NCT07061977

Brief 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 (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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
336

participants targeted

Target at P50-P75 for phase_3

Timeline
57mo left

Started Nov 2025

Longer than P75 for phase_3

Geographic Reach
1 country

225 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress10%
Nov 2025Dec 2030

First Submitted

Initial submission to the registry

July 11, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 14, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

November 5, 2025

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

May 5, 2026

Status Verified

November 1, 2025

Enrollment Period

5.2 years

First QC Date

July 11, 2025

Last Update Submit

May 2, 2026

Conditions

Outcome Measures

Primary Outcomes (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.

    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)

  • Overall survival (OS)

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

  • Incidence of adverse events (AEs)

    Up to 7 years

  • Duration of concurrent chemoradiation therapy (CCRT) completion

    From CCRT start date to CCRT end date

  • Number of cycles of cisplatin

    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

    Up to 2 years

  • +3 more secondary outcomes

Other Outcomes (2)

  • T cell receptor (TCR) expression

    Up to 7 years

  • Tumor microenvironment

    At baseline

Study Arms (2)

Arm 1 (Standard care)

ACTIVE COMPARATOR

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: Biospecimen CollectionRadiation: BrachytherapyProcedure: Chest RadiographyDrug: CisplatinProcedure: Computed TomographyRadiation: External Beam Radiation TherapyRadiation: Intensity-Modulated Radiation TherapyProcedure: Magnetic Resonance ImagingBiological: PembrolizumabProcedure: Positron Emission Tomography

Arm 2 (induction and standard care)

EXPERIMENTAL

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.

Procedure: Biospecimen CollectionRadiation: BrachytherapyDrug: CarboplatinProcedure: Chest RadiographyDrug: CisplatinProcedure: Computed TomographyRadiation: External Beam Radiation TherapyRadiation: Intensity-Modulated Radiation TherapyProcedure: Magnetic Resonance ImagingDrug: PaclitaxelBiological: PembrolizumabProcedure: Positron Emission Tomography

Interventions

Undergo chest x-ray

Also known as: Chest X-ray
Arm 1 (Standard care)Arm 2 (induction and standard care)

Given IV

Also known as: Abiplatin, Blastolem, Briplatin, CDDP, Cis-diammine-dichloroplatinum, Cis-diamminedichloridoplatinum, Cis-diamminedichloro Platinum (II), Cis-diamminedichloroplatinum, Cis-dichloroammine Platinum (II), Cis-platinous Diamine Dichloride, Cis-platinum, Cis-platinum II, Cis-platinum II Diamine Dichloride, Cismaplat, Cisplatina, Cisplatinum, Cisplatyl, Citoplatino, Citosin, Cysplatyna, DDP, Lederplatin, Metaplatin, Neoplatin, Peyrone's Chloride, Peyrone's Salt, Placis, Plastistil, Platamine, Platiblastin, Platiblastin-S, Platinex, Platinol, Platinol- AQ, Platinol-AQ, Platinol-AQ VHA Plus, Platinoxan, Platinum, Platinum Diamminodichloride, Platiran, Platistin, Platosin
Arm 1 (Standard care)Arm 2 (induction and standard care)

Undergo CT scan

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, Diagnostic CAT Scan, Diagnostic CAT Scan Service Type, tomography
Arm 1 (Standard care)Arm 2 (induction and standard care)

Undergo IMRT

Also known as: IMRT, Intensity modulated radiation therapy (procedure), Intensity Modulated RT, Intensity-Modulated Radiotherapy, Radiation, Intensity-Modulated Radiotherapy
Arm 1 (Standard care)Arm 2 (induction and standard care)

Undergo MRI

Also known as: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI
Arm 1 (Standard care)Arm 2 (induction and standard care)

Undergo PET scan

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, PT
Arm 1 (Standard care)Arm 2 (induction and standard care)
BrachytherapyRADIATION

Undergo brachytherapy

Also known as: Brachytherapy, NOS, Internal Radiation, Internal Radiation Brachytherapy, Internal Radiation Therapy, Radiation Brachytherapy, Radiation, Internal
Arm 1 (Standard care)Arm 2 (induction and standard care)

