Ibrutinib + Nivolumab for Hodgkin's Lymphoma

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byLapo Alinari, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Ohio State University Comprehensive Cancer Center

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This phase II trial studies how well ibrutinib and nivolumab work in treating patients with classical Hodgkin lymphoma that has come back or has not responded to treatment. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as nivolumab, may block cancer growth in different ways by targeting certain cells. Giving ibrutinib and nivolumab may work better in treating patients with classical Hodgkin lymphoma.

Eligibility Criteria

This trial is for adults with classical Hodgkin lymphoma that has returned or hasn't responded to treatment. They must have had at least one prior therapy, not be pregnant or nursing, and agree to use contraception. People can't join if they've had certain other cancers, severe heart disease, gastrointestinal issues, CNS lymphoma involvement, significant liver impairment, a history of stroke recently, ongoing immunosuppression (except low-dose steroids), active autoimmune diseases or need strong CYP3A inhibitors.

Inclusion Criteria

I have had a transplant using my own cells before.

I have previously been treated with nivolumab.

I am not planning to undergo a transplant using my own cells.

+17 more

Exclusion Criteria

I do not have serious heart problems like recent heart attacks or uncontrolled heart rhythm issues.

My lymphoma has spread to my brain or spinal cord.

I need treatment with a strong medication that affects liver enzymes.

+10 more

Participant Groups

The trial tests how well the combination of Ibrutinib (an enzyme blocker) and Nivolumab (a monoclonal antibody) works in treating relapsed/refractory classical Hodgkin lymphoma compared to previous treatments. It's a phase II study which means it focuses on the effectiveness and further examines side effects.

1Treatment groups

Experimental Treatment

Group I: Treatment (ibrutinib, nivolumab)Experimental Treatment3 Interventions

Patients receive ibrutinib PO QD on days 1-21 and nivolumab IV continuously over 60 minutes on day 1. Treatment with nivolumab repeats every 21 days for up to 16 courses and treatment with ibrutinib continues in the absence of disease progression or unacceptable toxicity.

Ibrutinib is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Imbruvica for: