Adding immunotherapy to chemotherapy for advanced soft tissue sarcoma
Tests pembrolizumab with doxorubicin in adults with spreading or unremovable liposarcoma or sarcoma.
Plain-language title generated from the registry record
Registry title: Measuring if Immunotherapy Plus Chemotherapy is Better Than Chemotherapy Alone for Patients With Aggressive Poorly Differentiated Sarcomas
Key facts
- Where
- Albuquerque, Anaconda, Ankeny, Ann Arbor, Appleton, Ashland, Atlanta, Aurora, Avon, Barrington, Basking Ridge, Baton Rouge, Beachwood, Bellevue, Bemidji, Billings, Bismarck, Bloomington, Boise, Boston, Bozeman, Brownstown, Buffalo, Burlington, Caldwell, Canton, Carroll, Carthage, Centerville, Centralia, Charleston, Charlottesville, Chicago, Cleveland, Clinton Township, Clive, Coeur d'Alene, Columbus, Coon Rapids, Coral Gables, Coral Springs, Creve Coeur, Crown Point, Crystal Lake, Cudahy, Danville, Dayton, Dearborn, Decatur, Deer River, Deerfield Beach, DeKalb, Derby, Des Moines, Detroit, Dixon, Downers Grove, Dublin, Duluth, Durham, Eau Claire, Edina, Effingham, Elgin, Elmhurst, Erie, Eureka, Fairfield, Fargo, Fort Collins, Fort Dodge, Franklin, Fremont, Fresno, Gainesville, Galesburg, Geneva, Germantown, Glenview, Grafton, Grayslake, Great Falls, Greeley, Green Bay, Greenville, Greenwich, Guilford, Harvey, Hazel Crest, Hibbing, Hollywood, Honolulu, Houston, Indianapolis, Iowa City, Jackson, Jacksonville, Jefferson Hills, Kalispell, Kenosha, Kewanee, La Jolla, Lake Forest, Lake Success, Lebanon, Libertyville, Los Angeles, Louisville, Loveland, Macomb, Maplewood, Marinette, Marshfield, Mattoon, Miami, Millville, Milwaukee, Minneapolis, Missoula, Modesto, Monroeville, Montvale, Mukwonago, Nampa, Naperville, Nashville, New Haven, New Lenox, New York, Newark, Newport Beach, North Miami, Novi, O'Fallon, Oak Lawn, Oakland, Oconomowoc, Oklahoma City, Omaha, Ontario, Orland Park, Orlando, Oshkosh, Oswego, Ottawa, Palo Alto, Park Ridge, Pasadena, Pekin, Peoria, Peru, Philadelphia, Phoenix, Pittsburgh, Plainfield, Plantation, Portland, Post Falls, Princeton, Racine, Rehoboth Beach, Rice Lake, Richmond, Rochester, Roseville, Sacramento, Saint Louis Park, Saint Paul, San Francisco, San Jose, San Leandro, San Rafael, Sandpoint, Sandstone, Santa Clara, Santa Rosa, Sheboygan, Sioux Falls, South San Francisco, Springfield, St Louis, Stamford, Stevens Point, Summit, Syracuse, Tampa, The Bronx, Torrington, Troy, Trumbull, Tucson, Two Rivers, Uniondale, Urbana, Vallejo, Verona, Virginia, Walnut Creek, Warrenville, Washington, Waterbury, Waterford, Waukee, Waukesha, Wauwatosa, West Allis, West Bloomfield, Weston, Wexford, and Wyandotte, United StatesSee the 258 sites
- Phase
- Phase 3
Where in United States
- University of New Mexico Cancer CenterAlbuquerque, United StatesTaking people
- Community Hospital of AnacondaAnaconda, United StatesTaking people
- UI Health Care Mission Cancer and Blood - Ankeny ClinicAnkeny, United StatesTaking people
- University of Michigan Rogel Cancer CenterAnn Arbor, United StatesTaking people
- ThedaCare Regional Cancer CenterAppleton, United StatesTaking people
- Duluth Clinic AshlandAshland, United StatesTaking people
- Emory University Hospital MidtownAtlanta, United StatesTaking people
- Advocate Outpatient Center - AuroraAurora, United StatesTaking people
- UCHealth University of Colorado HospitalAurora, United StatesTaking people
- UH Seidman Cancer Center at UH Avon Health CenterAvon, United StatesTaking people
- Advocate Good Shepherd HospitalBarrington, United StatesTaking people
- Memorial Sloan Kettering Basking RidgeBasking Ridge, United StatesTaking people
- Louisiana Hematology Oncology Associates LLCBaton Rouge, United StatesNo longer taking part
- UHHS-Chagrin Highlands Medical CenterBeachwood, United StatesTaking people
- Nebraska Medicine-BellevueBellevue, United StatesTaking people
- Sanford Joe Lueken Cancer CenterBemidji, United StatesTaking people
- Billings Clinic Cancer CenterBillings, United StatesTaking people
- Sanford Bismarck Medical CenterBismarck, United StatesTaking people
- Illinois CancerCare-BloomingtonBloomington, United StatesNo longer taking part
- Saint Alphonsus Cancer Care Center-BoiseBoise, United StatesNo longer taking part
