Anti-Lag-3 (Relatlimab) and Anti-PD-1 Blockade (Nivolumab) Versus Standard of Care (Lomustine) for the Treatment of Patients With Recurrent Glioblastoma
Purpose
This phase II trial compares the safety, side effects and effectiveness of anti-lag-3 (relatlimab) and anti-PD-1 blockade (nivolumab) to standard of care lomustine for the treatment of patients with glioblastoma that has come back after a period of improvement (recurrent). Relatlimab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Lomustine is a chemotherapy drug and in a class of medications called alkylating agents. It damages the cell's deoxyribonucleic acid and may kill tumor cells. Giving relatlimab and nivolumab may be safe, tolerable, and/or effective compared to standard of care lomustine in treating patients with recurrent glioblastoma.
Conditions
- Progressive Glioblastoma
- Recurrent Glioblastoma
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Criteria
Inclusion Criteria:
- Histologically-proven glioblastoma (World Health Organization [WHO] 2021 criteria)
- Progressive or recurrent disease per Response Assessment in Neuro-Oncology (RANO)
criteria
- No IDH mutation (IDH1 R132H negative by immunohistochemistry [IHC] or sequencing)
- Patients must be in first recurrence of glioblastoma following radiation therapy and
temozolomide
- No prior therapies except radiation, surgery, temozolomide, Tumor Treating Fields
(TTFields), and/or Gliadel wafers (placed during the first surgery at diagnosis of
glioblastoma multiforme [GBM]). Prior radiation therapy, TTFields, or placement of
Gliadel wafers must be completed at least 2 weeks prior to registration. Prior
temozolomide must be completed at least 3 weeks prior to registration
- No prior use of nivolumab or other anti-PD1 agents
- Patients must be neurologically stable off corticosteroids for at least 5 days prior
to registration
- Age: ≥ 18 years
- Karnofsky Performance Status: ≥ 60% (i.e. patient must be able to care for
themselves with occasional help from others)
- Absolute lymphocyte count (ALC): ≥ 1000/mm^3
- Absolute neutrophil count (ANC): ≥ 1500/mm^3
- Platelet count: ≥ 100,000/mm^3
- Hemoglobin: ≥ 9.0 g/dL
- Activated partial thromboplastin time (APTT) or partial thromboplastin time (PTT): ≤
1.5 x upper limit of normal (ULN)
- Total bilirubin: < 2.0 x ULN (Except for patients with Gilbert's syndrome, who must
have direct bilirubin < 2.0 x ULN)
- Aspartate aminotransferase (AST) / alanine aminotransferase (ALT): < 3.0 x ULN
- Calculated (calc.) creatinine clearance (CrCl): ≥ 50 mL/min
- Calculated by Cockcroft-Gault equation
- Not pregnant and not nursing, because this study involves an investigational agent
whose genotoxic, mutagenic and teratogenic effects on the developing fetus and
newborn are unknown and an agent that has known genotoxic, mutagenic and teratogenic
effects. Therefore, for women of childbearing potential only, a negative pregnancy
test done within 14 days prior to registration is required
- Patients with a prior or concurrent malignancy whose natural history or treatment
does not have the potential to interfere with the safety or efficacy assessment of
the investigational regimen are eligible for this trial
- No active brain metastases or leptomeningeal disease
- HIV: HIV-infected patients on effective anti-retroviral therapy with undetectable
viral load within 6 months prior to registration are eligible for this trial
- Hepatitis B: For patients with evidence of chronic hepatitis B virus (HBV)
infection, the HBV viral load must be undetectable on suppressive therapy, if
indicated
- Hepatitis C: 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
- No known medical condition causing an inability to swallow oral formulations of
agents
- No current symptomatic pulmonary disease
- No autoimmune disorders that require systemic treatment (except hyperthyroidism or
diabetes mellitus)
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Arm I (nivolumab, relatlimab) |
Patients receive nivolumab IV over 30 minutes followed by relatlimab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo surgery or biopsy, MRI, and blood sample collection throughout study. |
|
|
Active Comparator Arm II (lomustine) |
Patients receive lomustine PO on day 1 of each cycle. Cycles repeat every 42 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo surgery or biopsy, MRI, and blood sample collection throughout study. |
|
Recruiting Locations
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Jonesboro, Arkansas 72401
Jonesboro, Arkansas 72401
Sutter Auburn Faith Hospital
Auburn, California 95602
Auburn, California 95602
City of Hope Comprehensive Cancer Center
Duarte, California 91010
Duarte, California 91010
Kaiser Permanente Dublin
Dublin, California 94568
Dublin, California 94568
Contact:
Site Public Contact
877-642-4691
Site Public Contact
877-642-4691
Kaiser Permanente-Fremont
Fremont, California 94538
Fremont, California 94538
