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

June 16, 2026 updated by: National Cancer Institute (NCI)

NRG-GY037: A Phase III Study of Induction Pembrolizumab and Chemotherapy Followed by Chemoradiation and Pembrolizumab Versus 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVE:

I. 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:

I. 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:

I. 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.

Study Type

Interventional

Enrollment (Estimated)

336

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Not yet recruiting
        • University of Alabama at Birmingham Cancer Center
        • Principal Investigator:
          • Charles A. Leath
        • Contact:
    • Arkansas
      • Fayetteville, Arkansas, United States, 72703
        • Recruiting
        • Highlands Oncology Group - Fayetteville
        • Principal Investigator:
          • Joseph T. Beck
        • Contact:
      • Little Rock, Arkansas, United States, 72205
        • Recruiting
        • University of Arkansas for Medical Sciences
        • Contact:
          • Site Public Contact
          • Phone Number: 501-686-8274
        • Principal Investigator:
          • Heather R. Williams
      • Rogers, Arkansas, United States, 72758
        • Recruiting
        • Highlands Oncology Group - Rogers
        • Principal Investigator:
          • Joseph T. Beck
        • Contact:
      • Springdale, Arkansas, United States, 72762
        • Recruiting
        • Highlands Oncology Group
        • Principal Investigator:
          • Joseph T. Beck
        • Contact:
    • California
      • Bellflower, California, United States, 90706
        • Recruiting
        • Kaiser Permanente-Bellflower
        • Contact:
        • Principal Investigator:
          • Devansu Tewari
      • Corona, California, United States, 92882
        • Recruiting
        • City of Hope Corona
        • Principal Investigator:
          • Scott M. Glaser
        • Contact:
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Scott M. Glaser
      • Harbor City, California, United States, 90710
        • Recruiting
        • Kaiser Permanente South Bay
        • Contact:
        • Principal Investigator:
          • Devansu Tewari
      • Irvine, California, United States, 92618
        • Recruiting
        • Kaiser Permanente-Irvine
        • Contact:
        • Principal Investigator:
          • Devansu Tewari
      • Irvine, California, United States, 92618
        • Recruiting
        • City of Hope at Irvine Lennar
        • Contact:
          • Site Public Contact
          • Phone Number: 877-467-3411
        • Principal Investigator:
          • Scott M. Glaser
      • Irvine, California, United States, 92612
        • Recruiting
        • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
        • Principal Investigator:
          • Erin H. Healy
        • Contact:
      • La Jolla, California, United States, 92093
        • Recruiting
        • UC San Diego Moores Cancer Center
        • Contact:
        • Principal Investigator:
          • Jyoti S. Mayadev
      • Lancaster, California, United States, 93534
        • Suspended
        • City of Hope Antelope Valley
      • Los Angeles, California, United States, 90027
        • Recruiting
        • Kaiser Permanente Los Angeles Medical Center
        • Contact:
        • Principal Investigator:
          • Devansu Tewari
      • Los Angeles, California, United States, 90034
        • Recruiting
        • Kaiser Permanente West Los Angeles
        • Contact:
        • Principal Investigator:
          • Devansu Tewari
      • Orange, California, United States, 92868
        • Recruiting
        • UC Irvine Health/Chao Family Comprehensive Cancer Center
        • Principal Investigator:
          • Erin H. Healy
        • Contact:
      • Panorama City, California, United States, 91402
        • Recruiting
        • Kaiser Permanente - Panorama City
        • Contact:
        • Principal Investigator:
          • Devansu Tewari
      • San Diego, California, United States, 92120
        • Recruiting
        • Kaiser Permanente-San Diego Zion
        • Contact:
        • Principal Investigator:
          • Devansu Tewari
      • San Marcos, California, United States, 92078
        • Recruiting
        • Kaiser Permanente-San Marcos
        • Contact:
        • Principal Investigator:
          • Devansu Tewari
      • South Pasadena, California, United States, 91030
        • Recruiting
        • City of Hope South Pasadena
        • Contact:
        • Principal Investigator:
          • Scott M. Glaser
      • Upland, California, United States, 91786
        • Recruiting
        • City of Hope Upland
        • Contact:
        • Principal Investigator:
          • Scott M. Glaser
      • Woodland Hills, California, United States, 91367
        • Recruiting
        • Kaiser Permanente-Woodland Hills
        • Contact:
        • Principal Investigator:
          • Devansu Tewari
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • UCHealth University of Colorado Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 720-848-0650
        • Principal Investigator:
          • Spyridon A. Mastroyannis
      • Highlands Ranch, Colorado, United States, 80129
        • Recruiting
        • UCHealth Highlands Ranch Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 720-848-0650
        • Principal Investigator:
          • Spyridon A. Mastroyannis
    • Connecticut
      • Danbury, Connecticut, United States, 06810
        • Recruiting
        • Danbury Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 203-739-8074
        • Principal Investigator:
          • Leslie Andriani
      • Norwalk, Connecticut, United States, 06856
        • Recruiting
        • Norwalk Hospital
        • Contact:
        • Principal Investigator:
          • Leslie Andriani
    • Delaware
      • Millville, Delaware, United States, 19967
        • Recruiting
        • Beebe South Coastal Health Campus
        • Contact:
        • Principal Investigator:
          • Gregory A. Masters
      • Newark, Delaware, United States, 19713
        • Recruiting
        • Helen F Graham Cancer Center
        • Principal Investigator:
          • Gregory A. Masters
        • Contact:
      • Newark, Delaware, United States, 19713
        • Recruiting
        • Medical Oncology Hematology Consultants PA
        • Principal Investigator:
          • Gregory A. Masters
        • Contact:
      • Rehoboth Beach, Delaware, United States, 19971
        • Recruiting
        • Beebe Health Campus
        • Contact:
        • Principal Investigator:
          • Gregory A. Masters
    • Florida
      • Coral Gables, Florida, United States, 33146
        • Recruiting
        • UM Sylvester Comprehensive Cancer Center at Coral Gables
        • Principal Investigator:
          • Navya Nair
        • Contact:
          • Site Public Contact
          • Phone Number: 305-243-2647
      • Coral Springs, Florida, United States, 33065
        • Recruiting
        • UM Sylvester Comprehensive Cancer Center at Coral Springs
        • Principal Investigator:
          • Navya Nair
        • Contact:
          • Site Public Contact
          • Phone Number: 305-243-2647
      • Deerfield Beach, Florida, United States, 33442
        • Recruiting
        • UM Sylvester Comprehensive Cancer Center at Deerfield Beach
        • Principal Investigator:
          • Navya Nair
        • Contact:
          • Site Public Contact
          • Phone Number: 305-243-2647
      • Doral, Florida, United States, 33166
        • Recruiting
        • UM Sylvester Comprehensive Cancer Center at Doral
        • Principal Investigator:
          • Navya Nair
        • Contact:
      • Fort Lauderdale, Florida, United States, 33316
        • Recruiting
        • Broward Health Medical Center
        • Contact:
        • Principal Investigator:
          • Scott E. Jordan
      • Hollywood, Florida, United States, 33021
        • Recruiting
        • Memorial Regional Hospital/Joe DiMaggio Children's Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 954-265-1847
          • Email: OHR@mhs.net
        • Principal Investigator:
          • Tamara L. Smith
      • Hollywood, Florida, United States, 33021
        • Recruiting
        • UM Sylvester Comprehensive Cancer Center at Hollywood
        • Principal Investigator:
          • Navya Nair
        • Contact:
          • Site Public Contact
          • Phone Number: 305-243-2647
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami Miller School of Medicine-Sylvester Cancer Center
        • Principal Investigator:
          • Navya Nair
        • Contact:
          • Site Public Contact
          • Phone Number: 305-243-2647
      • Miami, Florida, United States, 33176
        • Recruiting
        • UM Sylvester Comprehensive Cancer Center at Kendall
        • Principal Investigator:
          • Navya Nair
        • Contact:
          • Site Public Contact
          • Phone Number: 305-243-2647
      • North Miami, Florida, United States, 33181
        • Recruiting
        • University of Miami Sylvester Comprehensive Cancer Center at Sole Mia
        • Principal Investigator:
          • Navya Nair
        • Contact:
      • Ocoee, Florida, United States, 34761
        • Recruiting
        • Health Central
        • Contact:
        • Principal Investigator:
          • Shelly M. Seward
      • Orlando, Florida, United States, 32806
      • Pembroke Pines, Florida, United States, 33028
        • Recruiting
        • Memorial Hospital West
        • Contact:
          • Site Public Contact
          • Phone Number: 954-265-4325
        • Principal Investigator:
          • Tamara L. Smith
      • Plantation, Florida, United States, 33324
        • Recruiting
        • UM Sylvester Comprehensive Cancer Center at Plantation
        • Principal Investigator:
          • Navya Nair
        • Contact:
          • Site Public Contact
          • Phone Number: 305-243-2647
      • Ruskin, Florida, United States, 33570
        • Recruiting
        • Moffitt Cancer Center at SouthShore
        • Principal Investigator:
          • Lorraine Portelance
        • Contact:
      • Tampa, Florida, United States, 33607
        • Recruiting
        • Moffitt Cancer Center-International Plaza
        • Principal Investigator:
          • Lorraine Portelance
        • Contact:
      • Tampa, Florida, United States, 33612
        • Recruiting
        • Moffitt Cancer Center - McKinley Campus
        • Principal Investigator:
          • Lorraine Portelance
        • Contact:
      • Tampa, Florida, United States, 33612
        • Recruiting
        • Moffitt Cancer Center
        • Principal Investigator:
          • Lorraine Portelance
        • Contact:
      • Wesley Chapel, Florida, United States, 33544
        • Recruiting
        • Moffitt Cancer Center at Wesley Chapel
        • Principal Investigator:
          • Lorraine Portelance
        • Contact:
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University Hospital/Winship Cancer Institute
        • Principal Investigator:
          • Sarah Dilley
        • Contact:
          • Site Public Contact
          • Phone Number: 404-778-1868
      • Atlanta, Georgia, United States, 30308