Given IV

Also known as: Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino, Carboplatinum, Carbosin, Carbosol, Carbotec, CBDCA, Displata, Ercar, JM-8, JM8, Nealorin, Novoplatinum, Paraplatin, Paraplatin AQ, Paraplatine, Platinwas, Ribocarbo
Arm 2 (induction and standard care)

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection
Arm 1 (Standard care)Arm 2 (induction and standard care)

Undergo EBRT

Also known as: Definitive Radiation Therapy, EBRT, External Beam Radiation, External Beam Radiotherapy, External Beam Radiotherapy (conventional), External Beam RT, external radiation, External Radiation Therapy, external-beam radiation, Radiation, External Beam, Teleradiotherapy, Teletherapy, Teletherapy Radiation
Arm 1 (Standard care)Arm 2 (induction and standard care)

Given IV

Also known as: Anzatax, Asotax, Bristaxol, Praxel, Taxol, Taxol Konzentrat
Arm 2 (induction and standard care)
PembrolizumabBIOLOGICAL

Given IV

Also known as: BCD-201, GME 751, GME751, Keytruda, Lambrolizumab, MK 3475, MK-3475, MK3475, Pembrolizumab Biosimilar BCD-201, Pembrolizumab Biosimilar GME751, Pembrolizumab Biosimilar QL2107, Pembrolizumab Biosimilar RPH-075, Pembrolizumab Biosimilar SB27, QL2107, RPH 075, RPH-075, RPH075, SB 27, SB-27, SB27, SCH 900475, SCH-900475, SCH900475
Arm 1 (Standard care)Arm 2 (induction and standard care)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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:
  • +21 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (225)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, 35233, United States

NOT YET RECRUITING

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

RECRUITING

Kaiser Permanente-Bellflower

Bellflower, California, 90706, United States

RECRUITING

City of Hope Corona

Corona, California, 92882, United States

RECRUITING

City of Hope Comprehensive Cancer Center

Duarte, California, 91010, United States

RECRUITING

Kaiser Permanente South Bay

Harbor City, California, 90710, United States

RECRUITING

UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

Irvine, California, 92612, United States

RECRUITING

City of Hope at Irvine Lennar

Irvine, California, 92618, United States

RECRUITING

Kaiser Permanente-Irvine

Irvine, California, 92618, United States

RECRUITING

UC San Diego Moores Cancer Center

La Jolla, California, 92093, United States

RECRUITING

City of Hope Antelope Valley

Lancaster, California, 93534, United States

SUSPENDED

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, 90027, United States

RECRUITING

Kaiser Permanente West Los Angeles

Los Angeles, California, 90034, United States

RECRUITING

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, 92868, United States

RECRUITING

Kaiser Permanente - Panorama City

Panorama City, California, 91402, United States

RECRUITING

Kaiser Permanente-San Diego Zion

San Diego, California, 92120, United States

RECRUITING

Kaiser Permanente-San Marcos

San Marcos, California, 92078, United States

RECRUITING

City of Hope South Pasadena

South Pasadena, California, 91030, United States

RECRUITING

City of Hope Upland

Upland, California, 91786, United States

RECRUITING

Kaiser Permanente-Woodland Hills

Woodland Hills, California, 91367, United States

RECRUITING

UCHealth University of Colorado Hospital

Aurora, Colorado, 80045, United States

RECRUITING

UCHealth Highlands Ranch Hospital

Highlands Ranch, Colorado, 80129, United States

RECRUITING

Danbury Hospital

Danbury, Connecticut, 06810, United States

RECRUITING

Norwalk Hospital

Norwalk, Connecticut, 06856, United States

RECRUITING

Helen F Graham Cancer Center

Newark, Delaware, 19713, United States

RECRUITING

Medical Oncology Hematology Consultants PA

Newark, Delaware, 19713, United States

RECRUITING

UM Sylvester Comprehensive Cancer Center at Coral Gables

Coral Gables, Florida, 33146, United States

RECRUITING

UM Sylvester Comprehensive Cancer Center at Coral Springs

Coral Springs, Florida, 33065, United States

RECRUITING

UM Sylvester Comprehensive Cancer Center at Deerfield Beach

Deerfield Beach, Florida, 33442, United States

RECRUITING

UM Sylvester Comprehensive Cancer Center at Doral

Doral, Florida, 33166, United States

RECRUITING

Broward Health Medical Center

Fort Lauderdale, Florida, 33316, United States

RECRUITING

Memorial Regional Hospital/Joe DiMaggio Children's Hospital

Hollywood, Florida, 33021, United States

RECRUITING

UM Sylvester Comprehensive Cancer Center at Hollywood

Hollywood, Florida, 33021, United States

RECRUITING

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, 33136, United States

RECRUITING

UM Sylvester Comprehensive Cancer Center at Kendall

Miami, Florida, 33176, United States

RECRUITING

University of Miami Sylvester Comprehensive Cancer Center at Sole Mia

North Miami, Florida, 33181, United States

RECRUITING

Orlando Health Cancer Institute

Orlando, Florida, 32806, United States

RECRUITING

Memorial Hospital West

Pembroke Pines, Florida, 33028, United States

RECRUITING

UM Sylvester Comprehensive Cancer Center at Plantation

Plantation, Florida, 33324, United States

RECRUITING

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

RECRUITING

Piedmont Hospital

Atlanta, Georgia, 30309, United States

RECRUITING

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

RECRUITING

Emory Decatur Hospital

Decatur, Georgia, 30033, United States

RECRUITING

CTCA at Southeastern Regional Medical Center

Newnan, Georgia, 30265, United States

RECRUITING

Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho, 83706, United States

RECRUITING

Saint Luke's Cancer Institute - Boise

Boise, Idaho, 83712, United States

RECRUITING

Saint Alphonsus Cancer Care Center-Caldwell

Caldwell, Idaho, 83605, United States

RECRUITING

