Recruiting
Phase 3

Cetuximab & Pembrolizumab

Sponsor:

National Cancer Institute (NCI)

Code:

NCT06589804

Conditions

Metastatic Head and Neck Squamous Cell Carcinoma

Metastatic Hypopharyngeal Squamous Cell Carcinoma

Metastatic Laryngeal Squamous Cell Carcinoma

Metastatic Oral Cavity Squamous Cell Carcinoma

Metastatic Oropharyngeal Squamous Cell Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biospecimen Collection

Cetuximab

Computed Tomography

Magnetic Resonance Imaging

Pembrolizumab

Study Details

Brief summary:

This phase III trial compares the effect of adding cetuximab to pembrolizumab versus pembrolizumab alone in treating patients with head and neck squamous cell carcinoma (HNSCC) that has come back after a period of improvement (recurrent) and/or that has spread from where it first started (primary site) to other places in the body (metastatic). Cetuximab is in a class of medications called monoclonal antibodies. It binds to a protein called EGFR, which is found on some types of tumor cells. This may help keep tumor cells from growing. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Giving cetuximab and pembrolizumab together may be more effective at treating patients with recurrent and/or metastatic HNSCC than pembrolizumab alone.

Conditions

Metastatic Head and Neck Squamous Cell Carcinoma

Metastatic Hypopharyngeal Squamous Cell Carcinoma

Metastatic Laryngeal Squamous Cell Carcinoma

Metastatic Oral Cavity Squamous Cell Carcinoma

Metastatic Oropharyngeal Squamous Cell Carcinoma

Study ID

NCT06589804

Start date

Mar 27, 2025

Status verified date

Mar, 2026

Completion date

Nov 30, 2029

Anticipated

Primary completion date

Nov 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Histologically confirmed diagnosis head and neck squamous cell carcinomas (HNSCC).
  • Previously untreated for recurrent and/or metastatic disease incurable by local therapies.
  • Primary tumor location of oral cavity, oropharynx, larynx, or hypopharynx.

  • Note: Other primary tumor sites of HNSCC, including nasopharynx primary tumor are not eligible. Unknown primary tumors may be eligible and can be enrolled at the discretion of the treatment team with approval by the study chair.
  • Measurable disease.
  • Must have platinum-refractory disease defined as disease progression during or ≤ 29 weeks after completion of definitive therapy (chemoradiation therapy) or adjuvant (post-operative) therapy.
  • Patient must have a combined positive score PD-L1 positive (CPS >/= 1) tumor.
  • Any radiation therapy must be completed >= 10 days prior to registration.
  • Patients should not have received any prior treatment in the recurrent or metastatic setting.
  • Prior therapy with neoadjuvant or induction anti PD-1/PD-L1 monoclonal antibody or cetuximab in the curative setting is allowed if last treatment dose was >= 26 weeks prior to registration without evidence of disease progression during that treatment period.
  • Patient has not received a live vaccine within 30 days prior to registration.
  • Patient does not have a history of any contraindication or has a severe hypersensitivity to any component of pembrolizumab or cetuximab (≥ grade 3).
  • Patient has not received chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to registration.
  • Patient with oropharyngeal cancer only must have negative results from testing of human papillomavirus (HPV) status defined as p16 immunohistochemistry (IHC) and/or HPV in situ hybridization (ISH).

  • Note: A Clinical Laboratory Improvement Act (CLIA) certified circulating tumor HPV deoxyribonucleic acid (ctHPVDNA) assay can be used if tissue sample is not available.
  • Age ≥ 18 years.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
  • Absolute neutrophil count (ANC) ≥ 1,500/mm\^3.
  • Platelet count ≥ 100,000/mm\^3.
  • Hemoglobin (Hgb) ≥ 9 g/dL (if < 9 g/dL, then transfusions are acceptable to increase hemoglobin above 9 g/dL).
  • Creatinine ≤ 1.5 x upper limit of normal (ULN) OR calculated (calc.) creatinine clearance ≥ 30 mL/min using the Cockcroft-Gault formula for participant with creatinine levels > 1.5 x institutional ULN.
  • Total bilirubin ≤ 1.5 x ULN OR direct bilirubin < ULN for participant with total bilirubin > 1.5 x institutional ULN.
  • Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase \[SGPT\]) ≤ 3.0 x ULN unless liver metastases are present in which case < 5.0 x ULN.
  • Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic, and teratogenic effects.

  • Therefore, for women of childbearing potential only, a negative pregnancy test done ≤ 7 days prior to registration is required.
  • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen should be included.
  • For treated/stable brain metastases: Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression.

  • Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy.
  • HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible for this trial.
  • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
  • Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
  • Patients with 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.
  • Patients does not have a history of active myocarditis.
  • Patients does not have a history of any form of pneumonitis or diffuse idiopathic or immune mediated interstitial pulmonary disease.
  • Patient does not have a history of solid organ transplantation.

