Anti-Lag-3 (Relatlimab) and Anti-PD-1 Blockade (Nivolumab) Versus Standard of Care (Lomustine) for the Treatment of Patients With Recurrent Glioblastoma

June 2, 2026 updated by: National Cancer Institute (NCI)

Randomized Phase II Trial of Anti-Lag-3 and Anti-PD-1 Blockade vs. SOC in Patients With Recurrent Glioblastoma

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

184

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
    • California
      • Auburn, California, United States, 95602
        • Sutter Auburn Faith Hospital
      • Duarte, California, United States, 91010
        • City of Hope Comprehensive Cancer Center
      • Dublin, California, United States, 94568
        • Kaiser Permanente Dublin
      • Fremont, California, United States, 94538
        • Kaiser Permanente-Fremont
      • Fresno, California, United States, 93720
        • Kaiser Permanente Fresno Orchard Plaza
      • Irvine, California, United States, 92612
        • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
      • La Jolla, California, United States, 92093
        • UC San Diego Moores Cancer Center
      • Lancaster, California, United States, 93534
        • City of Hope Antelope Valley
      • Long Beach, California, United States, 90813
        • City of Hope at Long Beach Elm
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center
      • Los Angeles, California, United States, 90027
        • Kaiser Permanente Los Angeles Medical Center
      • Modesto, California, United States, 95356
        • Kaiser Permanente-Modesto
      • Modesto, California, United States, 95356
        • Kaiser Permanente- Modesto MOB II
      • Oakland, California, United States, 94611
        • Kaiser Permanente-Oakland
      • Orange, California, United States, 92868
        • UC Irvine Health/Chao Family Comprehensive Cancer Center
      • Palo Alto, California, United States, 94304
        • Stanford Cancer Institute Palo Alto
      • Palo Alto, California, United States, 94301
        • Palo Alto Medical Foundation Health Care
      • Redwood City, California, United States, 94063
        • Kaiser Permanente- Marshall Medical Offices
      • Roseville, California, United States, 95661
        • Kaiser Permanente-Roseville
      • Roseville, California, United States, 95661
        • Sutter Roseville Medical Center
      • Sacramento, California, United States, 95816
        • Sutter Medical Center Sacramento
      • Sacramento, California, United States, 95814
        • Kaiser Permanente Downtown Commons
      • Sacramento, California, United States, 95823
        • Kaiser Permanente-South Sacramento
      • San Diego, California, United States, 92120
        • Kaiser Permanente-San Diego Zion
      • San Francisco, California, United States, 94115
        • Kaiser Permanente-San Francisco
      • San Francisco, California, United States, 94115
        • California Pacific Medical Center-Pacific Campus
      • San Jose, California, United States, 95119
        • Kaiser Permanente-Santa Teresa-San Jose
      • San Leandro, California, United States, 94577
        • Kaiser Permanente San Leandro
      • San Rafael, California, United States, 94903
        • Kaiser San Rafael-Gallinas
      • Santa Clara, California, United States, 95051
        • Kaiser Permanente Medical Center - Santa Clara
      • Santa Rosa, California, United States, 95403
        • Kaiser Permanente-Santa Rosa
      • South San Francisco, California, United States, 94080
        • Kaiser Permanente-South San Francisco
      • Upland, California, United States, 91786
        • City of Hope Upland
      • Vallejo, California, United States, 94589
        • Kaiser Permanente-Vallejo
      • Walnut Creek, California, United States, 94596
        • Kaiser Permanente-Walnut Creek
      • Walnut Creek, California, United States, 94598
        • John Muir Medical Center-Walnut Creek
    • Colorado
      • Colorado Springs, Colorado, United States, 80909
        • UCHealth Memorial Hospital Central
      • Colorado Springs, Colorado, United States, 80920
        • Memorial Hospital North
      • Denver, Colorado, United States, 80205
        • Kaiser Permanente-Franklin
      • Fort Collins, Colorado, United States, 80524
        • Poudre Valley Hospital
      • Fort Collins, Colorado, United States, 80528
        • Cancer Care and Hematology-Fort Collins
      • Greeley, Colorado, United States, 80631
        • UCHealth Greeley Hospital
      • Lafayette, Colorado, United States, 80026
        • Kaiser Permanente-Rock Creek
      • Loveland, Colorado, United States, 80538
        • Medical Center of the Rockies
    • Connecticut
