AzTrials
AzTrials

Locally Advanced Cervical AdenocarcinomaPhase 3NCT07061977

Induction Pembrolizumab and Chemotherapy Followed by Pembrolizumab Before Chemoradiation and Pembrolizumab Maintenance Compared to Standard Chemoradiation With Pembrolizumab Followed by Pembrolizumab Maintenance in High-Risk Cervical Cancer

A Phase 3 study testing Biospecimen Collection, Brachytherapy and Carboplatin in people with Locally Advanced Cervical Adenocarcinoma and Locally Advanced Cervical Adenosquamous Carcinoma, run by National Cancer Institute (NCI) at 344 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial summary

This phase III trial compares the addition of induction chemotherapy, with carboplatin, paclitaxel and pembrolizumab, to chemotherapy and radiation, with cisplatin and pembrolizumab followed by pembrolizumab maintenance for the treatment of patients with cervical cancer that has spread to nearby tissue or lymph nodes… Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Biospecimen Collection, Brachytherapy and Carboplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
336 participants
Where
344 sitesin 2 countries
Study dates
5 Nov 2025to 31 Dec 2030
Phase
Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have pathologically confirmed newly diagnosed cervical cancer. Eligible pathologic types: squamous cell carcinoma, adenocarcinoma, adenosquamous cell carcinoma
  • Patients must have locally advanced cervical cancer (LACC) with T3 or T4 disease with or without lymph node involvement:
  • IIIA (T3aN0M0)
  • IIIB (T3bN0M0)
  • IIIC1(T3aN1M0, T3bN1M0)
  • IIIC2 (T3aN2M0, T3bN2M0)
Show all 36Show fewer
  • IVA (T4aN0M0, T4aN1M0, T4aN2M0) No prior hysterectomy defined as removal of the entire uterus.
  • NOTE: prior partial/subtotal hysterectomy for reasons other than cervical cancer are eligible to participate in the study. No plan to perform a hysterectomy as part of initial cervical cancer therapy.
  • No paraaortic lymph node (PALN) metastases above the T12/L1 interspace.
  • Note: Nodal status can be confirmed by imaging (CT, MRI, or PET/CT), fine needle aspirate/core biopsy, extra peritoneal biopsy, laparoscopic biopsy, or lymphadenectomy.
  • Radiologic definition of lymph node staging:
  • N1:
  • One or more pelvic lymph nodes with short axis diameter of ≥ 15 mm (axial plane) by CT or MRI, and/or
  • One or more pelvic lymph nodes with short axis diameter of ≥ 10 mm and standardized uptake value maximum (SUVmax) ≥ 2.5 by fludeoxyglucose (FDG)-PET
  • N2:
  • One or more para-aortic lymph node with short axis diameter of ≥ 15 mm (axial plane) by CT or MRI, and/or
  • One or more para-aortic lymph node with short axis diameter of ≥ 10 mm and SUVmax ≥ 2.5 by FDG-PET
  • No prior definitive surgical, radiation, or systemic therapy for cervical cancer
  • No prior immunotherapy
  • No prior pelvic radiation therapy for any disease
  • Age ≥ 18
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
  • Not pregnant and not nursing
  • Absolute neutrophil count (ANC) ≥ 1,500 cells/mm^3
  • Platelets ≥ 100,000 cells/mm^3
  • Hemoglobin ≥ 8 g/dl (Note: The use of transfusion or other intervention to achieve hemoglobulin [Hgb] ≥ 8 g/dl is acceptable)
  • Creatinine clearance (CrCL) of ≥ 50 mL/min by the Cockcroft-Gault formula
  • Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (patients with known Gilbert's disease who have bilirubin level ≤ 3 x institutional ULN may be enrolled)
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x institutional ULN
  • 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
  • No active infection requiring parenteral antibiotics
  • No live vaccine within 30 days prior to registration. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacille Calmette Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines are live attenuated vaccines and are not allowed
  • No diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior registration
  • No active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed
  • No history of (non-infectious) pneumonitis that required steroids, or current pneumonitis
  • No history of allergic reaction to the study agent(s) or compounds of similar chemical or biologic composition to the study agent(s) (or any of its excipients)

Who cannot join

None listed.

Trial locations and contacts

344 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

302 sites in 2 countries

United States300 sites, 294 recruiting
  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87106

