Study on Ipilimumab With or Without Nivolumab for Relapsed or Hard-to-Treat Classic Hodgkin's Lymphoma
Sponsor: Dana-Farber Cancer Institute
ClinicalTrials ID:NCT04938232
This clinical trial is exploring the effects of using Ipilimumab alone or combined with Nivolumab to treat patients with classic Hodgkin's lymphoma that has returned or not responded to previous treatments.
Patient Parameters
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Program Overview
This study is testing the effects of Ipilimumab, either by itself or with Nivolumab, in patients with classic Hodgkin's lymphoma (cHL) that has come back or is not responding to treatment. Ipilimumab is approved for certain skin and kidney cancers, while Nivolumab is approved for Hodgkin's lymphoma after other treatments have failed. This trial aims to see if these drugs can work together to help patients with cHL.
Description
This is a phase II study where patients with relapsed or refractory classic Hodgkin lymphoma (cHL) will receive Ipilimumab alone or in combination with Nivolumab. Nivolumab is already approved for treating Hodgkin lymphoma after other treatments have failed, and Ipilimumab is approved for certain other cancers. However, their combination is not yet approved for cHL. Participants will first receive Ipilimumab alone for 4 cycles. If their cancer responds, they will continue with Ipilimumab. If not, they will receive both Ipilimumab and Nivolumab. The treatment can last up to 24 months. After treatment, participants will have follow-up visits every 3 months for 2 years, then every 6 months for 5 years. About 13 people are expected to join this study, which is supported by Bristol Myers Squibb.
Eligibility Criteria
Inclusion Criteria
- Must have classic Hodgkin lymphoma confirmed by a participating institution.
- Must have measurable disease, with a tumor or lymph node at least 1.5 cm in size.
- Must have had at least two previous treatments, including stem cell transplant if eligible.
- Must have had disease progression after treatment with Nivolumab or Pembrolizumab.
- May have had a stem cell transplant and CAR T-cell therapy.
- Must be 18 years or older.
- Must have a performance status score of 0-2, indicating good overall health.
- Must have adequate blood and organ function.
- Must be able to understand and sign a consent form.
- Must be willing to provide a tumor sample before treatment.
- Must agree to use contraception during and after treatment.
Exclusion Criteria
- Currently receiving or have recently received other cancer treatments.
- Taking part in another clinical trial or have recently taken investigational drugs.
- Have severe allergies to monoclonal antibody therapy.
- Have had an allogeneic stem cell transplant.
- Have active autoimmune diseases or require high-dose steroids.
- Have had severe immune-related side effects from PD-1 therapy.
- Have active lung or bowel inflammation, or liver cirrhosis.
- Have had major surgery recently or not recovered from surgery.
- Have active infections like HIV or hepatitis B/C.
- Have had another cancer unless disease-free for 2 years.
- Have received a live vaccine recently.
- Have a history of not following medical advice.
- Have severe medical conditions that could affect participation.
- Have had recent serious heart conditions or strokes.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Chicago Medicine | 60637 | Chicago | Illinois |
| Massachusetts General Hospital | 02114 | Boston | Massachusetts |
| Brigham and Women's Hospital | 02115 | Boston | Massachusetts |
| Dana-Farber Cancer Institute | 02215 | Boston | Massachusetts |
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