      • Bridgeport, Connecticut, United States, 06606
        • Hartford HealthCare - Saint Vincent's Medical Center
      • Hartford, Connecticut, United States, 06102
        • Hartford Hospital
      • New Haven, Connecticut, United States, 06520
        • Yale University
      • Trumbull, Connecticut, United States, 06611
        • Smilow Cancer Hospital Care Center-Trumbull
    • Delaware
      • Millville, Delaware, United States, 19967
        • Beebe South Coastal Health Campus
      • Newark, Delaware, United States, 19713
        • Helen F Graham Cancer Center
      • Newark, Delaware, United States, 19713
        • Medical Oncology Hematology Consultants PA
      • Rehoboth Beach, Delaware, United States, 19971
        • Beebe Health Campus
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20016
        • Sibley Memorial Hospital
    • Florida
      • Aventura, Florida, United States, 33180
        • UM Sylvester Comprehensive Cancer Center at Aventura
      • Coral Gables, Florida, United States, 33146
        • UM Sylvester Comprehensive Cancer Center at Coral Gables
      • Coral Springs, Florida, United States, 33065
        • UM Sylvester Comprehensive Cancer Center at Coral Springs
      • Deerfield Beach, Florida, United States, 33442
        • UM Sylvester Comprehensive Cancer Center at Deerfield Beach
      • Doral, Florida, United States, 33166
        • UM Sylvester Comprehensive Cancer Center at Doral
      • Gainesville, Florida, United States, 32610
        • UF Health Cancer Institute - Gainesville
      • Hollywood, Florida, United States, 33021
        • Memorial Regional Hospital/Joe DiMaggio Children's Hospital
      • Hollywood, Florida, United States, 33021
        • UM Sylvester Comprehensive Cancer Center at Hollywood
      • Jacksonville, Florida, United States, 32207
        • Baptist MD Anderson Cancer Center
      • Jacksonville, Florida, United States, 32224-9980
        • Mayo Clinic in Florida
      • Miami, Florida, United States, 33136
        • University of Miami Miller School of Medicine-Sylvester Cancer Center
      • Miami, Florida, United States, 33176
        • Miami Cancer Institute
      • Miami, Florida, United States, 33176
        • UM Sylvester Comprehensive Cancer Center at Kendall
      • Orlando, Florida, United States, 32806
        • Orlando Health Cancer Institute
      • Plantation, Florida, United States, 33324
        • UM Sylvester Comprehensive Cancer Center at Plantation
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Augusta University Medical Center
    • Hawaii
      • Honolulu, Hawaii, United States, 96819
        • Kaiser Permanente Moanalua Medical Center
    • Idaho
      • Boise, Idaho, United States, 83706
        • Saint Alphonsus Cancer Care Center-Boise
      • Boise, Idaho, United States, 83712
        • Saint Luke's Cancer Institute - Boise
      • Caldwell, Idaho, United States, 83605
        • Saint Alphonsus Cancer Care Center-Caldwell
      • Coeur d'Alene, Idaho, United States, 83814
        • Kootenai Health - Coeur d'Alene
      • Fruitland, Idaho, United States, 83619
        • Saint Luke's Cancer Institute - Fruitland
      • Meridian, Idaho, United States, 83642
        • Saint Luke's Cancer Institute - Meridian
      • Nampa, Idaho, United States, 83687
        • Saint Alphonsus Cancer Care Center-Nampa
      • Nampa, Idaho, United States, 83687
        • Saint Luke's Cancer Institute - Nampa
      • Post Falls, Idaho, United States, 83854
        • Kootenai Clinic Cancer Services - Post Falls
      • Sandpoint, Idaho, United States, 83864
        • Kootenai Clinic Cancer Services - Sandpoint
    • Illinois
      • Aurora, Illinois, United States, 60506
        • Advocate Outpatient Center - Aurora
      • Barrington, Illinois, United States, 60010
        • Advocate Good Shepherd Hospital
      • Bloomington, Illinois, United States, 61704
        • Illinois CancerCare-Bloomington
      • Canton, Illinois, United States, 61520
        • Illinois CancerCare-Canton
      • Carthage, Illinois, United States, 62321
        • Illinois CancerCare-Carthage
      • Chicago, Illinois, United States, 60612
        • University of Illinois
      • Chicago, Illinois, United States, 60657
        • Advocate Illinois Masonic Medical Center
      • Chicago, Illinois, United States, 60612
        • Rush MD Anderson Cancer Center
      • Crystal Lake, Illinois, United States, 60014
        • AMG Crystal Lake - Oncology
      • Decatur, Illinois, United States, 62526
        • Decatur Memorial Hospital
      • Decatur, Illinois, United States, 62526
        • Cancer Care Specialists of Illinois - Decatur
