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A Phase 1 Study With an Expansion Cohort/Randomized Phase 2 Study of the Combinations of Ipilimumab, Nivolumab and Brentuximab Vedotin in Patients With Relapsed/Refractory Hodgkin Lymphoma

Clinical Trial Details

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. 

Treatment arms: 
Patients on ARM K will receive: 

  • Nivolumab for 34 treatment cycles 
  • Brentuximab vedotin for 16 treatment cycles 

Patients on ARM L will receive

  • Ipilimumab for 34 treatment cycles 
  • Nivolumab for 34 treatment cycles 
  • Brentuximab vedotin for 16 treatment cycles 

The researchers estimate that you will be in the study for up to 3 years. You will receive study treatment for about 14 months if you are not receiving nivolumab. If you are receiving nivolumab, you may receive study treatment for up to two years. 

After all of your study treatment is completed, you will be asked to return to the clinic for standard follow-up tests every 3 months for one year, then every 6 months for years 2-3. You may be seen more often if your doctor determines that this is necessary. You will continue on treatment as long as you are responding to therapy and not experiencing unacceptable side effects. 

Key Eligibility: 
  • Men and women age 18 and older. 
  • Patients must have pathologically confirmed relapsed or refractory classical Hodgkin Lymphoma (cHL). 
  • Prior treatment with brentuximab vedotin is OK as long as it has not been within the past 6 months and your cancer did not come back within 6 months of completing this treatment. 
  • Patients may not have received prior nivolumab 
  • Patients should not have other serious, uncontrolled medical conditions 
  • Detailed eligibility reviewed when you contact the study team. 

Study contact by location

Upper East Side - Manhattan


Rita Vaccaro, RN
(212) 746-0702

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:






Open to Enrollment

Age Group