Kootenai Health - Coeur d'Alene

Coeur d'Alene, Idaho, 83814, United States

SUSPENDED

Saint Luke's Cancer Institute - Fruitland

Fruitland, Idaho, 83619, United States

RECRUITING

Saint Luke's Cancer Institute - Meridian

Meridian, Idaho, 83642, United States

RECRUITING

Saint Alphonsus Cancer Care Center-Nampa

Nampa, Idaho, 83687, United States

RECRUITING

Saint Luke's Cancer Institute - Nampa

Nampa, Idaho, 83687, United States

RECRUITING

Kootenai Clinic Cancer Services - Post Falls

Post Falls, Idaho, 83854, United States

SUSPENDED

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

Rush MD Anderson Cancer Center

Chicago, Illinois, 60612, United States

RECRUITING

Carle at The Riverfront

Danville, Illinois, 61832, United States

RECRUITING

Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, 62526, United States

RECRUITING

Decatur Memorial Hospital

Decatur, Illinois, 62526, United States

RECRUITING

Northwestern Medicine Cancer Center Kishwaukee

DeKalb, Illinois, 60115, United States

RECRUITING

Carle Physician Group-Effingham

Effingham, Illinois, 62401, United States

RECRUITING

Crossroads Cancer Center

Effingham, Illinois, 62401, United States

SUSPENDED

Northwestern Medicine Cancer Center Delnor

Geneva, Illinois, 60134, United States

RECRUITING

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, 61938, United States

RECRUITING

Loyola University Medical Center

Maywood, Illinois, 60153, United States

RECRUITING

Northwestern Medicine Oak Brook

Oak Brook, Illinois, 60523, United States

RECRUITING

Northwestern Medicine Orland Park

Orland Park, Illinois, 60462, United States

RECRUITING

UW Health Carbone Cancer Center Rockford

Rockford, Illinois, 61114, United States

RECRUITING

Southern Illinois University School of Medicine

Springfield, Illinois, 62702, United States

RECRUITING

Springfield Clinic

Springfield, Illinois, 62702, United States

RECRUITING

Springfield Memorial Hospital

Springfield, Illinois, 62781, United States

RECRUITING

Carle Cancer Center

Urbana, Illinois, 61801, United States

RECRUITING

Northwestern Medicine Cancer Center Warrenville

Warrenville, Illinois, 60555, United States

RECRUITING

Midwestern Regional Medical Center

Zion, Illinois, 60099, United States

RECRUITING

Parkview Regional Medical Center

Fort Wayne, Indiana, 46845, United States

RECRUITING

UI Health Care Mission Cancer and Blood - Ankeny Clinic

Ankeny, Iowa, 50023, United States

RECRUITING

Mercy Hospital

Cedar Rapids, Iowa, 52403, United States

RECRUITING

Oncology Associates at Mercy Medical Center

Cedar Rapids, Iowa, 52403, United States

RECRUITING

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

Clive, Iowa, 50325, United States

RECRUITING

Iowa Methodist Medical Center

Des Moines, Iowa, 50309, United States

RECRUITING

UI Health Care Mission Cancer and Blood - Des Moines Clinic

Des Moines, Iowa, 50309, United States

RECRUITING

Mercy Medical Center - Des Moines

Des Moines, Iowa, 50314, United States

RECRUITING

UI Health Care Mission Cancer and Blood - Laurel Clinic

Des Moines, Iowa, 50314, United States

RECRUITING

University of Iowa/Holden Comprehensive Cancer Center

Iowa City, Iowa, 52242, United States

RECRUITING

UI Health Care Mission Cancer and Blood - Waukee Clinic

Waukee, Iowa, 50263, United States

RECRUITING

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, 40536, United States

RECRUITING

West Jefferson Medical Center

Marrero, Louisiana, 70072, United States

RECRUITING

East Jefferson General Hospital

Metairie, Louisiana, 70006, United States

RECRUITING

LSU Healthcare Network / Metairie Multi-Specialty Clinic

Metairie, Louisiana, 70006, United States

RECRUITING

University Medical Center New Orleans

New Orleans, Louisiana, 70112, United States

RECRUITING

Ochsner Baptist Medical Center

New Orleans, Louisiana, 70115, United States

RECRUITING

Ochsner Medical Center Jefferson

New Orleans, Louisiana, 70121, United States

RECRUITING

MaineHealth Coastal Cancer Treatment Center

Bath, Maine, 04530, United States

RECRUITING

MaineHealth Maine Medical Center - Portland

Portland, Maine, 04102, United States

RECRUITING

MaineHealth Cancer Care Center of York County