Kaiser Permanente Fresno Orchard Plaza
Fresno, California 93720
Fresno, California 93720
Contact:
Site Public Contact
833-574-2273
Site Public Contact
833-574-2273
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California 92612
Irvine, California 92612
UC San Diego Moores Cancer Center
La Jolla, California 92093
La Jolla, California 92093
City of Hope Antelope Valley
Lancaster, California 93534
Lancaster, California 93534
City of Hope at Long Beach Elm
Long Beach, California 90813
Long Beach, California 90813
Contact:
Site Public Contact
877-467-3411
Site Public Contact
877-467-3411
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California 90027
Los Angeles, California 90027
Cedars Sinai Medical Center
Los Angeles, California 90048
Los Angeles, California 90048
Contact:
Site Public Contact
310-423-8965
Site Public Contact
310-423-8965
Kaiser Permanente- Modesto MOB II
Modesto, California 95356
Modesto, California 95356
Contact:
Site Public Contact
877-642-4691
Site Public Contact
877-642-4691
Kaiser Permanente-Modesto
Modesto, California 95356
Modesto, California 95356
Kaiser Permanente-Oakland
Oakland, California 94611
Oakland, California 94611
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California 92868
Orange, California 92868
Palo Alto Medical Foundation Health Care
Palo Alto, California 94301
Palo Alto, California 94301
Stanford Cancer Institute Palo Alto
Palo Alto, California 94304
Palo Alto, California 94304
Kaiser Permanente- Marshall Medical Offices
Redwood City, California 94063
Redwood City, California 94063
Contact:
Site Public Contact
877-642-4691
Site Public Contact
877-642-4691
Kaiser Permanente-Roseville
Roseville, California 95661
Roseville, California 95661
Sutter Roseville Medical Center
Roseville, California 95661
Roseville, California 95661
Kaiser Permanente Downtown Commons
Sacramento, California 95814
Sacramento, California 95814
Sutter Medical Center Sacramento
Sacramento, California 95816
Sacramento, California 95816
Kaiser Permanente-South Sacramento
Sacramento, California 95823
Sacramento, California 95823
Kaiser Permanente-San Diego Zion
San Diego, California 92120
San Diego, California 92120
California Pacific Medical Center-Pacific Campus
San Francisco, California 94115
San Francisco, California 94115
Kaiser Permanente-San Francisco
San Francisco, California 94115
San Francisco, California 94115
Kaiser Permanente-Santa Teresa-San Jose
San Jose, California 95119
San Jose, California 95119
Kaiser Permanente San Leandro
San Leandro, California 94577
San Leandro, California 94577
Kaiser San Rafael-Gallinas
San Rafael, California 94903
San Rafael, California 94903
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California 95051
Santa Clara, California 95051
Kaiser Permanente-Santa Rosa
Santa Rosa, California 95403
Santa Rosa, California 95403
Kaiser Permanente-South San Francisco
South San Francisco, California 94080
South San Francisco, California 94080
City of Hope Upland
Upland, California 91786
Upland, California 91786
Kaiser Permanente-Vallejo
Vallejo, California 94589
Vallejo, California 94589
Kaiser Permanente-Walnut Creek
Walnut Creek, California 94596
Walnut Creek, California 94596
John Muir Medical Center-Walnut Creek
Walnut Creek, California 94598
Walnut Creek, California 94598
UCHealth Memorial Hospital Central
Colorado Springs, Colorado 80909
Colorado Springs, Colorado 80909
Contact:
Site Public Contact
719-365-2406
Site Public Contact
719-365-2406
Memorial Hospital North
Colorado Springs, Colorado 80920
Colorado Springs, Colorado 80920
Contact:
Site Public Contact
719-364-6700
Site Public Contact
719-364-6700
Poudre Valley Hospital
Fort Collins, Colorado 80524
Fort Collins, Colorado 80524
Contact:
Site Public Contact
970-297-6150
Site Public Contact
970-297-6150
Cancer Care and Hematology-Fort Collins
Fort Collins, Colorado 80528
Fort Collins, Colorado 80528
UCHealth Greeley Hospital
Greeley, Colorado 80631
Greeley, Colorado 80631
Medical Center of the Rockies
Loveland, Colorado 80538
Loveland, Colorado 80538
Contact:
Site Public Contact
970-203-7083
Site Public Contact
970-203-7083
Hartford HealthCare - Saint Vincent's Medical Center
Bridgeport, Connecticut 06606
Bridgeport, Connecticut 06606
Contact:
Site Public Contact
860-972-4700
Site Public Contact
860-972-4700
Hartford Hospital
Hartford, Connecticut 06102
Hartford, Connecticut 06102
Contact:
Site Public Contact
860-545-5363
Site Public Contact
860-545-5363
Yale University
New Haven, Connecticut 06520
New Haven, Connecticut 06520
Smilow Cancer Hospital Care Center-Trumbull
Trumbull, Connecticut 06611
Trumbull, Connecticut 06611
Beebe South Coastal Health Campus
Millville, Delaware 19967
Millville, Delaware 19967
Helen F Graham Cancer Center
Newark, Delaware 19713
Newark, Delaware 19713
Medical Oncology Hematology Consultants PA
Newark, Delaware 19713
Newark, Delaware 19713
Beebe Health Campus
Rehoboth Beach, Delaware 19971
Rehoboth Beach, Delaware 19971
