Measuring if Immunotherapy Plus Chemotherapy is Better Than Chemotherapy Alone for Patients With Aggressive Poorly Differentiated Sarcomas
A Randomized Phase III Trial of Doxorubicin + Pembrolizumab Versus Doxorubicin Alone for the Treatment of Dedifferentiated Liposarcoma (DDLPS), Undifferentiated Pleomorphic Sarcoma (UPS) and Related Poorly Differentiated Sarcomas
3 other identifiers
interventional
365
3 countries
248
Brief Summary
This phase III trial compares the effect of immunotherapy (pembrolizumab) plus chemotherapy (doxorubicin) to chemotherapy (doxorubicin) alone in treating patients with dedifferentiated liposarcoma (DDLPS), undifferentiated pleomorphic sarcoma (UPS) or a related poorly differentiated sarcoma that has spread from where it first started (primary site) to other places in the body (metastatic) or that cannot be removed by surgery (unresectable). Doxorubicin is in a class of medications called anthracyclines. Doxorubicin damages the cell's deoxyribonucleic acid (DNA) and may kill tumor cells. It also blocks a certain enzyme needed for cell division and DNA repair. 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 pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Adding immunotherapy (pembrolizumab) to the standard chemotherapy (doxorubicin) may help patients with metastatic or unresectable DDLPS, UPS or a related poorly differentiated sarcoma live longer without having disease progression.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Sep 2024
248 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
May 18, 2024
CompletedFirst Posted
Study publicly available on registry
May 21, 2024
CompletedStudy Start
First participant enrolled
September 11, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
April 14, 2026
March 1, 2026
1.8 years
May 18, 2024
April 11, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Progression free survival (PFS)
Will be compared between the treatment arms (doxorubicin + pembrolizumab versus \[vs\] doxorubicin alone). The comparison of PFS between treatment arms will be done using a stratified (on Eastern Cooperative Oncology group performance status \[0 vs 1\]) log-rank test with a 2.5% type I error (1-sided). Will be analyzed separately for the undifferentiated pleomorphic sarcoma and related malignancies and for the dedifferentiated liposarcoma.
From randomization to documented progression (per Response Evaluation Criteria in Solid Tumors version 1.1) or death from any cause without prior progression, up to 5 years
Secondary Outcomes (1)
Overall survival
From randomization to death, up to 5 years
Other Outcomes (2)
Progression status
From randomization to documented progression (per RECIST version 1.1) or death from any cause without prior progression, up to 5 years
Progression time
From randomization to documented progression (per RECIST version 1.1) or death from any cause without prior progression, up to 5 years
Study Arms (2)
Arm A (doxorubicin and pembrolizumab
EXPERIMENTALPatients receive doxorubicin IV over 3-10 minutes or up to 3 hours on day 1 of each cycle. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients also undergo ECHO or MUGA scan, standard imaging scans and blood sample collection throughout the study.
Arm B (doxorubicin)
ACTIVE COMPARATORPatients receive doxorubicin IV over 3-10 minutes or up to 3 hours on day 1 of each cycle. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. At time of disease progression, patients may begin receiving pembrolizumab alone IV over 30 minutes on day 1 of each cycle. Cycles repeat every 21 days for 2 years in the absence of additional progression or unacceptable toxicity. Patients also undergo ECHO or MUGA scan, standard imaging scans and blood sample collection throughout the study.
Interventions
Undergo blood sample collection
Given IV
Undergo ECHO
Undergo MUGA scan
Given IV
Undergo standard imaging scans
Eligibility Criteria
You may qualify if:
- Patient must be \>= 18 years of age
- Patient must have a confirmed histopathologic diagnosis of dedifferentiated liposarcoma (DDLPS), undifferentiated pleomorphic sarcoma (UPS) or a related poorly differentiated sarcoma. Because UPS can sometimes exist in a spectrum among related diagnoses, the following additional diagnostic will be allowed, but not limited to:
- Pleomorphic sarcoma with inflammation or with limited areas of differentiation
- Pleomorphic sarcoma with giant cells
- Malignant fibrous histiocytoma (including storiform-pleomorphic and inflammatory subtypes)
- Myxofibrosarcoma
- Poorly differentiated sarcoma not otherwise specified (NOS)
- Undifferentiated spindle cell sarcoma
- Poorly differentiated spindle cell sarcoma NOS Any of these subtypes may have areas of focal myogenic differentiation
- Patient must have metastatic or unresectable sarcoma
- Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All patients of childbearing potential must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy. A patient of childbearing potential is defined as anyone, regardless of whether they have undergone tubal ligation, who meets the following criteria:
- Has achieved menarche at some point
- Has not undergone a hysterectomy or bilateral oophorectomy; or
- Has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
- Patient must not expect to conceive or father children by using an accepted and effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study. Contraception measures must continue for 6 months after the last dose of doxorubicin for patients of child bearing potential and for 3 months after the last dose of doxorubicin for male patients with partners of child bearing potential. Males with pregnant partners should use condoms during doxorubicin treatment and for at least 10 days after the last dose of doxorubicin. Contraception measures must also continue for 4 months after the last dose of pembrolizumab for patients of child bearing potential
- +27 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (248)
Mayo Clinic Hospital in Arizona
Phoenix, Arizona, 85054, United States
Banner University Medical Center - Tucson