    Site Public Contact, 505-925-0348, HSC-ClinicalTrialInfo@salud.unm.edu

    Amaranta D. Craig

    Recruiting
  • Inova Alexandria Hospital

    Alexandria, Virginia, 22304

    Site Public Contact, 703-776-2580, Stephanie.VanBebber@inova.org

    Leslie M. Randall

    Recruiting
  • Lehigh Valley Hospital-Cedar Crest

    Allentown, Pennsylvania, 18103

    Site Public Contact, 610-402-9543, Morgan_M.Horton@lvhn.org

    J. R. Liu

    Recruiting
  • Saint Luke's Cancer Center - Allentown

    Allentown, Pennsylvania, 18104

    Site Public Contact, 610-776-4714

    Nicholas P. Taylor

    Recruiting
  • UI Health Care Mission Cancer and Blood - Ankeny Clinic

    Ankeny, Iowa, 50023

    Site Public Contact, 515-241-3305

    Seema Harichand-Herdt

    Recruiting
  • Trinity Health Saint Joseph Mercy Hospital Ann Arbor

    Ann Arbor, Michigan, 48106

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    J. R. Liu

    Recruiting
  • University of Michigan Rogel Cancer Center

    Ann Arbor, Michigan, 48109

    Site Public Contact, 800-865-1125, CancerAnswerLine@med.umich.edu

    Zhen Ni Zhou

    Recruiting
  • Duluth Clinic Ashland

    Ashland, Wisconsin, 54806

    Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org

    Bret E. Friday

    Recruiting
  • Northwest Wisconsin Cancer Center

    Ashland, Wisconsin, 54806

    Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org

    Bret E. Friday

    Recruiting
  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

    Site Public Contact, 888-946-7447

    Sarah Dilley

    Recruiting
  • Piedmont Hospital

    Atlanta, Georgia, 30309

    Site Public Contact, 404-425-7943, ORS@piedmont.org

    Leda Portia A. Gattoc

    Recruiting
  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322

    Site Public Contact, 404-778-1868

    Sarah Dilley

    Recruiting
  • UCHealth University of Colorado Hospital

    Aurora, Colorado, 80045

    Site Public Contact, 720-848-0650

    Spyridon A. Mastroyannis

    Recruiting
  • University of Maryland/Greenebaum Cancer Center

    Baltimore, Maryland, 21201

    Site Public Contact, 800-888-8823

    Sarah A. Mcavoy

    Recruiting
  • Johns Hopkins University/Sidney Kimmel Cancer Center

    Baltimore, Maryland, 21287

    Site Public Contact, 410-955-8804, jhcccro@jhmi.edu

    Colleen C. McCormick

    Recruiting
  • Memorial Sloan Kettering Basking Ridge

    Basking Ridge, New Jersey, 07920

    Site Public Contact, 212-639-7592

    Carol Aghajanian

    Recruiting
  • MaineHealth Coastal Cancer Treatment Center

    Bath, Maine, 04530

    Site Public Contact, 412-339-5294, Roster@nrgoncology.org

    Leslie S. Bradford

    Recruiting
  • Northwell Health Imbert Cancer Center

    Bay Shore, New York, 11706

    Site Public Contact, 516-734-8896

    Joan R. Tymon-Rosario

    Recruiting
  • UHHS-Chagrin Highlands Medical Center

    Beachwood, Ohio, 44122

    Site Public Contact, 800-641-2422, CTUReferral@UHhospitals.org

    Stacy A. Smrz

    Recruiting
  • UM Upper Chesapeake Medical Center

    Bel Air, Maryland, 21014

    Site Public Contact, 443-643-3010

    Sarah A. Mcavoy

    Recruiting
  • Nebraska Medicine-Bellevue

    Bellevue, Nebraska, 68123

    Site Public Contact, 402-559-6941, unmcrsa@unmc.edu

    Lindsey A. McAlarnen

    Recruiting
  • Kaiser Permanente-Bellflower

    Bellflower, California, 90706

    Site Public Contact, 800-398-3996, clinical.trials@kp.org

    Devansu Tewari

    Recruiting
  • Saint Luke's University Hospital-Bethlehem Campus

    Bethlehem, Pennsylvania, 18015

    Site Public Contact, 484-503-4151

    Nicholas P. Taylor

    Recruiting
  • Lehigh Valley Hospital - Muhlenberg

    Bethlehem, Pennsylvania, 18017

    Site Public Contact, 610-402-9543, Morgan_M.Horton@lvhn.org

    J. R. Liu

    Recruiting
  • Billings Clinic Cancer Center

    Billings, Montana, 59101

    Site Public Contact, 800-996-2663, research@billingsclinic.org

    John M. Schallenkamp

    Recruiting
  • University of Alabama at Birmingham Cancer Center

    Birmingham, Alabama, 35233

    Site Public Contact, gingerreeves@uabmc.edu

    Charles A. Leath

    Recruiting
  • Saint Alphonsus Cancer Care Center-Boise

    Boise, Idaho, 83706

    Site Public Contact, 734-712-3671, stephanie.couch@stjoeshealth.org

    J. R. Liu

    Recruiting
  • Saint Luke's Cancer Institute - Boise

    Boise, Idaho, 83712

    Site Public Contact, 208-381-2774, eslinget@slhs.org

    Dan S. Zuckerman

    Recruiting
  • Tufts Medical Center

    Boston, Massachusetts, 02111

    Site Public Contact, 617-636-5000, ContactUsCancerCenter@TuftsMedicalCenter.org

    Brett Diamond

    Recruiting
  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

    Site Public Contact, 617-667-9925

    Joanne W. Jang

    Recruiting
  • Essentia Health Saint Joseph's Medical Center

    Brainerd, Minnesota, 56401

    Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org

    Bret E. Friday

    Recruiting
  • United Hospital Center

    Bridgeport, West Virginia, 26330

    Site Public Contact, 304-293-7374, cancertrialsinfo@hsc.wvu.edu

    Krista S. Pfaendler

    Recruiting
  • Trinity Health Medical Center - Brighton

    Brighton, Michigan, 48114

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    J. R. Liu

    Recruiting
  • University of Michigan - Brighton Center for Specialty Care

    Brighton, Michigan, 48116

    Site Public Contact, 800-865-1125

    Zhen Ni Zhou

    Recruiting
  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

    Site Public Contact, 800-767-9355, askroswell@roswellpark.org

    Peter J. Frederick

    Recruiting
  • University of Vermont Medical Center

    Burlington, Vermont, 05401

    Site Public Contact, 802-656-4101, rpo@uvm.edu

    Puyao Li

    Recruiting
  • University of Vermont and State Agricultural College

    Burlington, Vermont, 05405

    Site Public Contact, 802-656-8990, rpo@uvm.edu

    Puyao Li

    Recruiting
  • Saint Alphonsus Cancer Care Center-Caldwell

    Caldwell, Idaho, 83605

    Site Public Contact, 734-712-3671, stephanie.couch@stjoeshealth.org

    J. R. Liu

    Recruiting
  • Cooper Hospital University Medical Center

    Camden, New Jersey, 08103

    Site Public Contact, 856-325-6757

    Lauren D. Krill

    Recruiting
  • Trinity Health Medical Center - Canton

    Canton, Michigan, 48188

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    J. R. Liu

    Recruiting
  • Aultman Health Foundation

    Canton, Ohio, 44710

    Site Public Contact, 330-363-7274, ClinicalReserachDept@aultman.com

    Raza A. Khan

    Recruiting
  • IU Health North Hospital

    Carmel, Indiana, 46032

    Site Public Contact, 317-278-5632, iutrials@iu.edu

    Sharon Robertson

    Recruiting
  • Mercy Hospital

    Cedar Rapids, Iowa, 52403

    Site Public Contact, 319-365-4673

    Deborah W. Wilbur

    Recruiting
  • Oncology Associates at Mercy Medical Center

    Cedar Rapids, Iowa, 52403

    Site Public Contact, 319-363-2690

    Deborah W. Wilbur

    Recruiting
  • Miami Valley Hospital South

    Centerville, Ohio, 45459

    Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org

    Michael S. Guy

    Recruiting
  • UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599

    Site Public Contact, 877-668-0683, cancerclinicaltrials@med.unc.edu

    Linda Van Le

    Recruiting
  • Geauga Hospital

    Chardon, Ohio, 44024

    Site Public Contact, 800-641-2422, CTUReferral@UHhospitals.org

    Stacy A. Smrz

    Recruiting
  • Medical University of South Carolina

    Charleston, South Carolina, 29425

    Site Public Contact, 843-792-9321, hcc-clinical-trials@musc.edu

    Brian Orr

    Recruiting
  • Vandalia Health/CAMC Institute for Academic Medicine

    Charleston, West Virginia, 25304

    Site Public Contact, 304-388-9944, CAMCClinicalTrials@vandaliahealth.org

    Stephen H. Bush

    Recruiting
  • Carolinas Medical Center/Levine Cancer Institute

    Charlotte, North Carolina, 28203

    Site Public Contact, 800-804-9376

    Yovanni Casablanca

    Recruiting
  • Novant Health Presbyterian Medical Center

    Charlotte, North Carolina, 28204

    Site Public Contact, 980-201-6360, kashah@novanthealth.org

    Malcolm Ross

    Recruiting
  • University of Virginia Cancer Center

    Charlottesville, Virginia, 22908

    Site Public Contact, 434-243-6303, uvacancertrials@hscmail.mcc.virginia.edu

    Linda R. Duska

    Recruiting
  • Chelsea Hospital

    Chelsea, Michigan, 48118

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    J. R. Liu

    Recruiting
  • Memorial Hospital of Laramie County

    Cheyenne, Wyoming, 82001

    Site Public Contact, 412-339-5294, Roster@nrgoncology.org

    John M. Schallenkamp

    Recruiting
  • Northwestern University

    Chicago, Illinois, 60611

    Site Public Contact, 312-695-1301, cancer@northwestern.edu

    Eric D. Donnelly

    Recruiting
  • Rush MD Anderson Cancer Center

    Chicago, Illinois, 60612

    Site Public Contact, 312-226-2371, Cancer_Studies@rush.edu

    Andrew Cook

    Recruiting
  • University of Illinois

    Chicago, Illinois, 60612

    Site Public Contact, 312-355-3046

    Rajul Kothari

    Recruiting
  • University of Cincinnati Cancer Center-UC Medical Center

    Cincinnati, Ohio, 45219

    Site Public Contact, 513-584-7698, cancer@uchealth.com

    Sarah M. Sittenfeld

    Recruiting
  • Clackamas Radiation Oncology Center

    Clackamas, Oregon, 97015

    Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org

    Dan S. Zuckerman

    Recruiting
  • Case Western Reserve University

    Cleveland, Ohio, 44106

    Site Public Contact, 800-641-2422, CTUReferral@UHhospitals.org

    Stacy A. Smrz

    Recruiting
  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

    Site Public Contact, 866-223-8100, TaussigResearch@ccf.org

    Lindsey Beffa

    Recruiting
  • UI Health Care Mission Cancer and Blood - West Des Moines Clinic

    Clive, Iowa, 50325

    Site Public Contact, 515-241-3305

    Seema Harichand-Herdt

    Recruiting
  • Kootenai Health - Coeur d'Alene

    Coeur d'Alene, Idaho, 83814

    Suspended
  • Central Maryland Radiation Oncology in Howard County

    Columbia, Maryland, 21044

    Site Public Contact, 443-546-1300

    Sarah A. Mcavoy

    Recruiting
  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