        • Recruiting
        • Emory University Hospital Midtown
        • Principal Investigator:
          • Sarah Dilley
        • Contact:
          • Site Public Contact
          • Phone Number: 888-946-7447
      • Atlanta, Georgia, United States, 30309
        • Recruiting
        • Piedmont Hospital
        • Contact:
        • Principal Investigator:
          • Leda Portia A. Gattoc
      • Decatur, Georgia, United States, 30033
      • Newnan, Georgia, United States, 30265
        • Recruiting
        • CTCA at Southeastern Regional Medical Center
        • Principal Investigator:
          • Natalie S. Godbee
        • Contact:
          • Site Public Contact
          • Phone Number: 770-400-6629
    • Idaho
      • Boise, Idaho, United States, 83712
        • Recruiting
        • Saint Luke's Cancer Institute - Boise
        • Principal Investigator:
          • Dan S. Zuckerman
        • Contact:
      • Boise, Idaho, United States, 83706
        • Recruiting
        • Saint Alphonsus Cancer Care Center-Boise
        • Contact:
        • Principal Investigator:
          • J. R. Liu
      • Caldwell, Idaho, United States, 83605
        • Recruiting
        • Saint Alphonsus Cancer Care Center-Caldwell
        • Contact:
        • Principal Investigator:
          • J. R. Liu
      • Coeur d'Alene, Idaho, United States, 83814
        • Suspended
        • Kootenai Health - Coeur d'Alene
      • Fruitland, Idaho, United States, 83619
        • Recruiting
        • Saint Luke's Cancer Institute - Fruitland
        • Principal Investigator:
          • Dan S. Zuckerman
        • Contact:
      • Meridian, Idaho, United States, 83642
        • Recruiting
        • Saint Luke's Cancer Institute - Meridian
        • Principal Investigator:
          • Dan S. Zuckerman
        • Contact:
      • Nampa, Idaho, United States, 83687
        • Recruiting
        • Saint Luke's Cancer Institute - Nampa
        • Principal Investigator:
          • Dan S. Zuckerman
        • Contact:
      • Nampa, Idaho, United States, 83687
        • Recruiting
        • Saint Alphonsus Cancer Care Center-Nampa
        • Contact:
        • Principal Investigator:
          • J. R. Liu
      • Post Falls, Idaho, United States, 83854
        • Suspended
        • Kootenai Clinic Cancer Services - Post Falls
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern University
        • Contact:
        • Principal Investigator:
          • Eric D. Donnelly
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • Rush MD Anderson Cancer Center
        • Contact:
        • Principal Investigator:
          • Andrew Cook
      • Danville, Illinois, United States, 61832
        • Recruiting
        • Carle at The Riverfront
        • Contact:
        • Principal Investigator:
          • Kendrith M. Rowland
      • DeKalb, Illinois, United States, 60115
        • Recruiting
        • Northwestern Medicine Cancer Center Kishwaukee
        • Contact:
        • Principal Investigator:
          • Eric D. Donnelly
      • Decatur, Illinois, United States, 62526
        • Recruiting
        • Cancer Care Specialists of Illinois - Decatur
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Decatur, Illinois, United States, 62526
        • Recruiting
        • Decatur Memorial Hospital
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Effingham, Illinois, United States, 62401
        • Recruiting
        • Carle Physician Group-Effingham
        • Contact:
        • Principal Investigator:
          • Kendrith M. Rowland
      • Effingham, Illinois, United States, 62401
        • Suspended
        • Crossroads Cancer Center
      • Geneva, Illinois, United States, 60134
        • Recruiting
        • Northwestern Medicine Cancer Center Delnor
        • Contact:
        • Principal Investigator:
          • Eric D. Donnelly
      • Mattoon, Illinois, United States, 61938
        • Recruiting
        • Carle Physician Group-Mattoon/Charleston
        • Contact:
        • Principal Investigator:
          • Kendrith M. Rowland
      • Maywood, Illinois, United States, 60153
        • Recruiting
        • Loyola University Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 708-226-4357
        • Principal Investigator:
          • Matthew M. Harkenrider
      • Oak Brook, Illinois, United States, 60523
      • Orland Park, Illinois, United States, 60462
      • Peoria, Illinois, United States, 61615
        • Recruiting
        • OSF Saint Francis Radiation Oncology at Peoria Cancer Center
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Peoria, Illinois, United States, 61637
        • Recruiting
        • OSF Saint Francis Medical Center
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Rockford, Illinois, United States, 61114
        • Recruiting
        • UW Health Carbone Cancer Center Rockford
        • Contact:
        • Principal Investigator:
          • Fahrettin Covut
      • Springfield, Illinois, United States, 62702
        • Recruiting
        • Southern Illinois University School of Medicine
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 217-545-7929
      • Springfield, Illinois, United States, 62702
        • Recruiting
        • Springfield Clinic
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 800-444-7541
      • Springfield, Illinois, United States, 62781
        • Recruiting
        • Springfield Memorial Hospital
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Urbana, Illinois, United States, 61801
        • Recruiting
        • Carle Cancer Center
        • Contact:
        • Principal Investigator:
          • Kendrith M. Rowland
      • Warrenville, Illinois, United States, 60555
        • Recruiting
        • Northwestern Medicine Cancer Center Warrenville
        • Contact:
        • Principal Investigator:
          • Eric D. Donnelly
      • Zion, Illinois, United States, 60099
        • Recruiting
        • Midwestern Regional Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 844-793-0745
        • Principal Investigator:
          • Barbara M. Buttin
    • Indiana
      • Crown Point, Indiana, United States, 46307
        • Recruiting
        • Northwest Cancer Center - Crown Point
        • Principal Investigator:
          • Kendrith M. Rowland
        • Contact:
      • Dyer, Indiana, United States, 46311
        • Recruiting
        • Northwest Oncology LLC
        • Contact:
          • Site Public Contact
          • Phone Number: 219-924-8178
        • Principal Investigator:
          • Kendrith M. Rowland
      • Fort Wayne, Indiana, United States, 46845
        • Recruiting
        • Parkview Regional Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 877-784-4673
        • Principal Investigator:
          • Bogna Brzezinska
      • Hobart, Indiana, United States, 46342
        • Recruiting
        • Northwest Cancer Center - Hobart
        • Contact:
          • Site Public Contact
          • Phone Number: 219-947-1795
        • Principal Investigator:
          • Kendrith M. Rowland
      • Hobart, Indiana, United States, 46342
        • Recruiting
        • Saint Mary Medical Center
        • Principal Investigator:
          • Kendrith M. Rowland
        • Contact:
      • Munster, Indiana, United States, 46321
        • Recruiting
        • The Community Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 219-836-3349
        • Principal Investigator:
          • Kendrith M. Rowland
      • Munster, Indiana, United States, 46321
        • Recruiting
        • Women's Diagnostic Center - Munster
        • Contact:
        • Principal Investigator:
          • Kendrith M. Rowland
      • Valparaiso, Indiana, United States, 46383
        • Recruiting
        • Northwest Cancer Center - Valparaiso
        • Principal Investigator:
          • Kendrith M. Rowland
        • Contact:
    • Iowa
      • Ankeny, Iowa, United States, 50023
        • Recruiting
        • UI Health Care Mission Cancer and Blood - Ankeny Clinic
        • Contact:
          • Site Public Contact
          • Phone Number: 515-241-3305
        • Principal Investigator:
          • Seema Harichand-Herdt
      • Cedar Rapids, Iowa, United States, 52403
        • Recruiting
        • Mercy Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 319-365-4673
        • Principal Investigator:
          • Deborah W. Wilbur
      • Cedar Rapids, Iowa, United States, 52403
        • Recruiting
        • Oncology Associates at Mercy Medical Center
        • Principal Investigator:
          • Deborah W. Wilbur
        • Contact:
          • Site Public Contact
          • Phone Number: 319-363-2690
      • Clive, Iowa, United States, 50325
        • Recruiting
        • UI Health Care Mission Cancer and Blood - West Des Moines Clinic
        • Contact:
          • Site Public Contact
          • Phone Number: 515-241-3305
        • Principal Investigator:
          • Seema Harichand-Herdt
      • Des Moines, Iowa, United States, 50314
        • Recruiting
        • Mercy Medical Center - Des Moines
        • Contact:
          • Site Public Contact
          • Phone Number: 515-241-3305
        • Principal Investigator:
          • Richard L. Deming
      • Des Moines, Iowa, United States, 50309
        • Recruiting
        • Iowa Methodist Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 515-241-6727
        • Principal Investigator:
          • Seema Harichand-Herdt
      • Des Moines, Iowa, United States, 50309
        • Recruiting
        • UI Health Care Mission Cancer and Blood - Des Moines Clinic
        • Contact:
          • Site Public Contact
          • Phone Number: 515-241-3305
        • Principal Investigator:
          • Seema Harichand-Herdt
      • Des Moines, Iowa, United States, 50314
        • Recruiting
        • UI Health Care Mission Cancer and Blood - Laurel Clinic
        • Contact:
          • Site Public Contact
          • Phone Number: 515-241-3305
        • Principal Investigator:
          • Seema Harichand-Herdt
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa/Holden Comprehensive Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 800-237-1225
        • Principal Investigator:
          • David P. Bender
      • Waukee, Iowa, United States, 50263
        • Recruiting
        • UI Health Care Mission Cancer and Blood - Waukee Clinic
        • Contact:
          • Site Public Contact
          • Phone Number: 515-241-3305
        • Principal Investigator:
          • Seema Harichand-Herdt
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • University of Kansas Cancer Center
        • Contact:
        • Principal Investigator:
          • Andrew C. Hoover
      • Overland Park, Kansas, United States, 66211
        • Recruiting
        • University of Kansas Hospital-Indian Creek Campus
        • Contact:
        • Principal Investigator:
          • Andrew C. Hoover
      • Overland Park, Kansas, United States, 66210
        • Recruiting
        • University of Kansas Cancer Center-Overland Park
        • Contact:
        • Principal Investigator:
          • Andrew C. Hoover
      • Westwood, Kansas, United States, 66205
        • Recruiting
        • University of Kansas Hospital-Westwood Cancer Center
        • Contact:
        • Principal Investigator:
          • Andrew C. Hoover
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Recruiting
        • University of Kentucky/Markey Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 859-257-3379
        • Principal Investigator:
          • Rachel W. Miller
    • Louisiana
      • Marrero, Louisiana, United States, 70072
        • Recruiting
        • West Jefferson Medical Center
        • Contact:
        • Principal Investigator:
          • Amma Agyemang
      • Metairie, Louisiana, United States, 70006
        • Recruiting
        • East Jefferson General Hospital
        • Contact:
        • Principal Investigator:
          • Amma Agyemang
      • Metairie, Louisiana, United States, 70006
        • Recruiting
        • LSU Healthcare Network / Metairie Multi-Specialty Clinic
        • Contact:
        • Principal Investigator:
          • Amma Agyemang
      • New Orleans, Louisiana, United States, 70121
        • Recruiting
        • Ochsner Medical Center Jefferson
        • Contact:
        • Principal Investigator:
          • Katrina S. Wade
      • New Orleans, Louisiana, United States, 70112
        • Recruiting
        • University Medical Center New Orleans
        • Contact:
        • Principal Investigator:
          • Amma Agyemang
      • New Orleans, Louisiana, United States, 70115
        • Recruiting
        • Ochsner Baptist Medical Center
        • Contact:
        • Principal Investigator:
          • Katrina S. Wade
    • Maine
      • Bath, Maine, United States, 04530
        • Recruiting
        • MaineHealth Coastal Cancer Treatment Center
        • Contact:
        • Principal Investigator:
          • Leslie S. Bradford
      • Portland, Maine, United States, 04102
        • Recruiting
        • MaineHealth Maine Medical Center - Portland
        • Principal Investigator:
          • Leslie S. Bradford
        • Contact:
      • Sanford, Maine, United States, 04073
        • Recruiting
        • MaineHealth Cancer Care Center of York County
        • Principal Investigator:
          • Leslie S. Bradford
        • Contact:
          • Site Public Contact
          • Phone Number: 207-459-1600
      • Scarborough, Maine, United States, 04074
        • Recruiting
        • MaineHealth Maine Medical Center- Scarborough
        • Principal Investigator:
          • Leslie S. Bradford
        • Contact:
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
        • Recruiting
        • Trinity Health Saint Joseph Mercy Hospital Ann Arbor
        • Contact:
        • Principal Investigator:
          • J. R. Liu
      • Brighton, Michigan, United States, 48114
      • Canton, Michigan, United States, 48188
      • Chelsea, Michigan, United States, 48118
      • Kalamazoo, Michigan, United States, 49007
        • Recruiting
        • Bronson Methodist Hospital
        • Contact:
        • Principal Investigator:
          • Kathleen Y. Butler
      • Kalamazoo, Michigan, United States, 49007
        • Recruiting
        • West Michigan Cancer Center
        • Contact:
        • Principal Investigator:
          • Kathleen Y. Butler
      • Livonia, Michigan, United States, 48154
        • Recruiting
        • Trinity Health Saint Mary Mercy Livonia Hospital
        • Contact:
        • Principal Investigator:
          • J. R. Liu
      • Pontiac, Michigan, United States, 48341
        • Suspended
        • Trinity Health Saint Joseph Mercy Oakland Hospital
    • Missouri
      • Joplin, Missouri, United States, 64804
        • Recruiting
        • Freeman Health System
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Kansas City, Missouri, United States, 64154
        • Recruiting
        • University of Kansas Cancer Center - North
        • Contact:
        • Principal Investigator:
          • Andrew C. Hoover
      • Kansas City, Missouri, United States, 64116
        • Recruiting
        • University of Kansas Cancer Center - Briarcliff
        • Contact:
          • Site Public Contact
          • Phone Number: 913-588-3671
        • Principal Investigator:
          • Andrew C. Hoover
      • Lee's Summit, Missouri, United States, 64064
        • Recruiting
        • University of Kansas Cancer Center - Lee's Summit
        • Contact:
        • Principal Investigator:
          • Andrew C. Hoover
      • Rolla, Missouri, United States, 65401
        • Recruiting
        • Phelps Health Delbert Day Cancer Institute
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Springfield, Missouri, United States, 65804
        • Recruiting
        • Mercy Hospital Springfield
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 417-269-4520
      • St Louis, Missouri, United States, 63141
        • Recruiting
        • Mercy Hospital Saint Louis
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 314-251-7066
    • Montana
      • Billings, Montana, United States, 59101
        • Recruiting
        • Billings Clinic Cancer Center
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Missoula, Montana, United States, 59804
        • Suspended
        • Community Medical Center
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Recruiting
        • University of Nebraska Medical Center
        • Contact:
        • Principal Investigator:
          • Lindsey A. McAlarnen
      • Omaha, Nebraska, United States, 68114
        • Recruiting
        • Nebraska Methodist Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 402-354-5144
        • Principal Investigator:
          • Brent J. Tierney
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Recruiting
        • Women's Cancer Center of Nevada
        • Principal Investigator:
          • Nicola M. Spirtos
        • Contact:
          • Site Public Contact
          • Phone Number: 702-851-4672
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Recruiting
        • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
        • Principal Investigator:
          • Michael L. Pearl
        • Contact:
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Recruiting
        • Memorial Sloan Kettering Basking Ridge
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
        • Principal Investigator:
          • Carol Aghajanian
      • Camden, New Jersey, United States, 08103
        • Recruiting
        • Cooper Hospital University Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 856-325-6757
        • Principal Investigator:
          • Lauren D. Krill
      • Jersey City, New Jersey, United States, 07302
        • Recruiting
        • Jersey City Medical Center
        • Contact:
        • Principal Investigator:
          • Ana I. Tergas
      • Middletown, New Jersey, United States, 07748
        • Recruiting
        • Memorial Sloan Kettering Monmouth
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
        • Principal Investigator:
          • Carol Aghajanian
      • Montvale, New Jersey, United States, 07645
        • Recruiting
        • Memorial Sloan Kettering Bergen
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
        • Principal Investigator:
          • Carol Aghajanian
      • New Brunswick, New Jersey, United States, 08903
        • Recruiting
        • Rutgers Cancer Institute of New Jersey
        • Contact:
          • Site Public Contact
          • Phone Number: 732-235-7356
        • Principal Investigator:
          • Ana I. Tergas
      • Newark, New Jersey, United States, 07101
        • Recruiting
        • Rutgers New Jersey Medical School
        • Contact:
          • Site Public Contact
          • Phone Number: 732-235-7356
        • Principal Investigator:
          • Ana I. Tergas
      • Pennington, New Jersey, United States, 08534
        • Recruiting
        • Capital Health Medical Center-Hopewell
        • Contact:
        • Principal Investigator:
          • Nikhil Thaker
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • Recruiting
        • University of New Mexico Cancer Center
        • Contact:
        • Principal Investigator:
          • Amaranta D. Craig
    • New York
      • Bay Shore, New York, United States, 11706
        • Recruiting
        • Northwell Health Imbert Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 516-734-8896
        • Principal Investigator:
          • Joan R. Tymon-Rosario
      • Buffalo, New York, United States, 14263
        • Recruiting
        • Roswell Park Cancer Institute
        • Principal Investigator:
          • Peter J. Frederick
        • Contact:
      • Commack, New York, United States, 11725
        • Recruiting
        • Memorial Sloan Kettering Commack
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
        • Principal Investigator:
          • Carol Aghajanian
      • Flushing, New York, United States, 11354
        • Recruiting
        • Northwell Health Physician Partners at Flushing
        • Contact:
        • Principal Investigator:
          • Joan R. Tymon-Rosario
      • Forest Hills, New York, United States, 11375
        • Recruiting
        • Northwell Health Physicians Partners Radiation Medicine at Queens
        • Contact:
          • Site Public Contact
          • Phone Number: 718-520-6620
        • Principal Investigator:
          • Joan R. Tymon-Rosario
      • Greenlawn, New York, United States, 11740
        • Recruiting
        • Northwell Health Cancer Institute at Huntington
        • Contact:
          • Site Public Contact
          • Phone Number: 516-734-8896
        • Principal Investigator:
          • Joan R. Tymon-Rosario
      • Harrison, New York, United States, 10604
        • Recruiting
        • Memorial Sloan Kettering Westchester
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
        • Principal Investigator:
          • Carol Aghajanian
      • Lake Success, New York, United States, 11042
        • Recruiting
        • Northwell Health/Center for Advanced Medicine
        • Contact:
          • Site Public Contact
          • Phone Number: 516-734-8896
        • Principal Investigator:
          • Joan R. Tymon-Rosario
      • Mineola, New York, United States, 11501
        • Recruiting
        • NYU Langone Hospital - Long Island
        • Contact:
        • Principal Investigator:
          • Leslie R. Boyd
      • Mount Kisco, New York, United States, 10549
        • Recruiting
        • Northern Westchester Hospital
        • Contact:
        • Principal Investigator:
          • Joan R. Tymon-Rosario
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
        • Principal Investigator:
          • Carol Aghajanian
      • New York, New York, United States, 10011
        • Recruiting
        • Mount Sinai Chelsea
        • Contact:
          • Site Public Contact
          • Phone Number: 212-824-7309
          • Email: CCTO@mssm.edu
        • Principal Investigator:
          • Dmitriy Zamarin
      • New York, New York, United States, 10016
        • Recruiting
        • Laura and Isaac Perlmutter Cancer Center at NYU Langone
        • Contact:
        • Principal Investigator:
          • Leslie R. Boyd
      • New York, New York, United States, 10029
        • Recruiting
        • Mount Sinai Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 212-824-7309
          • Email: CCTO@mssm.edu
        • Principal Investigator:
          • Dmitriy Zamarin
      • New York, New York, United States, 10075
        • Recruiting
        • Lenox Hill Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 516-734-8896
        • Principal Investigator:
          • Joan R. Tymon-Rosario
      • New York, New York, United States, 10065
        • Recruiting
        • Manhattan Eye Ear and Throat Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 212-434-4460
        • Principal Investigator:
          • Joan R. Tymon-Rosario
      • Oswego, New York, United States, 13126
        • Recruiting
        • Upstate Cancer Center Radiation Oncology at Oswego
        • Contact:
        • Principal Investigator:
          • Mary J. Cunningham
      • Rego Park, New York, United States, 11374
        • Recruiting
        • Queens Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 718-312-3446
        • Principal Investigator:
          • Joan R. Tymon-Rosario
      • Sleepy Hollow, New York, United States, 10591
        • Recruiting
        • Phelps Memorial Hospital Center
        • Contact:
          • Site Public Contact
          • Phone Number: 914-366-1600
        • Principal Investigator:
          • Joan R. Tymon-Rosario
      • Stony Brook, New York, United States, 11794
        • Recruiting
        • Stony Brook University Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 800-862-2215
        • Principal Investigator:
          • Susan M. Lang
      • Syracuse, New York, United States, 13210
        • Recruiting
        • State University of New York Upstate Medical University
        • Contact:
          • Site Public Contact
          • Phone Number: 315-464-5476
        • Principal Investigator:
          • Mary J. Cunningham
      • Syracuse, New York, United States, 13210
        • Recruiting
        • Upstate Cancer Center at Hill Radiation Oncology
        • Contact:
        • Principal Investigator:
          • Mary J. Cunningham
      • The Bronx, New York, United States, 10461
        • Recruiting
        • Montefiore Medical Center-Einstein Campus
        • Contact:
        • Principal Investigator:
          • Anne R. Van Arsdale
      • The Bronx, New York, United States, 10467
        • Recruiting
        • Montefiore Medical Center - Moses Campus
        • Contact:
        • Principal Investigator:
          • Anne R. Van Arsdale
      • The Bronx, New York, United States, 10461
        • Suspended
        • Montefiore Medical Center-Weiler Hospital
      • Uniondale, New York, United States, 11553
        • Recruiting
        • Memorial Sloan Kettering Nassau
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
        • Principal Investigator:
          • Carol Aghajanian
      • Verona, New York, United States, 13478
        • Recruiting
        • Upstate Cancer Center at Verona
        • Contact:
        • Principal Investigator:
          • Mary J. Cunningham
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Recruiting
        • UNC Lineberger Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Linda Van Le
      • Charlotte, North Carolina, United States, 28203
        • Recruiting
        • Carolinas Medical Center/Levine Cancer Institute
        • Contact:
          • Site Public Contact
          • Phone Number: 800-804-9376
        • Principal Investigator:
          • Yovanni Casablanca
      • Charlotte, North Carolina, United States, 28204
        • Recruiting
        • Novant Health Presbyterian Medical Center
        • Contact:
        • Principal Investigator:
          • Malcolm Ross
      • Concord, North Carolina, United States, 28025
        • Recruiting
        • Atrium Health Cabarrus/LCI-Concord
        • Contact:
          • Site Public Contact
          • Phone Number: 800-804-9376
        • Principal Investigator:
          • Yovanni Casablanca
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 888-275-3853
        • Principal Investigator:
          • Diandra N. Ayala-Peacock
      • Gastonia, North Carolina, United States, 28054
        • Recruiting
        • Levine Cancer Institute-Gaston
        • Contact:
          • Site Public Contact
          • Phone Number: 800-804-9376
        • Principal Investigator:
          • Yovanni Casablanca
      • Matthews, North Carolina, United States, 28105
        • Recruiting
        • Matthews Radiation Oncology Center
        • Contact:
        • Principal Investigator:
          • Malcolm Ross
      • Raleigh, North Carolina, United States, 27607
        • Recruiting
        • Duke Women's Cancer Care Raleigh
        • Contact:
          • Site Public Contact
          • Phone Number: 919-785-4878
        • Principal Investigator:
          • Diandra N. Ayala-Peacock
      • Winston-Salem, North Carolina, United States, 27157
        • Recruiting
        • Wake Forest University Health Sciences
        • Principal Investigator:
          • Michael G. Kelly
        • Contact:
          • Site Public Contact
          • Phone Number: 336-713-6771
      • Winston-Salem, North Carolina, United States, 27103
        • Recruiting
        • Novant Health Forsyth Medical Center
        • Contact:
        • Principal Investigator:
          • Elizabeth N. Skinner
    • Ohio
      • Beachwood, Ohio, United States, 44122
        • Recruiting
        • UHHS-Chagrin Highlands Medical Center
        • Contact:
        • Principal Investigator:
          • Stacy A. Smrz
      • Canton, Ohio, United States, 44710
        • Recruiting
        • Aultman Health Foundation
        • Principal Investigator:
          • Raza A. Khan
        • Contact:
      • Centerville, Ohio, United States, 45459
        • Recruiting
        • Miami Valley Hospital South
        • Contact:
        • Principal Investigator:
          • Michael S. Guy
      • Chardon, Ohio, United States, 44024
        • Recruiting
        • Geauga Hospital
        • Contact:
        • Principal Investigator:
          • Stacy A. Smrz
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • University of Cincinnati Cancer Center-UC Medical Center
        • Contact:
        • Principal Investigator:
          • Sarah M. Sittenfeld
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic Foundation
        • Contact:
        • Principal Investigator:
          • Lindsey Beffa
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • Case Western Reserve University
        • Contact:
        • Principal Investigator:
          • Stacy A. Smrz
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • Ohio State University Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Laura Chambers
      • Dayton, Ohio, United States, 45409
        • Recruiting
        • Miami Valley Hospital
        • Contact:
        • Principal Investigator:
          • Michael S. Guy
      • Dayton, Ohio, United States, 45415
        • Recruiting
        • Miami Valley Hospital North
        • Contact:
        • Principal Investigator:
          • Michael S. Guy
      • Franklin, Ohio, United States, 45005-1066
        • Recruiting
        • Atrium Medical Center-Middletown Regional Hospital
        • Contact:
        • Principal Investigator:
          • Michael S. Guy
      • Greenville, Ohio, United States, 45331
        • Recruiting
        • Miami Valley Cancer Care and Infusion
        • Principal Investigator:
          • Michael S. Guy
        • Contact:
          • Site Public Contact
          • Phone Number: 937-569-7515
      • Mayfield Heights, Ohio, United States, 44124
        • Recruiting
        • Hillcrest Hospital Cancer Center
        • Contact:
        • Principal Investigator:
          • Lindsey Beffa
      • Mentor, Ohio, United States, 44060
        • Recruiting
        • UH Seidman Cancer Center at Lake Health Mentor Campus
        • Contact:
        • Principal Investigator:
          • Stacy A. Smrz
      • Parma, Ohio, United States, 44129
        • Recruiting
        • University Hospitals Parma Medical Center
        • Contact:
        • Principal Investigator:
          • Stacy A. Smrz
      • Sylvania, Ohio, United States, 43560
        • Recruiting
        • ProMedica Flower Hospital
        • Contact:
        • Principal Investigator:
          • Anjalika Gandhi
      • Troy, Ohio, United States, 45373
        • Recruiting
        • Upper Valley Medical Center
        • Contact:
        • Principal Investigator:
          • Michael S. Guy
      • West Chester, Ohio, United States, 45069
        • Recruiting
        • University of Cincinnati Cancer Center-West Chester
        • Contact:
        • Principal Investigator:
          • Sarah M. Sittenfeld
      • Westlake, Ohio, United States, 44145
        • Recruiting
        • UH Seidman Cancer Center at Saint John Medical Center
        • Contact:
        • Principal Investigator:
          • Stacy A. Smrz
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • University of Oklahoma Health Sciences Center
        • Contact:
        • Principal Investigator:
          • Jacqueline A. Bohn
      • Tulsa, Oklahoma, United States, 74146
        • Recruiting
        • Oklahoma Cancer Specialists and Research Institute-Tulsa
        • Contact:
          • Site Public Contact
          • Phone Number: 918-505-3200
        • Principal Investigator:
          • Katherine M. Moxley
    • Oregon
      • Clackamas, Oregon, United States, 97015
        • Recruiting
        • Clackamas Radiation Oncology Center
        • Principal Investigator:
          • Dan S. Zuckerman
        • Contact:
      • Newberg, Oregon, United States, 97132
        • Recruiting
        • Providence Newberg Medical Center
        • Principal Investigator:
          • Dan S. Zuckerman
        • Contact:
      • Oregon City, Oregon, United States, 97045
        • Recruiting
        • Providence Willamette Falls Medical Center
        • Principal Investigator:
          • Dan S. Zuckerman
        • Contact:
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health and Science University
        • Contact:
        • Principal Investigator:
          • Jessica Jou
      • Portland, Oregon, United States, 97213
        • Recruiting
        • Providence Portland Medical Center
        • Principal Investigator:
          • Dan S. Zuckerman
        • Contact:
      • Portland, Oregon, United States, 97225
        • Recruiting
        • Providence Saint Vincent Medical Center
        • Principal Investigator:
          • Dan S. Zuckerman
        • Contact:
      • Portland, Oregon, United States, 97210
        • Recruiting
        • Legacy Good Samaritan Hospital and Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 800-220-4937
          • Email: cancer@lhs.org
        • Principal Investigator:
          • Julia Fehniger
      • Portland, Oregon, United States, 97227
        • Recruiting
        • Kaiser Permanente Northwest
        • Contact:
        • Principal Investigator:
          • Abdul Hai Mansoor
      • Tualatin, Oregon, United States, 97062
        • Recruiting
        • Legacy Meridian Park Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 503-413-1742
        • Principal Investigator:
          • Julia Fehniger
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Recruiting
        • Lehigh Valley Hospital-Cedar Crest
        • Contact:
        • Principal Investigator:
          • J. R. Liu
      • Allentown, Pennsylvania, United States, 18104
        • Recruiting
        • Saint Luke's Cancer Center - Allentown
