Ipilimumab With or Without Nivolumab in Relapsed/Refractory cHL

Status Active, not recruiting

Clinical Trial 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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04938232
Study type	Interventional
Source	Dana-Farber Cancer Institute
Contact
Status	Active, not recruiting
Phase	Phase 2
Start date	June 4, 2021
Completion date	August 1, 2026

View Details

See also
Status	Clinical Trial	Phase
Suspended	`NCT05400122` - Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer	Phase 1
Completed	`NCT01947140` - Pralatrexate + Romidepsin in Relapsed/Refractory Lymphoid Malignancies	Phase 1/Phase 2
Recruiting	`NCT05019976` - Radiation Dose Study for Relapsed/Refractory Hodgkin/Non-Hodgkin Lymphoma	N/A
Active, not recruiting	`NCT03617666` - Avelumab in the Frontline Treatment of Advanced Classical Hodgkin Lymphoma - a Window Study	Phase 2
Completed	`NCT04666025` - SARS-CoV-2 Donor-Recipient Immunity Transfer
Recruiting	`NCT02507479` - Thiotepa-based Conditioning for Allogeneic Stem-cell Transplantation (SCT) in Lymphoid Malignancies	Phase 2
Active, not recruiting	`NCT02191930` - Brentuximab Vedotin or B-CAP in the Treatment of Older Patients With Newly Diagnosed Classical Hodgkin Lymphoma	Phase 2
Completed	`NCT01943682` - Safety Study of CPX-351 in Children With Relapsed Leukemia or Lymphoma	Phase 1
Completed	`NCT01393106` - Safety and Efficacy of Idelalisib in Relapsed or Refractory Hodgkin Lymphoma	Phase 2
Terminated	`NCT00992030` - R-ABVD vs ABVD-RT in Early Stage Hodgkin's Lymphoma	Phase 3
Terminated	`NCT00722865` - Avastin (Bevacizumab) Plus Adriamycin, Bleomycin, Vinblastine and Dacarbazine (ABVD) for Advanced Stage Hodgkin Lymphoma	Phase 2
Unknown status	`NCT00598624` - Clinical Trial to Evaluate the Safety and Efficacy of Treosulfan Based Conditioning Prior to Allogeneic Haematopoietic Stem Cell Transplantation (HSCT)	Phase 2
Completed	`NCT03242902` - To Decrease Fatigue With Light Therapy	Phase 3
Active, not recruiting	`NCT05205512` - Telehealth Exercise Intervention to Improve Cardiovascular Health in Lymphoma Survivors, TECHS Trial	N/A
Recruiting	`NCT03681561` - Nivolumab With Ruxolitinib in Relapsed or Refractory Classical Hodgkin Lymphoma	Phase 1/Phase 2
Recruiting	`NCT03250962` - SHR-1210 Alone or in Combination With Decitabine in Relapsed or Refractory Hodgkin Lymphoma	Phase 2
Recruiting	`NCT04510610` - Camrelizumab Plus Decitabine in Anti-PD-1 Treatment-naive Patients With Relapsed/Refractory Classical Hodgkin Lymphoma	Phase 2/Phase 3
Completed	`NCT06295211` - Brentuximab Vedotin Combined With Bendamustine Supercharge, a Low-toxicity and Efficient Salvage Regimen for Primary Refractory or First-relapsed Classic Hodgkin Lymphoma: Long-term Results of a Retrospective Monocenter Study.
Active, not recruiting	`NCT02256137` - A Longitudinal Assessment of Frailty in Young Adult Survivors of Childhood Cancer
Completed	`NCT02432235` - Study of ADCT-301 in Patients With Relapsed or Refractory Hodgkin and Non-Hodgkin Lymphoma	Phase 1