      • Dixon, Illinois, United States, 61021
        • Illinois CancerCare-Dixon
      • Downers Grove, Illinois, United States, 60515
        • Advocate Good Samaritan Hospital
      • Effingham, Illinois, United States, 62401
        • Crossroads Cancer Center
      • Elgin, Illinois, United States, 60123
        • Advocate Sherman Hospital
      • Eureka, Illinois, United States, 61530
        • Illinois CancerCare-Eureka
      • Evanston, Illinois, United States, 60201
        • NorthShore University HealthSystem-Evanston Hospital
      • Galesburg, Illinois, United States, 61401
        • Illinois CancerCare-Galesburg
      • Glenview, Illinois, United States, 60026
        • NorthShore University HealthSystem-Glenbrook Hospital
      • Hazel Crest, Illinois, United States, 60429
        • Advocate South Suburban Hospital
      • Kewanee, Illinois, United States, 61443
        • Illinois CancerCare-Kewanee Clinic
      • Libertyville, Illinois, United States, 60048
        • Condell Memorial Hospital
      • Libertyville, Illinois, United States, 60048
        • AMG Libertyville - Oncology
      • Macomb, Illinois, United States, 61455
        • Illinois CancerCare-Macomb
      • O'Fallon, Illinois, United States, 62269
        • Cancer Care Center of O'Fallon
      • O'Fallon, Illinois, United States, 62269
        • HSHS Saint Elizabeth's Hospital
      • Oak Lawn, Illinois, United States, 60453-2699
        • Advocate Christ Medical Center
      • Oak Lawn, Illinois, United States, 60453
        • Advocate Outpatient Center - Oak Lawn
      • Ottawa, Illinois, United States, 61350
        • Illinois CancerCare-Ottawa Clinic
      • Palos Heights, Illinois, United States, 60463
        • Advocate High Tech Medical Park
      • Park Ridge, Illinois, United States, 60068
        • Advocate Lutheran General Hospital
      • Pekin, Illinois, United States, 61554
        • Illinois CancerCare-Pekin
      • Peoria, Illinois, United States, 61615
        • Illinois CancerCare-Peoria
      • Peru, Illinois, United States, 61354
        • Illinois CancerCare-Peru
      • Princeton, Illinois, United States, 61356
        • Illinois CancerCare-Princeton
      • Shiloh, Illinois, United States, 62269
        • Memorial Hospital East
      • Springfield, Illinois, United States, 62702
        • Southern Illinois University School of Medicine
      • Springfield, Illinois, United States, 62702
        • Springfield Clinic
      • Springfield, Illinois, United States, 62781
        • Springfield Memorial Hospital
      • Washington, Illinois, United States, 61571
        • Illinois CancerCare - Washington
    • Indiana
      • Indianapolis, Indiana, United States, 46237
        • Franciscan Health Indianapolis
    • Iowa
      • Ames, Iowa, United States, 50010
        • Mary Greeley Medical Center
      • Ames, Iowa, United States, 50010
        • McFarland Clinic - Ames
      • Ankeny, Iowa, United States, 50023
        • UI Health Care Mission Cancer and Blood - Ankeny Clinic
      • Bettendorf, Iowa, United States, 52722
        • University of Iowa Healthcare Cancer Services Quad Cities
      • Boone, Iowa, United States, 50036
        • McFarland Clinic - Boone
      • Carroll, Iowa, United States, 51401
        • Saint Anthony Regional Hospital
      • Cedar Rapids, Iowa, United States, 52403
        • Mercy Hospital
      • Cedar Rapids, Iowa, United States, 52403
        • Oncology Associates at Mercy Medical Center
      • Clive, Iowa, United States, 50325
        • UI Health Care Mission Cancer and Blood - West Des Moines Clinic
      • Des Moines, Iowa, United States, 50309
        • Iowa Methodist Medical Center
      • Des Moines, Iowa, United States, 50314
        • Broadlawns Medical Center
      • Des Moines, Iowa, United States, 50309
        • UI Health Care Mission Cancer and Blood - Des Moines Clinic
      • Des Moines, Iowa, United States, 50314
        • UI Health Care Mission Cancer and Blood - Laurel Clinic
      • Fort Dodge, Iowa, United States, 50501
        • McFarland Clinic - Trinity Cancer Center
      • Fort Dodge, Iowa, United States, 50501
        • UI Healthcare Mission Cancer and Blood - Fort Dodge
      • Iowa City, Iowa, United States, 52242
        • University of Iowa/Holden Comprehensive Cancer Center
      • Jefferson, Iowa, United States, 50129
        • McFarland Clinic - Jefferson
      • Marshalltown, Iowa, United States, 50158
        • McFarland Clinic - Marshalltown
      • Waukee, Iowa, United States, 50263
        • UI Health Care Mission Cancer and Blood - Waukee Clinic
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Cancer Center
