Ipilimumab With or Without Nivolumab in Relapsed/Refractory cHL
Part of paid clinical trials in Chicago, Illinois.
- Sponsor
- Dana-Farber Cancer Institute
- Study ID
- NCT04938232
- Phase
- PHASE2
- Status
- Active Not Recruiting
Conditions
- Hodgkin Lymphoma
- Refractory Hodgkin Lymphoma
- Relapsed Hodgkin's Disease, Adult
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Nivolumab — DRUGIntravenous infusion
- Ipilimumab — DRUGIntravenous infusion
Study Details
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
Key Dates
- Start date
- Jun 4, 2021
- Status verified
- Jan 2026
- Primary completion
- Apr 1, 2024
- Completion
- Aug 1, 2026
Study Design
- Enrollment
- 13 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Disease Progression after previous therapyParticipants 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
Primary Outcome Measure
Overall Response Rate (ORR) [ Time Frame: From enrollment to completion of 4 cycles (each cycle is 21 days) of treatment ]
Locations (4)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Chicago Medicine | Chicago | Illinois | 60637 | - |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | - |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | - |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | - |
Related coverage on Hipa.ai
- Nivolumab Combination Trial in Relapsed/Refractory cHL Reports ORR of 15%Nivolumab · Apr 3, 2025 · ClinicalTrials.gov
Find similar trials in Chicago, IL
Related Studies
- A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs)Recruiting · Center for International Blood and Marrow Transplant Research · Birmingham, Alabama
- Nivolumab With Ruxolitinib in Relapsed or Refractory Classical Hodgkin LymphomaPHASE1/PHASE2 · Recruiting · Veronika Bachanova · Chicago, Illinois
- Testing the Combination of Nivolumab and ASTX727 for Relapsed or Refractory B-Cell LymphomaPHASE1 · Recruiting · National Cancer Institute (NCI) · Birmingham, Alabama
- Tagraxofusp in Pediatric Patients With Relapsed or Refractory CD123 Expressing Hematologic MalignanciesPHASE1 · Recruiting · Therapeutic Advances in Childhood Leukemia Consortium · Los Angeles, California