    Site Public Contact, 800-293-5066, Jamesline@osumc.edu

    Laura Chambers

    Recruiting
  • Memorial Sloan Kettering Commack

    Commack, New York, 11725

    Site Public Contact, 212-639-7592

    Carol Aghajanian

    Recruiting
  • Atrium Health Cabarrus/LCI-Concord

    Concord, North Carolina, 28025

    Site Public Contact, 800-804-9376

    Yovanni Casablanca

    Recruiting
  • UM Sylvester Comprehensive Cancer Center at Coral Gables

    Coral Gables, Florida, 33146

    Site Public Contact, 305-243-2647

    Navya Nair

    Recruiting
  • UM Sylvester Comprehensive Cancer Center at Coral Springs

    Coral Springs, Florida, 33065

    Site Public Contact, 305-243-2647

    Navya Nair

    Recruiting
  • City of Hope Corona

    Corona, California, 92882

    Site Public Contact, 626-256-4673, becomingapatient@coh.org

    Scott M. Glaser

    Recruiting
  • Northwest Cancer Center - Crown Point

    Crown Point, Indiana, 46307

    Site Public Contact, 219-836-6879, CancerResearch@powershealth.org

    Kendrith M. Rowland

    Recruiting
  • Parkland Memorial Hospital

    Dallas, Texas, 75235

    Site Public Contact, 214-590-5582, canceranswerline@UTSouthwestern.edu

    Jayanthi S. Lea

    Recruiting
  • UT Southwestern/Simmons Cancer Center-Dallas

    Dallas, Texas, 75390

    Site Public Contact, 214-648-7097, canceranswerline@UTSouthwestern.edu

    Jayanthi S. Lea

    Recruiting
  • Danbury Hospital

    Danbury, Connecticut, 06810

    Site Public Contact, 833-223-4732

    Leslie Andriani

    Recruiting
  • Carle at The Riverfront

    Danville, Illinois, 61832

    Site Public Contact, 800-446-5532, Research@Carle.com

    Kendrith M. Rowland

    Recruiting
  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

    Site Public Contact, 570-271-5251, cancerresearch@geisinger.edu

    Julie Jiang

    Recruiting
  • Miami Valley Hospital

    Dayton, Ohio, 45409

    Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org

    Michael S. Guy

    Recruiting
  • Miami Valley Hospital North

    Dayton, Ohio, 45415

    Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org

    Michael S. Guy

    Recruiting
  • Corewell Health Dearborn Hospital

    Dearborn, Michigan, 48124

    Site Public Contact, 248-551-7695

    Ira S. Winer

    Recruiting
  • Emory Decatur Hospital

    Decatur, Georgia, 30033

    Site Public Contact, 440-778-1868, clinicaltrialsoncology@dekalbmedical.org

    Sarah Dilley

    Recruiting
  • Cancer Care Specialists of Illinois - Decatur

    Decatur, Illinois, 62526

    Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com

    Bryan A. Faller

    Recruiting
  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

    Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com

    Bryan A. Faller

    Recruiting
  • Essentia Health - Deer River Clinic

    Deer River, Minnesota, 56636

    Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org

    Bret E. Friday

    Recruiting
  • UM Sylvester Comprehensive Cancer Center at Deerfield Beach

    Deerfield Beach, Florida, 33442

    Site Public Contact, 305-243-2647

    Navya Nair

    Recruiting
  • Northwestern Medicine Cancer Center Kishwaukee

    DeKalb, Illinois, 60115

    Site Public Contact, 630-352-5360, Donald.Smith3@nm.org

    Eric D. Donnelly

    Recruiting
  • Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

    Site Public Contact, 515-241-6727

    Seema Harichand-Herdt

    Recruiting
  • UI Health Care Mission Cancer and Blood - Des Moines Clinic

    Des Moines, Iowa, 50309

    Site Public Contact, 515-241-3305

    Seema Harichand-Herdt

    Recruiting
  • Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

    Site Public Contact, 515-241-3305

    Richard L. Deming

    Recruiting
  • UI Health Care Mission Cancer and Blood - Laurel Clinic

    Des Moines, Iowa, 50314

    Site Public Contact, 515-241-3305

    Seema Harichand-Herdt

    Recruiting
  • Geisinger Cancer Center Dickson City

    Dickson City, Pennsylvania, 18519

    Site Public Contact, 877-204-6081, cancerresearch@geisinger.edu

    Julie Jiang

    Recruiting
  • UM Sylvester Comprehensive Cancer Center at Doral

    Doral, Florida, 33166

    Site Public Contact, kginnity@med.miami.edu

    Navya Nair

    Recruiting
  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010

    Site Public Contact, 800-826-4673, becomingapatient@coh.org

    Scott M. Glaser

    Recruiting
  • Essentia Health Cancer Center

    Duluth, Minnesota, 55805

    Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org

    Bret E. Friday

    Recruiting
  • Miller-Dwan Hospital

    Duluth, Minnesota, 55805

    Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org

    Bret E. Friday

    Recruiting
  • Duke University Medical Center

    Durham, North Carolina, 27710

    Site Public Contact, 888-275-3853

    Diandra N. Ayala-Peacock

    Recruiting
  • Northwest Oncology LLC

    Dyer, Indiana, 46311

    Site Public Contact, 219-924-8178

    Kendrith M. Rowland

    Recruiting
  • Pocono Medical Center

    East Stroudsburg, Pennsylvania, 18301

    Site Public Contact, 610-402-9543, Morgan_M.Horton@lvhn.org

    J. R. Liu

    Recruiting
  • University of Maryland Shore Medical Center at Easton

    Easton, Maryland, 21601

    Site Public Contact, 410-822-1000, Christina.weisenborn@umm.edu

    Sarah A. Mcavoy

    Recruiting
  • Saint Luke's Hospital-Anderson Campus

    Easton, Pennsylvania, 18045

    Site Public Contact, 412-339-5294, Roster@nrgoncology.org

    Nicholas P. Taylor

    Recruiting
  • Carle Physician Group-Effingham

    Effingham, Illinois, 62401

    Site Public Contact, 800-446-5532, Research@carle.com

    Kendrith M. Rowland

    Recruiting
  • Crossroads Cancer Center

    Effingham, Illinois, 62401

    Suspended
  • UPMC Hillman Cancer Center Erie

    Erie, Pennsylvania, 16505

    Site Public Contact, 412-864-7716, ClinicalResearchServices@upmc.edu

    Bhanu Prasad Venkatesulu

    Recruiting
  • NorthShore University HealthSystem-Evanston Hospital

    Evanston, Illinois, 60201

    Site Public Contact, 847-570-2109

    Mary T. Jenkins Vogel

    Recruiting
  • Inova Schar Cancer Institute

    Fairfax, Virginia, 22031

    Site Public Contact, 703-720-5210, Stephanie.VanBebber@inova.org

    Leslie M. Randall

    Recruiting
  • Inova Fair Oaks Hospital

    Fairfax, Virginia, 22033

    Site Public Contact, 703-720-5210, Stephanie.VanBebber@inova.org

    Leslie M. Randall

    Recruiting
  • Inova Fairfax Hospital

    Falls Church, Virginia, 22042

    Site Public Contact, 703-208-6650, Stephanie.VanBebber@inova.org

    Leslie M. Randall

    Recruiting
  • Farmington Health Center

    Farmington, Utah, 84025

    Site Public Contact, 888-424-2100, cancerinfo@hci.utah.edu

    Shashank Sama

    Recruiting
  • Highlands Oncology Group - Fayetteville

    Fayetteville, Arkansas, 72703

    Site Public Contact, 479-872-8100, research@hogonc.com

    Joseph T. Beck

    Recruiting
  • Northwell Health Physician Partners at Flushing

    Flushing, New York, 11354

    Site Public Contact, 718-559-3600, nhppflushing@northwell.edu

    Joan R. Tymon-Rosario

    Recruiting
  • Northwell Health Physicians Partners Radiation Medicine at Queens

    Forest Hills, New York, 11375

    Site Public Contact, 718-520-6620

    Joan R. Tymon-Rosario

    Recruiting
  • Broward Health Medical Center

    Fort Lauderdale, Florida, 33316

    Site Public Contact, 302-651-5572, Allison.bruce@nemours.org

    Scott E. Jordan

    Recruiting
  • Parkview Regional Medical Center

    Fort Wayne, Indiana, 46845

    Site Public Contact, 877-784-4673

    Bogna Brzezinska

    Recruiting
  • UT Southwestern/Simmons Cancer Center-Fort Worth

    Fort Worth, Texas, 76104

    Site Public Contact, 214-648-7097, canceranswerline@UTSouthwestern.edu

    Jayanthi S. Lea

    Recruiting
  • Atrium Medical Center-Middletown Regional Hospital

    Franklin, Ohio, 45005-1066

    Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org

    Michael S. Guy

    Recruiting
  • Saint Luke's Cancer Institute - Fruitland

    Fruitland, Idaho, 83619

    Site Public Contact, 208-381-2774, eslinget@slhs.org

    Dan S. Zuckerman

    Recruiting
  • Gibbs Cancer Center-Gaffney

    Gaffney, South Carolina, 29341

    Site Public Contact, 864-560-6104, kmertz-rivera@gibbscc.org

    Carlton L. Schwab

    Recruiting
  • Levine Cancer Institute-Gaston

    Gastonia, North Carolina, 28054

    Site Public Contact, 800-804-9376

    Yovanni Casablanca

    Recruiting
  • Northwestern Medicine Cancer Center Delnor

    Geneva, Illinois, 60134

    Site Public Contact, 630-352-5360, Donald.Smith3@nm.org

    Eric D. Donnelly

    Recruiting
  • UM Baltimore Washington Medical Center/Tate Cancer Center

    Glen Burnie, Maryland, 21061

    Site Public Contact, 410-553-8100

    Sarah A. Mcavoy

    Recruiting
  • NorthShore University HealthSystem-Glenbrook Hospital

    Glenview, Illinois, 60026

    Site Public Contact, 847-570-2109

    Mary T. Jenkins Vogel

    Recruiting
  • Northwell Health Cancer Institute at Huntington

    Greenlawn, New York, 11740

    Site Public Contact, 516-734-8896

    Joan R. Tymon-Rosario

    Recruiting
  • UPMC Cancer Centers - Arnold Palmer Pavilion

    Greensburg, Pennsylvania, 15601

    Site Public Contact, 724-838-1900

    Bhanu Prasad Venkatesulu

    Recruiting
  • Miami Valley Cancer Care and Infusion

    Greenville, Ohio, 45331

    Site Public Contact, 937-569-7515

    Michael S. Guy

    Recruiting
  • Gibbs Cancer Center-Pelham

    Greer, South Carolina, 29651

    Site Public Contact, 864-560-6104, kmertz-rivera@gibbscc.org

    Carlton L. Schwab

    Recruiting
  • Kaiser Permanente South Bay

    Harbor City, California, 90710

    Site Public Contact, 800-398-3996, clinical.trials@kp.org

    Devansu Tewari

    Recruiting
  • UPMC Pinnacle Cancer Center/Community Osteopathic Campus

    Harrisburg, Pennsylvania, 17109

    Site Public Contact, 717-724-6765, klitchfield@PINNACLEHEALTH.org

    Bhanu Prasad Venkatesulu

    Recruiting
  • Memorial Sloan Kettering Westchester

    Harrison, New York, 10604

    Site Public Contact, 212-639-7592

    Carol Aghajanian

    Recruiting
  • Penn State Milton S Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