Sanford, Maine, 04073, United States

RECRUITING

MaineHealth Maine Medical Center- Scarborough

Scarborough, Maine, 04074, United States

RECRUITING

Bronson Methodist Hospital

Kalamazoo, Michigan, 49007, United States

RECRUITING

West Michigan Cancer Center

Kalamazoo, Michigan, 49007, United States

RECRUITING

Trinity Health Saint Joseph Mercy Oakland Hospital

Pontiac, Michigan, 48341, United States

SUSPENDED

Freeman Health System

Joplin, Missouri, 64804, United States

RECRUITING

Phelps Health Delbert Day Cancer Institute

Rolla, Missouri, 65401, United States

RECRUITING

Mercy Hospital Springfield

Springfield, Missouri, 65804, United States

RECRUITING

Mercy Hospital Saint Louis

St Louis, Missouri, 63141, United States

RECRUITING

Billings Clinic Cancer Center

Billings, Montana, 59101, United States

RECRUITING

Community Medical Center

Missoula, Montana, 59804, United States

SUSPENDED

Nebraska Methodist Hospital

Omaha, Nebraska, 68114, United States

RECRUITING

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

RECRUITING

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, 07920, United States

RECRUITING

Cooper Hospital University Medical Center

Camden, New Jersey, 08103, United States

RECRUITING

Jersey City Medical Center

Jersey City, New Jersey, 07302, United States

RECRUITING

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, 07748, United States

RECRUITING

Memorial Sloan Kettering Bergen

Montvale, New Jersey, 07645, United States

RECRUITING

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

RECRUITING

Rutgers New Jersey Medical School

Newark, New Jersey, 07101, United States

RECRUITING

Capital Health Medical Center-Hopewell

Pennington, New Jersey, 08534, United States

RECRUITING

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87106, United States

RECRUITING

Northwell Health Imbert Cancer Center

Bay Shore, New York, 11706, United States

RECRUITING

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

RECRUITING

Memorial Sloan Kettering Commack

Commack, New York, 11725, United States

RECRUITING

Northwell Health Physician Partners at Flushing

Flushing, New York, 11354, United States

RECRUITING

Northwell Health Physicians Partners Radiation Medicine at Queens

Forest Hills, New York, 11375, United States

RECRUITING

Northwell Health Cancer Institute at Huntington

Greenlawn, New York, 11740, United States

RECRUITING

Memorial Sloan Kettering Westchester

Harrison, New York, 10604, United States

RECRUITING

Northwell Health/Center for Advanced Medicine

Lake Success, New York, 11042, United States

RECRUITING

NYU Langone Hospital - Long Island

Mineola, New York, 11501, United States

RECRUITING

Mount Sinai Chelsea

New York, New York, 10011, United States

RECRUITING

Laura and Isaac Perlmutter Cancer Center at NYU Langone

New York, New York, 10016, United States

RECRUITING

Mount Sinai Hospital

New York, New York, 10029, United States

RECRUITING

Manhattan Eye Ear and Throat Hospital

New York, New York, 10065, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

Lenox Hill Hospital

New York, New York, 10075, United States

RECRUITING

Upstate Cancer Center Radiation Oncology at Oswego

Oswego, New York, 13126, United States

RECRUITING

Queens Cancer Center

Rego Park, New York, 11374, United States

RECRUITING

Stony Brook University Medical Center

Stony Brook, New York, 11794, United States

RECRUITING

State University of New York Upstate Medical University

Syracuse, New York, 13210, United States

RECRUITING

Upstate Cancer Center at Hill Radiation Oncology

Syracuse, New York, 13210, United States

RECRUITING

Montefiore Medical Center-Einstein Campus

The Bronx, New York, 10461, United States

RECRUITING

Montefiore Medical Center-Weiler Hospital

The Bronx, New York, 10461, United States

RECRUITING

Montefiore Medical Center - Moses Campus

The Bronx, New York, 10467, United States

RECRUITING

Memorial Sloan Kettering Nassau

Uniondale, New York, 11553, United States

RECRUITING

Upstate Cancer Center at Verona

Verona, New York, 13478, United States

RECRUITING

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Carolinas Medical Center/Levine Cancer Institute