- Dana-Farber Cancer InstituteBoston, United StatesTaking people
- Bozeman Health Deaconess HospitalBozeman, United StatesTaking people
- Henry Ford Cancer Institute-DownriverBrownstown, United StatesTaking people
- Roswell Park Cancer InstituteBuffalo, United StatesTaking people
- Aurora Cancer Care-Southern Lakes VLCCBurlington, United StatesTaking people
- Saint Alphonsus Cancer Care Center-CaldwellCaldwell, United StatesNo longer taking part
- Illinois CancerCare-CantonCanton, United StatesNo longer taking part
- Saint Anthony Regional HospitalCarroll, United StatesTaking people
- Illinois CancerCare-CarthageCarthage, United StatesNo longer taking part
- Miami Valley Hospital SouthCenterville, United StatesTaking people
- Centralia Oncology ClinicCentralia, United StatesTaking people
- Medical University of South CarolinaCharleston, United StatesTaking people
- University of Virginia Cancer CenterCharlottesville, United StatesTaking people
- Advocate Illinois Masonic Medical CenterChicago, United StatesTaking people
- Northwestern UniversityChicago, United StatesTaking people
- University of Chicago Comprehensive Cancer CenterChicago, United StatesTaking people
- University of IllinoisChicago, United StatesTaking people
- Case Western Reserve UniversityCleveland, United StatesTaking people
- Cleveland Clinic FoundationCleveland, United StatesTaking people
- Henry Ford Macomb Hospital-Clinton TownshipClinton Township, United StatesTaking people
- UI Health Care Mission Cancer and Blood - West Des Moines ClinicClive, United StatesTaking people
- Kootenai Health - Coeur d'AleneCoeur d'Alene, United StatesTaking people
- Ohio State University Comprehensive Cancer CenterColumbus, United StatesTaking people
- Mercy HospitalCoon Rapids, United StatesTaking people
- UM Sylvester Comprehensive Cancer Center at Coral GablesCoral Gables, United StatesTaking people
- UM Sylvester Comprehensive Cancer Center at Coral SpringsCoral Springs, United StatesTaking people
- Siteman Cancer Center at West County HospitalCreve Coeur, United StatesTaking people
- UChicago Medicine Northwest IndianaCrown Point, United StatesTaking people
- AMG Crystal Lake - OncologyCrystal Lake, United StatesTaking people
- Aurora Saint Luke's South ShoreCudahy, United StatesTaking people
- Carle at The RiverfrontDanville, United StatesTaking people
- Miami Valley HospitalDayton, United StatesTaking people
- Miami Valley Hospital NorthDayton, United StatesTaking people
- Premier Blood and Cancer CenterDayton, United StatesTaking people
- Henry Ford Medical Center-FairlaneDearborn, United StatesTaking people
- Cancer Care Specialists of Illinois - DecaturDecatur, United StatesTaking people
- Decatur Memorial HospitalDecatur, United StatesTaking people
- Essentia Health - Deer River ClinicDeer River, United StatesTaking people
- UM Sylvester Comprehensive Cancer Center at Deerfield BeachDeerfield Beach, United StatesTaking people
- Northwestern Medicine Cancer Center KishwaukeeDeKalb, United StatesTaking people
- Smilow Cancer Hospital-Derby Care CenterDerby, United StatesTaking people
- Broadlawns Medical CenterDes Moines, United StatesTaking people
- UI Health Care Mission Cancer and Blood - Des Moines ClinicDes Moines, United StatesTaking people
- UI Health Care Mission Cancer and Blood - Laurel ClinicDes Moines, United StatesTaking people
- Henry Ford HospitalDetroit, United StatesTaking people
- Illinois CancerCare-DixonDixon, United StatesNo longer taking part
- Advocate Good Samaritan HospitalDowners Grove, United StatesTaking people
- Kaiser Permanente DublinDublin, United StatesTaking people
- Essentia Health Cancer CenterDuluth, United StatesTaking people
- Duke University Medical CenterDurham, United StatesTaking people
- Marshfield Medical Center-EC Cancer CenterEau Claire, United StatesTaking people
- Fairview Southdale HospitalEdina, United StatesTaking people
- Minnesota Oncology - EdinaEdina, United StatesTaking people
- Carle Physician Group-EffinghamEffingham, United StatesTaking people
- Crossroads Cancer CenterEffingham, United StatesTaking people
- Advocate Sherman HospitalElgin, United StatesTaking people
- Elmhurst Memorial HospitalElmhurst, United StatesNo longer taking part