Tucson, Arizona, 85719, United States
University of Arizona Cancer Center-North Campus
Tucson, Arizona, 85719, 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
Kaiser Permanente-Fresno
Fresno, California, 93720, United States
UC San Diego Moores Cancer Center
La Jolla, California, 92093, United States
Keck Medicine of USC Koreatown
Los Angeles, California, 90020, United States
Los Angeles General Medical Center
Los Angeles, California, 90033, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033, 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
USC Norris Oncology/Hematology-Newport Beach
Newport Beach, California, 92663, United States
Kaiser Permanente-Oakland
Oakland, California, 94611, United States
Stanford Cancer Institute Palo Alto
Palo Alto, California, 94304, United States
VA Palo Alto Health Care System
Palo Alto, California, 94304, United States
Huntington Memorial Hospital
Pasadena, California, 91105, United States
Kaiser Permanente-Roseville
Roseville, California, 95661, United States
Kaiser Permanente Downtown Commons
Sacramento, California, 95814, United States
Kaiser Permanente-South Sacramento
Sacramento, California, 95823, United States
Kaiser Permanente-San Francisco
San Francisco, California, 94115, United States
UCSF Medical Center-Mission Bay
San Francisco, California, 94158, 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
Kaiser Permanente-Vallejo
Vallejo, California, 94589, United States
Kaiser Permanente-Walnut Creek
Walnut Creek, California, 94596, United States
UCHealth University of Colorado Hospital
Aurora, Colorado, 80045, 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
Medical Center of the Rockies
Loveland, Colorado, 80538, United States
Smilow Cancer Hospital-Derby Care Center
Derby, Connecticut, 06418, United States
Smilow Cancer Hospital Care Center-Fairfield
Fairfield, Connecticut, 06824, United States
Smilow Cancer Hospital Care Center at Greenwich
Greenwich, Connecticut, 06830, United States
Smilow Cancer Hospital Care Center - Guilford
Guilford, Connecticut, 06437, United States
Yale University
New Haven, Connecticut, 06520, United States
Smilow Cancer Hospital Care Center at Long Ridge
Stamford, Connecticut, 06902, United States
Smilow Cancer Hospital-Torrington Care Center
Torrington, Connecticut, 06790, United States
Smilow Cancer Hospital Care Center-Trumbull
Trumbull, Connecticut, 06611, United States
Smilow Cancer Hospital-Waterbury Care Center
Waterbury, Connecticut, 06708, United States
Smilow Cancer Hospital Care Center - Waterford
Waterford, Connecticut, 06385, 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
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
UF Health Cancer Institute - Gainesville
Gainesville, Florida, 32610, United States
UM Sylvester Comprehensive Cancer Center at Hollywood
Hollywood, Florida, 33021, 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
UM Sylvester Comprehensive Cancer Center at Kendall
Miami, Florida, 33176, United States
University of Miami Sylvester Comprehensive Cancer Center at Sole Mia
North Miami, Florida, 33181, United States
UM Sylvester Comprehensive Cancer Center at Plantation
Plantation, Florida, 33324, United States
Moffitt Cancer Center - McKinley Campus
Tampa, Florida, 33612, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Emory University Hospital Midtown
Atlanta, Georgia, 30308, United States
Kaiser Permanente Moanalua Medical Center
Honolulu, Hawaii, 96819, United States
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, 83706, 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 Alphonsus Cancer Care Center-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
Centralia Oncology Clinic
Centralia, Illinois, 62801, United States
Northwestern University
Chicago, Illinois, 60611, United States
University of Illinois
Chicago, Illinois, 60612, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637, United States
Advocate Illinois Masonic Medical Center
Chicago, Illinois, 60657, United States
AMG Crystal Lake - Oncology
Crystal Lake, Illinois, 60014, United States
Carle at The Riverfront
Danville, Illinois, 61832, United States
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526, United States
Decatur Memorial Hospital
Decatur, Illinois, 62526, United States
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois, 60115, United States
Illinois CancerCare-Dixon
Dixon, Illinois, 61021, United States
Advocate Good Samaritan Hospital
Downers Grove, Illinois, 60515, United States
Carle Physician Group-Effingham
Effingham, Illinois, 62401, United States
Crossroads Cancer Center
Effingham, Illinois, 62401, United States
Advocate Sherman Hospital
Elgin, Illinois, 60123, United States
Elmhurst Memorial Hospital
Elmhurst, Illinois, 60126, United States
Illinois CancerCare-Eureka
Eureka, Illinois, 61530, United States
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401, United States
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, 60134, United States
Northwestern Medicine Glenview Outpatient Center
Glenview, Illinois, 60026, United States
Northwestern Medicine Grayslake Outpatient Center
Grayslake, Illinois, 60030, United States
Ingalls Memorial Hospital
Harvey, Illinois, 60426, United States
Advocate South Suburban Hospital
Hazel Crest, Illinois, 60429, United States
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, 61443, United States
Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois, 60045, 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
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938, United States
Edward Hospital/Cancer Center
Naperville, Illinois, 60540, United States
UC Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois, 60451, United States
Cancer Care Center of O'Fallon
O'Fallon, Illinois, 62269, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453-2699, United States
Northwestern Medicine Orland Park
Orland Park, Illinois, 60462, United States
University of Chicago Medicine-Orland Park
Orland Park, Illinois, 60462, United States
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, 61350, 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