    Site Public Contact, 717-531-3779, CTO@hmc.psu.edu

    Mark S. Shahin

    Recruiting
  • Essentia Health Hibbing Clinic

    Hibbing, Minnesota, 55746

    Site Public Contact, 218-786-3308

    Bret E. Friday

    Recruiting
  • Hayworth Cancer Center

    High Point, North Carolina, 27262

    Site Public Contact, 336-802-2500

    Michael G. Kelly

    Recruiting
  • UCHealth Highlands Ranch Hospital

    Highlands Ranch, Colorado, 80129

    Site Public Contact, 720-848-0650

    Spyridon A. Mastroyannis

    Recruiting
  • Northwest Cancer Center - Hobart

    Hobart, Indiana, 46342

    Site Public Contact, 219-947-1795

    Kendrith M. Rowland

    Recruiting
  • Saint Mary Medical Center

    Hobart, Indiana, 46342

    Site Public Contact, 219-836-6875, CancerResearch@COMHS.org

    Kendrith M. Rowland

    Recruiting
  • Memorial Regional Hospital/Joe DiMaggio Children's Hospital

    Hollywood, Florida, 33021

    Site Public Contact, 954-265-1847, OHR@mhs.net

    Tamara L. Smith

    Recruiting
  • UM Sylvester Comprehensive Cancer Center at Hollywood

    Hollywood, Florida, 33021

    Site Public Contact, 305-243-2647

    Navya Nair

    Recruiting
  • Novant Health Cancer Institute - Huntersville

    Huntersville, North Carolina, 28078

    Site Public Contact, 980-201-6360, kashah@novanthealth.org

    Malcolm Ross

    Recruiting
  • IRMC Cancer Center

    Indiana, Pennsylvania, 15701

    Site Public Contact, 412-389-5208, haneydl@upmc.edu

    Bhanu Prasad Venkatesulu

    Recruiting
  • Indiana University/Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

    Site Public Contact, 317-278-5632, iutrials@iu.edu

    Sharon Robertson

    Recruiting
  • Sidney and Lois Eskenazi Hospital

    Indianapolis, Indiana, 46202

    Site Public Contact, 317-278-5632, iutrials@iu.edu

    Sharon Robertson

    Recruiting
  • University of Iowa/Holden Comprehensive Cancer Center

    Iowa City, Iowa, 52242

    Site Public Contact, 800-237-1225

    David P. Bender

    Recruiting
  • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

    Irvine, California, 92612

    Site Public Contact, 877-827-8839, ucstudy@uci.edu

    Erin H. Healy

    Recruiting
  • City of Hope at Irvine Lennar

    Irvine, California, 92618

    Site Public Contact, 877-467-3411

    Scott M. Glaser

    Recruiting
  • Kaiser Permanente-Irvine

    Irvine, California, 92618

    Site Public Contact, 800-398-3996, clinical.trials@kp.org

    Devansu Tewari

    Recruiting
  • Jefferson Hospital

    Jefferson Hills, Pennsylvania, 15025

    Site Public Contact, 412-359-3043, ddefazio@wpahs.org

    Sarah M. Crafton

    Recruiting
  • Jersey City Medical Center

    Jersey City, New Jersey, 07302

    Site Public Contact, 412-339-5294, Roster@nrgoncology.org

    Ana I. Tergas

    Recruiting
  • UPMC-Johnstown/John P. Murtha Regional Cancer Center

    Johnstown, Pennsylvania, 15901

    Site Public Contact, 814-534-4724

    Bhanu Prasad Venkatesulu

    Recruiting
  • Freeman Health System

    Joplin, Missouri, 64804

    Site Public Contact, 417-347-4030, LJCrockett@freemanhealth.com

    Jay W. Carlson

    Recruiting
  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

    Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org

    Kathleen Y. Butler

    Recruiting
  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

    Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org

    Kathleen Y. Butler

    Recruiting
  • University of Kansas Cancer Center

    Kansas City, Kansas, 66160

    Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu

    Andrew C. Hoover

    Recruiting
  • University of Kansas Cancer Center - Briarcliff

    Kansas City, Missouri, 64116

    Site Public Contact, 913-588-3671

    Andrew C. Hoover

    Recruiting
  • University of Kansas Cancer Center - North

    Kansas City, Missouri, 64154

    Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu

    Andrew C. Hoover

    Recruiting
  • Novant Health Cancer Institute - Kernersville

    Kernersville, North Carolina, 27284

    Site Public Contact, 336-718-8335, asmarrs@novanthealth.org

    Elizabeth N. Skinner

    Recruiting
  • UC San Diego Moores Cancer Center

    La Jolla, California, 92093

    Site Public Contact, 858-822-5354, cancercto@ucsd.edu

    Jyoti S. Mayadev

    Recruiting
  • Northwell Health/Center for Advanced Medicine

    Lake Success, New York, 11042

    Site Public Contact, 516-734-8896

    Joan R. Tymon-Rosario

    Recruiting
  • City of Hope Antelope Valley

    Lancaster, California, 93534

    Suspended
  • University of Michigan Health - Sparrow Lansing

    Lansing, Michigan, 48912

    Site Public Contact, 517-364-3712, harsha.trivedi@umhsparrow.org

    J. R. Liu

    Recruiting
  • UM Capital Region Medical Center

    Largo, Maryland, 20774

    Site Public Contact, 301-755-4397, Sarah.Larson@umm.edu

    Sarah A. Mcavoy

    Recruiting
  • Women's Cancer Center of Nevada

    Las Vegas, Nevada, 89106

    Site Public Contact, 702-851-4672

    Nicola M. Spirtos

    Recruiting
  • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

    Lebanon, New Hampshire, 03756

    Site Public Contact, 800-639-6918, cancer.research.nurse@dartmouth.edu

    Michael L. Pearl

    Recruiting
  • University of Kansas Cancer Center - Lee's Summit

    Lee's Summit, Missouri, 64064

    Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu

    Andrew C. Hoover

    Recruiting
  • Inova Loudoun Hospital

    Leesburg, Virginia, 20176

    Site Public Contact, 703-858-6000, Keary.janet@inova.org

    Leslie M. Randall

    Recruiting
  • Geisinger Medical Oncology-Lewisburg

    Lewisburg, Pennsylvania, 17837

    Site Public Contact, 570-523-9200, cancerresearch@geisinger.edu

    Julie Jiang

    Recruiting
  • University of Kentucky/Markey Cancer Center

    Lexington, Kentucky, 40536

    Site Public Contact, 859-257-3379

    Rachel W. Miller

    Recruiting
  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

    Site Public Contact, 501-686-8274

    Heather R. Williams

    Recruiting
  • Cooperman Barnabas Medical Center

    Livingston, New Jersey, 07039

    Site Public Contact, 973-322-5200

    Ana I. Tergas

    Recruiting
  • Trinity Health Saint Mary Mercy Livonia Hospital

    Livonia, Michigan, 48154

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    J. R. Liu

    Recruiting
  • Monmouth Medical Center

    Long Branch, New Jersey, 07740

    Site Public Contact, 732-923-6564, mary.danish@rwjbh.org

    Ana I. Tergas

    Recruiting
  • Kaiser Permanente Los Angeles Medical Center

    Los Angeles, California, 90027

    Site Public Contact, 800-398-3996, clinical.trials@kp.org

    Devansu Tewari

    Recruiting
  • Kaiser Permanente West Los Angeles

    Los Angeles, California, 90034

    Site Public Contact, 800-398-3996, clinical.trials@kp.org

    Devansu Tewari

    Recruiting
  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

    Site Public Contact, 310-423-2133, Cancer.trial.info@cshs.org

    Emily N. Prendergast

    Recruiting
  • University of Wisconsin Carbone Cancer Center - Eastpark Medical Center