Sibley Memorial Hospital
Washington D.C., District of Columbia 20016
Washington D.C., District of Columbia 20016
UM Sylvester Comprehensive Cancer Center at Aventura
Aventura, Florida 33180
Aventura, Florida 33180
Contact:
Site Public Contact
954-461-2180
Site Public Contact
954-461-2180
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida 33146
Coral Gables, Florida 33146
Contact:
Site Public Contact
305-243-2647
Site Public Contact
305-243-2647
UM Sylvester Comprehensive Cancer Center at Coral Springs
Coral Springs, Florida 33065
Coral Springs, Florida 33065
Contact:
Site Public Contact
305-243-2647
Site Public Contact
305-243-2647
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida 33442
Deerfield Beach, Florida 33442
Contact:
Site Public Contact
305-243-2647
Site Public Contact
305-243-2647
UM Sylvester Comprehensive Cancer Center at Doral
Doral, Florida 33166
Doral, Florida 33166
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood, Florida 33021
Hollywood, Florida 33021
UM Sylvester Comprehensive Cancer Center at Hollywood
Hollywood, Florida 33021
Hollywood, Florida 33021
Contact:
Site Public Contact
305-243-2647
Site Public Contact
305-243-2647
Baptist MD Anderson Cancer Center
Jacksonville, Florida 32207
Jacksonville, Florida 32207
Contact:
Site Public Contact
904-202-7468
Site Public Contact
904-202-7468
Mayo Clinic in Florida
Jacksonville, Florida 32224-9980
Jacksonville, Florida 32224-9980
Contact:
Site Public Contact
855-776-0015
Site Public Contact
855-776-0015
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida 33136
Miami, Florida 33136
Contact:
Site Public Contact
305-243-2647
Site Public Contact
305-243-2647
Miami Cancer Institute
Miami, Florida 33176
Miami, Florida 33176
Contact:
Site Public Contact
786-596-2000
Site Public Contact
786-596-2000
UM Sylvester Comprehensive Cancer Center at Kendall
Miami, Florida 33176
Miami, Florida 33176
Contact:
Site Public Contact
305-243-2647
Site Public Contact
305-243-2647
Orlando Health Cancer Institute
Orlando, Florida 32806
Orlando, Florida 32806
UM Sylvester Comprehensive Cancer Center at Plantation
Plantation, Florida 33324
Plantation, Florida 33324
Contact:
Site Public Contact
305-243-2647
Site Public Contact
305-243-2647
Augusta University Medical Center
Augusta, Georgia 30912
Augusta, Georgia 30912
Kaiser Permanente Moanalua Medical Center
Honolulu, Hawaii 96819
Honolulu, Hawaii 96819
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho 83706
Boise, Idaho 83706
Saint Luke's Cancer Institute - Boise
Boise, Idaho 83712
Boise, Idaho 83712
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho 83605
Caldwell, Idaho 83605
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho 83814
Coeur d'Alene, Idaho 83814
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho 83619
Fruitland, Idaho 83619
Saint Luke's Cancer Institute - Meridian
Meridian, Idaho 83642
Meridian, Idaho 83642
Saint Alphonsus Cancer Care Center-Nampa
Nampa, Idaho 83687
Nampa, Idaho 83687
Saint Luke's Cancer Institute - Nampa
Nampa, Idaho 83687
Nampa, Idaho 83687
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho 83854
Post Falls, Idaho 83854
Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho 83864
Sandpoint, Idaho 83864
Advocate Outpatient Center - Aurora
Aurora, Illinois 60506
Aurora, Illinois 60506
Advocate Good Shepherd Hospital
Barrington, Illinois 60010
Barrington, Illinois 60010
Contact:
Site Public Contact
847-842-4847
Site Public Contact
847-842-4847
Illinois CancerCare-Bloomington
Bloomington, Illinois 61704
Bloomington, Illinois 61704
Illinois CancerCare-Canton
Canton, Illinois 61520
Canton, Illinois 61520
Illinois CancerCare-Carthage
Carthage, Illinois 62321
Carthage, Illinois 62321
Rush MD Anderson Cancer Center
Chicago, Illinois 60612
Chicago, Illinois 60612
University of Illinois
Chicago, Illinois 60612
Chicago, Illinois 60612
Contact:
Site Public Contact
312-355-3046
Site Public Contact
312-355-3046
Advocate Illinois Masonic Medical Center
Chicago, Illinois 60657
Chicago, Illinois 60657
Contact:
Site Public Contact
773-296-5360
Site Public Contact
773-296-5360
AMG Crystal Lake - Oncology
Crystal Lake, Illinois 60014
Crystal Lake, Illinois 60014
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois 62526
Decatur, Illinois 62526
Decatur Memorial Hospital
Decatur, Illinois 62526
Decatur, Illinois 62526
Illinois CancerCare-Dixon
Dixon, Illinois 61021
Dixon, Illinois 61021
Contact:
Site Public Contact
815-285-7800
Site Public Contact
815-285-7800
Advocate Good Samaritan Hospital
Downers Grove, Illinois 60515
Downers Grove, Illinois 60515
Crossroads Cancer Center
Effingham, Illinois 62401
Effingham, Illinois 62401
Advocate Sherman Hospital
Elgin, Illinois 60123
Elgin, Illinois 60123
Contact:
Site Public Contact
847-429-2907
Site Public Contact
847-429-2907
Illinois CancerCare-Eureka
Eureka, Illinois 61530
Eureka, Illinois 61530
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois 60201
Evanston, Illinois 60201
