A Randomized Phase 3 Trial of Nivolumab (NSC# 748726) in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma NIVOLUMAB COMBINATION THERAPY

What's the purpose of this trial?

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.

This trial is currently open and accepting patients.

What will happen during the trial?

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

Inclusion Criteria:

* Age \>= 2 years
* Patient must have histologically confirmed primary mediastinal B-cell lymphoma (PMBCL) as defined by World Health Organization (WHO) criteria
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 or ECOG performance status of 3 if poor performance is related to lymphoma

* Children's Oncology Group (COG) Institutions: Use Karnofsky for patients \>= 17 and \< 18 years of age and Lansky for patients \< 17 years of age
* Adults (age 18 or older): Creatinine clearance \>= 30 mL/min, as estimated by the Cockcroft and Gault formula. The creatinine value used in the calculation must have been obtained within 28 days prior to registration. Estimated creatinine clearance is based on actual body weight
* Pediatric Patients (age \< 18 years): The following must have been obtained within 14 days prior to registration:

* Measured or calculated (based on institutional standard) creatinine clearance or radioisotope glomerular filtration rate (GFR) \>= 70 ml/min/1.73 m\^2, or
* Serum creatinine =\< 1.5 x institutional upper limit of normal (IULN), or a serum creatinine based on age/gender as follows:

* Age : 2 to \< 6 year; Maximum serum creatinine (mg/dL): 0.8 (male; 0.8 (female)
* Age : 6 to \< 10 years; Maximum serum creatinine (mg/dL): 1 (male); 1 (female)
* Age : 10 to \< 13 years; Maximum serum creatinine (mg/dL): 1.2 (male); 1.2 (female)
* Age : 13 to \< 16 years; Maximum serum creatinine (mg/dL): 1.5 (male); 1.4 (female)
* Age : \>= 16 years to \< 18 years; Maximum serum creatinine (mg/dL): 1.7 (male); 1.4 (female)
* Patients with abnormal liver function will be eligible to enroll if the lab abnormality is thought to be due to the lymphoma or Gilbert's syndrome
* Age \>= 18 years: Ejection fraction of \>= 50% by echocardiogram
* Age \< 18 years: Shortening fraction of \>= 27% by echocardiogram, or ejection fraction of \>= 50% by radionuclide angiogram
* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
* All patients and/or their parents or legal guardians must sign a written informed consent
* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Exclusion Criteria:

* Administration of prior anti-cancer therapy except as outlined below:

* A short course (=\< 2 weeks) of corticosteroids for the relief of lymphoma-related symptoms
* A single course of COP (cyclophosphamide, vincristine, and prednisone)
* One cycle of chemo-immunotherapy including R-CHOP, DA-EPOCH-R, a pediatric mature B-cell non-Hodgkin lymphoma (B-NHL) induction therapy (such as ANHL1131), or intrathecal chemotherapy that has not started more than 21 days prior to enrollment
* Active ischemic heart disease or heart failure
* Active uncontrolled infection
* Central nervous system (CNS) involvement of lymphoma
* Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with safety or efficacy assessment of this trial
* Active autoimmune disease that has required systemic treatment (such as disease modifying agents, corticosteroids, or immunosuppressive agents) in the past 2 years. Replacement therapy such as thyroxine, insulin or physiologic corticosteroid for adrenal or pituitary insufficiency is not considered a form of systemic treatment
* In patients \< 18 years of age hepatitis B serologies consistent with past or current infections
* Patients with severe hepatic impairment (Child-Pugh class C or serum total bilirubin \> 5.0 mg/dL) unless thought to be due to lymphoma or Gilbert's syndrome
* Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential
* Sexually active patients of reproductive potential who have not agreed to use a highly effective contraceptive method (failure rate of \< 1% per year when used consistently and correctly) for the duration of their study participation
* Lactating females are not eligible unless they have agreed not to breastfeed their infants starting with the first dose of study therapy and for at least 6 months after the last dose of rituximab

Additional Trial Information

Phase 3

Enrollment: 244 patients (estimated)

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Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.