    Madison, Wisconsin, 53718

    Site Public Contact, 800-622-8922, clinicaltrials@cancer.wisc.edu

    Lisa M. Barroilhet

    Recruiting
  • University of Wisconsin Carbone Cancer Center - University Hospital

    Madison, Wisconsin, 53792

    Site Public Contact, 800-622-8922, clinicaltrials@cancer.wisc.edu

    Lisa M. Barroilhet

    Recruiting
  • West Jefferson Medical Center

    Marrero, Louisiana, 70072

    Site Public Contact, 504-210-3539, emede1@lsuhsc.edu

    Amma Agyemang

    Recruiting
  • Matthews Radiation Oncology Center

    Matthews, North Carolina, 28105

    Site Public Contact, 980-201-6360, kashah@novanthealth.org

    Malcolm Ross

    Recruiting
  • Carle Physician Group-Mattoon/Charleston

    Mattoon, Illinois, 61938

    Site Public Contact, 800-446-5532, Research@carle.com

    Kendrith M. Rowland

    Recruiting
  • Hillcrest Hospital Cancer Center

    Mayfield Heights, Ohio, 44124

    Site Public Contact, 866-223-8100, TaussigResearch@ccf.org

    Lindsey Beffa

    Recruiting
  • Loyola University Medical Center

    Maywood, Illinois, 60153

    Site Public Contact, 708-226-4357

    Matthew M. Harkenrider

    Recruiting
  • UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion

    Mechanicsburg, Pennsylvania, 17050

    Site Public Contact, 412-389-5208, haneydl@upmc.edu

    Bhanu Prasad Venkatesulu

    Recruiting
  • UH Seidman Cancer Center at Lake Health Mentor Campus

    Mentor, Ohio, 44060

    Site Public Contact, 800-641-2422, CTUReferral@UHhospitals.org

    Stacy A. Smrz

    Recruiting
  • Saint Luke's Cancer Institute - Meridian

    Meridian, Idaho, 83642

    Site Public Contact, 208-381-2774, eslinget@slhs.org

    Dan S. Zuckerman

    Recruiting
  • East Jefferson General Hospital

    Metairie, Louisiana, 70006

    Site Public Contact, 504-210-3539, emede1@lsuhsc.edu

    Amma Agyemang

    Recruiting
  • LSU Healthcare Network / Metairie Multi-Specialty Clinic

    Metairie, Louisiana, 70006

    Site Public Contact, 504-210-3539, emede1@lsuhsc.edu

    Amma Agyemang

    Recruiting
  • University of Miami Miller School of Medicine-Sylvester Cancer Center

    Miami, Florida, 33136

    Site Public Contact, 305-243-2647

    Navya Nair

    Recruiting
  • Miami Cancer Institute

    Miami, Florida, 33176

    Site Public Contact, 786-596-2000

    Yonatan Weiss

    Recruiting
  • UM Sylvester Comprehensive Cancer Center at Kendall

    Miami, Florida, 33176

    Site Public Contact, 305-243-2647

    Navya Nair

    Recruiting
  • Mount Sinai Medical Center

    Miami Beach, Florida, 33140

    Site Public Contact, 305-674-2625, Yvonne.Enriquez@msmc.com

    Brian M. Slomovitz

    Recruiting
  • Memorial Sloan Kettering Monmouth

    Middletown, New Jersey, 07748

    Site Public Contact, 212-639-7592

    Carol Aghajanian

    Recruiting
  • Beebe South Coastal Health Campus

    Millville, Delaware, 19967

    Site Public Contact, 302-291-6730, research@beebehealthcare.org

    Gregory A. Masters

    Recruiting
  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

    Site Public Contact, 414-805-3666

    William H. Bradley

    Recruiting
  • NYU Langone Hospital - Long Island

    Mineola, New York, 11501

    Site Public Contact, 212-263-4432, cancertrials@nyulangone.org

    Leslie R. Boyd

    Recruiting
  • Community Medical Center

    Missoula, Montana, 59804

    Suspended
  • Forbes Hospital

    Monroeville, Pennsylvania, 15146

    Site Public Contact, 412-858-7746

    Sarah M. Crafton

    Recruiting
  • Memorial Sloan Kettering Bergen

    Montvale, New Jersey, 07645

    Site Public Contact, 212-639-7592

    Carol Aghajanian

    Recruiting
  • West Virginia University Healthcare

    Morgantown, West Virginia, 26506

    Site Public Contact, 304-293-7374, cancertrialsinfo@hsc.wvu.edu

    Krista S. Pfaendler

    Recruiting
  • Northern Westchester Hospital

    Mount Kisco, New York, 10549

    Site Public Contact, 914-666-1366, AMellor@northwell.edu

    Joan R. Tymon-Rosario

    Recruiting
  • ProHealth D N Greenwald Center

    Mukwonago, Wisconsin, 53149

    Site Public Contact, research.institute@phci.org

    Timothy R. Wassenaar

    Recruiting
  • The Community Hospital

    Munster, Indiana, 46321

    Site Public Contact, 219-836-3349

    Kendrith M. Rowland

    Recruiting
  • Women's Diagnostic Center - Munster

    Munster, Indiana, 46321

    Site Public Contact, 219-934-8869, mnicholson@comhs.org

    Kendrith M. Rowland

    Recruiting
  • Sarasota Memorial Hospital-Venice

    N. Venice, Florida, 34275

    Site Public Contact, 941-261-9000

    Toni P. Kilts

    Recruiting
  • Saint Alphonsus Cancer Care Center-Nampa

    Nampa, Idaho, 83687

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    J. R. Liu

    Recruiting
  • Saint Luke's Cancer Institute - Nampa

    Nampa, Idaho, 83687

    Site Public Contact, 208-381-2774, eslinget@slhs.org

    Dan S. Zuckerman

    Recruiting
  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903

    Site Public Contact, 732-235-7356

    Ana I. Tergas

    Recruiting
  • University Medical Center New Orleans

    New Orleans, Louisiana, 70112

    Site Public Contact, 504-210-3539, emede1@lsuhsc.edu

    Amma Agyemang

    Recruiting
  • Ochsner Baptist Medical Center

    New Orleans, Louisiana, 70115

    Site Public Contact, 504-842-8084, Elisemarie.curry@ochsner.org

    Katrina S. Wade

    Recruiting
  • Ochsner Medical Center Jefferson

    New Orleans, Louisiana, 70121

    Site Public Contact, 504-842-8084, Elisemarie.curry@ochsner.org

    Katrina S. Wade

    Recruiting
  • Cancer Center of Western Wisconsin

    New Richmond, Wisconsin, 54017

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    Joleen M. Hubbard

    Recruiting
  • Mount Sinai Chelsea

    New York, New York, 10011

    Site Public Contact, 212-824-7309, CCTO@mssm.edu

    Dmitriy Zamarin

    Recruiting
  • Laura and Isaac Perlmutter Cancer Center at NYU Langone

    New York, New York, 10016

    Site Public Contact, CancerTrials@nyulangone.org

    Leslie R. Boyd

    Recruiting
  • Mount Sinai West

    New York, New York, 10019

    Site Public Contact, 212-824-7309, CCTO@mssm.edu

    Dmitriy Zamarin

    Recruiting
  • Mount Sinai Hospital

    New York, New York, 10029

    Site Public Contact, 212-824-7309, CCTO@mssm.edu

    Dmitriy Zamarin

    Recruiting
  • Manhattan Eye Ear and Throat Hospital

    New York, New York, 10065

    Site Public Contact, 212-434-4460

    Joan R. Tymon-Rosario

    Recruiting
  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

    Site Public Contact, 212-639-7592

    Carol Aghajanian

    Recruiting
  • Lenox Hill Hospital

    New York, New York, 10075

    Site Public Contact, 516-734-8896

    Joan R. Tymon-Rosario

    Recruiting
  • Helen F Graham Cancer Center

    Newark, Delaware, 19713

    Site Public Contact, 302-623-4450, lbarone@christianacare.org

    Gregory A. Masters

    Recruiting
  • Medical Oncology Hematology Consultants PA

    Newark, Delaware, 19713

    Site Public Contact, 302-623-4450, lbarone@christianacare.org

    Gregory A. Masters

    Recruiting
  • Rutgers New Jersey Medical School

    Newark, New Jersey, 07101

    Site Public Contact, 732-235-7356

    Ana I. Tergas

    Recruiting
  • Providence Newberg Medical Center

    Newberg, Oregon, 97132

    Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org

    Dan S. Zuckerman

    Recruiting
  • CTCA at Southeastern Regional Medical Center

    Newnan, Georgia, 30265

    Site Public Contact, 770-400-6629

    Natalie S. Godbee

    Recruiting
  • University of Miami Sylvester Comprehensive Cancer Center at Sole Mia