- Saint Vincent HospitalErie, United StatesTaking people
- Illinois CancerCare-EurekaEureka, United StatesNo longer taking part
- Smilow Cancer Hospital Care Center-FairfieldFairfield, United StatesTaking people
- Essentia Health Cancer Center-South University ClinicFargo, United StatesTaking people
- Sanford Broadway Medical CenterFargo, United StatesTaking people
- Sanford Roger Maris Cancer CenterFargo, United StatesTaking people
- Cancer Care and Hematology-Fort CollinsFort Collins, United StatesTaking people
- Poudre Valley HospitalFort Collins, United StatesTaking people
- UI Healthcare Mission Cancer and Blood - Fort DodgeFort Dodge, United StatesTaking people
- Atrium Medical Center-Middletown Regional HospitalFranklin, United StatesTaking people
- Kaiser Permanente-FremontFremont, United StatesTaking people
- Kaiser Permanente Fresno Orchard PlazaFresno, United StatesTaking people
- Kaiser Permanente-FresnoFresno, United StatesTaking people
- UF Health Cancer Institute - GainesvilleGainesville, United StatesTaking people
- Illinois CancerCare-GalesburgGalesburg, United StatesNo longer taking part
- Northwestern Medicine Cancer Center DelnorGeneva, United StatesTaking people
- Aurora Health Care Germantown Health CenterGermantown, United StatesTaking people
- Northwestern Medicine Glenview Outpatient CenterGlenview, United StatesTaking people
- Aurora Cancer Care-GraftonGrafton, United StatesTaking people
- Northwestern Medicine Grayslake Outpatient CenterGrayslake, United StatesTaking people
- Benefis Sletten Cancer InstituteGreat Falls, United StatesTaking people
- UCHealth Greeley HospitalGreeley, United StatesTaking people
- Aurora BayCare Medical CenterGreen Bay, United StatesTaking people
- Miami Valley Cancer Care and InfusionGreenville, United StatesTaking people
- Smilow Cancer Hospital Care Center at GreenwichGreenwich, United StatesTaking people
- Smilow Cancer Hospital Care Center - GuilfordGuilford, United StatesTaking people
- Ingalls Memorial HospitalHarvey, United StatesTaking people
- Advocate South Suburban HospitalHazel Crest, United StatesTaking people
- Essentia Health Hibbing ClinicHibbing, United StatesTaking people
- UM Sylvester Comprehensive Cancer Center at HollywoodHollywood, United StatesTaking people
- Kaiser Permanente Moanalua Medical CenterHonolulu, United StatesTaking people
- UT MD Anderson Cancer CenterHouston, United StatesTaking people
- Indiana University/Melvin and Bren Simon Cancer CenterIndianapolis, United StatesTaking people
- Sidney and Lois Eskenazi HospitalIndianapolis, United StatesTaking people
- University of Iowa/Holden Comprehensive Cancer CenterIowa City, United StatesTaking people
- Allegiance HealthJackson, United StatesTaking people
- Mayo Clinic in FloridaJacksonville, United StatesTaking people
- Jefferson HospitalJefferson Hills, United StatesTaking people
- Logan Health Medical CenterKalispell, United StatesTaking people
- Aurora Cancer Care-Kenosha SouthKenosha, United StatesTaking people
- Illinois CancerCare-Kewanee ClinicKewanee, United StatesNo longer taking part
- UC San Diego Moores Cancer CenterLa Jolla, United StatesTaking people
- Northwestern Medicine Lake Forest HospitalLake Forest, United StatesTaking people
- Northwell Health/Center for Advanced MedicineLake Success, United StatesTaking people
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer CenterLebanon, United StatesTaking people
- AMG Libertyville - OncologyLibertyville, United StatesTaking people
- Condell Memorial HospitalLibertyville, United StatesTaking people
- Cedars-Sinai Medical CenterLos Angeles, United StatesTaking people
- Keck Medicine of USC KoreatownLos Angeles, United StatesTaking people
- Los Angeles General Medical CenterLos Angeles, United StatesTaking people
- USC / Norris Comprehensive Cancer CenterLos Angeles, United StatesTaking people
- The James Graham Brown Cancer Center at University of LouisvilleLouisville, United StatesTaking people
- UofL Health Medical Center NortheastLouisville, United StatesTaking people
- Medical Center of the RockiesLoveland, United StatesTaking people
- Illinois CancerCare-MacombMacomb, United StatesNo longer taking part
- Saint John's Hospital - HealtheastMaplewood, United StatesTaking people