      • Overland Park, Kansas, United States, 66210
        • University of Kansas Cancer Center-Overland Park
      • Overland Park, Kansas, United States, 66211
        • University of Kansas Hospital-Indian Creek Campus
      • Westwood, Kansas, United States, 66205
        • University of Kansas Hospital-Westwood Cancer Center
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky/Markey Cancer Center
      • Louisville, Kentucky, United States, 40202
        • The James Graham Brown Cancer Center at University of Louisville
    • Maine
      • Brewer, Maine, United States, 04412
        • Lafayette Family Cancer Center-EMMC
      • Scarborough, Maine, United States, 04074
        • MaineHealth Maine Medical Center- Scarborough
      • South Portland, Maine, United States, 04106
        • MaineHealth Cancer Care and IV Therapy - South Portland
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins University/Sidney Kimmel Cancer Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Rogel Cancer Center
      • Ann Arbor, Michigan, United States, 48106
        • Trinity Health Saint Joseph Mercy Hospital Ann Arbor
      • Brighton, Michigan, United States, 48114
        • Trinity Health IHA Medical Group Hematology Oncology - Brighton
      • Brighton, Michigan, United States, 48116
        • University of Michigan - Brighton Center for Specialty Care
      • Canton, Michigan, United States, 48188
        • Trinity Health IHA Medical Group Hematology Oncology - Canton
      • Chelsea, Michigan, United States, 48118
        • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
      • Escanaba, Michigan, United States, 49829
        • OSF Saint Francis Hospital and Medical Group
      • Flint, Michigan, United States, 48503
        • Hurley Medical Center
      • Flint, Michigan, United States, 48503
        • Genesee Hematology Oncology PC
      • Flint, Michigan, United States, 48503
        • Genesys Hurley Cancer Institute
      • Flint, Michigan, United States, 48503
        • Cancer Hematology Centers - Flint
      • Lansing, Michigan, United States, 48912
        • University of Michigan Health - Sparrow Lansing
      • Livonia, Michigan, United States, 48154
        • Trinity Health Saint Mary Mercy Livonia Hospital
      • Ypsilanti, Michigan, United States, 48197
        • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
    • Minnesota
      • Bemidji, Minnesota, United States, 56601
        • Sanford Joe Lueken Cancer Center
      • Brainerd, Minnesota, United States, 56401
        • Essentia Health Saint Joseph's Medical Center
      • Coon Rapids, Minnesota, United States, 55433
        • Mercy Hospital
      • Deer River, Minnesota, United States, 56636
        • Essentia Health - Deer River Clinic
      • Duluth, Minnesota, United States, 55805
        • Essentia Health Cancer Center
      • Edina, Minnesota, United States, 55435
        • Fairview Southdale Hospital
      • Hibbing, Minnesota, United States, 55746
        • Essentia Health Hibbing Clinic
      • Minneapolis, Minnesota, United States, 55415
        • Hennepin County Medical Center
      • Minneapolis, Minnesota, United States, 55407
        • Abbott-Northwestern Hospital
      • Saint Louis Park, Minnesota, United States, 55416
        • Park Nicollet Clinic - Saint Louis Park
      • Saint Paul, Minnesota, United States, 55101
        • Regions Hospital
      • Saint Paul, Minnesota, United States, 55102
        • United Hospital
      • Sandstone, Minnesota, United States, 55072
        • Essentia Health Sandstone
      • Virginia, Minnesota, United States, 55792
        • Essentia Health Virginia Clinic
    • Mississippi
      • Columbus, Mississippi, United States, 39705
        • Baptist Memorial Hospital and Cancer Center-Golden Triangle
      • Grenada, Mississippi, United States, 38901
        • Baptist Cancer Center-Grenada
      • New Albany, Mississippi, United States, 38652
        • Baptist Memorial Hospital and Cancer Center-Union County
      • Oxford, Mississippi, United States, 38655
        • Baptist Memorial Hospital and Cancer Center-Oxford
      • Southhaven, Mississippi, United States, 38671
        • Baptist Memorial Hospital and Cancer Center-Desoto
    • Missouri
      • Cape Girardeau, Missouri, United States, 63703
        • Saint Francis Medical Center
      • City of Saint Peters, Missouri, United States, 63376
        • Siteman Cancer Center at Saint Peters Hospital
      • Creve Coeur, Missouri, United States, 63141
        • Siteman Cancer Center at West County Hospital
      • St Louis, Missouri, United States, 63110
        • Washington University School of Medicine