        • Contact:
          • Site Public Contact
          • Phone Number: 610-776-4714
        • Principal Investigator:
          • Sarah P. Huepenbecker
      • Bethlehem, Pennsylvania, United States, 18017
        • Recruiting
        • Lehigh Valley Hospital - Muhlenberg
        • Contact:
        • Principal Investigator:
          • J. R. Liu
      • Bethlehem, Pennsylvania, United States, 18015
        • Recruiting
        • Saint Luke's University Hospital-Bethlehem Campus
        • Contact:
          • Site Public Contact
          • Phone Number: 484-503-4151
        • Principal Investigator:
          • Sarah P. Huepenbecker
      • Danville, Pennsylvania, United States, 17822
        • Recruiting
        • Geisinger Medical Center
        • Contact:
        • Principal Investigator:
          • Julie Jiang
      • Dickson City, Pennsylvania, United States, 18519
        • Recruiting
        • Geisinger Cancer Center Dickson City
        • Principal Investigator:
          • Julie Jiang
        • Contact:
      • East Stroudsburg, Pennsylvania, United States, 18301
        • Recruiting
        • Pocono Medical Center
        • Contact:
        • Principal Investigator:
          • J. R. Liu
      • Easton, Pennsylvania, United States, 18045
        • Recruiting
        • Saint Luke's Hospital-Anderson Campus
        • Contact:
        • Principal Investigator:
          • Sarah P. Huepenbecker
      • Erie, Pennsylvania, United States, 16505
        • Recruiting
        • UPMC Hillman Cancer Center Erie
        • Principal Investigator:
          • Bhanu Prasad Venkatesulu
        • Contact:
      • Greensburg, Pennsylvania, United States, 15601
        • Recruiting
        • UPMC Cancer Centers - Arnold Palmer Pavilion
        • Contact:
          • Site Public Contact
          • Phone Number: 724-838-1900
        • Principal Investigator:
          • Bhanu Prasad Venkatesulu
      • Harrisburg, Pennsylvania, United States, 17109
        • Recruiting
        • UPMC Pinnacle Cancer Center/Community Osteopathic Campus
        • Contact:
        • Principal Investigator:
          • Bhanu Prasad Venkatesulu
      • Hershey, Pennsylvania, United States, 17033-0850
        • Recruiting
        • Penn State Milton S Hershey Medical Center
        • Principal Investigator:
          • Mark S. Shahin
        • Contact:
      • Indiana, Pennsylvania, United States, 15701
        • Recruiting
        • IRMC Cancer Center
        • Contact:
        • Principal Investigator:
          • Bhanu Prasad Venkatesulu
      • Lewisburg, Pennsylvania, United States, 17837
        • Recruiting
        • Geisinger Medical Oncology-Lewisburg
        • Contact:
        • Principal Investigator:
          • Julie Jiang
      • Mechanicsburg, Pennsylvania, United States, 17050
        • Recruiting
        • UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
        • Contact:
        • Principal Investigator:
          • Bhanu Prasad Venkatesulu
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Thomas Jefferson University Hospital
        • Contact:
        • Principal Investigator:
          • Rebeca Kelly
      • Philadelphia, Pennsylvania, United States, 19111
        • Recruiting
        • Fox Chase Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 215-728-4790
        • Principal Investigator:
          • Jeremy Price
      • Philadelphia, Pennsylvania, United States, 19140
        • Recruiting
        • Temple University Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 215-728-2983
        • Principal Investigator:
          • Jeremy Price
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • UPMC-Magee Womens Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 412-647-2811
        • Principal Investigator:
          • Bhanu Prasad Venkatesulu
      • Pittsburgh, Pennsylvania, United States, 15237
        • Recruiting
        • UPMC-Passavant Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 412-367-6454
        • Principal Investigator:
          • Bhanu Prasad Venkatesulu
      • Quakertown, Pennsylvania, United States, 18951
        • Recruiting
        • Saint Luke's Hospital - Upper Bucks Campus
        • Contact:
          • Site Public Contact
          • Phone Number: 610-776-4714
        • Principal Investigator:
          • Sarah P. Huepenbecker
      • Seneca, Pennsylvania, United States, 16346
        • Recruiting
        • UPMC Cancer Center at UPMC Northwest
        • Contact:
          • Site Public Contact
          • Phone Number: 814-676-7900
        • Principal Investigator:
          • Bhanu Prasad Venkatesulu
      • Stroudsburg, Pennsylvania, United States, 18360
        • Recruiting
        • Saint Luke's Hospital - Monroe Campus
        • Contact:
        • Principal Investigator:
          • Sarah P. Huepenbecker
      • Wilkes-Barre, Pennsylvania, United States, 18711
        • Recruiting
        • Geisinger Wyoming Valley/Henry Cancer Center
        • Contact:
        • Principal Investigator:
          • Julie Jiang
      • Willow Grove, Pennsylvania, United States, 19090
        • Recruiting
        • Asplundh Cancer Pavilion
        • Contact:
        • Principal Investigator:
          • Rebeca Kelly
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • Recruiting
        • Women and Infants Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 401-274-1122
        • Principal Investigator:
          • Katherine Miller
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Contact:
        • Principal Investigator:
          • Brian Orr
      • Gaffney, South Carolina, United States, 29341
        • Recruiting
        • Gibbs Cancer Center-Gaffney
        • Principal Investigator:
          • Carlton L. Schwab
        • Contact:
      • Greer, South Carolina, United States, 29651
        • Recruiting
        • Gibbs Cancer Center-Pelham
        • Principal Investigator:
          • Carlton L. Schwab
        • Contact:
      • Spartanburg, South Carolina, United States, 29303
        • Recruiting
        • Spartanburg Medical Center
        • Principal Investigator:
          • Carlton L. Schwab
        • Contact:
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Recruiting
        • Avera Cancer Institute
        • Contact:
        • Principal Investigator:
          • David C. Starks
    • Texas
      • Dallas, Texas, United States, 75390
        • Recruiting
        • UT Southwestern/Simmons Cancer Center-Dallas
        • Principal Investigator:
          • Jayanthi S. Lea
        • Contact:
      • Dallas, Texas, United States, 75235
        • Recruiting
        • Parkland Memorial Hospital
        • Principal Investigator:
          • Jayanthi S. Lea
        • Contact:
      • Fort Worth, Texas, United States, 76104
        • Recruiting
        • UT Southwestern/Simmons Cancer Center-Fort Worth
        • Principal Investigator:
          • Jayanthi S. Lea
        • Contact:
      • Richardson, Texas, United States, 75080
        • Recruiting
        • UT Southwestern Clinical Center at Richardson/Plano
        • Principal Investigator:
          • Jayanthi S. Lea
        • Contact:
    • Utah
      • Farmington, Utah, United States, 84025
        • Recruiting
        • Farmington Health Center
        • Contact:
        • Principal Investigator:
          • Shashank Sama
      • Salt Lake City, Utah, United States, 84106
        • Recruiting
        • University of Utah Sugarhouse Health Center
        • Contact:
        • Principal Investigator:
          • Shashank Sama
      • Salt Lake City, Utah, United States, 84112
        • Recruiting
        • Huntsman Cancer Institute/University of Utah
        • Contact:
        • Principal Investigator:
          • Shashank Sama
    • Virginia
      • Alexandria, Virginia, United States, 22304
        • Recruiting
        • Inova Alexandria Hospital
        • Contact:
        • Principal Investigator:
          • Leslie M. Randall
      • Charlottesville, Virginia, United States, 22908
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • Inova Schar Cancer Institute
        • Contact:
        • Principal Investigator:
          • Leslie M. Randall
      • Fairfax, Virginia, United States, 22033
        • Recruiting
        • Inova Fair Oaks Hospital
        • Contact:
        • Principal Investigator:
          • Leslie M. Randall
      • Falls Church, Virginia, United States, 22042
        • Recruiting
        • Inova Fairfax Hospital
        • Contact:
        • Principal Investigator:
          • Leslie M. Randall
      • Leesburg, Virginia, United States, 20176
        • Recruiting
        • Inova Loudoun Hospital
        • Contact:
        • Principal Investigator:
          • Leslie M. Randall
      • Richmond, Virginia, United States, 23298
        • Recruiting
        • VCU Massey Comprehensive Cancer Center
        • Principal Investigator:
          • Jaclyn Wall
        • Contact:
      • Roanoke, Virginia, United States, 24033
        • Recruiting
        • Carilion Roanoke Memorial Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 540-981-7377
        • Principal Investigator:
          • Jaclyn Wall
    • Washington
      • Vancouver, Washington, United States, 98686
        • Recruiting
        • Legacy Salmon Creek Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 503-413-2150
        • Principal Investigator:
          • Julia Fehniger
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • Recruiting
        • West Virginia University Healthcare
        • Contact:
        • Principal Investigator:
          • Krista S. Pfaendler
      • Parkersburg, West Virginia, United States, 26101
        • Recruiting
        • Camden Clark Medical Center
        • Contact:
        • Principal Investigator:
          • Krista S. Pfaendler
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Recruiting
        • University of Wisconsin Carbone Cancer Center - University Hospital
        • Principal Investigator:
          • Lisa M. Barroilhet
        • Contact:
      • Madison, Wisconsin, United States, 53718
        • Recruiting
        • University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
        • Principal Investigator:
          • Lisa M. Barroilhet
        • Contact:
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Medical College of Wisconsin
        • Contact:
          • Site Public Contact
          • Phone Number: 414-805-3666
        • Principal Investigator:
          • William H. Bradley
      • Mukwonago, Wisconsin, United States, 53149
        • Recruiting
        • ProHealth D N Greenwald Center
        • Contact:
        • Principal Investigator:
          • Timothy R. Wassenaar
      • Oconomowoc, Wisconsin, United States, 53066
        • Recruiting
        • ProHealth Oconomowoc Memorial Hospital
        • Principal Investigator:
          • Timothy R. Wassenaar
        • Contact:
          • Site Public Contact
          • Phone Number: 262-928-7878
      • Waukesha, Wisconsin, United States, 53188
        • Recruiting
        • UW Cancer Center at ProHealth Care
        • Principal Investigator:
          • Timothy R. Wassenaar
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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)
    • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm 1 (Standard care)