Contact:
Site Public Contact
847-570-2109
Site Public Contact
847-570-2109
Illinois CancerCare-Galesburg
Galesburg, Illinois 61401
Galesburg, Illinois 61401
NorthShore University HealthSystem-Glenbrook Hospital
Glenview, Illinois 60026
Glenview, Illinois 60026
Contact:
Site Public Contact
847-570-2109
Site Public Contact
847-570-2109
Advocate South Suburban Hospital
Hazel Crest, Illinois 60429
Hazel Crest, Illinois 60429
Contact:
Site Public Contact
708-799-9995
Site Public Contact
708-799-9995
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois 61443
Kewanee, Illinois 61443
AMG Libertyville - Oncology
Libertyville, Illinois 60048
Libertyville, Illinois 60048
Condell Memorial Hospital
Libertyville, Illinois 60048
Libertyville, Illinois 60048
Illinois CancerCare-Macomb
Macomb, Illinois 61455
Macomb, Illinois 61455
Cancer Care Center of O'Fallon
O'Fallon, Illinois 62269
O'Fallon, Illinois 62269
HSHS Saint Elizabeth's Hospital
O'Fallon, Illinois 62269
O'Fallon, Illinois 62269
Advocate Christ Medical Center
Oak Lawn, Illinois 60453-2699
Oak Lawn, Illinois 60453-2699
Contact:
Site Public Contact
800-323-8622
Site Public Contact
800-323-8622
Advocate Outpatient Center - Oak Lawn
Oak Lawn, Illinois 60453
Oak Lawn, Illinois 60453
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois 61350
Ottawa, Illinois 61350
Advocate High Tech Medical Park
Palos Heights, Illinois 60463
Palos Heights, Illinois 60463
Advocate Lutheran General Hospital
Park Ridge, Illinois 60068
Park Ridge, Illinois 60068
Contact:
Site Public Contact
847-384-3621
Site Public Contact
847-384-3621
Illinois CancerCare-Pekin
Pekin, Illinois 61554
Pekin, Illinois 61554
Illinois CancerCare-Peoria
Peoria, Illinois 61615
Peoria, Illinois 61615
Illinois CancerCare-Peru
Peru, Illinois 61354
Peru, Illinois 61354
Illinois CancerCare-Princeton
Princeton, Illinois 61356
Princeton, Illinois 61356
Memorial Hospital East
Shiloh, Illinois 62269
Shiloh, Illinois 62269
Southern Illinois University School of Medicine
Springfield, Illinois 62702
Springfield, Illinois 62702
Contact:
Site Public Contact
217-545-7929
Site Public Contact
217-545-7929
Springfield Clinic
Springfield, Illinois 62702
Springfield, Illinois 62702
Contact:
Site Public Contact
800-444-7541
Site Public Contact
800-444-7541
Springfield Memorial Hospital
Springfield, Illinois 62781
Springfield, Illinois 62781
Illinois CancerCare - Washington
Washington, Illinois 61571
Washington, Illinois 61571
Franciscan Health Indianapolis
Indianapolis, Indiana 46237
Indianapolis, Indiana 46237
Contact:
Site Public Contact
317-528-7060
Site Public Contact
317-528-7060
Mary Greeley Medical Center
Ames, Iowa 50010
Ames, Iowa 50010
Contact:
Site Public Contact
515-956-4132
Site Public Contact
515-956-4132
McFarland Clinic - Ames
Ames, Iowa 50010
Ames, Iowa 50010
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny, Iowa 50023
Ankeny, Iowa 50023
Contact:
Site Public Contact
515-241-3305
Site Public Contact
515-241-3305
University of Iowa Healthcare Cancer Services Quad Cities
Bettendorf, Iowa 52722
Bettendorf, Iowa 52722
Saint Anthony Regional Hospital
Carroll, Iowa 51401
Carroll, Iowa 51401
Mercy Hospital
Cedar Rapids, Iowa 52403
Cedar Rapids, Iowa 52403
Contact:
Site Public Contact
319-365-4673
Site Public Contact
319-365-4673
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa 52403
Cedar Rapids, Iowa 52403
Contact:
Site Public Contact
319-363-2690
Site Public Contact
319-363-2690
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, Iowa 50325
Clive, Iowa 50325
Contact:
Site Public Contact
515-241-3305
Site Public Contact
515-241-3305
Iowa Methodist Medical Center
Des Moines, Iowa 50309
Des Moines, Iowa 50309
Contact:
Site Public Contact
515-241-6727
Site Public Contact
515-241-6727
UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, Iowa 50309
Des Moines, Iowa 50309
Contact:
Site Public Contact
515-241-3305
Site Public Contact
515-241-3305
Broadlawns Medical Center
Des Moines, Iowa 50314
Des Moines, Iowa 50314
Contact:
Site Public Contact
515-282-2200
Site Public Contact
515-282-2200
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa 50314
Des Moines, Iowa 50314
Contact:
Site Public Contact
515-241-3305
Site Public Contact
515-241-3305
McFarland Clinic - Trinity Cancer Center
Fort Dodge, Iowa 50501
Fort Dodge, Iowa 50501
Contact:
Site Public Contact
515-956-4132
Site Public Contact
515-956-4132
UI Healthcare Mission Cancer and Blood - Fort Dodge
Fort Dodge, Iowa 50501
Fort Dodge, Iowa 50501
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa 52242
Iowa City, Iowa 52242
Contact:
Site Public Contact
800-237-1225
Site Public Contact
800-237-1225
McFarland Clinic - Marshalltown
Marshalltown, Iowa 50158
Marshalltown, Iowa 50158
Contact:
Site Public Contact
515-956-4132
Site Public Contact
515-956-4132
UI Health Care Mission Cancer and Blood - Waukee Clinic
Waukee, Iowa 50263
Waukee, Iowa 50263
Contact:
Site Public Contact
515-241-3305
Site Public Contact
