NCT04938232

Ipilimumab With or Without Nivolumab in Relapsed/Refractory cHL

A Phase II Trial of Ipilimumab With and Without Nivolumab in Patients With Relapsed/Refractory Classic Hodgkin Lymphoma

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This is an open-label, multi-center, phase II study of ipilimumab with or without nivolumab for patients with relapsed or refractory (R/R) classic Hodgkin lymphoma (cHL). Nivolumab is a drug which is approved by the United States Food and Drug Administration (FDA) for the treatment of adult patients experiencing relapsed Hodgkin lymphoma (cHL) who have received at least two prior systemic therapies. Ipilimumab has been approved by the FDA for the treatment of metastatic melanoma (a type of skin cancer), and specific types of previously treated advanced kidney cancers. The study drugs have not been approved in combination for cHL by the Food and Drug Administration (FDA). This study is for participants who previously had progressive disease when receiving a PD-1 mAb. Participants will receive 4 cycles of ipilimumab monotherapy and then undergo restaging imaging. Patients who achieved an objective response will continue treatment with ipilimumab maintenance. Other patients will receive 4 cycles of nivolumab and ipilimumab followed by ipilimumab maintenance treatment. Patients who have progressive disease after fewer than 4 cycles of ipilimumab are eligible to proceed to combination therapy with nivolumab and ipilimumab if they are clinically stable. Participants will receive up to \~ 24 months of study treatment. After completion of therapy, participants will be followed every 3 months for 2 years and then every 6 months for the next 5 years. It is expected that about 13 people will participate in this research study. Bristol Myers Squibb (BMS) is supporting this research study by providing the study drugs and funding for the study.

Conditions

• Hodgkin Lymphoma
• Relapsed Hodgkin's Disease, Adult
• Refractory Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	Nivolumab	Intravenous infusion
DRUG	Ipilimumab	Intravenous infusion

Timeline

• Start date: 2021-06-04
• Primary completion: 2024-04-01
• Completion: 2026-08-01
• First posted: 2021-06-24
• Last updated: 2026-02-05
• Results posted: 2025-04-03

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study