Study Stopped
Scheduled Interim Monitoring
Anti-Lag-3 (Relatlimab) and Anti-PD-1 Blockade (Nivolumab) Versus Standard of Care (Lomustine) for the Treatment of Patients With Recurrent Glioblastoma
Randomized Phase II Trial of Anti-Lag-3 and Anti-PD-1 Blockade vs. SOC in Patients With Recurrent Glioblastoma
3 other identifiers
interventional
184
1 country
324
Brief 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). 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2024
Typical duration for phase_2
324 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 20, 2024
CompletedFirst Posted
Study publicly available on registry
March 22, 2024
CompletedStudy Start
First participant enrolled
November 8, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 15, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 15, 2028
May 4, 2026
April 1, 2026
3.7 years
March 20, 2024
May 1, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
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).
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.
From randomization until death due to any cause, assessed at 12 months
Secondary Outcomes (3)
Progression-free survival
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
Up to 5 years
Incidence of adverse events (AEs)
Up to 5 years
Study Arms (2)
Arm I (nivolumab, relatlimab)
EXPERIMENTALPatients 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.
Arm II (lomustine)
ACTIVE COMPARATORPatients 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.
Interventions
Undergo blood sample collection
Given PO
Undergo MRI
Given IV
Undergo biopsy
Given IV
Undergo surgery
Eligibility Criteria
You may qualify if:
- 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)
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (324)
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Jonesboro, Arkansas, 72401, United States
Sutter Auburn Faith Hospital
Auburn, California, 95602, United States
City of Hope Comprehensive Cancer Center
Duarte, California, 91010, United States
Kaiser Permanente Dublin
Dublin, California, 94568, United States
Kaiser Permanente-Fremont
Fremont, California, 94538, United States
Kaiser Permanente Fresno Orchard Plaza
Fresno, California, 93720, United States
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, 92612, United States
UC San Diego Moores Cancer Center
La Jolla, California, 92093, United States
City of Hope Antelope Valley
Lancaster, California, 93534, United States
City of Hope at Long Beach Elm
Long Beach, California, 90813, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Kaiser Permanente- Modesto MOB II
Modesto, California, 95356, United States
Kaiser Permanente-Modesto
Modesto, California, 95356, United States
Kaiser Permanente-Oakland
Oakland, California, 94611, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, 92868, United States
Palo Alto Medical Foundation Health Care
Palo Alto, California, 94301, United States
Stanford Cancer Institute Palo Alto
Palo Alto, California, 94304, United States
Kaiser Permanente- Marshall Medical Offices
Redwood City, California, 94063, United States
Kaiser Permanente-Roseville
Roseville, California, 95661, United States
Sutter Roseville Medical Center
Roseville, California, 95661, United States
Kaiser Permanente Downtown Commons
Sacramento, California, 95814, United States
Sutter Medical Center Sacramento
Sacramento, California, 95816, United States
Kaiser Permanente-South Sacramento
Sacramento, California, 95823, United States
Kaiser Permanente-San Diego Zion
San Diego, California, 92120, United States
California Pacific Medical Center-Pacific Campus
San Francisco, California, 94115, United States
Kaiser Permanente-San Francisco
San Francisco, California, 94115, United States
Kaiser Permanente-Santa Teresa-San Jose
San Jose, California, 95119, United States
Kaiser Permanente San Leandro
San Leandro, California, 94577, United States
Kaiser San Rafael-Gallinas
San Rafael, California, 94903, United States
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, 95051, United States
Kaiser Permanente-Santa Rosa
Santa Rosa, California, 95403, United States
Kaiser Permanente-South San Francisco
South San Francisco, California, 94080, United States
City of Hope Upland
Upland, California, 91786, United States
Kaiser Permanente-Vallejo
Vallejo, California, 94589, United States
Kaiser Permanente-Walnut Creek
Walnut Creek, California, 94596, United States
John Muir Medical Center-Walnut Creek
Walnut Creek, California, 94598, United States
UCHealth Memorial Hospital Central
Colorado Springs, Colorado, 80909, United States
Memorial Hospital North
Colorado Springs, Colorado, 80920, United States
Kaiser Permanente-Franklin
Denver, Colorado, 80205, United States
Poudre Valley Hospital
Fort Collins, Colorado, 80524, United States
Cancer Care and Hematology-Fort Collins
Fort Collins, Colorado, 80528, United States
UCHealth Greeley Hospital
Greeley, Colorado, 80631, United States
Kaiser Permanente-Rock Creek
Lafayette, Colorado, 80026, United States
Medical Center of the Rockies
Loveland, Colorado, 80538, United States
Hartford HealthCare - Saint Vincent's Medical Center
Bridgeport, Connecticut, 06606, United States