Alabama

Children's of Alabama

Birmingham, AL

Open and Accepting

USA Health Strada Patient Care Center

Mobile, AL

Open and Accepting

Alaska

Providence Alaska Medical Center

Anchorage, AK

Open and Accepting

Arizona

Banner Children's at Desert

Mesa, AZ

Open and Accepting

Banner Health University Medical Center

Tucson, AZ

Open and Accepting

Arkansas

Arkansas Children's Hospital

Little Rock, AR

Temporarily Suspended

California

UCI Health - Costa Mesa

Costa Mesa, CA

Open and Accepting

Kaiser Permanente - The Oncology Institute of Hope and Innovation (Downey Center)

Downey, CA

Open and Accepting

City of Hope Comprehensive Cancer Center Beckman Research Institute

Duarte, CA

Open and Accepting

City of Hope Orange County Lennar Foundation Cancer Center

Irvine, CA

Open and Accepting

Loma Linda University Cancer Center

Loma Linda, CA

Open and Accepting

Miller Children's and Women's Hospital Long Beach

Long Beach, CA

Open and Accepting

Children's Hospital Los Angeles

Los Angeles, CA

Open and Accepting

Cedars-Sinai Medical Center - UCLA School of Medicine Samuel Oschin Comprehensive Cancer Institute

Los Angeles, CA

Open and Accepting

UCLA - Mattel Children's Hospital

Los Angeles, CA

Open and Accepting

Valley Children's Hospital

Madera, CA

Open and Accepting

Kaiser Permanente - Oakland Medical Center

Oakland, CA

Open and Accepting

Chao Family Comprehensive Cancer Center University of California, Irvine

Orange, CA

Open and Accepting

Children's Hospital Orange County

Orange, CA

Open and Accepting

Stanford Univ Med Ctr. / Lucile Packard Children's Hosp

Palo Alto, CA

Open and Accepting

University of California Davis Comprehensive Cancer Center

Sacramento, CA

Open and Accepting

Rady Children's Hospital

San Diego, CA

Open and Accepting

Colorado

The Children's Hospital of Colorado

Aurora, CO

Open and Accepting

St. Francis Medical Center Catholic Health Initiatives

Colorado Springs, CO

Open and Accepting

Rocky Mountain Cancer Centers (Midtown)

Denver, CO

Open and Accepting

Connecticut

Connecticut Children's Medical Center

Hartford, CT

Open and Accepting

Delaware

Alfred I. DuPont Hospital for Children

Wilmington, DE

Open and Accepting

Florida

Broward Oncology Associates, PA

Fort Lauderdale, FL

Temporarily Suspended

Golisano Children's Hospital of Southwest Florida

Fort Myers, FL

Open and Accepting

Shands Hospital University of Florida Health

Gainesville, FL

Open and Accepting

Joe DiMaggio Children's Hospital Memorial Regional Hospital

Hollywood, FL

Open and Accepting

Nemour's Children's Health (Jacksonville)

Jacksonville, FL

Open and Accepting

Sylvester Comprehensive Cancer Center (Main) University of Miami Health System

Miami, FL

Open and Accepting

Arnold Palmer Hospital for Children

Orlando, FL

Open and Accepting

Nemours Children's Hospital

Orlando, FL

Open and Accepting

Johns Hopkins All Children's Hospital

Saint Petersburg, FL

Temporarily Suspended

Tampa General Hospital Cancer Institute

Tampa, FL

Open and Accepting

Saint Joseph's Hospital/Children's Hospital-Tampa

Tampa, FL

Open and Accepting

Georgia

Winship Cancer Institute Emory University

Atlanta, GA

Open and Accepting

Emory University Winship Cancer Institute - Midtown

Atlanta, GA

Open and Accepting

Children's Hospital of Atlanta

Atlanta, GA

Open and Accepting

Emory University Winship Cancer Institute - St. Joseph

Atlanta, GA

Open and Accepting

Memorial Health University Medical Center

Savannah, GA

Open and Accepting

Hawaii

Kapiolani Medical Center for Women and Children

Honolulu, HI

Open and Accepting

Illinois

Rush - Copley Medical Center

Aurora, IL

Open and Accepting

Robert H. Lurie Comprehensive Cancer Center Northwestern University Feinberg School of Medicine

Chicago, IL

Open and Accepting

University of Chicago Medicine Comprehensive Cancer Center

Chicago, IL

Open and Accepting

University of Illinois at Chicago

Chicago, IL

Open and Accepting

Carle Foundation Hospital (Vermilion)

Danville, IL

Open and Accepting

Memorial Health - Decatur Memorial Hospital Memorial Health

Decatur, IL

Open and Accepting

Carle (Effingham)

Effingham, IL

Open and Accepting

Northwestern Medicine Lake Forest Hospital

Lake Forest, IL

Open and Accepting

Carle Foundation Hospital (Mattoon)