- Aurora Bay Area Medical Group-MarinetteMarinette, United StatesTaking people
- Marshfield Medical Center-MarshfieldMarshfield, United StatesTaking people
- Carle Physician Group-Mattoon/CharlestonMattoon, United StatesTaking people
- UM Sylvester Comprehensive Cancer Center at KendallMiami, United StatesTaking people
- University of Miami Miller School of Medicine-Sylvester Cancer CenterMiami, United StatesTaking people
- Beebe South Coastal Health CampusMillville, United StatesTaking people
- Aurora Cancer Care-MilwaukeeMilwaukee, United StatesTaking people
- Aurora Saint Luke's Medical CenterMilwaukee, United StatesTaking people
- Aurora Sinai Medical CenterMilwaukee, United StatesTaking people
- Medical College of WisconsinMilwaukee, United StatesTaking people
- Abbott-Northwestern HospitalMinneapolis, United StatesTaking people
- Community Medical CenterMissoula, United StatesTaking people
- Kaiser Permanente- Modesto MOB IIModesto, United StatesTaking people
- Kaiser Permanente-ModestoModesto, United StatesTaking people
- Forbes HospitalMonroeville, United StatesTaking people
- Memorial Sloan Kettering BergenMontvale, United StatesTaking people
- ProHealth D N Greenwald CenterMukwonago, United StatesTaking people
- Saint Alphonsus Cancer Care Center-NampaNampa, United StatesNo longer taking part
- Edward Hospital/Cancer CenterNaperville, United StatesNo longer taking part
- Vanderbilt University/Ingram Cancer CenterNashville, United StatesTaking people
- Yale UniversityNew Haven, United StatesTaking people
- UC Comprehensive Cancer Center at Silver CrossNew Lenox, United StatesTaking people
- Laura and Isaac Perlmutter Cancer Center at NYU LangoneNew York, United StatesTaking people
- Memorial Sloan-Kettering Cancer CenterNew York, United StatesTaking people
- Helen F Graham Cancer CenterNewark, United StatesTaking people
- Medical Oncology Hematology Consultants PANewark, United StatesTaking people
- USC Norris Oncology/Hematology-Newport BeachNewport Beach, United StatesTaking people
- University of Miami Sylvester Comprehensive Cancer Center at Sole MiaNorth Miami, United StatesTaking people
- Henry Ford Medical Center-ColumbusNovi, United StatesTaking people
- Cancer Care Center of O'FallonO'Fallon, United StatesTaking people
- Advocate Christ Medical CenterOak Lawn, United StatesTaking people
- Kaiser Permanente-OaklandOakland, United StatesTaking people
- ProHealth Oconomowoc Memorial HospitalOconomowoc, United StatesTaking people
- University of Oklahoma Health Sciences CenterOklahoma City, United StatesTaking people
- Nebraska Medicine-Village PointeOmaha, United StatesTaking people
- University of Nebraska Medical CenterOmaha, United StatesTaking people
- Saint Alphonsus Cancer Care Center-OntarioOntario, United StatesNo longer taking part
- Northwestern Medicine Orland ParkOrland Park, United StatesTaking people
- University of Chicago Medicine-Orland ParkOrland Park, United StatesTaking people
- AdventHealth OrlandoOrlando, United StatesTaking people
- Vince Lombardi Cancer Clinic - OshkoshOshkosh, United StatesTaking people
- Upstate Cancer Center at OswegoOswego, United StatesTaking people
- Illinois CancerCare-Ottawa ClinicOttawa, United StatesNo longer taking part
- Stanford Cancer Institute Palo AltoPalo Alto, United StatesTaking people
- VA Palo Alto Health Care SystemPalo Alto, United StatesTaking people
- Advocate Lutheran General HospitalPark Ridge, United StatesTaking people
- Huntington Memorial HospitalPasadena, United StatesTaking people
- Illinois CancerCare-PekinPekin, United StatesNo longer taking part
- Illinois CancerCare-PeoriaPeoria, United StatesNo longer taking part
- Illinois CancerCare-PeruPeru, United StatesNo longer taking part
- Fox Chase Cancer CenterPhiladelphia, United StatesTaking people
- Pennsylvania HospitalPhiladelphia, United StatesTaking people
- Thomas Jefferson University HospitalPhiladelphia, United StatesTaking people
- Mayo Clinic Hospital in ArizonaPhoenix, United StatesTaking people
- Allegheny General HospitalPittsburgh, United StatesTaking people
- UPMC Hillman Cancer CenterPittsburgh, United StatesTaking people
- West Penn HospitalPittsburgh, United StatesTaking people