Edward Hospital/Cancer Center?Plainfield
Plainfield, Illinois, 60585, United States
Illinois CancerCare-Princeton
Princeton, Illinois, 61356, 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
Carle Cancer Center
Urbana, Illinois, 61801, United States
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, 60555, United States
Illinois CancerCare - Washington
Washington, Illinois, 61571, United States
UChicago Medicine Northwest Indiana
Crown Point, Indiana, 46307, United States
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202, United States
Sidney and Lois Eskenazi Hospital
Indianapolis, Indiana, 46202, United States
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny, Iowa, 50023, United States
Saint Anthony Regional Hospital
Carroll, Iowa, 51401, United States
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, Iowa, 50325, 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
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
UI Health Care Mission Cancer and Blood - Waukee Clinic
Waukee, Iowa, 50263, United States
The James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, 40202, United States
UofL Health Medical Center Northeast
Louisville, Kentucky, 40245, United States
Louisiana Hematology Oncology Associates LLC
Baton Rouge, Louisiana, 70809, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109, United States
Henry Ford Cancer Institute-Downriver
Brownstown, Michigan, 48183, United States
Henry Ford Macomb Hospital-Clinton Township
Clinton Township, Michigan, 48038, United States
Henry Ford Medical Center-Fairlane
Dearborn, Michigan, 48126, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Allegiance Health
Jackson, Michigan, 49201, United States
Henry Ford Medical Center-Columbus
Novi, Michigan, 48377, United States
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan, 48322, United States
Henry Ford Wyandotte Hospital
Wyandotte, Michigan, 48192, United States
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, 56601, United States
Essentia Health - Deer River Clinic
Deer River, Minnesota, 56636, United States
Essentia Health Cancer Center
Duluth, Minnesota, 55805, United States
Essentia Health Hibbing Clinic
Hibbing, Minnesota, 55746, United States
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Essentia Health Sandstone
Sandstone, Minnesota, 55072, United States
Essentia Health Virginia Clinic
Virginia, Minnesota, 55792, 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
Siteman Cancer Center-South County
St Louis, Missouri, 63129, 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
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, 03756, United States
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Northwell Health/Center for Advanced Medicine
Lake Success, New York, 11042, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, 10016, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
University of Rochester
Rochester, New York, 14642, United States
Montefiore Medical Center-Einstein Campus
The Bronx, New York, 10461, United States
Montefiore Medical Center - Moses Campus
The Bronx, New York, 10467, United States
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Sanford Bismarck Medical Center
Bismarck, North Dakota, 58501, United States
Sanford Broadway Medical Center
Fargo, North Dakota, 58122, United States
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58122, United States
UH Seidman Cancer Center at UH Avon Health Center
Avon, Ohio, 44011, United States
UHHS-Chagrin Highlands Medical Center
Beachwood, Ohio, 44122, United States
Miami Valley Hospital South
Centerville, Ohio, 45459, United States
Case Western Reserve University
Cleveland, Ohio, 44106, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, 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 Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Saint Alphonsus Cancer Care Center-Ontario
Ontario, Oregon, 97914, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Pennsylvania Hospital
Philadelphia, Pennsylvania, 19107, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, 15232, 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
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232, United States
University of Virginia Cancer Center
Charlottesville, Virginia, 22908, United States
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, 23298, United States
ThedaCare Regional Cancer Center
Appleton, Wisconsin, 54911, 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
Aurora BayCare Medical Center
Green Bay, Wisconsin, 54311, United States
Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin, 53142, 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
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, 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
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin, 54904, United States
Aurora Cancer Care-Racine
Racine, Wisconsin, 53406, 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
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
Arthur J E Child Comprehensive Cancer Centre
Calgary, Alberta, T2N 5G2, Canada
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9, Canada
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, L8V 5C2, Canada
Ottawa Hospital and Cancer Center-General Campus
Ottawa, Ontario, K1H 8L6, Canada
University Health Network-Princess Margaret Hospital
Toronto, Ontario, M5G 2M9, Canada
CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ)
Québec, Quebec, G1R 2J6, Canada
Pan American Center for Oncology Trials LLC - Dorado
Dorado, 00646, Puerto Rico
Pan American Center for Oncology Trials LLC
San Juan, 00902, Puerto Rico
Pan American Center for Oncology Trials LLC - Ciudadela
San Juan, 00909, Puerto Rico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Seth M Pollack
ECOG-ACRIN Cancer Research Group
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 18, 2024
First Posted
May 21, 2024
Study Start
September 11, 2024
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
April 14, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
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