CHEMORADIATION: 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.
Procedure: Magnetic Resonance Imaging
Undergo MRI
Other Names:
  • MRI
  • Magnetic Resonance
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MR
  • MR Imaging
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging
  • Magnetic Resonance Imaging (MRI)
  • sMRI
  • Magnetic resonance imaging (procedure)
  • MRIs
  • Structural MRI
Drug: Cisplatin
Given IV
Other Names:
  • CDDP
  • Cis-diamminedichloridoplatinum
  • Cismaplat
  • Cisplatinum
  • Neoplatin
  • Platinol
  • Abiplatin
  • Blastolem
  • Briplatin
  • Cis-diammine-dichloroplatinum
  • Cis-diamminedichloro Platinum (II)
  • Cis-diamminedichloroplatinum
  • Cis-dichloroammine Platinum (II)
  • Cis-platinous Diamine Dichloride
  • Cis-platinum
  • Cis-platinum II
  • Cis-platinum II Diamine Dichloride
  • Cisplatina
  • Cisplatyl
  • Citoplatino
  • Citosin
  • Cysplatyna
  • DDP
  • Lederplatin
  • Metaplatin
  • Peyrone's Chloride
  • Peyrone's Salt
  • Placis
  • Plastistil
  • Platamine
  • Platiblastin
  • Platiblastin-S
  • Platinex
  • Platinol- AQ
  • Platinol-AQ
  • Platinol-AQ VHA Plus
  • Platinoxan
  • Platinum
  • Platinum Diamminodichloride
  • Platiran
  • Platistin
  • Platosin
Biological: Pembrolizumab
Given IV
Other Names:
  • Keytruda
  • MK-3475
  • Lambrolizumab
  • SCH 900475
  • MK3475
  • SCH-900475
  • BCD-201
  • Pembrolizumab Biosimilar BCD-201
  • Pembrolizumab Biosimilar QL2107
  • QL2107
  • GME 751
  • GME751
  • Pembrolizumab Biosimilar GME751
  • MK 3475
  • SCH900475
  • Pembrolizumab Biosimilar RPH-075
  • RPH 075
  • RPH-075
  • RPH075
  • Pembrolizumab Biosimilar SB27
  • SB 27
  • SB-27
  • SB27
Procedure: Biospecimen Collection
Undergo blood sample collection
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
  • Sample Collection
Radiation: Brachytherapy
Undergo brachytherapy
Other Names:
  • Brachytherapy, NOS
  • Internal Radiation
  • Internal Radiation Brachytherapy
  • Internal Radiation Therapy
  • Radiation Brachytherapy
  • Radiation, Internal
Radiation: External Beam Radiation Therapy
Undergo EBRT
Other Names:
  • EBRT
  • Definitive Radiation Therapy
  • External Beam Radiation
  • External Beam Radiotherapy
  • External Beam RT
  • external radiation
  • External Radiation Therapy
  • external-beam radiation
  • Radiation, External Beam
  • Teleradiotherapy
  • Teletherapy
  • Teletherapy Radiation
  • External Beam Radiotherapy (conventional)
Radiation: Intensity-Modulated Radiation Therapy
Undergo IMRT
Other Names:
  • IMRT
  • Intensity Modulated RT
  • Intensity-Modulated Radiotherapy
  • Radiation, Intensity-Modulated Radiotherapy
  • Intensity modulated radiation therapy (procedure)
Procedure: Positron Emission Tomography
Undergo PET scan
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET Scan
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • PT
  • Positron emission tomography (procedure)
Procedure: Computed Tomography
Undergo CT scan
Other Names:
  • CT
  • CAT
  • CAT Scan
  • Computed Axial Tomography
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT Scan
  • tomography
  • Computerized axial tomography (procedure)
  • Computerized Tomography (CT) scan
  • Diagnostic CAT Scan
  • Diagnostic CAT Scan Service Type
Procedure: Chest Radiography
Undergo chest x-ray
Other Names:
  • Chest X-ray
Experimental: Arm 2 (induction and standard care)