- Edward Hospital/Cancer Center?PlainfieldPlainfield, United StatesNo longer taking part
- UM Sylvester Comprehensive Cancer Center at PlantationPlantation, United StatesTaking people
- Oregon Health and Science UniversityPortland, United StatesTaking people
- Kootenai Clinic Cancer Services - Post FallsPost Falls, United StatesTaking people
- Illinois CancerCare-PrincetonPrinceton, United StatesNo longer taking part
- Aurora Cancer Care-RacineRacine, United StatesTaking people
- Beebe Health CampusRehoboth Beach, United StatesTaking people
- Marshfield Medical Center-Rice LakeRice Lake, United StatesTaking people
- VCU Massey Comprehensive Cancer CenterRichmond, United StatesTaking people
- Mayo Clinic in RochesterRochester, United StatesTaking people
- University of RochesterRochester, United StatesTaking people
- Kaiser Permanente-RosevilleRoseville, United StatesTaking people
- Kaiser Permanente Downtown CommonsSacramento, United StatesTaking people
- Kaiser Permanente-South SacramentoSacramento, United StatesTaking people
- Park Nicollet Clinic - Saint Louis ParkSaint Louis Park, United StatesTaking people
- Regions HospitalSaint Paul, United StatesTaking people
- United HospitalSaint Paul, United StatesTaking people
- Kaiser Permanente-San FranciscoSan Francisco, United StatesTaking people
- UCSF Medical Center-Mission BaySan Francisco, United StatesTaking people
- Kaiser Permanente-Santa Teresa-San JoseSan Jose, United StatesTaking people
- Kaiser Permanente San LeandroSan Leandro, United StatesTaking people
- Kaiser San Rafael-GallinasSan Rafael, United StatesTaking people
- Kootenai Clinic Cancer Services - SandpointSandpoint, United StatesTaking people
- Essentia Health SandstoneSandstone, United StatesTaking people
- Kaiser Permanente Medical Center - Santa ClaraSanta Clara, United StatesTaking people
- Kaiser Permanente-Santa RosaSanta Rosa, United StatesTaking people
- Vince Lombardi Cancer Clinic-SheboyganSheboygan, United StatesTaking people
- Sanford Cancer Center Oncology ClinicSioux Falls, United StatesTaking people
- Sanford USD Medical Center - Sioux FallsSioux Falls, United StatesTaking people
- Kaiser Permanente-South San FranciscoSouth San Francisco, United StatesTaking people
- Southern Illinois University School of MedicineSpringfield, United StatesTaking people
- Springfield ClinicSpringfield, United StatesTaking people
- Springfield Memorial HospitalSpringfield, United StatesTaking people
- Siteman Cancer Center-South CountySt Louis, United StatesTaking people
- Washington University School of MedicineSt Louis, United StatesTaking people
- Smilow Cancer Hospital Care Center at Long RidgeStamford, United StatesTaking people
- Marshfield Medical Center-River Region at Stevens PointStevens Point, United StatesTaking people
- Aurora Medical Center in SummitSummit, United StatesTaking people
- State University of New York Upstate Medical UniversitySyracuse, United StatesTaking people
- Moffitt Cancer CenterTampa, United StatesTaking people
- Moffitt Cancer Center - McKinley CampusTampa, United StatesTaking people
- Montefiore Medical Center - Moses CampusThe Bronx, United StatesTaking people
- Montefiore Medical Center-Einstein CampusThe Bronx, United StatesTaking people
- Smilow Cancer Hospital-Torrington Care CenterTorrington, United StatesTaking people
- Upper Valley Medical CenterTroy, United StatesTaking people
- Smilow Cancer Hospital Care Center-TrumbullTrumbull, United StatesTaking people
- Banner University Medical Center - TucsonTucson, United StatesTaking people
- University of Arizona Cancer Center-North CampusTucson, United StatesTaking people
- Vince Lombardi Cancer Clinic-Two RiversTwo Rivers, United StatesTaking people
- Memorial Sloan Kettering NassauUniondale, United StatesTaking people
- Carle Cancer CenterUrbana, United StatesTaking people
- Kaiser Permanente-VallejoVallejo, United StatesTaking people
- Upstate Cancer Center at VeronaVerona, United StatesTaking people
- Essentia Health Virginia ClinicVirginia, United StatesTaking people
- Kaiser Permanente-Walnut CreekWalnut Creek, United StatesTaking people
- Northwestern Medicine Cancer Center WarrenvilleWarrenville, United StatesTaking people
- Illinois CancerCare - WashingtonWashington, United StatesNo longer taking part