515-241-3305
University of Kansas Cancer Center
Kansas City, Kansas 66160
Kansas City, Kansas 66160
University of Kansas Cancer Center-Overland Park
Overland Park, Kansas 66210
Overland Park, Kansas 66210
University of Kansas Hospital-Indian Creek Campus
Overland Park, Kansas 66211
Overland Park, Kansas 66211
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas 66205
Westwood, Kansas 66205
University of Kentucky/Markey Cancer Center
Lexington, Kentucky 40536
Lexington, Kentucky 40536
Contact:
Site Public Contact
859-257-3379
Site Public Contact
859-257-3379
The James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky 40202
Louisville, Kentucky 40202
Contact:
Site Public Contact
502-562-3429
Site Public Contact
502-562-3429
Lafayette Family Cancer Center-EMMC
Brewer, Maine 04412
Brewer, Maine 04412
Contact:
Site Public Contact
800-987-3005
Site Public Contact
800-987-3005
MaineHealth Cancer Care and IV Therapy - South Portland
South Portland, Maine 04106
South Portland, Maine 04106
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland 21287
Baltimore, Maryland 21287
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan 48106
Ann Arbor, Michigan 48106
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan 48114
Brighton, Michigan 48114
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan 48188
Canton, Michigan 48188
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan 48118
Chelsea, Michigan 48118
Henry Ford Hospital
Detroit, Michigan 48202
Detroit, Michigan 48202
OSF Saint Francis Hospital and Medical Group
Escanaba, Michigan 49829
Escanaba, Michigan 49829
Cancer Hematology Centers - Flint
Flint, Michigan 48503
Flint, Michigan 48503
Genesys Hurley Cancer Institute
Flint, Michigan 48503
Flint, Michigan 48503
Hurley Medical Center
Flint, Michigan 48503
Flint, Michigan 48503
University of Michigan Health - Sparrow Lansing
Lansing, Michigan 48912
Lansing, Michigan 48912
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan 48154
Livonia, Michigan 48154
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan 48197
Ypsilanti, Michigan 48197
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota 56601
Bemidji, Minnesota 56601
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota 56401
Brainerd, Minnesota 56401
Mercy Hospital
Coon Rapids, Minnesota 55433
Coon Rapids, Minnesota 55433
Essentia Health - Deer River Clinic
Deer River, Minnesota 56636
Deer River, Minnesota 56636
Essentia Health Cancer Center
Duluth, Minnesota 55805
Duluth, Minnesota 55805
Fairview Southdale Hospital
Edina, Minnesota 55435
Edina, Minnesota 55435
Essentia Health Hibbing Clinic
Hibbing, Minnesota 55746
Hibbing, Minnesota 55746
Contact:
Site Public Contact
218-786-3308
Site Public Contact
218-786-3308
Abbott-Northwestern Hospital
Minneapolis, Minnesota 55407
Minneapolis, Minnesota 55407
Hennepin County Medical Center
Minneapolis, Minnesota 55415
Minneapolis, Minnesota 55415
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota 55416
Saint Louis Park, Minnesota 55416
Regions Hospital
Saint Paul, Minnesota 55101
Saint Paul, Minnesota 55101
United Hospital
Saint Paul, Minnesota 55102
Saint Paul, Minnesota 55102
Essentia Health Sandstone
Sandstone, Minnesota 55072
Sandstone, Minnesota 55072
Essentia Health Virginia Clinic
Virginia, Minnesota 55792
Virginia, Minnesota 55792
Baptist Memorial Hospital and Cancer Center-Golden Triangle
Columbus, Mississippi 39705
Columbus, Mississippi 39705
Baptist Cancer Center-Grenada
Grenada, Mississippi 38901
Grenada, Mississippi 38901
Baptist Memorial Hospital and Cancer Center-Union County
New Albany, Mississippi 38652
New Albany, Mississippi 38652
Baptist Memorial Hospital and Cancer Center-Oxford
Oxford, Mississippi 38655
Oxford, Mississippi 38655
Baptist Memorial Hospital and Cancer Center-Desoto
Southhaven, Mississippi 38671
Southhaven, Mississippi 38671
Saint Francis Medical Center
Cape Girardeau, Missouri 63703
Cape Girardeau, Missouri 63703
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri 63376
City of Saint Peters, Missouri 63376
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri 63141
Creve Coeur, Missouri 63141
Washington University School of Medicine
St Louis, Missouri 63110
St Louis, Missouri 63110
Mercy Hospital South
St Louis, Missouri 63128
St Louis, Missouri 63128
Siteman Cancer Center-South County
St Louis, Missouri 63129
St Louis, Missouri 63129
Siteman Cancer Center at Christian Hospital
St Louis, Missouri 63136
St Louis, Missouri 63136
Community Hospital of Anaconda
Anaconda, Montana 59711
Anaconda, Montana 59711
Billings Clinic Cancer Center
Billings, Montana 59101
Billings, Montana 59101
Bozeman Health Deaconess Hospital
Bozeman, Montana 59715
Bozeman, Montana 59715
Benefis Sletten Cancer Institute
Great Falls, Montana 59405
Great Falls, Montana 59405
Logan Health Medical Center
Kalispell, Montana 59901
Kalispell, Montana 59901
Community Medical Center
Missoula, Montana 59804
Missoula, Montana 59804