Mattoon, IL

Open and Accepting

Loyola University Medical Center Cardinal Bernardin Cancer Center

Maywood, IL

Open and Accepting

HSHS Saint Elizabeth's Hospital

O'Fallon, IL

Open and Accepting

Saint Jude Midwest Affiliate

Peoria, IL

Open and Accepting

Southern Illinois University School of Medicine - Simmons Cancer Institute

Springfield, IL

Open and Accepting

Springfield Clinic 1st - 900 Building

Springfield, IL

Open and Accepting

Memorial Medical Center

Springfield, IL

Open and Accepting

Springfield Clinic Main Campus East

Springfield, IL

Open and Accepting

Carle Cancer Institute

Urbana, IL

Open and Accepting

Northwestern Medicine Cancer Center Warrenville

Warrenville, IL

Open and Accepting

Indiana

Riley Hospital for Children Indiana University Health

Indianapolis, IN

Open and Accepting

Simon Cancer Center Indiana University

Indianapolis, IN

Open and Accepting

Reid Health

Richmond, IN

Open and Accepting

Iowa

Holden Comprehensive Cancer Center - University of Iowa University of Iowa Hospitals and Clinics

Iowa City, IA

Open and Accepting

Mission Cancer & Blood

Ankeny, IA

Open and Accepting

Mission Cancer & Blood (Clive) In Clive Cancer Center

Clive, IA

Open and Accepting

Blank Children's Hospital

Des Moines, IA

Open and Accepting

MercyOne Des Moines Medical Center

Des Moines, IA

Open and Accepting

Mission Cancer MercyOne Cancer Center (Laurel)

Des Moines, IA

Open and Accepting

Mission Cancer and Blood

Waukee, IA

Open and Accepting

Kansas

Wesley Medical Center

Wichita, KS

Open and Accepting

Kentucky

UK Markey Cancer Center University of Kentucky

Lexington, KY

Open and Accepting

Norton Cancer Institute (St. Matthews) St. Matthews Campus

Louisville, KY

Open and Accepting

Louisiana

Ochsner Medical Center

Jefferson, LA

Open and Accepting

Children's Hospital New Orleans

New Orleans, LA

Open and Accepting

Maine

Eastern Maine Medical Center

Bangor, ME

Open and Accepting

Maine Children's Cancer Program

Scarborough, ME

Open and Accepting

Maryland

University of Maryland Medical Center Marlene and Stewart Greenebaum Comprehensive Cancer Center

Baltimore, MD

Open and Accepting

GBMC Cancer Center - Berman Cancer Institute

Baltimore, MD

Open and Accepting

Sinai Hospital LifeBridge Health

Baltimore, MD

Open and Accepting

Sidney Kimmel Comprehensive Cancer Center Johns Hopkins Medicine

Baltimore, MD

Open and Accepting

Walter Reed National Military Medical Center

Bethesda, MD

Open and Accepting

Massachusetts

Tufts Medical Center Cancer Center

Boston, MA

Open and Accepting

Dana-Farber Cancer Institute

Boston, MA

Open and Accepting

Michigan

C S Mott Children's Hospital University of Michigan

Ann Arbor, MI

Open and Accepting

University of Michigan Comprehensive Cancer Center Rogel Cancer Center

Ann Arbor, MI

Open and Accepting

Children's Hospital of Michigan

Detroit, MI

Open and Accepting

Henry Ford Hospital

Detroit, MI

Open and Accepting

Michigan State University Clinical Center

East Lansing, MI

Open and Accepting

Helen DeVos Children's Hospital

Grand Rapids, MI

Temporarily Suspended

Bronson Methodist Hospital

Kalamazoo, MI

Open and Accepting

Lakeland Community Hospital

Niles, MI

Open and Accepting

Beaumont Children's Hospital-Royal Oak

Royal Oak, MI

Open and Accepting

Minnesota

Minnesota Oncology - Burnsville

Burnsville, MN

Open and Accepting

Mercy Hospital

Coon Rapids, MN

Open and Accepting

Fairview Southdale Hospital

Edina, MN

Open and Accepting

Minnesota Oncology Maplewood Cancer Center

Maplewood, MN

Open and Accepting

Children's Hospitals and Clinics of Minnesota

Minneapolis, MN

Open and Accepting

Abbott-Northwestern Hospital Allina Health Cancer Institute

Minneapolis, MN

Open and Accepting

Park Nicollet Clinic

St. Louis Park, MN

Open and Accepting

United Hospital

St. Paul, MN

Open and Accepting

Mississippi

University of Mississippi Medical Center

Jackson, MS

Open and Accepting

Missouri

Alvin J. Siteman Cancer Center Washington University Medical Campus

St. Louis, MO

Open and Accepting

St. Luke's Hospital

Chesterfield, MO

Temporarily Suspended

Siteman Cancer Center at Barnes-Jewish West County Hospital

Creve Coeur, MO

Open and Accepting

Children's Mercy Hospitals and Clinics

Kansas City, MO

Open and Accepting

Siteman Cancer Center at Christian Hospital

Saint Louis, MO

Open and Accepting

Siteman Cancer Center at Saint Peters Hospital

Saint Peters, MO

Open and Accepting

Siteman Cancer Center (South St. Louis County)

