RecruitMe Clinical Trial

A Phase I Study with an Expansion Cohort/Randomized Phase II Study of the Combinations of Ipilimumab, Nivolumab and Brentuximab Vedotin in Patients with Relapsed/Refractory Hodgkin Lymphoma
Study of Combinations of Ipilimumab, Nivolumab, and Brentuximab Vedotin in Subjects with Hodgkin Lymphoma
Sponsor:National Cancer Institute NCI NIH DHHS
Enrolling:Male and Female Patients
Minimum Age:18 years old
IRB Number:AAAS7604
U.S. Government ID:NCT01896999
Contact: Jennifer Amengual, MD: 212-305-0591 / jea2149@cumc.columbia.edu
Additional Study Information:

Phase 1: The purpose of this study is to test the safety of the combination of multiple drugs: brentuximab vedotin which is approved for use in relapsed Hodgkin lymphoma, ipilimumab and nivolumab both drugs which stimulate your immune system, and which are approved for use in other cancers, but are investigational for Hodgkin lymphoma. We want to study using these drugs together to target your tumor and stimulate your immune system against your tumor at different dose levels, and to find out what effects, good and/or bad, these drugs used together at different dose levels have on you and your relapsed or refractory Hodgkin lymphoma. This drug combination is investigational. Brentuximab vedotin has been FDA approved used by itself to treat Hodgkin lymphoma that has relapsed after 2 chemotherapy treatments, or failed to respond to chemotherapy. Ipilimumab and Nivolumab are investigational, meaning they have not been approved by the FDA for use in your cancer, although they have been FDA approved for use in other cancers. Phase 2: The purpose of this study is to compare the combination of brentuximab vedotin and nivolumab to the combination of brentuximab vedotin, nivolumab, and ipilimumab. Both brentuximab vedotin and nivolumab are FDA-approved as single drugs for patients who have relapsed or refractory Hodgkins lymphoma. The combination of these drugs together, and with ipilimumab are not FDA-approved, so this therapy is considered an experimental treatment. The addition of ipilimumab to brentuximab vedotin and nivolumab may or may not shrink your cancer and keep it away for longer than the combination of brentuximab and nivolumab. It may also cause more side effects. This study will help the study doctors find out if this combination approach is the same or better than the usual approach of using these drugs alone. To decide if it is better, the study doctors will be looking to see if the study drugs shrink patients cancer using both treatments, and which combinat

Do You Qualify?
Are you 18 years of age or older?YesNo
Do you have relapsed or refractory classical Hodgkin Lymphoma (cHL)?YesNo
Have you been treated with at least one previous therapy (ie. chemotherapy, autologous or allogeneic stem cell transplant, etc)?YesNo
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Investigator
Jennifer Amengual, MD
You may be eligible for this study

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Who Can I Contact?
For more information, please contact:
Jennifer Amengual, MD
Email: jea2149@cumc.columbia.edu
Phone: 212-305-0591