Nebraska Medicine-Bellevue
Bellevue, Nebraska 68123
Bellevue, Nebraska 68123
Nebraska Medicine-Village Pointe
Omaha, Nebraska 68118
Omaha, Nebraska 68118
Contact:
Site Public Contact
402-559-5600
Site Public Contact
402-559-5600
University of Nebraska Medical Center
Omaha, Nebraska 68198
Omaha, Nebraska 68198
Renown Regional Medical Center
Reno, Nevada 89502
Reno, Nevada 89502
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire 03756
Lebanon, New Hampshire 03756
Cooper Hospital University Medical Center
Camden, New Jersey 08103
Camden, New Jersey 08103
Contact:
Site Public Contact
856-325-6757
Site Public Contact
856-325-6757
John F Kennedy Medical Center
Edison, New Jersey 08818
Edison, New Jersey 08818
Contact:
Site Public Contact
732-321-7010
Site Public Contact
732-321-7010
Jersey City Medical Center
Jersey City, New Jersey 07302
Jersey City, New Jersey 07302
Saint Barnabas Medical Center
Livingston, New Jersey 07039
Livingston, New Jersey 07039
Monmouth Medical Center
Long Branch, New Jersey 07740
Long Branch, New Jersey 07740
Morristown Medical Center
Morristown, New Jersey 07960
Morristown, New Jersey 07960
Contact:
Site Public Contact
973-971-5900
Site Public Contact
973-971-5900
Jersey Shore Medical Center
Neptune City, New Jersey 07753
Neptune City, New Jersey 07753
Contact:
Site Public Contact
732-776-4240
Site Public Contact
732-776-4240
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey 08903
New Brunswick, New Jersey 08903
Contact:
Site Public Contact
732-235-7356
Site Public Contact
732-235-7356
Newark Beth Israel Medical Center
Newark, New Jersey 07112
Newark, New Jersey 07112
Sidney Kimmel Cancer Center Washington Township
Sewell, New Jersey 08080
Sewell, New Jersey 08080
Overlook Hospital
Summit, New Jersey 07902
Summit, New Jersey 07902
Contact:
Site Public Contact
908-522-2043
Site Public Contact
908-522-2043
Community Medical Center
Toms River, New Jersey 08755
Toms River, New Jersey 08755
University of New Mexico Cancer Center
Albuquerque, New Mexico 87106
Albuquerque, New Mexico 87106
Presbyterian Kaseman Hospital
Albuquerque, New Mexico 87110
Albuquerque, New Mexico 87110
Presbyterian Rust Medical Center/Jorgensen Cancer Center
Rio Rancho, New Mexico 87124
Rio Rancho, New Mexico 87124
Northwell Health Imbert Cancer Center
Bay Shore, New York 11706
Bay Shore, New York 11706
Contact:
Site Public Contact
516-734-8896
Site Public Contact
516-734-8896
NYU Langone Hospital - Brooklyn
Brooklyn, New York 11220
Brooklyn, New York 11220
Roswell Park Cancer Institute
Buffalo, New York 14263
Buffalo, New York 14263
Glens Falls Hospital
Glens Falls, New York 12801
Glens Falls, New York 12801
Contact:
Site Public Contact
518-926-6700
Site Public Contact
518-926-6700
Northwell Health/Center for Advanced Medicine
Lake Success, New York 11042
Lake Success, New York 11042
Contact:
Site Public Contact
516-734-8896
Site Public Contact
516-734-8896
NYU Langone Hospital - Long Island
Mineola, New York 11501
Mineola, New York 11501
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York 10016
New York, New York 10016
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York 10032
New York, New York 10032
Upstate Cancer Center at Oswego
Oswego, New York 13126
Oswego, New York 13126
University of Rochester
Rochester, New York 14642
Rochester, New York 14642
Contact:
Site Public Contact
585-275-5830
Site Public Contact
585-275-5830
State University of New York Upstate Medical University
Syracuse, New York 13210
Syracuse, New York 13210
Contact:
Site Public Contact
315-464-5476
Site Public Contact
315-464-5476
Montefiore Medical Center-Einstein Campus
The Bronx, New York 10461
The Bronx, New York 10461
FirstHealth of the Carolinas-Moore Regional Hospital
Pinehurst, North Carolina 28374
Pinehurst, North Carolina 28374
Sanford Bismarck Medical Center
Bismarck, North Dakota 58501
Bismarck, North Dakota 58501
Essentia Health Cancer Center-South University Clinic
Fargo, North Dakota 58103
Fargo, North Dakota 58103
Sanford Broadway Medical Center
Fargo, North Dakota 58122
Fargo, North Dakota 58122
Sanford Roger Maris Cancer Center
Fargo, North Dakota 58122
Fargo, North Dakota 58122
Miami Valley Hospital South
Centerville, Ohio 45459
Centerville, Ohio 45459
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio 45219
Cincinnati, Ohio 45219
Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio 45220
Cincinnati, Ohio 45220
Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210
Columbus, Ohio 43210
Riverside Methodist Hospital
Columbus, Ohio 43214
Columbus, Ohio 43214
Miami Valley Hospital
Dayton, Ohio 45409
Dayton, Ohio 45409
Premier Blood and Cancer Center
Dayton, Ohio 45409
Dayton, Ohio 45409
Contact:
Site Public Contact
937-276-8320
Site Public Contact
937-276-8320
Miami Valley Hospital North
Dayton, Ohio 45415
Dayton, Ohio 45415
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio 45005-1066
Franklin, Ohio 45005-1066
Miami Valley Cancer Care and Infusion