    North Miami, Florida, 33181

    Site Public Contact, kginnity@med.miami.edu

    Navya Nair

    Recruiting
  • Norwalk Hospital

    Norwalk, Connecticut, 06856

    Site Public Contact, 203-852-2996, jennifer.long@norwalkhealth.org

    Leslie Andriani

    Recruiting
  • Northwestern Medicine Oak Brook

    Oak Brook, Illinois, 60523

    Site Public Contact, nctnprogram_rhlccc@northwestern.edu

    Eric D. Donnelly

    Recruiting
  • Health Central

    Ocoee, Florida, 34761

    Site Public Contact, 412-339-5294, Roster@nrgoncology.org

    Shelly M. Seward

    Recruiting
  • ProHealth Oconomowoc Memorial Hospital

    Oconomowoc, Wisconsin, 53066

    Site Public Contact, 262-928-7878

    Timothy R. Wassenaar

    Recruiting
  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

    Site Public Contact, 405-271-8777, ou-clinical-trials@ouhsc.edu

    Jacqueline A. Bohn

    Recruiting
  • Nebraska Methodist Hospital

    Omaha, Nebraska, 68114

    Site Public Contact, 402-354-5144

    Brent J. Tierney

    Recruiting
  • Nebraska Medicine-Village Pointe

    Omaha, Nebraska, 68118

    Site Public Contact, 402-559-5600

    Lindsey A. McAlarnen

    Recruiting
  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

    Site Public Contact, 402-559-6941, unmcrsa@unmc.edu

    Lindsey A. McAlarnen

    Recruiting
  • UC Irvine Health/Chao Family Comprehensive Cancer Center

    Orange, California, 92868

    Site Public Contact, 877-827-8839, ucstudy@uci.edu

    Erin H. Healy

    Recruiting
  • Providence Willamette Falls Medical Center

    Oregon City, Oregon, 97045

    Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org

    Dan S. Zuckerman

    Recruiting
  • Northwestern Medicine Orland Park

    Orland Park, Illinois, 60462

    Site Public Contact, nctnprogram_rhlccc@northwestern.edu

    Eric D. Donnelly

    Recruiting
  • Orlando Health Cancer Institute

    Orlando, Florida, 32806

    Site Public Contact, 321-841-7246, CancerClinicalTrials@orlandohealth.com

    Shelly M. Seward

    Recruiting
  • Upstate Cancer Center Radiation Oncology at Oswego

    Oswego, New York, 13126

    Site Public Contact, 315-464-3603, BinghamE@upstate.edu

    Mary J. Cunningham

    Recruiting
  • University of Kansas Cancer Center-Overland Park

    Overland Park, Kansas, 66210

    Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu

    Andrew C. Hoover

    Recruiting
  • University of Kansas Hospital-Indian Creek Campus

    Overland Park, Kansas, 66211

    Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu

    Andrew C. Hoover

    Recruiting
  • Kaiser Permanente - Panorama City

    Panorama City, California, 91402

    Site Public Contact, 800-398-3996, clinical.trials@kp.org

    Devansu Tewari

    Recruiting
  • Camden Clark Medical Center

    Parkersburg, West Virginia, 26101

    Site Public Contact, 304-293-7374, cancertrialsinfo@hsc.wvu.edu

    Krista S. Pfaendler

    Recruiting
  • University Hospitals Parma Medical Center

    Parma, Ohio, 44129

    Site Public Contact, 800-641-2422, CTUReferral@UHhospitals.org

    Stacy A. Smrz

    Recruiting
  • Memorial Hospital West

    Pembroke Pines, Florida, 33028

    Site Public Contact, 954-265-4325

    Tamara L. Smith

    Recruiting
  • Capital Health Medical Center-Hopewell

    Pennington, New Jersey, 08534

    Site Public Contact, 609-394-4130, clinicaltrials@capitalhealth.org

    Nikhil Thaker

    Recruiting
  • OSF Saint Francis Radiation Oncology at Peoria Cancer Center

    Peoria, Illinois, 61615

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting
  • OSF Saint Francis Medical Center

    Peoria, Illinois, 61637

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting
  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