INDUCTION: 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.
Drug: Carboplatin
Given IV
Other Names:
  • Blastocarb
  • Carboplat
  • Carboplatin Hexal
  • Carboplatino
  • Carboplatinum
  • Carbosin
  • Carbosol
  • Carbotec
  • CBDCA
  • Displata
  • Ercar
  • JM-8
  • Nealorin
  • Novoplatinum
  • Paraplatin
  • Paraplatin AQ
  • Paraplatine
  • Platinwas
  • Ribocarbo
  • JM8
Procedure: Magnetic Resonance Imaging
Undergo MRI
Other Names:
  • MRI
  • Magnetic Resonance
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MR
  • MR Imaging
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging
  • Magnetic Resonance Imaging (MRI)
  • sMRI
  • Magnetic resonance imaging (procedure)
  • MRIs
  • Structural MRI
Drug: Cisplatin
Given IV
Other Names:
  • CDDP
  • Cis-diamminedichloridoplatinum
  • Cismaplat
  • Cisplatinum
  • Neoplatin
  • Platinol
  • Abiplatin
  • Blastolem
  • Briplatin
  • Cis-diammine-dichloroplatinum
  • Cis-diamminedichloro Platinum (II)
  • Cis-diamminedichloroplatinum
  • Cis-dichloroammine Platinum (II)
  • Cis-platinous Diamine Dichloride
  • Cis-platinum
  • Cis-platinum II
  • Cis-platinum II Diamine Dichloride
  • Cisplatina
  • Cisplatyl
  • Citoplatino
  • Citosin
  • Cysplatyna
  • DDP
  • Lederplatin
  • Metaplatin
  • Peyrone's Chloride
  • Peyrone's Salt
  • Placis
  • Plastistil
  • Platamine
  • Platiblastin
  • Platiblastin-S
  • Platinex
  • Platinol- AQ
  • Platinol-AQ
  • Platinol-AQ VHA Plus
  • Platinoxan
  • Platinum
  • Platinum Diamminodichloride
  • Platiran
  • Platistin
  • Platosin
Drug: Paclitaxel
Given IV
Other Names:
  • Taxol
  • Anzatax
  • Asotax
  • Bristaxol
  • Praxel
  • Taxol Konzentrat
Biological: Pembrolizumab
Given IV
Other Names:
  • Keytruda
  • MK-3475
  • Lambrolizumab
  • SCH 900475
  • MK3475
  • SCH-900475
  • BCD-201
  • Pembrolizumab Biosimilar BCD-201
  • Pembrolizumab Biosimilar QL2107
  • QL2107
  • GME 751
  • GME751
  • Pembrolizumab Biosimilar GME751
  • MK 3475
  • SCH900475
  • Pembrolizumab Biosimilar RPH-075
  • RPH 075
  • RPH-075
  • RPH075
  • Pembrolizumab Biosimilar SB27
  • SB 27
  • SB-27
  • SB27
Procedure: Biospecimen Collection
Undergo blood sample collection
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
  • Sample Collection
Radiation: Brachytherapy
Undergo brachytherapy
Other Names:
  • Brachytherapy, NOS
  • Internal Radiation
  • Internal Radiation Brachytherapy
  • Internal Radiation Therapy
  • Radiation Brachytherapy
  • Radiation, Internal
Radiation: External Beam Radiation Therapy
Undergo EBRT
Other Names:
  • EBRT
  • Definitive Radiation Therapy
  • External Beam Radiation
  • External Beam Radiotherapy
  • External Beam RT
  • external radiation
  • External Radiation Therapy
  • external-beam radiation
  • Radiation, External Beam
  • Teleradiotherapy
  • Teletherapy
  • Teletherapy Radiation
  • External Beam Radiotherapy (conventional)
Radiation: Intensity-Modulated Radiation Therapy
Undergo IMRT
Other Names:
  • IMRT
  • Intensity Modulated RT
  • Intensity-Modulated Radiotherapy
  • Radiation, Intensity-Modulated Radiotherapy
  • Intensity modulated radiation therapy (procedure)
Procedure: Positron Emission Tomography
Undergo PET scan
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET Scan
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • PT
  • Positron emission tomography (procedure)
Procedure: Computed Tomography
Undergo CT scan
Other Names:
  • CT
  • CAT
  • CAT Scan
  • Computed Axial Tomography
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT Scan
  • tomography
  • Computerized axial tomography (procedure)
  • Computerized Tomography (CT) scan
  • Diagnostic CAT Scan
  • Diagnostic CAT Scan Service Type
Procedure: Chest Radiography
Undergo chest x-ray
Other Names:
  • Chest X-ray

