Progressive GlioblastomaPhase 2NCT06325683
Anti-Lag-3 (Relatlimab) and Anti-PD-1 Blockade (Nivolumab) Versus Standard of Care (Lomustine) for the Treatment of Patients With Recurrent Glioblastoma
A Phase 2 study testing Biopsy Procedure, Biospecimen Collection and Lomustine in people with Progressive Glioblastoma and Recurrent Glioblastoma, run by National Cancer Institute (NCI) at 325 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Progressive Glioblastoma, Recurrent Glioblastoma
- What is being tested?
- Biopsy Procedure, Biospecimen Collection and Lomustine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 325 sitesUnited States
- Study dates
- 8 Nov 2024to 15 Jul 2029
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
None listed.
Trial locations and contacts
325 sites in 1 country.
300 sites in 1 country
United States300 sites
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106
Presbyterian Kaseman Hospital
Albuquerque, New Mexico, 87110
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, 18103
Mary Greeley Medical Center
Ames, Iowa, 50010
McFarland Clinic - Ames
Ames, Iowa, 50010
Community Hospital of Anaconda
Anaconda, Montana, 59711
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny, Iowa, 50023
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan, 48106
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109
Duluth Clinic Ashland
Ashland, Wisconsin, 54806
Sutter Auburn Faith Hospital
Auburn, California, 95602
Augusta University Medical Center
Augusta, Georgia, 30912
Advocate Outpatient Center - Aurora
Aurora, Illinois, 60506
UM Sylvester Comprehensive Cancer Center at Aventura
Aventura, Florida, 33180
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287
Advocate Good Shepherd Hospital
Barrington, Illinois, 60010
Northwell Health Imbert Cancer Center
Bay Shore, New York, 11706
Nebraska Medicine-Bellevue
Bellevue, Nebraska, 68123
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, 56601
Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania, 18017
University of Iowa Healthcare Cancer Services Quad Cities
Bettendorf, Iowa, 52722
Billings Clinic Cancer Center
Billings, Montana, 59101
Sanford Bismarck Medical Center
Bismarck, North Dakota, 58501
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, 83706
Saint Luke's Cancer Institute - Boise
Boise, Idaho, 83712
McFarland Clinic - Boone
Boone, Iowa, 50036
Tufts Medical Center
Boston, Massachusetts, 02111
Bozeman Health Deaconess Hospital
Bozeman, Montana, 59715
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota, 56401
Lafayette Family Cancer Center-EMMC
Brewer, Maine, 04412
Hartford HealthCare - Saint Vincent's Medical Center
Bridgeport, Connecticut, 06606
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan, 48114
University of Michigan - Brighton Center for Specialty Care
Brighton, Michigan, 48116
NYU Langone Hospital - Brooklyn
Brooklyn, New York, 11220
Roswell Park Cancer Institute
Buffalo, New York, 14263
University of Vermont Medical Center
Burlington, Vermont, 05401
University of Vermont and State Agricultural College
Burlington, Vermont, 05405
Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin, 53105
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho, 83605
Cooper Hospital University Medical Center
Camden, New Jersey, 08103
Illinois CancerCare-Canton
Canton, Illinois, 61520
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan, 48188
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703
Saint Anthony Regional Hospital
Carroll, Iowa, 51401
Illinois CancerCare-Carthage
Carthage, Illinois, 62321
Mercy Hospital
Cedar Rapids, Iowa, 52403
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, 52403
Miami Valley Hospital South
Centerville, Ohio, 45459
Medical University of South Carolina
Charleston, South Carolina, 29425
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan, 48118
Rush MD Anderson Cancer Center
Chicago, Illinois, 60612
University of Illinois
Chicago, Illinois, 60612
Advocate Illinois Masonic Medical Center
Chicago, Illinois, 60657
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, 45219
Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio, 45220
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, 63376
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, Iowa, 50325
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, 83814
Baptist Memorial Hospital and Cancer Center-Collierville
Collierville, Tennessee, 38017
UCHealth Memorial Hospital Central
Colorado Springs, Colorado, 80909
Memorial Hospital North
Colorado Springs, Colorado, 80920
Baptist Memorial Hospital and Cancer Center-Golden Triangle
Columbus, Mississippi, 39705
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Riverside Methodist Hospital
Columbus, Ohio, 43214
Mercy Hospital
Coon Rapids, Minnesota, 55433
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida, 33146
UM Sylvester Comprehensive Cancer Center at Coral Springs
Coral Springs, Florida, 33065
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, 63141
AMG Crystal Lake - Oncology
Crystal Lake, Illinois, 60014
Aurora Saint Luke's South Shore
Cudahy, Wisconsin, 53110
Miami Valley Hospital
Dayton, Ohio, 45409
Premier Blood and Cancer Center
Dayton, Ohio, 45409
Miami Valley Hospital North
Dayton, Ohio, 45415
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526
Decatur Memorial Hospital
Decatur, Illinois, 62526
Essentia Health - Deer River Clinic
Deer River, Minnesota, 56636
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, 33442
Kaiser Permanente-Franklin
Denver, Colorado, 80205
Iowa Methodist Medical Center
Des Moines, Iowa, 50309
UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, Iowa, 50309
Broadlawns Medical Center
Des Moines, Iowa, 50314
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa, 50314
Henry Ford Hospital
Detroit, Michigan, 48202
Illinois CancerCare-Dixon
Dixon, Illinois, 61021
UM Sylvester Comprehensive Cancer Center at Doral
Doral, Florida, 33166
Advocate Good Samaritan Hospital
Downers Grove, Illinois, 60515
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
Kaiser Permanente Dublin
Dublin, California, 94568
Essentia Health Cancer Center
Duluth, Minnesota, 55805
Pocono Medical Center
East Stroudsburg, Pennsylvania, 18301
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, 54701
Fairview Southdale Hospital
Edina, Minnesota, 55435
John F Kennedy Medical Center
Edison, New Jersey, 08818
Crossroads Cancer Center
Effingham, Illinois, 62401
Advocate Sherman Hospital
Elgin, Illinois, 60123
UPMC Hillman Cancer Center Erie
Erie, Pennsylvania, 16505
Saint Vincent Hospital
Erie, Pennsylvania, 16544
OSF Saint Francis Hospital and Medical Group
Escanaba, Michigan, 49829
Illinois CancerCare-Eureka
Eureka, Illinois, 61530
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, 60201
Inova Schar Cancer Institute
Fairfax, Virginia, 22031
Essentia Health Cancer Center-South University Clinic
Fargo, North Dakota, 58103
Sanford Broadway Medical Center
Fargo, North Dakota, 58122
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58122
Cancer Hematology Centers - Flint
Flint, Michigan, 48503
Genesee Hematology Oncology PC
Flint, Michigan, 48503
Genesys Hurley Cancer Institute
Flint, Michigan, 48503
Hurley Medical Center
Flint, Michigan, 48503
Poudre Valley Hospital
Fort Collins, Colorado, 80524
Cancer Care and Hematology-Fort Collins
Fort Collins, Colorado, 80528
McFarland Clinic - Trinity Cancer Center
Fort Dodge, Iowa, 50501
UI Healthcare Mission Cancer and Blood - Fort Dodge
Fort Dodge, Iowa, 50501
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, 45005-1066
Kaiser Permanente-Fremont
Fremont, California, 94538
Kaiser Permanente Fresno Orchard Plaza
Fresno, California, 93720
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho, 83619
UF Health Cancer Institute - Gainesville
Gainesville, Florida, 32610
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401
Aurora Health Care Germantown Health Center
Germantown, Wisconsin, 53022
Glens Falls Hospital
Glens Falls, New York, 12801
NorthShore University HealthSystem-Glenbrook Hospital
Glenview, Illinois, 60026
Aurora Cancer Care-Grafton
Grafton, Wisconsin, 53024
Benefis Sletten Cancer Institute
Great Falls, Montana, 59405
UCHealth Greeley Hospital
Greeley, Colorado, 80631
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, 54301
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin, 54303
Aurora BayCare Medical Center
Green Bay, Wisconsin, 54311
Miami Valley Cancer Care and Infusion
Greenville, Ohio, 45331
Baptist Cancer Center-Grenada
Grenada, Mississippi, 38901
Legacy Mount Hood Medical Center
Gresham, Oregon, 97030
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Hartford Hospital
Hartford, Connecticut, 06102
Advocate South Suburban Hospital
Hazel Crest, Illinois, 60429
Essentia Health Hibbing Clinic
Hibbing, Minnesota, 55746
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood, Florida, 33021
UM Sylvester Comprehensive Cancer Center at Hollywood
Hollywood, Florida, 33021
Kaiser Permanente Moanalua Medical Center
Honolulu, Hawaii, 96819
Franciscan Health Indianapolis
Indianapolis, Indiana, 46237
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, 92612
Baptist MD Anderson Cancer Center
Jacksonville, Florida, 32207
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
Mercyhealth Hospital and Cancer Center - Janesville
Janesville, Wisconsin, 53548
McFarland Clinic - Jefferson
Jefferson, Iowa, 50129
Jefferson Hospital
Jefferson Hills, Pennsylvania, 15025
Jersey City Medical Center
Jersey City, New Jersey, 07302
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Jonesboro, Arkansas, 72401
Logan Health Medical Center
Kalispell, Montana, 59901
University of Kansas Cancer Center
Kansas City, Kansas, 66160
Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin, 53142
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, 61443
UC San Diego Moores Cancer Center
La Jolla, California, 92093
Kaiser Permanente-Rock Creek
Lafayette, Colorado, 80026
Northwell Health/Center for Advanced Medicine
Lake Success, New York, 11042
City of Hope Antelope Valley
Lancaster, California, 93534
University of Michigan Health - Sparrow Lansing
Lansing, Michigan, 48912
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, 03756
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, 40536
AMG Libertyville - Oncology
Libertyville, Illinois, 60048
Condell Memorial Hospital
Libertyville, Illinois, 60048
Cooperman Barnabas Medical Center
Livingston, New Jersey, 07039
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, 48154
City of Hope at Long Beach Elm
Long Beach, California, 90813
Monmouth Medical Center
Long Branch, New Jersey, 07740
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027
Cedars-Sinai Medical Center
Los Angeles, California, 90048
The James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, 40202
Medical Center of the Rockies
Loveland, Colorado, 80538
Illinois CancerCare-Macomb
Macomb, Illinois, 61455
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
Madison, Wisconsin, 53718
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, 53792
Aurora Bay Area Medical Group-Marinette
Marinette, Wisconsin, 54143
McFarland Clinic - Marshalltown
Marshalltown, Iowa, 50158
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449
Bon Secours Memorial Regional Medical Center
Mechanicsville, Virginia, 23116
Baptist Memorial Hospital and Cancer Center-Memphis
Memphis, Tennessee, 38120
Saint Luke's Cancer Institute - Meridian
Meridian, Idaho, 83642
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136
Miami Cancer Institute
Miami, Florida, 33176
UM Sylvester Comprehensive Cancer Center at Kendall
Miami, Florida, 33176
Bon Secours Saint Francis Medical Center
Midlothian, Virginia, 23114
Beebe South Coastal Health Campus
Millville, Delaware, 19967
Aurora Cancer Care-Milwaukee
Milwaukee, Wisconsin, 53209
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, 53215
Aurora Sinai Medical Center
Milwaukee, Wisconsin, 53233
NYU Langone Hospital - Long Island
Mineola, New York, 11501
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
Community Medical Center
Missoula, Montana, 59804
Kaiser Permanente- Modesto MOB II
Modesto, California, 95356
Kaiser Permanente-Modesto
Modesto, California, 95356
Forbes Hospital
Monroeville, Pennsylvania, 15146
West Virginia University Healthcare
Morgantown, West Virginia, 26506
Morristown Medical Center
Morristown, New Jersey, 07960
ProHealth D N Greenwald Center
Mukwonago, Wisconsin, 53149
Saint Alphonsus Cancer Care Center-Nampa
Nampa, Idaho, 83687
Saint Luke's Cancer Institute - Nampa
Nampa, Idaho, 83687
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232
Jersey Shore Medical Center
Neptune City, New Jersey, 07753
Baptist Memorial Hospital and Cancer Center-Union County
New Albany, Mississippi, 38652
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
Yale University
New Haven, Connecticut, 06520
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, 10016
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, 10032
Helen F Graham Cancer Center
Newark, Delaware, 19713
Medical Oncology Hematology Consultants PA
Newark, Delaware, 19713
Newark Beth Israel Medical Center
Newark, New Jersey, 07112
Cancer Care Center of O'Fallon
O'Fallon, Illinois, 62269
HSHS Saint Elizabeth's Hospital
O'Fallon, Illinois, 62269
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453-2699
Advocate Outpatient Center - Oak Lawn
Oak Lawn, Illinois, 60453
Kaiser Permanente-Oakland
Oakland, California, 94611
ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, 53066
Saint Vincent Hospital Cancer Center at Oconto Falls
Oconto Falls, Wisconsin, 54154
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Nebraska Medicine-Village Pointe
Omaha, Nebraska, 68118
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Saint Alphonsus Cancer Care Center-Ontario
Ontario, Oregon, 97914
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, 92868
Orlando Health Cancer Institute
Orlando, Florida, 32806
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin, 54904
Upstate Cancer Center at Oswego
Oswego, New York, 13126
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, 61350
University of Kansas Cancer Center-Overland Park
Overland Park, Kansas, 66210
University of Kansas Hospital-Indian Creek Campus
Overland Park, Kansas, 66211
Baptist Memorial Hospital and Cancer Center-Oxford
Oxford, Mississippi, 38655
Palo Alto Medical Foundation Health Care
Palo Alto, California, 94301
Stanford Cancer Institute Palo Alto
Palo Alto, California, 94304
Advocate High Tech Medical Park
Palos Heights, Illinois, 60463
Advocate Lutheran General Hospital
Park Ridge, Illinois, 60068
Camden Clark Medical Center
Parkersburg, West Virginia, 26101
Illinois CancerCare-Pekin
Pekin, Illinois, 61554
Illinois CancerCare-Peoria
Peoria, Illinois, 61615
Illinois CancerCare-Peru
Peru, Illinois, 61354
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
FirstHealth of the Carolinas-Moore Regional Hospital
Pinehurst, North Carolina, 28374
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
West Penn Hospital
Pittsburgh, Pennsylvania, 15224
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
UM Sylvester Comprehensive Cancer Center at Plantation
Plantation, Florida, 33324
Legacy Good Samaritan Hospital and Medical Center
Portland, Oregon, 97210
Providence Portland Medical Center
Portland, Oregon, 97213
Providence Saint Vincent Medical Center
Portland, Oregon, 97225
Oregon Health and Science University
Portland, Oregon, 97239
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho, 83854
Illinois CancerCare-Princeton
Princeton, Illinois, 61356
Aurora Cancer Care-Racine
Racine, Wisconsin, 53406
Kaiser Permanente- Marshall Medical Offices
Redwood City, California, 94063
Beebe Health Campus
Rehoboth Beach, Delaware, 19971
Renown Regional Medical Center
Reno, Nevada, 89502
Bon Secours Richmond Community Hospital
Richmond, Virginia, 23223
Bon Secours Saint Mary's Hospital
Richmond, Virginia, 23226
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, 23298
Presbyterian Rust Medical Center/Jorgensen Cancer Center
Rio Rancho, New Mexico, 87124
University of Rochester
Rochester, New York, 14642
Kaiser Permanente-Roseville
Roseville, California, 95661
Sutter Roseville Medical Center
Roseville, California, 95661
Kaiser Permanente Downtown Commons
Sacramento, California, 95814
Sutter Medical Center Sacramento
Sacramento, California, 95816
Kaiser Permanente-South Sacramento
Sacramento, California, 95823
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416
Regions Hospital
Saint Paul, Minnesota, 55101
United Hospital
Saint Paul, Minnesota, 55102
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112
Kaiser Permanente-San Diego Zion
San Diego, California, 92120
California Pacific Medical Center-Pacific Campus
San Francisco, California, 94115
Kaiser Permanente-San Francisco
San Francisco, California, 94115
Kaiser Permanente-Santa Teresa-San Jose
San Jose, California, 95119
Kaiser Permanente San Leandro
San Leandro, California, 94577
Kaiser San Rafael-Gallinas
San Rafael, California, 94903
Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho, 83864
Essentia Health Sandstone
Sandstone, Minnesota, 55072
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, 95051
Kaiser Permanente-Santa Rosa
Santa Rosa, California, 95403
MaineHealth Maine Medical Center- Scarborough
Scarborough, Maine, 04074
Swedish Medical Center-Cherry Hill
Seattle, Washington, 98122-5711
Sidney Kimmel Cancer Center Washington Township
Sewell, New Jersey, 08080
Saint Vincent Hospital Cancer Center at Sheboygan
Sheboygan, Wisconsin, 53081
Sheboygan Physicians Group
Sheboygan, Wisconsin, 53081
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin, 53081
Memorial Hospital East
Shiloh, Illinois, 62269
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, 57104
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134
MaineHealth Cancer Care and IV Therapy - South Portland
South Portland, Maine, 04106
Kaiser Permanente-South San Francisco
South San Francisco, California, 94080
Baptist Memorial Hospital and Cancer Center-Desoto
Southhaven, Mississippi, 38671
Southern Illinois University School of Medicine
Springfield, Illinois, 62702
Springfield Clinic
Springfield, Illinois, 62702
Springfield Memorial Hospital
Springfield, Illinois, 62781
Washington University School of Medicine
St Louis, Missouri, 63110
Mercy Hospital South
St Louis, Missouri, 63128
Siteman Cancer Center-South County
St Louis, Missouri, 63129
Siteman Cancer Center at Christian Hospital
St Louis, Missouri, 63136
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin, 54482
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Sturgeon Bay, Wisconsin, 54235-1495
Overlook Hospital
Summit, New Jersey, 07902
Aurora Medical Center in Summit
Summit, Wisconsin, 53066
State University of New York Upstate Medical University
Syracuse, New York, 13210
Montefiore Medical Center-Einstein Campus
The Bronx, New York, 10461
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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.
- Conditions
- Progressive Glioblastoma, Recurrent Glioblastoma
- Being tested
- Biopsy Procedure, Biospecimen Collection, Lomustine, Magnetic Resonance Imaging, Nivolumab
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biopsy ProcedureProcedure or surgery
Also called Biopsy, BIOPSY_TYPE, Bx
Undergo biopsy
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection
Undergo blood sample collection
LomustineDrug
Also called 1-(2-Chloroethyl)-3-cyclohexyl-1-nitrosourea, 1-Nitrosourea, 1-(2-chloroethyl)-3-cyclohexyl-, Belustin, Belustine
Given PO
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan
Undergo MRI
NivolumabBiological
Also called ABP 206, BCD-263, BMS 936558, BMS-936558
Given IV
RelatlimabBiological
Also called BMS 986016, BMS-986016, BMS986016, Immunoglobulin G4, Anti-(human Lymphocyte Activation Gene-3 Protein) (Human Heavy Chain), Disulfide with Human Light Chain, Dimer
Given IV
Surgical ProcedureProcedure or surgery
Also called Operation, Surgery, Surgery Type, Surgery, NOS
Undergo surgery
| Study group | Role | What they receive |
|---|---|---|
| Arm I (nivolumab, relatlimab) | Experimental | 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. Receives: Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Procedure: Magnetic Resonance Imaging; Biological: Nivolumab; Biological: Relatlimab; Procedure: Surgical Procedure |
| Arm II (lomustine) | Active comparator | 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. Receives: Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Drug: Lomustine; Procedure: Magnetic Resonance Imaging; Procedure: Surgical Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
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).
Measured: From randomization until death due to any cause, assessed at 30 months
OS rate
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.
Measured: From randomization until death due to any cause, assessed at 12 months
Secondary outcomes (3)
Progression-free survival
Measured: 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
Radiographic response
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.
Measured: Up to 5 years
Incidence of adverse events (AEs)
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.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start8 Nov 2024
- Primary completion15 Jul 2029 (estimated)
- Study completion15 Jul 2029 (estimated)
Why it stopped: Scheduled Interim Monitoring
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Progressive GlioblastomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 184 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Michael Lim, Principal investigator, Alliance for Clinical Trials in Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06325683
- Sponsor's protocol ID
- NCI-2024-01995
- Other IDs
- NCI-2024-01995, A072201, A072201, U10CA180821
- Status last verified
- Oct 2026
- First submitted
- 20 Mar 2024
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.