Charlotte, North Carolina, 28203, United States

RECRUITING

Atrium Health Cabarrus/LCI-Concord

Concord, North Carolina, 28025, United States

RECRUITING

Duke University Medical Center

Durham, North Carolina, 27710, United States

RECRUITING

Levine Cancer Institute-Gaston

Gastonia, North Carolina, 28054, United States

RECRUITING

Duke Women's Cancer Care Raleigh

Raleigh, North Carolina, 27607, United States

RECRUITING

UHHS-Chagrin Highlands Medical Center

Beachwood, Ohio, 44122, United States

RECRUITING

Aultman Health Foundation

Canton, Ohio, 44710, United States

RECRUITING

Miami Valley Hospital South

Centerville, Ohio, 45459, United States

RECRUITING

Geauga Hospital

Chardon, Ohio, 44024, United States

RECRUITING

University of Cincinnati Cancer Center-UC Medical Center

Cincinnati, Ohio, 45219, United States

RECRUITING

Case Western Reserve University

Cleveland, Ohio, 44106, United States

RECRUITING

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

RECRUITING

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

RECRUITING

Miami Valley Hospital

Dayton, Ohio, 45409, United States

RECRUITING

Miami Valley Hospital North

Dayton, Ohio, 45415, United States

RECRUITING

Atrium Medical Center-Middletown Regional Hospital

Franklin, Ohio, 45005-1066, United States

RECRUITING

Miami Valley Cancer Care and Infusion

Greenville, Ohio, 45331, United States

RECRUITING

Hillcrest Hospital Cancer Center

Mayfield Heights, Ohio, 44124, United States

RECRUITING

UH Seidman Cancer Center at Lake Health Mentor Campus

Mentor, Ohio, 44060, United States

RECRUITING

University Hospitals Parma Medical Center

Parma, Ohio, 44129, United States

RECRUITING

ProMedica Flower Hospital

Sylvania, Ohio, 43560, United States

RECRUITING

Upper Valley Medical Center

Troy, Ohio, 45373, United States

RECRUITING

University of Cincinnati Cancer Center-West Chester

West Chester, Ohio, 45069, United States

RECRUITING

UH Seidman Cancer Center at Saint John Medical Center

Westlake, Ohio, 44145, United States

RECRUITING

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

RECRUITING

Oklahoma Cancer Specialists and Research Institute-Tulsa

Tulsa, Oklahoma, 74146, United States

RECRUITING

Clackamas Radiation Oncology Center

Clackamas, Oregon, 97015, United States

RECRUITING

Providence Newberg Medical Center

Newberg, Oregon, 97132, United States

RECRUITING

Providence Willamette Falls Medical Center

Oregon City, Oregon, 97045, United States

RECRUITING

Legacy Good Samaritan Hospital and Medical Center

Portland, Oregon, 97210, United States

RECRUITING

Providence Portland Medical Center

Portland, Oregon, 97213, United States

RECRUITING

Providence Saint Vincent Medical Center

Portland, Oregon, 97225, United States

RECRUITING

Kaiser Permanente Northwest

Portland, Oregon, 97227, United States

RECRUITING

Oregon Health and Science University

Portland, Oregon, 97239, United States

RECRUITING

Legacy Meridian Park Hospital

Tualatin, Oregon, 97062, United States

RECRUITING

Lehigh Valley Hospital-Cedar Crest

Allentown, Pennsylvania, 18103, United States

RECRUITING

Saint Luke's Cancer Center - Allentown

Allentown, Pennsylvania, 18104, United States

RECRUITING

Saint Luke's University Hospital-Bethlehem Campus

Bethlehem, Pennsylvania, 18015, United States

RECRUITING

Lehigh Valley Hospital - Muhlenberg

Bethlehem, Pennsylvania, 18017, United States

RECRUITING

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

RECRUITING

Pocono Medical Center

East Stroudsburg, Pennsylvania, 18301, United States

RECRUITING

Saint Luke's Hospital-Anderson Campus

Easton, Pennsylvania, 18045, United States

RECRUITING

UPMC Hillman Cancer Center Erie

Erie, Pennsylvania, 16505, United States

RECRUITING

UPMC Pinnacle Cancer Center/Community Osteopathic Campus

Harrisburg, Pennsylvania, 17109, United States

RECRUITING

Penn State Milton S Hershey Medical Center

Hershey, Pennsylvania, 17033-0850, United States

RECRUITING

IRMC Cancer Center

Indiana, Pennsylvania, 15701, United States

RECRUITING

Geisinger Medical Oncology-Lewisburg

Lewisburg, Pennsylvania, 17837, United States

RECRUITING

UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion

Mechanicsburg, Pennsylvania, 17050, United States

RECRUITING

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