St. Louis, MO

Open and Accepting

Mercy Hospital St. Louis David C. Pratt Cancer Center

St. Louis, MO

Open and Accepting

Nebraska

Children's Hospital and Medical Center of Omaha

Omaha, NE

Open and Accepting

University of Nebraska Medical Center Fred & Pamela Buffett Cancer Center

Omaha, NE

Open and Accepting

Nevada

Cure 4 the Kids Foundation Roseman University of Health Sciences

Las Vegas, NV

Open and Accepting

Renown Regional Medical Center

Reno, NV

Open and Accepting

New Hampshire

Dartmouth-Hitchcock Medical Center Norris Cotton Cancer Center

Lebanon, NH

Open and Accepting

New Jersey

John Theurer Cancer Center at Hackensack University Medical Center  Hackensack Meridian Health

Hackensack, NJ

Open and Accepting

Memorial Sloan Kettering Basking Ridge

Basking Ridge, NJ

Open and Accepting

Memorial Sloan Kettering Monmouth

Middletown, NJ

Open and Accepting

Memorial Sloan Kettering Bergen

Montvale, NJ

Open and Accepting

Morristown Medical Center Atlantic Health System

Morristown, NJ

Open and Accepting

Rutgers Cancer Institute of New Jersey Rutgers, The State University of New Jersey

New Brunswick, NJ

Open and Accepting

St. Joseph’s University Medical Center

Paterson, NJ

Open and Accepting

New Mexico

Presbyterian Kaseman Hospital - New Mexico Cancer Research Alliance (NMCRA)

Albuquerque, NM

Open and Accepting

New York

Memorial Sloan Kettering Cancer Center

New York, NY

Open and Accepting

Albany Medical Cancer Center

Albany, NY

Open and Accepting

Roswell Park Cancer Institute

Buffalo, NY

Open and Accepting

Memorial Sloan Kettering Commack

Commack, NY

Open and Accepting

New York University Langone Medical Center Laura and Isaac Perlmutter Cancer Center

New York, NY

Open and Accepting

Herbert Irving Comprehensive Cancer Center (Columbia University) Columbia University Medical Center

New York, NY

Open and Accepting

Steven and Alexandra Cohen Children's Medical Center Northwell Health

Queens, NY

Open and Accepting

University of Rochester Medical Center Wilmot Cancer Center Strong Memorial Hospital

Rochester, NY

Open and Accepting

Stony Brook University Hospital

Stony Brook, NY

Open and Accepting

SUNY Upstate Medical University State University of New York

Syracuse, NY

Open and Accepting

Montefiore Medical Center (Moses Campus)