      • St Louis, Missouri, United States, 63129
        • Siteman Cancer Center-South County
      • St Louis, Missouri, United States, 63136
        • Siteman Cancer Center at Christian Hospital
      • St Louis, Missouri, United States, 63128
        • Mercy Hospital South
    • Montana
      • Anaconda, Montana, United States, 59711
        • Community Hospital of Anaconda
      • Billings, Montana, United States, 59101
        • Billings Clinic Cancer Center
      • Bozeman, Montana, United States, 59715
        • Bozeman Health Deaconess Hospital
      • Great Falls, Montana, United States, 59405
        • Benefis Sletten Cancer Institute
      • Kalispell, Montana, United States, 59901
        • Logan Health Medical Center
      • Missoula, Montana, United States, 59804
        • Community Medical Center
    • Nebraska
      • Bellevue, Nebraska, United States, 68123
        • Nebraska Medicine-Bellevue
      • Omaha, Nebraska, United States, 68198
        • University of Nebraska Medical Center
      • Omaha, Nebraska, United States, 68118
        • Nebraska Medicine-Village Pointe
    • Nevada
      • Reno, Nevada, United States, 89502
        • Renown Regional Medical Center
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Cooper Hospital University Medical Center
      • Edison, New Jersey, United States, 08818
        • John F Kennedy Medical Center
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center
      • Jersey City, New Jersey, United States, 07302
        • Jersey City Medical Center
      • Livingston, New Jersey, United States, 07039
        • Saint Barnabas Medical Center
      • Long Branch, New Jersey, United States, 07740
        • Monmouth Medical Center
      • Morristown, New Jersey, United States, 07960
        • Morristown Medical Center
      • Neptune City, New Jersey, United States, 07753
        • Jersey Shore Medical Center
      • New Brunswick, New Jersey, United States, 08903
        • Rutgers Cancer Institute of New Jersey
      • Newark, New Jersey, United States, 07112
        • Newark Beth Israel Medical Center
      • Sewell, New Jersey, United States, 08080
        • Sidney Kimmel Cancer Center Washington Township
      • Summit, New Jersey, United States, 07902
        • Overlook Hospital
      • Toms River, New Jersey, United States, 08755
        • Community Medical Center
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • University of New Mexico Cancer Center
      • Albuquerque, New Mexico, United States, 87110
        • Presbyterian Kaseman Hospital
      • Rio Rancho, New Mexico, United States, 87124
        • Presbyterian Rust Medical Center/Jorgensen Cancer Center
    • New York
      • Bay Shore, New York, United States, 11706
        • Northwell Health Imbert Cancer Center
      • Brooklyn, New York, United States, 11220
        • NYU Langone Hospital - Brooklyn
      • Buffalo, New York, United States, 14263
        • Roswell Park Cancer Institute
      • Glens Falls, New York, United States, 12801
        • Glens Falls Hospital
      • Lake Success, New York, United States, 11042
        • Northwell Health/Center for Advanced Medicine
      • Mineola, New York, United States, 11501
        • NYU Langone Hospital - Long Island
      • New York, New York, United States, 10032
        • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
      • New York, New York, United States, 10016
        • Laura and Isaac Perlmutter Cancer Center at NYU Langone
      • Oswego, New York, United States, 13126
        • Upstate Cancer Center at Oswego
      • Rochester, New York, United States, 14642
        • University of Rochester
      • Syracuse, New York, United States, 13210
        • State University of New York Upstate Medical University
      • The Bronx, New York, United States, 10461
        • Montefiore Medical Center-Einstein Campus
    • North Carolina
      • Pinehurst, North Carolina, United States, 28374
        • FirstHealth of the Carolinas-Moore Regional Hospital
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
        • Sanford Bismarck Medical Center
      • Fargo, North Dakota, United States, 58122
        • Sanford Roger Maris Cancer Center
      • Fargo, North Dakota, United States, 58103
        • Essentia Health Cancer Center-South University Clinic
      • Fargo, North Dakota, United States, 58122
        • Sanford Broadway Medical Center
    • Ohio
      • Centerville, Ohio, United States, 45459
        • Miami Valley Hospital South
      • Cincinnati, Ohio, United States, 45219
        • University of Cincinnati Cancer Center-UC Medical Center
      • Cincinnati, Ohio, United States, 45220
        • Good Samaritan Hospital - Cincinnati
      • Columbus, Ohio, United States, 43214
        • Riverside Methodist Hospital
      • Columbus, Ohio, United States, 43210
        • Ohio State University Comprehensive Cancer Center
      • Dayton, Ohio, United States, 45409
        • Miami Valley Hospital
      • Dayton, Ohio, United States, 45415
        • Miami Valley Hospital North
      • Dayton, Ohio, United States, 45409
        • Premier Blood and Cancer Center
      • Franklin, Ohio, United States, 45005-1066
        • Atrium Medical Center-Middletown Regional Hospital
      • Greenville, Ohio, United States, 45331
        • Miami Valley Cancer Care and Infusion
      • Troy, Ohio, United States, 45373
        • Upper Valley Medical Center
      • West Chester, Ohio, United States, 45069
        • University of Cincinnati Cancer Center-West Chester
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma Health Sciences Center
    • Oregon
      • Gresham, Oregon, United States, 97030
        • Legacy Mount Hood Medical Center
      • Ontario, Oregon, United States, 97914
        • Saint Alphonsus Cancer Care Center-Ontario
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University
      • Portland, Oregon, United States, 97210
        • Legacy Good Samaritan Hospital and Medical Center
      • Portland, Oregon, United States, 97213
        • Providence Portland Medical Center
      • Portland, Oregon, United States, 97225
        • Providence Saint Vincent Medical Center
      • Tualatin, Oregon, United States, 97062
        • Legacy Meridian Park Hospital
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Lehigh Valley Hospital-Cedar Crest
      • Bethlehem, Pennsylvania, United States, 18017
        • Lehigh Valley Hospital - Muhlenberg
      • East Stroudsburg, Pennsylvania, United States, 18301
        • Pocono Medical Center
      • Erie, Pennsylvania, United States, 16505
        • UPMC Hillman Cancer Center Erie
      • Erie, Pennsylvania, United States, 16544
        • Saint Vincent Hospital
      • Jefferson Hills, Pennsylvania, United States, 15025
        • Jefferson Hospital
      • Monroeville, Pennsylvania, United States, 15146
        • Forbes Hospital
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Hospital
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny General Hospital
      • Pittsburgh, Pennsylvania, United States, 15224
        • West Penn Hospital
      • Pittsburgh, Pennsylvania, United States, 15232
        • University of Pittsburgh Cancer Institute (UPCI)
      • Wexford, Pennsylvania, United States, 15090
        • Wexford Health and Wellness Pavilion
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57117-5134
        • Sanford USD Medical Center - Sioux Falls
      • Sioux Falls, South Dakota, United States, 57104
        • Sanford Cancer Center Oncology Clinic
    • Tennessee
      • Collierville, Tennessee, United States, 38017
        • Baptist Memorial Hospital and Cancer Center-Collierville
      • Memphis, Tennessee, United States, 38120
        • Baptist Memorial Hospital and Cancer Center-Memphis
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University/Ingram Cancer Center
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Huntsman Cancer Institute/University of Utah
    • Vermont
      • Burlington, Vermont, United States, 05401
        • University of Vermont Medical Center
      • Burlington, Vermont, United States, 05405
        • University of Vermont and State Agricultural College
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Inova Schar Cancer Institute
      • Mechanicsville, Virginia, United States, 23116
        • Bon Secours Memorial Regional Medical Center
      • Midlothian, Virginia, United States, 23114
        • Bon Secours Saint Francis Medical Center
      • Richmond, Virginia, United States, 23226
        • Bon Secours Saint Mary's Hospital
      • Richmond, Virginia, United States, 23223
        • Bon Secours Richmond Community Hospital
      • Richmond, Virginia, United States, 23298
        • VCU Massey Comprehensive Cancer Center
    • Washington
      • Seattle, Washington, United States, 98122-5711
        • Swedish Medical Center-Cherry Hill
      • Vancouver, Washington, United States, 98686
        • Legacy Salmon Creek Hospital
      • Vancouver, Washington, United States, 98684
        • Legacy Cancer Institute Medical Oncology and Day Treatment
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University Healthcare
      • Parkersburg, West Virginia, United States, 26101
        • Camden Clark Medical Center
      • Wheeling, West Virginia, United States, 26003
        • Wheeling Hospital/Schiffler Cancer Center