UPMC-Magee Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

UPMC-Passavant Hospital

Pittsburgh, Pennsylvania, 15237, United States

RECRUITING

Saint Luke's Hospital - Upper Bucks Campus

Quakertown, Pennsylvania, 18951, United States

RECRUITING

UPMC Cancer Center at UPMC Northwest

Seneca, Pennsylvania, 16346, United States

RECRUITING

Saint Luke's Hospital - Monroe Campus

Stroudsburg, Pennsylvania, 18360, United States

RECRUITING

Geisinger Wyoming Valley/Henry Cancer Center

Wilkes-Barre, Pennsylvania, 18711, United States

RECRUITING

Asplundh Cancer Pavilion

Willow Grove, Pennsylvania, 19090, United States

RECRUITING

Women and Infants Hospital

Providence, Rhode Island, 02905, United States

RECRUITING

Gibbs Cancer Center-Gaffney

Gaffney, South Carolina, 29341, United States

RECRUITING

Gibbs Cancer Center-Pelham

Greer, South Carolina, 29651, United States

RECRUITING

Spartanburg Medical Center

Spartanburg, South Carolina, 29303, United States

RECRUITING

Avera Cancer Institute

Sioux Falls, South Dakota, 57105, United States

RECRUITING

Parkland Memorial Hospital

Dallas, Texas, 75235, United States

RECRUITING

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, 75390, United States

RECRUITING

UT Southwestern/Simmons Cancer Center-Fort Worth

Fort Worth, Texas, 76104, United States

RECRUITING

UT Southwestern Clinical Center at Richardson/Plano

Richardson, Texas, 75080, United States

RECRUITING

Farmington Health Center

Farmington, Utah, 84025, United States

RECRUITING

University of Utah Sugarhouse Health Center

Salt Lake City, Utah, 84106, United States

RECRUITING

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, 84112, United States

RECRUITING

Inova Alexandria Hospital

Alexandria, Virginia, 22304, United States

RECRUITING

University of Virginia Cancer Center

Charlottesville, Virginia, 22908, United States

RECRUITING

Inova Schar Cancer Institute

Fairfax, Virginia, 22031, United States

RECRUITING

Inova Fair Oaks Hospital

Fairfax, Virginia, 22033, United States

RECRUITING

Inova Fairfax Hospital

Falls Church, Virginia, 22042, United States

RECRUITING

Inova Loudoun Hospital

Leesburg, Virginia, 20176, United States

RECRUITING

VCU Massey Comprehensive Cancer Center

Richmond, Virginia, 23298, United States

RECRUITING

Legacy Salmon Creek Hospital

Vancouver, Washington, 98686, United States

RECRUITING

West Virginia University Healthcare

Morgantown, West Virginia, 26506, United States

RECRUITING

Camden Clark Medical Center

Parkersburg, West Virginia, 26101, United States

RECRUITING

University of Wisconsin Carbone Cancer Center - Eastpark Medical Center

Madison, Wisconsin, 53718, United States

RECRUITING

University of Wisconsin Carbone Cancer Center - University Hospital

Madison, Wisconsin, 53792, United States

RECRUITING

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

ProHealth D N Greenwald Center

Mukwonago, Wisconsin, 53149, United States

RECRUITING

ProHealth Oconomowoc Memorial Hospital

Oconomowoc, Wisconsin, 53066, United States

RECRUITING

UW Cancer Center at ProHealth Care

Waukesha, Wisconsin, 53188, United States

RECRUITING

MeSH Terms

Interventions

Specimen HandlingBrachytherapyCarboplatinX-RaysCisplatin1,2-diaminocyclohexaneplatinum II citratePlatinumCongresses as TopicRadiationRadiotherapy, Intensity-ModulatedMagnetic Resonance SpectroscopyPaclitaxelTaxespembrolizumab

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesRadiotherapyTherapeuticsCoordination ComplexesOrganic ChemicalsElectromagnetic RadiationElectromagnetic PhenomenaMagnetic PhenomenaPhysical PhenomenaRadiation, IonizingChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsMetals, HeavyElementsTransition ElementsMetalsOrganizationsHealth Care Economics and OrganizationsRadiotherapy, ConformalRadiotherapy, Computer-AssistedSpectrum AnalysisChemistry Techniques, AnalyticalTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsDiterpenesTerpenesEconomics

Study Officials

  • Jyoti S Mayadev

    NRG Oncology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2025

First Posted

July 14, 2025

Study Start

November 5, 2025

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Last Updated

May 5, 2026

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share

NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.

More information

Locations