    Site Public Contact, 215-600-9151, ONCTrialNow@jefferson.edu

    Rebeca Kelly

    Recruiting
  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

    Site Public Contact, 215-728-4790

    Jeremy Price

    Recruiting
  • Temple University Hospital

    Philadelphia, Pennsylvania, 19140

    Site Public Contact, 215-728-2983

    Jeremy Price

    Recruiting
  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

    Site Public Contact, 877-284-2000

    Sarah M. Crafton

    Recruiting
  • UPMC-Magee Womens Hospital

    Pittsburgh, Pennsylvania, 15213

    Site Public Contact, 412-647-2811

    Bhanu Prasad Venkatesulu

    Recruiting
  • West Penn Hospital

    Pittsburgh, Pennsylvania, 15224

    Site Public Contact, 412-578-5000

    Sarah M. Crafton

    Recruiting
  • UPMC-Passavant Hospital

    Pittsburgh, Pennsylvania, 15237

    Site Public Contact, 412-367-6454

    Bhanu Prasad Venkatesulu

    Recruiting
  • UM Sylvester Comprehensive Cancer Center at Plantation

    Plantation, Florida, 33324

    Site Public Contact, 305-243-2647

    Navya Nair

    Recruiting
  • Trinity Health Saint Joseph Mercy Oakland Hospital

    Pontiac, Michigan, 48341

    Suspended
  • MaineHealth Maine Medical Center - Portland

    Portland, Maine, 04102

    Site Public Contact, 207-396-8670, clinicalresearch@mainehealth.org

    Leslie S. Bradford

    Recruiting
  • Legacy Good Samaritan Hospital and Medical Center

    Portland, Oregon, 97210

    Site Public Contact, 800-220-4937, cancer@lhs.org

    Julia Fehniger

    Recruiting
  • Providence Portland Medical Center

    Portland, Oregon, 97213

    Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org

    Dan S. Zuckerman

    Recruiting
  • Providence Saint Vincent Medical Center

    Portland, Oregon, 97225

    Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org

    Dan S. Zuckerman

    Recruiting
  • Kaiser Permanente Northwest

    Portland, Oregon, 97227

    Site Public Contact, 503-335-2400, information@kpchr.org

    Abdul Hai Mansoor

    Recruiting
  • Oregon Health and Science University

    Portland, Oregon, 97239

    Site Public Contact, 503-494-1080, trials@ohsu.edu

    Jessica Jou

    Recruiting
  • Kootenai Clinic Cancer Services - Post Falls

    Post Falls, Idaho, 83854

    Suspended
  • Women and Infants Hospital

    Providence, Rhode Island, 02905

    Site Public Contact, 401-274-1122

    Katherine Miller

    Recruiting
  • Saint Luke's Hospital - Upper Bucks Campus

    Quakertown, Pennsylvania, 18951

    Site Public Contact, 610-776-4714

    Nicholas P. Taylor

    Recruiting
  • Duke Women's Cancer Care Raleigh

    Raleigh, North Carolina, 27607

    Site Public Contact, 919-785-4878

    Diandra N. Ayala-Peacock

    Recruiting
  • Queens Cancer Center

    Rego Park, New York, 11374

    Site Public Contact, 718-312-3446

    Joan R. Tymon-Rosario

    Recruiting
  • Beebe Health Campus

    Rehoboth Beach, Delaware, 19971

    Site Public Contact, 302-291-6730, research@beebehealthcare.org

    Gregory A. Masters

    Recruiting
  • UT Southwestern Clinical Center at Richardson/Plano

    Richardson, Texas, 75080

    Site Public Contact, 972-669-7044, Suzanne.cole@utsouthwestern.edu

    Jayanthi S. Lea

    Recruiting
  • VCU Massey Comprehensive Cancer Center

    Richmond, Virginia, 23298

    Site Public Contact, 804-628-6430, CTOclinops@vcu.edu

    Jaclyn Wall

    Recruiting
  • Carilion Roanoke Memorial Hospital

    Roanoke, Virginia, 24033

    Site Public Contact, 540-981-7377

    Jaclyn Wall

    Recruiting
  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

    Site Public Contact, 855-776-0015

    Allison Garda

    Recruiting
  • UW Health Carbone Cancer Center Rockford

    Rockford, Illinois, 61114

    Site Public Contact, 779-696-9378, lkline@uwhealth.org

    Fahrettin Covut

    Recruiting
  • Highlands Oncology Group - Rogers

    Rogers, Arkansas, 72758

    Site Public Contact, 479-872-8130, research@hogonc.com

    Joseph T. Beck

    Recruiting
  • Phelps Health Delbert Day Cancer Institute

    Rolla, Missouri, 65401

    Site Public Contact, 573-458-7504, research@phelpshealth.org

    Jay W. Carlson

    Recruiting
  • Corewell Health William Beaumont University Hospital

    Royal Oak, Michigan, 48073

    Site Public Contact, 248-551-7695

    Ira S. Winer

    Recruiting
  • Moffitt Cancer Center at SouthShore

    Ruskin, Florida, 33570

    Site Public Contact, 800-679-0775, ClinicalTrials@moffitt.org

    Lorraine Portelance

    Recruiting
  • Sutter Medical Center Sacramento

    Sacramento, California, 95816

    Site Public Contact, clinicalresearch@sutterhealth.org

    Jorge A. Garcia-Young

    Recruiting
  • Regions Hospital

    Saint Paul, Minnesota, 55101

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    Joleen M. Hubbard

    Recruiting
  • Salinas Valley Memorial

    Salinas, California, 93901

    Site Public Contact, 831-759-1838, tnielsen2@svmh.com

    Geetha N. Varma

    Recruiting
  • University of Utah Sugarhouse Health Center

    Salt Lake City, Utah, 84106

    Site Public Contact, 888-424-2100, cancerinfo@hci.utah.edu

    Shashank Sama

    Recruiting
  • Huntsman Cancer Institute/University of Utah

    Salt Lake City, Utah, 84112

    Site Public Contact, 888-424-2100, cancerinfo@hci.utah.edu

    Shashank Sama

    Recruiting
  • Kaiser Permanente-San Diego Zion

    San Diego, California, 92120

    Site Public Contact, 800-398-3996, clinical.trials@kp.org

    Devansu Tewari

    Recruiting
  • Kaiser Permanente-San Marcos

    San Marcos, California, 92078

    Site Public Contact, 800-398-3996, clinical.trials@kp.org

    Devansu Tewari

    Recruiting
  • Essentia Health Sandstone

    Sandstone, Minnesota, 55072

    Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org

    Bret E. Friday

    Recruiting
  • MaineHealth Cancer Care Center of York County

    Sanford, Maine, 04073

    Site Public Contact, 207-459-1600

    Leslie S. Bradford

    Recruiting
  • Florida Cancer Specialists - Sarasota Downtown

    Sarasota, Florida, 34239

    Site Public Contact, 239-274-9930, ClinicalTrials@FLCancer.com

    Toni P. Kilts

    Recruiting
  • FPG - Surgical Oncology Clinics Gynecologic Oncology Surgery

    Sarasota, Florida, 34239

    Site Public Contact, 941-917-2225, Research-Institute@smh.com

    Toni P. Kilts

    Recruiting
  • Sarasota Memorial Hospital

    Sarasota, Florida, 34239

    Site Public Contact, 941-917-2225

    Toni P. Kilts

    Recruiting
  • Sarasota Memorial Health Care Center at University Parkway

    Sarasota, Florida, 34243

    Site Public Contact, 941-917-6519

    Toni P. Kilts

    Recruiting
  • MaineHealth Maine Medical Center- Scarborough

    Scarborough, Maine, 04074

    Site Public Contact, 207-396-8670, clinicalresearch@mainehealth.org

    Leslie S. Bradford

    Recruiting
  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109

    Site Public Contact, 800-804-8824

    Shauna McVorran

    Recruiting
  • UPMC Cancer Center at UPMC Northwest

    Seneca, Pennsylvania, 16346

    Site Public Contact, 814-676-7900

    Bhanu Prasad Venkatesulu

    Recruiting
  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105

    Site Public Contact, 605-322-3095, OncRegulatory@avera.org

    David C. Starks

    Recruiting
  • Phelps Memorial Hospital Center

    Sleepy Hollow, New York, 10591

    Site Public Contact, 914-366-1600

    Joan R. Tymon-Rosario

    Recruiting
  • City of Hope South Pasadena

    South Pasadena, California, 91030

    Site Public Contact, 800-826-4673, becomingapatient@coh.org

    Scott M. Glaser

    Recruiting
  • Spartanburg Medical Center

    Spartanburg, South Carolina, 29303

    Site Public Contact, 864-560-6104, kmertz-rivera@gibbscc.org

    Carlton L. Schwab

    Recruiting
  • Highlands Oncology Group

    Springdale, Arkansas, 72762

    Site Public Contact, 479-872-8130, research@hogonc.com

    Joseph T. Beck

    Recruiting
  • Southern Illinois University School of Medicine

    Springfield, Illinois, 62702

    Site Public Contact, 217-545-7929

    Bryan A. Faller

    Recruiting
  • Springfield Clinic

    Springfield, Illinois, 62702

    Site Public Contact, 800-444-7541

    Bryan A. Faller

    Recruiting
  • Springfield Memorial Hospital

    Springfield, Illinois, 62781

    Site Public Contact, 217-528-7541, pallante.beth@mhsil.com

    Bryan A. Faller

    Recruiting
  • Mercy Hospital Springfield

    Springfield, Missouri, 65804

    Site Public Contact, 417-269-4520

    Jay W. Carlson

    Recruiting
  • Mercy Hospital Saint Louis

    St Louis, Missouri, 63141

    Site Public Contact, 314-251-7066

    Jay W. Carlson

    Recruiting
  • Staten Island University Hospital

    Staten Island, New York, 10305

    Site Public Contact, 718-226-8888

    Joan R. Tymon-Rosario

    Recruiting
  • Stony Brook University Medical Center

    Stony Brook, New York, 11794

    Site Public Contact, 800-862-2215

    Susan M. Lang

    Recruiting

Other trials in United States

Puerto Rico2 sites, 2 recruiting
  • Doctors Cancer Center

    Manati, 00674

    Site Public Contact, 787-621-4397

    Luis J. Santos Reyes

    Recruiting
  • Centro Comprensivo de Cancer de UPR

    San Juan, 00927

    Site Public Contact, 412-339-5294, Roster@nrgoncology.org

    Luis J. Santos Reyes

    Recruiting

Other trials in Puerto Rico

About this study

Official title: A Phase III Study of Induction Pembrolizumab and Chemotherapy Followed by Chemoradiation and Pembrolizumab vs Chemoradiation and Pembrolizumab Both Followed by Pembrolizumab for High Risk Locally Advanced Cervical Cancer

This phase III trial compares the addition of induction chemotherapy, with carboplatin, paclitaxel and pembrolizumab, to chemotherapy and radiation, with cisplatin and pembrolizumab followed by pembrolizumab maintenance for the treatment of patients with cervical cancer that has spread to nearby tissue or lymph nodes (locally advanced). Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. 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. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of cancer cells. Adding induction chemotherapy to the usual treatment of chemotherapy and radiation followed by maintenance may be more effective in treating patients with high risk, locally advanced cervical cancer.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To determine whether induction immunotherapy (IO) and chemotherapy prior to concurrent chemoradiation therapy (CCRT) + IO improves progression-free survival (PFS) compared to CCRT+IO alone.

SECONDARY OBJECTIVES:

  1. To assess whether induction IO and chemotherapy prior to CCRT+IO improves the overall survival (OS) compared to CCRT+IO alone.

II. To determine the nature and degree of toxicity of induction IO and chemotherapy prior to CCRT + IO as compared to concurrent CCRT+IO as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0.

III. To determine the impact on CCRT start, CCRT completion time, and number of cycles of cisplatin administered; with induction IO and chemotherapy prior to CCRT+IO arm as compared to CCRT+IO.

IV. To assess the association between allostatic load and PFS/OS. V. To assess the predictive value of the integrated biomarker: PD-L1 expression at baseline for progression free survival.

VI. To assess the prognostic and predictive value of the integrated biomarker: circulating tumor deoxyribonucleic acid (ctDNA) at baseline and at 3 months post radiation therapy (RT) for progression free survival.

VII. To explore radiotherapy quality pretreatment scores conducted by expert review with assistance from artificial intelligence (AI) models and correlation with outcomes.

EXPLORATORY OBJECTIVES:

  1. To assess the evolution of T cell receptor (TCR) repertoire on treatment and its correlation with clinical outcomes.

II. To identify pre-treatment tumor microenvironment biomarkers predictive of outcomes.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM 1:

CHEMORADIATION: Patients receive cisplatin intravenously (IV) once weekly (QW) for 5 weeks and pembrolizumab IV over 30 minutes every 3 weeks (Q3W) for 5 doses. Patients also undergo radiation therapy once daily 5 days per week for 25-29 treatments in weeks 1-5 followed by brachytherapy up to twice per week for 4-5 treatments in weeks 5-7. Treatment is given in the absence of disease progression or unacceptable toxicity

MAINTENANCE: Patients receive pembrolizumab IV over 30 minutes every 6 weeks (Q6W) for 15 cycles in the absence of disease progression or unacceptable toxicity.

Patients undergo positron emission tomography (PET) scan, computed tomography (CT) scan, chest x-ray and/or magnetic resonance imaging (MRI) and blood sample collection throughout the study.