    • Wisconsin
      • Ashland, Wisconsin, United States, 54806
        • Duluth Clinic Ashland
      • Burlington, Wisconsin, United States, 53105
        • Aurora Cancer Care-Southern Lakes VLCC
      • Cudahy, Wisconsin, United States, 53110
        • Aurora Saint Luke's South Shore
      • Eau Claire, Wisconsin, United States, 54701
        • Marshfield Medical Center-EC Cancer Center
      • Germantown, Wisconsin, United States, 53022
        • Aurora Health Care Germantown Health Center
      • Grafton, Wisconsin, United States, 53024
        • Aurora Cancer Care-Grafton
      • Green Bay, Wisconsin, United States, 54311
        • Aurora BayCare Medical Center
      • Green Bay, Wisconsin, United States, 54301
        • Saint Vincent Hospital Cancer Center Green Bay
      • Green Bay, Wisconsin, United States, 54303
        • Saint Vincent Hospital Cancer Center at Saint Mary's
      • Janesville, Wisconsin, United States, 53548
        • Mercyhealth Hospital and Cancer Center - Janesville
      • Kenosha, Wisconsin, United States, 53142
        • Aurora Cancer Care-Kenosha South
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin Carbone Cancer Center - University Hospital
      • Madison, Wisconsin, United States, 53718
        • University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
      • Marinette, Wisconsin, United States, 54143
        • Aurora Bay Area Medical Group-Marinette
      • Marshfield, Wisconsin, United States, 54449
        • Marshfield Medical Center-Marshfield
      • Milwaukee, Wisconsin, United States, 53209
        • Aurora Cancer Care-Milwaukee
      • Milwaukee, Wisconsin, United States, 53215
        • Aurora Saint Luke's Medical Center
      • Milwaukee, Wisconsin, United States, 53233
        • Aurora Sinai Medical Center
      • Mukwonago, Wisconsin, United States, 53149
        • ProHealth D N Greenwald Center
      • Oconomowoc, Wisconsin, United States, 53066
        • ProHealth Oconomowoc Memorial Hospital
      • Oconto Falls, Wisconsin, United States, 54154
        • Saint Vincent Hospital Cancer Center at Oconto Falls
      • Oshkosh, Wisconsin, United States, 54904
        • Vince Lombardi Cancer Clinic - Oshkosh
      • Racine, Wisconsin, United States, 53406
        • Aurora Cancer Care-Racine
      • Sheboygan, Wisconsin, United States, 53081
        • Vince Lombardi Cancer Clinic-Sheboygan
      • Sheboygan, Wisconsin, United States, 53081
        • Saint Vincent Hospital Cancer Center at Sheboygan
      • Sheboygan, Wisconsin, United States, 53081
        • Sheboygan Physicians Group
      • Stevens Point, Wisconsin, United States, 54482
        • Marshfield Medical Center-River Region at Stevens Point
      • Sturgeon Bay, Wisconsin, United States, 54235-1495
        • Saint Vincent Hospital Cancer Center at Sturgeon Bay
      • Summit, Wisconsin, United States, 53066
        • Aurora Medical Center in Summit
      • Two Rivers, Wisconsin, United States, 54241
        • Vince Lombardi Cancer Clinic-Two Rivers
      • Waukesha, Wisconsin, United States, 53188
        • UW Cancer Center at ProHealth Care
      • Waukesha, Wisconsin, United States, 53188
        • ProHealth Waukesha Memorial Hospital
      • Wauwatosa, Wisconsin, United States, 53226
        • Aurora Cancer Care-Milwaukee West
      • West Allis, Wisconsin, United States, 53227
        • Aurora West Allis Medical Center
      • Weston, Wisconsin, United States, 54476
        • Marshfield Medical Center - Weston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Biological: Nivolumab
Given IV
Other Names:
  • BMS-936558
  • MDX-1106
  • NIVO
  • ONO-4538
  • Opdivo
  • CMAB819
  • Nivolumab Biosimilar CMAB819
  • MDX 1106
  • MDX1106
  • BMS 936558
  • ABP 206
  • Nivolumab Biosimilar ABP 206
  • BCD-263
  • Nivolumab Biosimilar BCD-263
  • BMS936558
  • ONO 4538
  • ONO4538
Procedure: Magnetic Resonance Imaging
Undergo MRI
Other Names:
  • MRI
  • Magnetic Resonance
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MR
  • MR Imaging
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging
  • Magnetic Resonance Imaging (MRI)
  • sMRI
  • Magnetic resonance imaging (procedure)
  • MRIs
  • Structural MRI
Procedure: Biospecimen Collection
Undergo blood sample collection
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
  • Sample Collection
Procedure: Surgical Procedure
Undergo surgery
Other Names:
  • Operation
  • Surgery
  • Surgery Type
  • Surgical
  • Surgical Intervention
  • Surgical Interventions
  • Surgical Procedures
  • Type of Surgery
  • Surgery, NOS
Biological: Relatlimab
Given IV
Other Names:
  • BMS-986016
  • BMS986016
