Nivolumab in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma
Condition(s) studied
Investigational drug(s) / intervention(s)
Biospecimen Collection: Undergo blood and CSF sample collection
Bone Marrow Aspiration: Undergo bone marrow biopsy and aspiration
Bone Marrow Biopsy: Undergo bone marrow biopsy and aspiration
Computed Tomography: Undergo CT or PET/CT
Cyclophosphamide: Given IV
Doxorubicin Hydrochloride: Given IV
Echocardiography Test: Undergo ECHO
Etoposide Phosphate: Given IV
Filgrastim: Given SC
Lumbar Puncture: Undergo LP
Nivolumab: Given IV
Pegfilgrastim: Given SC
Positron Emission Tomography: Undergo PET/CT
Prednisolone: Given PO
Prednisone: Given PO
Radiation Therapy: Undergo radiation therapy
Rituximab: Given IV
Rituximab and Hyaluronidase Human: Given SC
Vincristine Sulfate: Given IV
Study summary
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.
Eligibility
Primary outcome measure(s)
- Progression-free survival (PFS) — From enrollment on the study to first occurrence of relapse/progression or death, assessed up to 7 years
The primary analysis will be a one-sided Log-rank test stratified by choice of backbone and radiation therapy and whether the patient had a cycle of therapy prior to enrolling.
Trial sites (233)
| Facility | City | Region | Status |
|---|---|---|---|
| Children's Hospital of Alabama | Birmingham | Alabama | |
| USA Health Strada Patient Care Center | Mobile | Alabama | |
| Providence Alaska Medical Center | Anchorage | Alaska | |
| Banner Children's at Desert | Mesa | Arizona | |
| Banner University Medical Center - Tucson | Tucson | Arizona | |
| Arkansas Children's Hospital | Little Rock | Arkansas | |
| UC Irvine Health Cancer Center-Newport | Costa Mesa | California | |
| Kaiser Permanente Downey Medical Center | Downey | California | |
| City of Hope Comprehensive Cancer Center | Duarte | California | |
| UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care | Irvine | California | |
| City of Hope at Irvine Lennar | Irvine | California | |
| Loma Linda University Medical Center | Loma Linda | California | |
| Miller Children's and Women's Hospital Long Beach | Long Beach | California | |
| Children's Hospital Los Angeles | Los Angeles | California | |
| Cedars-Sinai Medical Center | Los Angeles | California | |
| Mattel Children's Hospital UCLA | Los Angeles | California | |
| Valley Children's Hospital | Madera | California | |
| Kaiser Permanente-Oakland | Oakland | California | |
| Children's Hospital of Orange County | Orange | California | |
| UC Irvine Health/Chao Family Comprehensive Cancer Center | Orange | California | |
| Lucile Packard Children's Hospital Stanford University | Palo Alto | California | |
| University of California Davis Comprehensive Cancer Center | Sacramento | California | |
| Rady Children's Hospital - San Diego | San Diego | California | |
| Children's Hospital Colorado | Aurora | Colorado | |
| Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center | Denver | Colorado | |
| Connecticut Children's Medical Center | Hartford | Connecticut | |
| Alfred I duPont Hospital for Children | Wilmington | Delaware | |
| MedStar Georgetown University Hospital | Washington D.C. | District of Columbia | |
| Children's National Medical Center | Washington D.C. | District of Columbia | |
| Broward Health Medical Center | Fort Lauderdale | Florida | |
| Golisano Children's Hospital of Southwest Florida | Fort Myers | Florida | |
| UF Health Cancer Institute - Gainesville | Gainesville | Florida | |
| Memorial Regional Hospital/Joe DiMaggio Children's Hospital | Hollywood | Florida | |
| Nemours Children's Clinic-Jacksonville | Jacksonville | Florida | |
| University of Miami Miller School of Medicine-Sylvester Cancer Center | Miami | Florida | |
| Arnold Palmer Hospital for Children | Orlando | Florida | |
| Nemours Children's Hospital | Orlando | Florida | |
| Johns Hopkins All Children's Hospital | St. Petersburg | Florida | |
| Tampa General Hospital | Tampa | Florida | |
| Saint Joseph's Hospital/Children's Hospital-Tampa | Tampa | Florida |
+ 193 more sites — see the full list on the official registry below.
On this site
📄 Opdivo (nivolumab) drug profile → 📄 Deltasone (prednisone) drug profile → 📄 Rituxan (rituximab) drug profile →More National Cancer Institute (NCI) trials in Australia
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04759586 on ClinicalTrials.gov ↗ ← All trials in Australia