- Smilow Cancer Hospital-Waterbury Care CenterWaterbury, United StatesTaking people
- Smilow Cancer Hospital Care Center - WaterfordWaterford, United StatesTaking people
- UI Health Care Mission Cancer and Blood - Waukee ClinicWaukee, United StatesTaking people
- ProHealth Waukesha Memorial HospitalWaukesha, United StatesTaking people
- UW Cancer Center at ProHealth CareWaukesha, United StatesTaking people
- Aurora Cancer Care-Milwaukee WestWauwatosa, United StatesTaking people
- Aurora West Allis Medical CenterWest Allis, United StatesTaking people
- Henry Ford West Bloomfield HospitalWest Bloomfield, United StatesTaking people
- Marshfield Medical Center - WestonWeston, United StatesTaking people
- Wexford Health and Wellness PavilionWexford, United StatesTaking people
- Henry Ford Wyandotte HospitalWyandotte, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- National Cancer Institute (NCI)
- Trial code
- NCT06422806
- Record updated
- 6 November 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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; Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible; Patient must have a left ventricular ejection fraction (LVEF) > 50% by either MUGA scan or echocardiogram obtained within 28 days prior to randomization; Absolute neutrophil count (ANC) ≥ 1,500 cells/uL (must be obtained ≤ 7 days prior to protocol randomization); Platelets ≥ 75,000 cells/uL (must be obtained ≤ 7 days prior to protocol randomization); Total bilirubin < 1.2 mg/dL (must be obtained ≤ 7 days prior to protocol randomization); Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) ≤ 3.0 × institutional upper limit of normal (ULN) (must be obtained ≤ 7 days prior to protocol randomization); Creatinine clearance ≥ 30 mL/min according to the Cockcroft-Gault formula (must be obtained ≤ 7 days prior to protocol randomization); Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of randomization are eligible for this trial; For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated; 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; Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression; Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy; 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; Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better; Patient must not have a history of or active interstitial lung disease; Patient must have measurable disease. Baseline imaging must include a chest computed tomography (CT). Imaging should be inclusive of all measurable and non-measurable disease and must be obtained within 28 days prior to randomization. Imaging must be available for uploading to Transfer of Images and Data (TRIAD); NOTE: CT with (w/) contrast preferred, chest CT without contrast is acceptable, CT portion of positron emission tomography (PET) may be acceptable. Magnetic resonance imaging (MRI) is acceptable for measuring other sites of disease; Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-1; Patient must not have had prior treatment with an anthracycline; Patient must not have a diagnosis of clinically significant immunodeficiency or an autoimmune disorder requiring the patient to use systemic steroid chronically, or systemic steroids within 7 days prior to randomization; Patient must not have a known history of active TB (Bacillus Tuberculosis); Patient must not have a known hypersensitivity to doxorubicin or pembrolizumab or any of their excipients; Patients who have received prior chemotherapy, targeted small molecule therapy or radiation therapy must have recovered from the prior therapy at the time of randomization; Patient must have recovered adequately from any prior major surgery prior to randomization; Patient must not have had prior pericardial or mediastinal radiation; Patient must not have received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2 or anti-CTLA4 agent; Patient must not have an autoimmune or other disease that requires the use of daily corticosteroids of > 10 mg of prednisone (or equivalent). Patients who are on an active steroid taper at the time of randomization must finish prior to beginning study treatment. Patients who require inhaled or topical steroids are eligible.