  • Immunoglobulin G4, Anti-(human Lymphocyte Activation Gene-3 Protein) (Human Heavy Chain), Disulfide with Human Light Chain, Dimer
  • BMS 986016
Procedure: Biopsy Procedure
Undergo biopsy
Other Names:
  • Bx
  • BIOPSY_TYPE
  • Biopsy
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.
Procedure: Magnetic Resonance Imaging
Undergo MRI
Other Names:
  • MRI
  • Magnetic Resonance
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MR
  • MR Imaging
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging
  • Magnetic Resonance Imaging (MRI)
  • sMRI
  • Magnetic resonance imaging (procedure)
  • MRIs
  • Structural MRI
Procedure: Biospecimen Collection
Undergo blood sample collection
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
  • Sample Collection
Procedure: Surgical Procedure
Undergo surgery
Other Names:
  • Operation
  • Surgery
  • Surgery Type
  • Surgical
  • Surgical Intervention
  • Surgical Interventions
  • Surgical Procedures
  • Type of Surgery
  • Surgery, NOS
Drug: Lomustine
Given PO
Other Names:
  • CCNU
  • CeeNU
  • Gleostine
  • 1-(2-Chloroethyl)-3-cyclohexyl-1-nitrosourea
  • 1-Nitrosourea, 1-(2-chloroethyl)-3-cyclohexyl-
  • Belustin
  • Belustine
  • Cecenu
  • Chloroethylcyclohexylnitrosourea
  • Citostal
  • Lomeblastin
  • Lomustinum
  • Lucostin
  • Lucostine
  • N-(2-Chloroethyl)-N'-cyclohexyl-N-nitrosourea
  • Prava
  • RB-1509
  • WR-139017
Procedure: Biopsy Procedure
Undergo biopsy
Other Names:
  • Bx
  • BIOPSY_TYPE
  • Biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: From randomization until death due to any cause, assessed at 30 months
The comparison of OS between the arms will be made with respect to restricted mean survival time (RMST) at 30 months. The RMST difference between arms will be determined as a point estimate with a corresponding 90% confidence interval (CI).
From randomization until death due to any cause, assessed at 30 months
OS rate
Time Frame: From randomization until death due to any cause, assessed at 12 months
The OS rate between the 2 arms will be compared using a chi-square test. The point estimate and corresponding 90% CI will be generated for the difference in proportion.
From randomization until death due to any cause, assessed at 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiographic response
Time Frame: Up to 5 years
Radiographic response will be assessed using Immunotherapy Response Assessment in Neuro-Oncology criteria. Patients with a complete response or partial response will be deemed a radiographic response. Patients with no follow-up imaging assessment will be deemed as a non-response. The proportion of patients with a radiographic response will be compared between the treatment arms with a Fisher's exact test.
Up to 5 years
Incidence of adverse events (AEs)
Time Frame: Up to 5 years
AEs will be assessed using Common Terminology Criteria for Adverse Events version 5.0. AEs will be summarized with frequencies and relative frequencies. The maximum grade for an AE will be recorded for each patient. The number (percent) of patients that experience each observed AE will be summarized by the treatment a patient received. The proportion of patients who experience a grade 3+, a grade 4+, and grade 5 AEs will be summarized by number and percent for each treatment arm. The primary summary will be for AEs regardless of attribution to treatment. An analogous summary will be performed for AEs deemed at least possibly related to treatment.
Up to 5 years
Progression-free survival
Time Frame: From randomization until confirmed disease progression as assessed by the treating physician or death due to any cause, whichever occurs first, assessed up to 5 years
From randomization until confirmed disease progression as assessed by the treating physician or death due to any cause, whichever occurs first, assessed up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Michael Lim, Alliance for Clinical Trials in Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 8, 2024

Primary Completion (Estimated)

July 15, 2028

Study Completion (Estimated)

July 15, 2028

Study Registration Dates

First Submitted

March 20, 2024

First Submitted That Met QC Criteria

March 20, 2024

First Posted (Actual)

March 22, 2024

Study Record Updates

Last Update Posted (Actual)

June 3, 2026

Last Update Submitted That Met QC Criteria

June 2, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCI-2024-01995 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • U10CA180821 (U.S. NIH Grant/Contract)
  • A072201 (Other Identifier: CTEP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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