in patients with relapse/refractory Hodgkin's lymphoma. [2023]
Strategies for Recognizing and Managing Immune-Mediated Adverse Events in the Treatment of Hodgkin Lymphoma with Checkpoint Inhibitors. [2020]
Concurrent pembrolizumab with AVD for untreated classic Hodgkin lymphoma. [2023]
Multicenter phase II study of nivolumab in Japanese patients with relapsed or refractory classical Hodgkin lymphoma. [2022]
Final results of a phase II study of nivolumab in Japanese patients with relapsed or refractory classical Hodgkin lymphoma. [2022]
Two primary cancers appeared after discontinuation of nivolumab in the course of treating Hodgkin lymphoma: a case report. [2023]
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