Greenville, Ohio 45331
Greenville, Ohio 45331
Contact:
Site Public Contact
937-569-7515
Site Public Contact
937-569-7515
Upper Valley Medical Center
Troy, Ohio 45373
Troy, Ohio 45373
University of Cincinnati Cancer Center-West Chester
West Chester, Ohio 45069
West Chester, Ohio 45069
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
Oklahoma City, Oklahoma 73104
Legacy Mount Hood Medical Center
Gresham, Oregon 97030
Gresham, Oregon 97030
Contact:
Site Public Contact
503-413-2150
Site Public Contact
503-413-2150
Saint Alphonsus Cancer Care Center-Ontario
Ontario, Oregon 97914
Ontario, Oregon 97914
Legacy Good Samaritan Hospital and Medical Center
Portland, Oregon 97210
Portland, Oregon 97210
Providence Portland Medical Center
Portland, Oregon 97213
Portland, Oregon 97213
Providence Saint Vincent Medical Center
Portland, Oregon 97225
Portland, Oregon 97225
Oregon Health and Science University
Portland, Oregon 97239
Portland, Oregon 97239
Legacy Meridian Park Hospital
Tualatin, Oregon 97062
Tualatin, Oregon 97062
Contact:
Site Public Contact
503-413-1742
Site Public Contact
503-413-1742
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania 18103
Allentown, Pennsylvania 18103
Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania 18017
Bethlehem, Pennsylvania 18017
Pocono Medical Center
East Stroudsburg, Pennsylvania 18301
East Stroudsburg, Pennsylvania 18301
UPMC Hillman Cancer Center Erie
Erie, Pennsylvania 16505
Erie, Pennsylvania 16505
Saint Vincent Hospital
Erie, Pennsylvania 16544
Erie, Pennsylvania 16544
Contact:
Site Public Contact
814-452-5000
Site Public Contact
814-452-5000
Jefferson Hospital
Jefferson Hills, Pennsylvania 15025
Jefferson Hills, Pennsylvania 15025
Forbes Hospital
Monroeville, Pennsylvania 15146
Monroeville, Pennsylvania 15146
Contact:
Site Public Contact
412-858-7746
Site Public Contact
412-858-7746
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania 19107
Philadelphia, Pennsylvania 19107
Allegheny General Hospital
Pittsburgh, Pennsylvania 15212
Pittsburgh, Pennsylvania 15212
Contact:
Site Public Contact
877-284-2000
Site Public Contact
877-284-2000
West Penn Hospital
Pittsburgh, Pennsylvania 15224
Pittsburgh, Pennsylvania 15224
Contact:
Site Public Contact
412-578-5000
Site Public Contact
412-578-5000
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania 15232
Pittsburgh, Pennsylvania 15232
Contact:
Site Public Contact
412-647-8073
Site Public Contact
412-647-8073
Wexford Health and Wellness Pavilion
Wexford, Pennsylvania 15090
Wexford, Pennsylvania 15090
Medical University of South Carolina
Charleston, South Carolina 29425
Charleston, South Carolina 29425
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota 57104
Sioux Falls, South Dakota 57104
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota 57117-5134
Sioux Falls, South Dakota 57117-5134
Baptist Memorial Hospital and Cancer Center-Collierville
Collierville, Tennessee 38017
Collierville, Tennessee 38017
Baptist Memorial Hospital and Cancer Center-Memphis
Memphis, Tennessee 38120
Memphis, Tennessee 38120
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee 37232
Nashville, Tennessee 37232
Contact:
Site Public Contact
800-811-8480
Site Public Contact
800-811-8480
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah 84112
Salt Lake City, Utah 84112
University of Vermont Medical Center
Burlington, Vermont 05401
Burlington, Vermont 05401
University of Vermont and State Agricultural College
Burlington, Vermont 05405
Burlington, Vermont 05405
Inova Schar Cancer Institute
Fairfax, Virginia 22031
Fairfax, Virginia 22031
Bon Secours Memorial Regional Medical Center
Mechanicsville, Virginia 23116
Mechanicsville, Virginia 23116
Bon Secours Saint Francis Medical Center
Midlothian, Virginia 23114
Midlothian, Virginia 23114
Bon Secours Richmond Community Hospital
Richmond, Virginia 23223
Richmond, Virginia 23223
Bon Secours Saint Mary's Hospital
Richmond, Virginia 23226
Richmond, Virginia 23226
VCU Massey Comprehensive Cancer Center
Richmond, Virginia 23298
Richmond, Virginia 23298
Swedish Medical Center-Cherry Hill
Seattle, Washington 98122-5711
Seattle, Washington 98122-5711
Legacy Cancer Institute Medical Oncology and Day Treatment
Vancouver, Washington 98684
Vancouver, Washington 98684
Legacy Salmon Creek Hospital
Vancouver, Washington 98686
Vancouver, Washington 98686
Contact:
Site Public Contact
503-413-2150
Site Public Contact
503-413-2150
West Virginia University Healthcare
Morgantown, West Virginia 26506
Morgantown, West Virginia 26506
Camden Clark Medical Center
Parkersburg, West Virginia 26101
Parkersburg, West Virginia 26101
Wheeling Hospital/Schiffler Cancer Center
Wheeling, West Virginia 26003
Wheeling, West Virginia 26003
Contact:
Site Public Contact
304-243-6442
Site Public Contact
304-243-6442
Duluth Clinic Ashland
Ashland, Wisconsin 54806
Ashland, Wisconsin 54806
Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin 53105
Burlington, Wisconsin 53105