ARM 2:

INDUCTION: Patients receive carboplatin IV and paclitaxel IV QW on weeks 1-3 and pembrolizumab IV over 30 minutes Q3W on weeks 1 for each cycle. Cycles repeat every 3 weeks for 2 cycles in the absence of disease progression or unacceptable toxicity.

CHEMORADIATION: Patients receive cisplatin IV QW for 5 weeks and pembrolizumab IV over 30 minutes every Q3W for 5 doses. Patients also undergo radiation therapy once daily 5 days per week for 25-29 treatments in weeks 7-11 followed by brachytherapy up to twice per week for 4-5 treatments in weeks 11-13. Treatment is given in the absence of disease progression or unacceptable toxicity

MAINTENANCE: Patients receive pembrolizumab IV over 30 minutes Q6W for 14 cycles in the absence of disease progression or unacceptable toxicity.

Patients undergo PET scan, CT scan, chest x-ray and/or MRI and blood sample collection throughout the study.

After completion of study treatment, patients are followed up every 3 months for 2 years then every 6 months for 3 years.

Being tested
Biospecimen Collection, Brachytherapy, Carboplatin, Chest Radiography, Cisplatin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

    Undergo blood sample collection

  • BrachytherapyRadiation

    Also called Brachytherapy, NOS, Internal Radiation, Internal Radiation Brachytherapy, Internal Radiation Therapy

    Undergo brachytherapy

  • CarboplatinDrug

    Also called Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino

    Given IV

  • Chest RadiographyProcedure or surgery

    Also called Chest X-ray

    Undergo chest x-ray

  • CisplatinDrug

    Also called Abiplatin, Blastolem, Briplatin, CDDP

    Given IV

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT scan

  • External Beam Radiation TherapyRadiation

    Also called Definitive Radiation Therapy, EBRT, External Beam Radiation, External Beam Radiotherapy

    Undergo EBRT

  • Intensity-Modulated Radiation TherapyRadiation

    Also called IMRT, Intensity modulated radiation therapy (procedure), Intensity Modulated RT, Intensity-Modulated Radiotherapy

    Undergo IMRT

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan

    Undergo MRI

  • PaclitaxelDrug

    Also called Anzatax, Asotax, Bristaxol, Praxel

    Given IV

  • PembrolizumabBiological

    Also called BCD-201, GME 751, GME751, Keytruda

    Given IV

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)

    Undergo PET scan

Study groups in NCT07061977
Study groupRoleWhat they receive
Arm 1 (Standard care)Active comparatorCHEMORADIATION: Patients receive cisplatin IV QW for 5 weeks and pembrolizumab IV over 30 minutes Q3W for 5 doses. Patients also undergo radiation therapy with EBRT or IMRT once daily 5 days per week for 25-29 treatments in weeks 1-5 followed by brachytherapy up to twice per week for 4-5 treatments in weeks 5-7. Treatment is given in the absence of disease progression or unacceptable toxicity MAINTENANCE: Patients receive pembrolizumab IV over 30 minutes Q6W for 14 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo PET scan, CT scan, chest x-ray and/or MRI and blood sample collection throughout the study.
Receives: Procedure: Biospecimen Collection; Radiation: Brachytherapy; Procedure: Chest Radiography; Drug: Cisplatin; Procedure: Computed Tomography; Radiation: External Beam Radiation Therapy; Radiation: Intensity-Modulated Radiation Therapy; Procedure: Magnetic Resonance Imaging; Biological: Pembrolizumab; Procedure: Positron Emission Tomography
Arm 2 (induction and standard care)ExperimentalINDUCTION: Patients receive carboplatin IV and paclitaxel IV QW on weeks 1-3 and pembrolizumab IV over 30 minutes Q3W on week 1 for each cycle. Cycles repeat every 3 weeks for 2 cycles in the absence of disease progression or unacceptable toxicity. CHEMORADIATION: Patients receive cisplatin IV QW for 5 weeks and pembrolizumab IV over 30 minutes every Q3W for 5 doses. Patients also undergo radiation therapy with EBRT or IMRT once daily 5 days per week for 25-29 treatments in weeks 7-11 followed by brachytherapy up to twice per week for 4-5 treatments in weeks 11-13. Treatment is given in the absence of disease progression or unacceptable toxicity MAINTENANCE: Patients receive pembrolizumab IV over 30 minutes Q6W for 14 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo PET scan, CT scan, chest x-ray and/or MRI and blood sample collection throughout the study.
Receives: Procedure: Biospecimen Collection; Radiation: Brachytherapy; Drug: Carboplatin; Procedure: Chest Radiography; Drug: Cisplatin; Procedure: Computed Tomography; Radiation: External Beam Radiation Therapy; Radiation: Intensity-Modulated Radiation Therapy; Procedure: Magnetic Resonance Imaging; Drug: Paclitaxel; Biological: Pembrolizumab; Procedure: Positron Emission Tomography

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression free survival (PFS)

    Analysis will be performed using a one-sided log-rank test stratified by factors declared at randomization when (at least) 190 PFS events are observed in both arms. Patients will be grouped by their randomized treatment for intention-to-treat (ITT) analyses, supported by patients in ITT population. Treatment hazard ratio and confidence will be estimated using Cox proportional hazard models specified with a main effect for the randomized treatment assignment and stratified by factors declared at randomization. PFS at 2 years will be estimated using Kaplan-Meier method for each arm.

    Measured: From randomization to time of progression or death from any cause, whichever occurs first, or date of last contact if neither progression nor death has occurred, up to 7 years

Secondary outcomes (8)
  1. Overall survival (OS)

    The OS treatment hypothesis test (Arm 2 versus [vs.] Arm 1) will be based on a 1-sided log-rank test, stratified by the factors specified at randomization. Comparisons of the OS distributions by treatment arm will be described using Kaplan-Meier methods. Treatment hazard ratio estimates and their 95% confidence intervals will be estimated using a multivariable proportional hazards model specified with main effects for the randomized treatment assignment (Arm 2 vs Arm 1) and stratified by the factors declared at randomization.

    Measured: From randomization to death from any cause, up to 7 years

  2. Incidence of adverse events (AEs)

    Assessed by Common Terminology Criteria for Adverse Events version 5.0. The nature, frequency, and degree of toxicity will be tabulated at the System Organ Class and AE-specific term levels. Tabulations will show the number and percentage of patients by maximum grade, within the treatment group received, regardless of the randomized treatment assignment. Differences in the level of toxicities by treatment arm will be assessed by classifying them as severe (grade 3 or higher) or not severe (grade 2 or lower) and examining the relative proportion of severe toxicities by Fisher's exact test.

    Measured: Up to 7 years

  3. Duration of concurrent chemoradiation therapy (CCRT) completion

    Will be summarized and compared using 2-sample Wilcoxon rank sum tests. The proportion of patients with a delayed time to initiate CCRT by 2 weeks or more will be estimated and investigated by Fisher's exact test.

    Measured: From CCRT start date to CCRT end date

  4. Number of cycles of cisplatin

    Will be summarized and compared using 2-sample Wilcoxon rank sum tests.

    Measured: From 7 days after the last dose of induction chemotherapy to the CCRT start date for Arm 2, the planned CCRT start date to actual CCRT start date for Arm 1

  5. Allostatic load

    Will be summarized by treatment arm, and its association with OS will be evaluated using Cox PH model adjusted with main effects for the randomized treatment assignment (Arm 2 vs Arm 1) and stratified by the factors declared at randomization.

    Measured: Up to 2 years

  6. Tumor PD-L1 expression

    The predictive value of tumor PD-L1 expression at baseline for PFS will be investigated using Cox PH model adjusted with main effects for the randomized treatment assignment (Arm 2 vs Arm 1) and stratified by the factors declared at randomization.

    Measured: At baseline

  7. Circulating tumor deoxyribonucleic acid expression

    Will be summarized by treatment arm and by collection time. Will be investigated using Cox PH model adjusted with main effects for the randomized treatment assignment (Arm 2 vs Arm 1) and stratified by the factors declared at randomization.

    Measured: At baseline and at 3 months post radiation therapy

  8. Radiation quality pre-treatment score

    Will be summarized by treatment arm, and its associations with PFS and OS will be evaluated using Cox PH model adjusted with main effects for the randomized treatment assignment (Arm 2 vs Arm 1) and stratified by the factors declared at randomization.

    Measured: At time of radiation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2025
  2. Study start5 Nov 2025
  3. Primary completion31 Dec 2030 (estimated)
  4. Study completion31 Dec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
336 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07061977
Sponsor's protocol ID
NCI-2025-04695
Other IDs
NCI-2025-04695, NRG-GY037, NRG-GY037, U10CA180868
Status last verified
Sep 2026
First submitted
11 Jul 2025
Last updated
22 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.

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