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival (PFS)
Time Frame: 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
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: From randomization to death from any cause, up to 7 years
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.
From randomization to death from any cause, up to 7 years
Incidence of adverse events (AEs)
Time Frame: Up to 7 years
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.
Up to 7 years
Duration of concurrent chemoradiation therapy (CCRT) completion
Time Frame: From CCRT start date to CCRT end date
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.
From CCRT start date to CCRT end date
Number of cycles of cisplatin
Time Frame: 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
Will be summarized and compared using 2-sample Wilcoxon rank sum tests.
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
Allostatic load
Time Frame: Up to 2 years
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.
Up to 2 years
Tumor PD-L1 expression
Time Frame: At baseline
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.
At baseline
Circulating tumor deoxyribonucleic acid expression
Time Frame: At baseline and at 3 months post radiation therapy
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.
At baseline and at 3 months post radiation therapy
Radiation quality pre-treatment score
Time Frame: At time of radiation
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.
At time of radiation

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
T cell receptor (TCR) expression
Time Frame: Up to 7 years
Will be summarized by treatment arm, and its correlation with PFS/OS 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. Repeated measure methods (e.g., linear mixed model) will be used for exploration of TCR evolution/trajectory on treatment.
Up to 7 years
Tumor microenvironment
Time Frame: At baseline
The predictive values of each of the pre-treatment tumor microenvironment biomarkers for PFS and OS 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.
At baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Jyoti S Mayadev, NRG Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 5, 2025

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

July 11, 2025

First Submitted That Met QC Criteria

July 11, 2025

First Posted (Actual)

July 14, 2025

Study Record Updates

Last Update Posted (Actual)

June 17, 2026

Last Update Submitted That Met QC Criteria

June 16, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCI-2025-04695 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • U10CA180868 (U.S. NIH Grant/Contract)
  • NRG-GY037 (Other Identifier: CTEP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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