Clinical trialNCT04759586Active, not recruitingPhase 3Interventional

Nivolumab in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma

SponsorNational Cancer Institute (NCI)Enrollment244Primary Mediastinal Large B-Cell Lymphoma

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This phase III trial compares the effects of nivolumab with chemo-immunotherapy versus chemo-immunotherapy alone in treating patients with newly diagnosed primary mediastinal B-cell lymphoma (PMBCL). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of cancer cells to grow and spread. Treatment for PMBCL involves chemotherapy combined with an immunotherapy called rituximab. Chemotherapy drugs work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Giving nivolumab with chemo-immunotherapy may help treat patients with PMBCL.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Lisa G Roth
Children's Oncology Group
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

233 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Australia

John Hunter Children'S Hospital
Hunter Regional Mail Centre, New South Wales, Australia
the Children'S Hospital at Westmead
Westmead, New South Wales, Australia
Queensland Children'S Hospital
South Brisbane, Queensland, Australia
Royal Children'S Hospital
Parkville, Victoria, Australia
Perth Children'S Hospital
Perth, Western Australia, Australia

Canada

University of Alberta Hospital
Edmonton, Alberta, Canada
Cancercare Manitoba
Winnipeg, Manitoba, Canada
Janeway Child Health Centre
St. John's, Newfoundland and Labrador, Canada
Iwk Health Centre
Halifax, Nova Scotia, Canada
Mcmaster Children'S Hospital at Hamilton Health Sciences
Hamilton, Ontario, Canada
Children'S Hospital
London, Ontario, Canada
Children'S Hospital of Eastern Ontario
Ottawa, Ontario, Canada
Hospital for Sick Children
Toronto, Ontario, Canada
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, Canada
the Montreal Children'S Hospital of the Muhc
Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
Sherbrooke, Quebec, Canada
Chu de Quebec-Centre Hospitalier de L'Universite Laval (chul)
Québec, Canada

Puerto Rico

Hima San Pablo Oncologic Hospital
Caguas, Puerto Rico

United States

Children'S Hospital of Alabama
Birmingham, Alabama, United States
Usa Health Strada Patient Care Center
Mobile, Alabama, United States
Providence Alaska Medical Center
Anchorage, Alaska, United States
Banner Children'S at Desert
Mesa, Arizona, United States
Banner University Medical Center - Tucson
Tucson, Arizona, United States
Arkansas Children'S Hospital
Little Rock, Arkansas, United States
Uc Irvine Health Cancer Center-Newport
Costa Mesa, California, United States
Kaiser Permanente Downey Medical Center
Downey, California, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
City of Hope at Irvine Lennar
Irvine, California, United States
Uci Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, United States
Loma Linda University Medical Center
Loma Linda, California, United States
Miller Children'S and Women'S Hospital Long Beach
Long Beach, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Children'S Hospital Los Angeles
Los Angeles, California, United States
Mattel Children'S Hospital Ucla
Los Angeles, California, United States
Valley Children'S Hospital
Madera, California, United States
Kaiser Permanente-Oakland
Oakland, California, United States
Children'S Hospital of Orange County
Orange, California, United States
Uc Irvine Health/chao Family Comprehensive Cancer Center
Orange, California, United States
Lucile Packard Children'S Hospital Stanford University
Palo Alto, California, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States

193 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Cyclophosphamide →Doxorubicin →Etoposide →Filgrastim →Nivolumab →Pegfilgrastim →Prednisolone →Prednisone →Rituximab →Rituximab and Hyaluronidase HumanVincristine →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 5 Oct 2021
Primary completion: 30 Jun 2027
Completion: 30 Jun 2027
Last update posted: 4 Nov 2026
Registered enrollment: 244
Registry id: NCT04759586

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 11 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.