Hartford Hospital
Hartford, Connecticut, 06102, United States
Yale University
New Haven, Connecticut, 06520, United States
Smilow Cancer Hospital Care Center-Trumbull
Trumbull, Connecticut, 06611, United States
Beebe South Coastal Health Campus
Millville, Delaware, 19967, United States
Helen F Graham Cancer Center
Newark, Delaware, 19713, United States
Medical Oncology Hematology Consultants PA
Newark, Delaware, 19713, United States
Beebe Health Campus
Rehoboth Beach, Delaware, 19971, United States
Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016, United States
UM Sylvester Comprehensive Cancer Center at Aventura
Aventura, Florida, 33180, United States
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida, 33146, United States
UM Sylvester Comprehensive Cancer Center at Coral Springs
Coral Springs, Florida, 33065, United States
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, 33442, United States
UM Sylvester Comprehensive Cancer Center at Doral
Doral, Florida, 33166, United States
UF Health Cancer Institute - Gainesville
Gainesville, Florida, 32610, United States
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood, Florida, 33021, United States
UM Sylvester Comprehensive Cancer Center at Hollywood
Hollywood, Florida, 33021, United States
Baptist MD Anderson Cancer Center
Jacksonville, Florida, 32207, United States
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136, United States
Miami Cancer Institute
Miami, Florida, 33176, United States
UM Sylvester Comprehensive Cancer Center at Kendall
Miami, Florida, 33176, United States
Orlando Health Cancer Institute
Orlando, Florida, 32806, United States
UM Sylvester Comprehensive Cancer Center at Plantation
Plantation, Florida, 33324, United States
Augusta University Medical Center
Augusta, Georgia, 30912, United States
Kaiser Permanente Moanalua Medical Center
Honolulu, Hawaii, 96819, United States
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, 83706, United States
Saint Luke's Cancer Institute - Boise
Boise, Idaho, 83712, United States
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho, 83605, United States
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, 83814, United States
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho, 83619, United States
Saint Luke's Cancer Institute - Meridian
Meridian, Idaho, 83642, United States
Saint Alphonsus Cancer Care Center-Nampa
Nampa, Idaho, 83687, United States
Saint Luke's Cancer Institute - Nampa
Nampa, Idaho, 83687, United States
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho, 83854, United States
Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho, 83864, United States
Advocate Outpatient Center - Aurora
Aurora, Illinois, 60506, United States
Advocate Good Shepherd Hospital
Barrington, Illinois, 60010, United States
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704, United States
Illinois CancerCare-Canton
Canton, Illinois, 61520, United States
Illinois CancerCare-Carthage
Carthage, Illinois, 62321, United States
Rush MD Anderson Cancer Center
Chicago, Illinois, 60612, United States
University of Illinois
Chicago, Illinois, 60612, United States
Advocate Illinois Masonic Medical Center
Chicago, Illinois, 60657, United States
AMG Crystal Lake - Oncology
Crystal Lake, Illinois, 60014, United States
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526, United States
Decatur Memorial Hospital
Decatur, Illinois, 62526, United States
Illinois CancerCare-Dixon
Dixon, Illinois, 61021, United States
Advocate Good Samaritan Hospital
Downers Grove, Illinois, 60515, United States
Crossroads Cancer Center
Effingham, Illinois, 62401, United States
Advocate Sherman Hospital
Elgin, Illinois, 60123, United States
Illinois CancerCare-Eureka
Eureka, Illinois, 61530, United States
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, 60201, United States
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401, United States
NorthShore University HealthSystem-Glenbrook Hospital
Glenview, Illinois, 60026, United States
Advocate South Suburban Hospital
Hazel Crest, Illinois, 60429, United States
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, 61443, United States
AMG Libertyville - Oncology
Libertyville, Illinois, 60048, United States
Condell Memorial Hospital
Libertyville, Illinois, 60048, United States
Illinois CancerCare-Macomb
Macomb, Illinois, 61455, United States
Cancer Care Center of O'Fallon
O'Fallon, Illinois, 62269, United States
HSHS Saint Elizabeth's Hospital
O'Fallon, Illinois, 62269, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453-2699, United States
Advocate Outpatient Center - Oak Lawn
Oak Lawn, Illinois, 60453, United States
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, 61350, United States
Advocate High Tech Medical Park
Palos Heights, Illinois, 60463, United States
Advocate Lutheran General Hospital
Park Ridge, Illinois, 60068, United States
Illinois CancerCare-Pekin
Pekin, Illinois, 61554, United States
Illinois CancerCare-Peoria
Peoria, Illinois, 61615, United States
Illinois CancerCare-Peru
Peru, Illinois, 61354, United States
Illinois CancerCare-Princeton
Princeton, Illinois, 61356, United States
Memorial Hospital East
Shiloh, Illinois, 62269, United States
Southern Illinois University School of Medicine
Springfield, Illinois, 62702, United States
Springfield Clinic
Springfield, Illinois, 62702, United States
Springfield Memorial Hospital
Springfield, Illinois, 62781, United States
Illinois CancerCare - Washington
Washington, Illinois, 61571, United States
Franciscan Health Indianapolis
Indianapolis, Indiana, 46237, United States
Mary Greeley Medical Center
Ames, Iowa, 50010, United States
McFarland Clinic - Ames
Ames, Iowa, 50010, United States
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny, Iowa, 50023, United States
University of Iowa Healthcare Cancer Services Quad Cities
Bettendorf, Iowa, 52722, United States
McFarland Clinic - Boone
Boone, Iowa, 50036, United States
Saint Anthony Regional Hospital
Carroll, Iowa, 51401, United States
Mercy Hospital
Cedar Rapids, Iowa, 52403, United States
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, 52403, United States
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, Iowa, 50325, United States
Iowa Methodist Medical Center
Des Moines, Iowa, 50309, United States
UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, Iowa, 50309, United States
Broadlawns Medical Center
Des Moines, Iowa, 50314, United States
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa, 50314, United States
McFarland Clinic - Trinity Cancer Center
Fort Dodge, Iowa, 50501, United States
UI Healthcare Mission Cancer and Blood - Fort Dodge
Fort Dodge, Iowa, 50501, United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242, United States
McFarland Clinic - Jefferson
Jefferson, Iowa, 50129, United States
McFarland Clinic - Marshalltown
Marshalltown, Iowa, 50158, United States
UI Health Care Mission Cancer and Blood - Waukee Clinic
Waukee, Iowa, 50263, United States
University of Kansas Cancer Center
Kansas City, Kansas, 66160, United States
University of Kansas Cancer Center-Overland Park
Overland Park, Kansas, 66210, United States
University of Kansas Hospital-Indian Creek Campus
Overland Park, Kansas, 66211, United States
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, 66205, United States
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, 40536, United States
The James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, 40202, United States
Lafayette Family Cancer Center-EMMC
Brewer, Maine, 04412, United States
MaineHealth Cancer Care and IV Therapy - South Portland
South Portland, Maine, 04106, United States
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan, 48106, United States
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109, United States
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan, 48114, United States
University of Michigan - Brighton Center for Specialty Care
Brighton, Michigan, 48116, United States
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan, 48188, United States
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan, 48118, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
OSF Saint Francis Hospital and Medical Group
Escanaba, Michigan, 49829, United States
Cancer Hematology Centers - Flint
Flint, Michigan, 48503, United States
Genesee Hematology Oncology PC
Flint, Michigan, 48503, United States
Genesys Hurley Cancer Institute
Flint, Michigan, 48503, United States
Hurley Medical Center
Flint, Michigan, 48503, United States
University of Michigan Health - Sparrow Lansing
Lansing, Michigan, 48912, United States
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, 48154, United States
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan, 48197, United States
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, 56601, United States
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota, 56401, United States
Mercy Hospital
Coon Rapids, Minnesota, 55433, United States
Essentia Health - Deer River Clinic
Deer River, Minnesota, 56636, United States
Essentia Health Cancer Center
Duluth, Minnesota, 55805, United States
Fairview Southdale Hospital
Edina, Minnesota, 55435, United States
Essentia Health Hibbing Clinic
Hibbing, Minnesota, 55746, United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55415, United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416, United States
Regions Hospital
Saint Paul, Minnesota, 55101, United States
United Hospital
Saint Paul, Minnesota, 55102, United States
Essentia Health Sandstone
Sandstone, Minnesota, 55072, United States
Essentia Health Virginia Clinic
Virginia, Minnesota, 55792, United States
Baptist Memorial Hospital and Cancer Center-Golden Triangle
Columbus, Mississippi, 39705, United States
Baptist Cancer Center-Grenada
Grenada, Mississippi, 38901, United States
Baptist Memorial Hospital and Cancer Center-Union County
New Albany, Mississippi, 38652, United States
Baptist Memorial Hospital and Cancer Center-Oxford
Oxford, Mississippi, 38655, United States
Baptist Memorial Hospital and Cancer Center-Desoto
Southhaven, Mississippi, 38671, United States
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703, United States
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, 63376, United States
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, 63141, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Mercy Hospital South
St Louis, Missouri, 63128, United States
Siteman Cancer Center-South County
St Louis, Missouri, 63129, United States
Siteman Cancer Center at Christian Hospital
St Louis, Missouri, 63136, United States
Community Hospital of Anaconda
Anaconda, Montana, 59711, United States
Billings Clinic Cancer Center
Billings, Montana, 59101, United States
Bozeman Health Deaconess Hospital
Bozeman, Montana, 59715, United States
Benefis Sletten Cancer Institute
Great Falls, Montana, 59405, United States
Logan Health Medical Center
Kalispell, Montana, 59901, United States
Community Medical Center
Missoula, Montana, 59804, United States
Nebraska Medicine-Bellevue
Bellevue, Nebraska, 68123, United States
Nebraska Medicine-Village Pointe
Omaha, Nebraska, 68118, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Renown Regional Medical Center
Reno, Nevada, 89502, United States
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, 03756, United States
Cooper Hospital University Medical Center
Camden, New Jersey, 08103, United States
John F Kennedy Medical Center
Edison, New Jersey, 08818, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Jersey City Medical Center
Jersey City, New Jersey, 07302, United States
Saint Barnabas Medical Center
Livingston, New Jersey, 07039, United States
Monmouth Medical Center
Long Branch, New Jersey, 07740, United States
Morristown Medical Center
Morristown, New Jersey, 07960, United States
Jersey Shore Medical Center
Neptune City, New Jersey, 07753, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903, United States
Newark Beth Israel Medical Center
Newark, New Jersey, 07112, United States
Sidney Kimmel Cancer Center Washington Township
Sewell, New Jersey, 08080, United States
Overlook Hospital
Summit, New Jersey, 07902, United States
Community Medical Center
Toms River, New Jersey, 08755, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106, United States
Presbyterian Kaseman Hospital
Albuquerque, New Mexico, 87110, United States
Presbyterian Rust Medical Center/Jorgensen Cancer Center
Rio Rancho, New Mexico, 87124, United States
Northwell Health Imbert Cancer Center
Bay Shore, New York, 11706, United States
NYU Langone Hospital - Brooklyn
Brooklyn, New York, 11220, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Glens Falls Hospital
Glens Falls, New York, 12801, United States
Northwell Health/Center for Advanced Medicine
Lake Success, New York, 11042, United States
NYU Langone Hospital - Long Island
Mineola, New York, 11501, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, 10016, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, 10032, United States
Upstate Cancer Center at Oswego
Oswego, New York, 13126, United States
University of Rochester
Rochester, New York, 14642, United States
State University of New York Upstate Medical University
Syracuse, New York, 13210, United States
Montefiore Medical Center-Einstein Campus
The Bronx, New York, 10461, United States
FirstHealth of the Carolinas-Moore Regional Hospital
Pinehurst, North Carolina, 28374, United States
Sanford Bismarck Medical Center
Bismarck, North Dakota, 58501, United States
Essentia Health Cancer Center-South University Clinic
Fargo, North Dakota, 58103, United States
Sanford Broadway Medical Center
Fargo, North Dakota, 58122, United States
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58122, United States
Miami Valley Hospital South
Centerville, Ohio, 45459, United States
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, 45219, United States
Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio, 45220, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
Riverside Methodist Hospital
Columbus, Ohio, 43214, United States
Miami Valley Hospital
Dayton, Ohio, 45409, United States
Premier Blood and Cancer Center
Dayton, Ohio, 45409, United States
Miami Valley Hospital North
Dayton, Ohio, 45415, United States
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, 45005-1066, United States
Miami Valley Cancer Care and Infusion
Greenville, Ohio, 45331, United States
Upper Valley Medical Center
Troy, Ohio, 45373, United States
University of Cincinnati Cancer Center-West Chester
West Chester, Ohio, 45069, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Legacy Mount Hood Medical Center
Gresham, Oregon, 97030, United States
Saint Alphonsus Cancer Care Center-Ontario
Ontario, Oregon, 97914, United States
Legacy Good Samaritan Hospital and Medical Center
Portland, Oregon, 97210, United States
Providence Portland Medical Center
Portland, Oregon, 97213, United States
Providence Saint Vincent Medical Center
Portland, Oregon, 97225, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Legacy Meridian Park Hospital
Tualatin, Oregon, 97062, United States
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, 18103, United States
Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania, 18017, United States
Pocono Medical Center
East Stroudsburg, Pennsylvania, 18301, United States
UPMC Hillman Cancer Center Erie
Erie, Pennsylvania, 16505, United States
Saint Vincent Hospital
Erie, Pennsylvania, 16544, United States
Jefferson Hospital
Jefferson Hills, Pennsylvania, 15025, United States
Forbes Hospital
Monroeville, Pennsylvania, 15146, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
West Penn Hospital
Pittsburgh, Pennsylvania, 15224, United States
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, 15232, United States
Wexford Health and Wellness Pavilion
Wexford, Pennsylvania, 15090, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, 57104, United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134, United States
Baptist Memorial Hospital and Cancer Center-Collierville
Collierville, Tennessee, 38017, United States
Baptist Memorial Hospital and Cancer Center-Memphis
Memphis, Tennessee, 38120, United States
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232, United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112, United States
University of Vermont Medical Center
Burlington, Vermont, 05401, United States
University of Vermont and State Agricultural College
Burlington, Vermont, 05405, United States
Inova Schar Cancer Institute
Fairfax, Virginia, 22031, United States
Bon Secours Memorial Regional Medical Center
Mechanicsville, Virginia, 23116, United States
Bon Secours Saint Francis Medical Center
Midlothian, Virginia, 23114, United States
Bon Secours Richmond Community Hospital
Richmond, Virginia, 23223, United States
Bon Secours Saint Mary's Hospital
Richmond, Virginia, 23226, United States
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, 23298, United States
Swedish Medical Center-Cherry Hill
Seattle, Washington, 98122-5711, United States
Legacy Cancer Institute Medical Oncology and Day Treatment
Vancouver, Washington, 98684, United States
Legacy Salmon Creek Hospital
Vancouver, Washington, 98686, United States
West Virginia University Healthcare
Morgantown, West Virginia, 26506, United States
Camden Clark Medical Center
Parkersburg, West Virginia, 26101, United States
Wheeling Hospital/Schiffler Cancer Center
Wheeling, West Virginia, 26003, United States
Duluth Clinic Ashland
Ashland, Wisconsin, 54806, United States
Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin, 53105, United States
Aurora Saint Luke's South Shore
Cudahy, Wisconsin, 53110, United States
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, 54701, United States
Aurora Health Care Germantown Health Center
Germantown, Wisconsin, 53022, United States
Aurora Cancer Care-Grafton
Grafton, Wisconsin, 53024, United States
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, 54301, United States
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin, 54303, United States
Aurora BayCare Medical Center
Green Bay, Wisconsin, 54311, United States
Mercyhealth Hospital and Cancer Center - Janesville
Janesville, Wisconsin, 53548, United States
Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin, 53142, United States
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
Madison, Wisconsin, 53718, United States
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, 53792, United States
Aurora Bay Area Medical Group-Marinette
Marinette, Wisconsin, 54143, United States
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449, United States
Aurora Cancer Care-Milwaukee
Milwaukee, Wisconsin, 53209, United States
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
Aurora Sinai Medical Center
Milwaukee, Wisconsin, 53233, United States
ProHealth D N Greenwald Center
Mukwonago, Wisconsin, 53149, United States
ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, 53066, United States
Saint Vincent Hospital Cancer Center at Oconto Falls
Oconto Falls, Wisconsin, 54154, United States
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin, 54904, United States
Aurora Cancer Care-Racine
Racine, Wisconsin, 53406, United States
Saint Vincent Hospital Cancer Center at Sheboygan
Sheboygan, Wisconsin, 53081, United States
Sheboygan Physicians Group
Sheboygan, Wisconsin, 53081, United States
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin, 53081, United States
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin, 54482, United States
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Sturgeon Bay, Wisconsin, 54235-1495, United States
Aurora Medical Center in Summit
Summit, Wisconsin, 53066, United States
Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers, Wisconsin, 54241, United States
ProHealth Waukesha Memorial Hospital
Waukesha, Wisconsin, 53188, United States
UW Cancer Center at ProHealth Care
Waukesha, Wisconsin, 53188, United States
Aurora Cancer Care-Milwaukee West
Wauwatosa, Wisconsin, 53226, United States
Aurora West Allis Medical Center
West Allis, Wisconsin, 53227, United States
Marshfield Medical Center - Weston
Weston, Wisconsin, 54476, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Lim
Alliance for Clinical Trials in Oncology
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 20, 2024
First Posted
March 22, 2024
Study Start
November 8, 2024
Primary Completion (Estimated)
July 15, 2028
Study Completion (Estimated)
July 15, 2028
Last Updated
May 4, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
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.