The Bronx, NY

Temporarily Suspended

Memorial Sloan Kettering Nassau

Uniondale, NY

Open and Accepting

Westchester Medical Center New York Medical College

Valhalla, NY

Open and Accepting

Memorial Sloan Kettering Westchester

West Harrison, NY

Open and Accepting

North Carolina

Wake Forest Baptist - Comprehensive Cancer Center Atrium Health

Winston-Salem, NC

Open and Accepting

Mission Hospital Inc Memorial Campus

Asheville, NC

Open and Accepting

AdventHealth Hematology Oncology Infusion Services - Asheville

Asheville, NC

Open and Accepting

Carolinas Medical Center

Charlotte, NC

Open and Accepting

Novant Health Presbyterian Medical Center Novant Health

Charlotte, NC

Open and Accepting

East Carolina University Vidant Cancer Care Eddie and Jo Allison Smith Tower

Greenville, NC

Open and Accepting

AdventHealth Hendersonville Formerly Park Ridge Health

Hendersonville, NC

Temporarily Suspended

North Dakota

Sanford Medical Center - Broadway

Fargo, ND

Open and Accepting

Ohio

Akron Children's Hospital

Akron, OH

Open and Accepting

Cincinnati Children's Hospital Medical Center

Cincinnati, OH

Open and Accepting

Rainbow Babies and Childrens Hospital

Cleveland, OH

Open and Accepting

Cleveland Clinic - Taussig Cancer Center Taussig Cancer Institute

Cleveland, OH

Open and Accepting

Nationwide Children's Hospital

Columbus, OH

Open and Accepting

Dayton Children's Hospital

Dayton, OH

Open and Accepting

Greater Dayton Cancer Center Dayton Physicians

Dayton, OH

Open and Accepting

Kettering Cancer Care

Kettering, OH

Open and Accepting

ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital

Toledo, OH

Open and Accepting

Oklahoma

University of Oklahoma Health Sciences Center

Oklahoma City, OK

Open and Accepting

Oregon

Legacy Emanuel Children's Hospital

Portland, OR

Open and Accepting

Oregon Health and Science University OHSU Knight Cancer Institute

Portland, OR

Open and Accepting

Pennsylvania

Lehigh Valley Hospital-Cedar Crest

Allentown, PA

Open and Accepting

Geisinger Medical Center - Danville

Danville, PA

Open and Accepting

Penn State Children's Hospital

Hummelstown, PA

Open and Accepting

Children's Hospital of Philadelphia

Philadelphia, PA

Open and Accepting

Saint Christopher's Hospital for Children

Philadelphia, PA

Open and Accepting

UPMC Children's Hospital of Pittsburgh

Pittsburgh, PA

Open and Accepting

Rhode Island

Lifespan Rhode Island Hospital

Providence, RI

Open and Accepting

South Carolina

Prisma Health - Richland Hospital

Columbia, SC

Open and Accepting

BI-LO Charities Children's Cancer Center

Greenville, SC

Open and Accepting

Prisma Health Cancer Institute - Eastside Eastside

Greenville, SC

Open and Accepting

South Dakota

Sanford USD Medical Center (Sioux Falls)

Sioux Falls, SD

Open and Accepting

Tennessee

East Tennessee Childrens Hospital

Knoxville, TN

Open and Accepting

St. Jude Children's Research Center

Memphis, TN

Open and Accepting

Vanderbilt-Ingram Cancer Center Henry-Joyce Cancer Clinic

Nashville, TN

Open and Accepting

Texas

Dell Children's Medical Center of Central Texas

Austin, TX

Open and Accepting

Driscoll Children's Hospital

Corpus Christi, TX

Open and Accepting

Medical City Dallas Hospital

Dallas, TX

Open and Accepting

El Paso Children's Hospital

El Paso, TX

Open and Accepting

Baylor College of Medicine - Dan L. Duncan Comprehensive Cancer Center

Houston, TX

Open and Accepting

Houston Methodist Hospital

Houston, TX

Open and Accepting

MD Anderson Cancer Center The University of Texas

Houston, TX

Open and Accepting

UMC Cancer Center / UMC Health System

Lubbock, TX

Open and Accepting

Children's Hospital of San Antonio

San Antonio, TX

Open and Accepting

Methodist Children's Hospital of South Texas

San Antonio, TX

Open and Accepting

Utah

Primary Children's Hospital

Salt Lake City, UT

Open and Accepting

Virginia

UVA Cancer Center University of Virginia Health System

Charlottesville, VA

Open and Accepting

Inova Fairfax Medical Hospital Inova Schar Cancer Institute

Falls Church, VA

Temporarily Suspended

Children's Hospital of The King's Daughters

Norfolk, VA

Open and Accepting

Massey Cancer Center Virginia Commonwealth University (VCU Health)

Richmond, VA

Open and Accepting

Carilion Children's

Roanoke, VA

Open and Accepting

Washington

Saint Francis Hospital

Federal Way, WA

Open and Accepting

Valley Medical Center

Renton, WA

Open and Accepting

Seattle Children's Hospital

Seattle, WA

Open and Accepting

Providence Sacred Heart Medical Center and Children's Hospital

Spokane, WA

Open and Accepting

Mary Bridge Children's Hospital and Health Center

Tacoma, WA

Open and Accepting

Madigan Army Medical Center

Tacoma, WA

Open and Accepting

Washington, D.C.

Children's National Medical Center

Washington, DC

Open and Accepting

Georgetown Lombardi Comprehensive Cancer Center MedStar Georgetown University Hospital

Washington, DC

Open and Accepting

West Virginia

WVU Charleston

Charleston, WV

Open and Accepting

Wisconsin

Marshfield Medical Center - Hospital

Marshfield, WI

Temporarily Suspended
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