Ipilimumab +/− Nivolumab for Hodgkin's Lymphoma

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen byReid W Merryman, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Dana-Farber Cancer Institute

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This study is looking at the effects of Ipilimumab when it is given alone or in combination with Nivolumab to patients with relapsed or refractory classic Hodgkin's lymphoma (cHL). The names of the study drugs involved in this study are: * Ipilimumab * Nivolumab

Research Team

Reid W Merryman, MD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

Adults over 18 with relapsed or refractory classic Hodgkin's lymphoma, who have measurable disease and have progressed after two or more systemic treatments including a stem cell transplant if eligible. They must not have certain infections, severe allergies to monoclonal antibodies, recent major surgeries, uncontrolled medical conditions, active pneumonitis or colitis, other cancers within the last 2 years (with some exceptions), and should agree to use contraception.

Inclusion Criteria

My Hodgkin lymphoma diagnosis was confirmed through tissue examination.

My condition worsened after at least two treatments, including a stem cell transplant if I was eligible.

I am able to get out of my bed or chair and move around.

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Exclusion Criteria

I have had a stem cell transplant from a donor.

Other uncontrolled intercurrent illness that would limit adherence to study requirements

History of noncompliance to medical regimens

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Treatment Details

Interventions

Ipilimumab (Checkpoint Inhibitor)
Nivolumab (Checkpoint Inhibitor)

Trial OverviewThe trial is testing the effectiveness of Ipilimumab alone versus in combination with Nivolumab for patients whose Hodgkin's lymphoma has returned or hasn't responded to treatment. It aims to see which approach is better at controlling the disease.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Disease Progression after previous therapyExperimental Treatment2 Interventions

Participants will receive Ipilimumab alone and depending on response will receive either a maintenance course of Ipilimumab or a course of Nivolumab and Ipilimumab in combination followed by a maintenance course of Ipilimumab. Patients who have progressive disease after fewer than 4 cycles of ipilimumab are also eligible to proceed to combination therapy with nivolumab and ipilimumab, if they are clinically stable. * Ipilimumab Monotherapy: Every 3 weeks for 4 study cycles * Complete Response/Partial Response: Maintenance Ipilimumab every 12 weeks for 8 cycles * Stable or Progressive Disease Response: Nivolumab and Ipilimumab every 3 weeks for 4 study cycles, followed by Maintenance Ipilimumab every 12 weeks for 7 cycles