Aurora Saint Luke's South Shore
Cudahy, Wisconsin 53110
Cudahy, Wisconsin 53110
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin 54701
Eau Claire, Wisconsin 54701
Aurora Health Care Germantown Health Center
Germantown, Wisconsin 53022
Germantown, Wisconsin 53022
Aurora Cancer Care-Grafton
Grafton, Wisconsin 53024
Grafton, Wisconsin 53024
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin 54301
Green Bay, Wisconsin 54301
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin 54303
Green Bay, Wisconsin 54303
Aurora BayCare Medical Center
Green Bay, Wisconsin 54311
Green Bay, Wisconsin 54311
Mercyhealth Hospital and Cancer Center - Janesville
Janesville, Wisconsin 53548
Janesville, Wisconsin 53548
Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin 53142
Kenosha, Wisconsin 53142
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
Madison, Wisconsin 53718
Madison, Wisconsin 53718
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin 53792
Madison, Wisconsin 53792
Aurora Bay Area Medical Group-Marinette
Marinette, Wisconsin 54143
Marinette, Wisconsin 54143
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin 54449
Marshfield, Wisconsin 54449
Aurora Cancer Care-Milwaukee
Milwaukee, Wisconsin 53209
Milwaukee, Wisconsin 53209
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin 53215
Milwaukee, Wisconsin 53215
Aurora Sinai Medical Center
Milwaukee, Wisconsin 53233
Milwaukee, Wisconsin 53233
ProHealth D N Greenwald Center
Mukwonago, Wisconsin 53149
Mukwonago, Wisconsin 53149
ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin 53066
Oconomowoc, Wisconsin 53066
Contact:
Site Public Contact
262-928-7878
Site Public Contact
262-928-7878
Saint Vincent Hospital Cancer Center at Oconto Falls
Oconto Falls, Wisconsin 54154
Oconto Falls, Wisconsin 54154
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin 54904
Oshkosh, Wisconsin 54904
Aurora Cancer Care-Racine
Racine, Wisconsin 53406
Racine, Wisconsin 53406
Saint Vincent Hospital Cancer Center at Sheboygan
Sheboygan, Wisconsin 53081
Sheboygan, Wisconsin 53081
Sheboygan Physicians Group
Sheboygan, Wisconsin 53081
Sheboygan, Wisconsin 53081
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin 53081
Sheboygan, Wisconsin 53081
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin 54482
Stevens Point, Wisconsin 54482
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Sturgeon Bay, Wisconsin 54235-1495
Sturgeon Bay, Wisconsin 54235-1495
Aurora Medical Center in Summit
Summit, Wisconsin 53066
Summit, Wisconsin 53066
Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers, Wisconsin 54241
Two Rivers, Wisconsin 54241
ProHealth Waukesha Memorial Hospital
Waukesha, Wisconsin 53188
Waukesha, Wisconsin 53188
Contact:
Site Public Contact
262-928-7632
Site Public Contact
262-928-7632
UW Cancer Center at ProHealth Care
Waukesha, Wisconsin 53188
Waukesha, Wisconsin 53188
Aurora Cancer Care-Milwaukee West
Wauwatosa, Wisconsin 53226
Wauwatosa, Wisconsin 53226
Aurora West Allis Medical Center
West Allis, Wisconsin 53227
West Allis, Wisconsin 53227
Marshfield Medical Center - Weston
Weston, Wisconsin 54476
Weston, Wisconsin 54476
More Details
- Status
- Recruiting
- Sponsor
- National Cancer Institute (NCI)
Study Contact
Detailed Description
PRIMARY OBJECTIVE: I. To compare the restricted mean survival time (RMST) for overall survival (OS) between patients receiving the combination of relatlimab (BMS-986016) and nivolumab versus patients receiving standard of care chloroethylcyclohexylnitrosourea (CCNU) (lomustine). SECONDARY OBJECTIVES: I. To compare the 12-month OS rates between patients receiving the combination of relatlimab (BMS-986016) and nivolumab versus patients receiving standard of care CCNU (lomustine). II. To compare the restricted mean survival times for progression-free survival (PFS) between patients receiving the combination of relatlimab (BMS-986016) and nivolumab versus patients receiving standard of care CCNU (lomustine). III. To compare the radiographic response rate between patients receiving the combination of relatlimab (BMS-986016) and nivolumab versus patients receiving standard of care CCNU (lomustine). IV. To compare the safety/adverse event rate between patients receiving the combination of relatlimab (BMS-986016) and nivolumab versus patients receiving standard of care CCNU (lomustine). OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive nivolumab intravenously (IV) over 30 minutes followed by relatlimab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo surgery or biopsy, magnetic resonance imaging (MRI), and blood sample collection throughout study. ARM II: Patients receive lomustine orally (PO) on day 1 of each cycle. Cycles repeat every 42 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo surgery or biopsy, MRI, and blood sample collection throughout study. After completion of study treatment, patients are followed up every 6 months for up to 5 years from time of randomization.