Study Design

Enrollment

158 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Arm 1 (pembrolizumab)

Patients receive pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 42 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, PET/CT or MRI throughout the trial and optionally undergo blood sample collection on study and at disease progression or end of treatment.

experimental: Arm 2 (cetuximab, pembrolizumab)

Patients receive cetuximab IV over 120 minutes on day -14 prior to cycle 1 and then on days 1, 15 and 29 of each cycle and pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 42 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, PET/CT or MRI throughout the trial and optionally undergo blood sample collection on study and at disease progression or end of treatment.

Interventions

Biospecimen Collection

Undergo blood sample collection

Cetuximab

Given IV

Computed Tomography

Undergo CT or PET/CT

Magnetic Resonance Imaging

Undergo MRI

Pembrolizumab

Given IV

Positron Emission Tomography

Undergo PET/CT

Primary outcome measure

  • Overall survival (OS) [ Time Frame: Time from randomization to death from any cause, assessed up to 5 years ]

Central Contacts and Locations

Locations

University of Arkansas for Medical Sciences

Recruiting

Little Rock, Arkansas, United States, 72205

Contacts

Site Public Contact

501-686-8274

Principal Investigator:

Omar T. Atiq

VA Palo Alto Health Care System

Recruiting

Palo Alto, California, United States, 94304

Contacts

Site Public Contact

800-455-0057

Principal Investigator:

Harlan A. Pinto

UCHealth Memorial Hospital Central

Recruiting

Colorado Springs, Colorado, United States, 80909

Contacts

Site Public Contact

719-365-2406

Principal Investigator:

Steven R. Schuster

Memorial Hospital North

Recruiting

Colorado Springs, Colorado, United States, 80920

Contacts

Site Public Contact

719-364-6700

Principal Investigator:

Steven R. Schuster

Poudre Valley Hospital

Recruiting

Fort Collins, Colorado, United States, 80524

Contacts

Site Public Contact

970-297-6150

Principal Investigator:

Steven R. Schuster

Cancer Care and Hematology-Fort Collins

Recruiting

Fort Collins, Colorado, United States, 80528

Contacts

Principal Investigator:

Steven R. Schuster

Lutheran Hospital - Cancer Centers of Colorado

Recruiting

Golden, Colorado, United States, 80401

Contacts

Site Public Contact

peaksresearch@imail.org

Principal Investigator:

Karng S. Log

UCHealth Greeley Hospital

Recruiting

Greeley, Colorado, United States, 80631

Contacts

Principal Investigator:

Steven R. Schuster

Medical Center of the Rockies

Recruiting

Loveland, Colorado, United States, 80538

Contacts

Site Public Contact

970-203-7083

Principal Investigator:

Steven R. Schuster

Mount Sinai Medical Center

Recruiting

Miami Beach, Florida, United States, 33140

Contacts

Principal Investigator:

Mike Cusnir

Saint Alphonsus Cancer Care Center-Boise

Recruiting

Boise, Idaho, United States, 83706

Contacts

Principal Investigator:

Christopher M. Reynolds

Saint Alphonsus Cancer Care Center-Caldwell

Recruiting

Caldwell, Idaho, United States, 83605

Contacts

Principal Investigator:

Christopher M. Reynolds

Kootenai Health - Coeur d'Alene

Recruiting

Coeur d'Alene, Idaho, United States, 83814

Contacts

Principal Investigator:

John M. Schallenkamp

Saint Alphonsus Cancer Care Center-Nampa

Recruiting

Nampa, Idaho, United States, 83687

Contacts

Principal Investigator:

Christopher M. Reynolds

Kootenai Clinic Cancer Services - Post Falls

Recruiting

Post Falls, Idaho, United States, 83854

Contacts

Principal Investigator:

John M. Schallenkamp

Kootenai Clinic Cancer Services - Sandpoint

Recruiting

Sandpoint, Idaho, United States, 83864

Contacts

Principal Investigator:

John M. Schallenkamp

Advocate Good Shepherd Hospital

Recruiting

Barrington, Illinois, United States, 60010

Contacts

Site Public Contact

847-842-4847

Principal Investigator:

Peter J. Polewski

University of Chicago Comprehensive Cancer Center

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Principal Investigator:

Ari J. Rosenberg

Advocate Illinois Masonic Medical Center

Recruiting

Chicago, Illinois, United States, 60657

Contacts

Site Public Contact

773-296-5360

Principal Investigator:

Peter J. Polewski

AMG Crystal Lake - Oncology

Recruiting

Crystal Lake, Illinois, United States, 60014

Contacts

Principal Investigator:

Peter J. Polewski

Carle at The Riverfront

Recruiting

Danville, Illinois, United States, 61832

Contacts

Principal Investigator:

Suparna Mantha

Cancer Care Specialists of Illinois - Decatur

Recruiting

Decatur, Illinois, United States, 62526

Contacts

Principal Investigator:

Bryan A. Faller

Decatur Memorial Hospital

Recruiting

Decatur, Illinois, United States, 62526

Contacts

Principal Investigator:

Bryan A. Faller

Advocate Good Samaritan Hospital

Recruiting

Downers Grove, Illinois, United States, 60515

Contacts

Principal Investigator:

Peter J. Polewski

Carle Physician Group-Effingham

Recruiting

Effingham, Illinois, United States, 62401

Contacts

Principal Investigator:

Suparna Mantha

Crossroads Cancer Center

Recruiting

Effingham, Illinois, United States, 62401

Contacts

Principal Investigator:

Bryan A. Faller

Advocate Sherman Hospital

Recruiting

Elgin, Illinois, United States, 60123

Contacts

Site Public Contact

847-429-2907

Principal Investigator:

Peter J. Polewski

Advocate South Suburban Hospital

Recruiting

Hazel Crest, Illinois, United States, 60429

Contacts

Site Public Contact

708-799-9995

Principal Investigator:

Peter J. Polewski

AMG Libertyville - Oncology

Recruiting

Libertyville, Illinois, United States, 60048

Contacts

Principal Investigator:

Peter J. Polewski

Condell Memorial Hospital

Recruiting

Libertyville, Illinois, United States, 60048

Contacts

Principal Investigator:

Peter J. Polewski

Illinois CancerCare-Macomb

Recruiting

Macomb, Illinois, United States, 61455

Contacts

Principal Investigator:

Bryan A. Faller

Carle Physician Group-Mattoon/Charleston

Recruiting

Mattoon, Illinois, United States, 61938

Contacts

Principal Investigator:

Suparna Mantha

UC Comprehensive Cancer Center at Silver Cross

Recruiting

New Lenox, Illinois, United States, 60451

Contacts

Principal Investigator:

Ari J. Rosenberg

Carle BroMenn Medical Center

Recruiting

Normal, Illinois, United States, 61761

Contacts

Principal Investigator:

Suparna Mantha

Carle Cancer Institute Normal

Recruiting

Normal, Illinois, United States, 61761

Contacts

Principal Investigator:

Suparna Mantha

Cancer Care Center of O'Fallon

Recruiting

O'Fallon, Illinois, United States, 62269

Contacts

Principal Investigator:

Bryan A. Faller

Advocate Christ Medical Center

Recruiting

Oak Lawn, Illinois, United States, 60453-2699

Contacts

Site Public Contact

800-323-8622

Principal Investigator:

Peter J. Polewski

Advocate Outpatient Center - Oak Lawn

Recruiting

Oak Lawn, Illinois, United States, 60453

Contacts

Site Public Contact

ncorp@aah.org

Principal Investigator:

Peter J. Polewski

University of Chicago Medicine-Orland Park

Recruiting

Orland Park, Illinois, United States, 60462

Contacts

Principal Investigator:

Ari J. Rosenberg

Advocate High Tech Medical Park

Recruiting

Palos Heights, Illinois, United States, 60463

Contacts

Site Public Contact

ncorp@aah.org

Principal Investigator:

Peter J. Polewski

Advocate Lutheran General Hospital

Recruiting

Park Ridge, Illinois, United States, 60068

Contacts

Site Public Contact

847-384-3621

Principal Investigator:

Peter J. Polewski

Illinois CancerCare-Peoria

Recruiting

Peoria, Illinois, United States, 61615

Contacts

Principal Investigator:

Bryan A. Faller

UW Health Carbone Cancer Center Rockford

Recruiting

Rockford, Illinois, United States, 61114

Contacts

Principal Investigator:

Fahrettin Covut

Memorial Hospital East

Recruiting

Shiloh, Illinois, United States, 62269

Contacts

Principal Investigator:

Christine Auberle

Southern Illinois University School of Medicine

Recruiting

Springfield, Illinois, United States, 62702

Contacts

Site Public Contact

217-545-7929

Principal Investigator:

Bryan A. Faller

Springfield Clinic

Recruiting

Springfield, Illinois, United States, 62702

Contacts

Site Public Contact

800-444-7541

Principal Investigator:

Bryan A. Faller

Springfield Memorial Hospital

Recruiting

Springfield, Illinois, United States, 62781

Contacts

Principal Investigator:

Bryan A. Faller

Carle Cancer Center

Recruiting

Urbana, Illinois, United States, 61801

Contacts

Principal Investigator:

Suparna Mantha

UChicago Medicine Northwest Indiana

Recruiting

Crown Point, Indiana, United States, 46307

Contacts

Principal Investigator:

Ari J. Rosenberg

Mary Greeley Medical Center

Recruiting

Ames, Iowa, United States, 50010

Contacts

Site Public Contact

515-956-4132

Principal Investigator:

Joseph J. Merchant

McFarland Clinic - Ames

Recruiting

Ames, Iowa, United States, 50010

Contacts

Principal Investigator:

Joseph J. Merchant

Mercy Hospital

Recruiting

Cedar Rapids, Iowa, United States, 52403

Contacts

Site Public Contact

319-365-4673

Principal Investigator:

Deborah W. Wilbur

Oncology Associates at Mercy Medical Center

Recruiting

Cedar Rapids, Iowa, United States, 52403

Contacts

Site Public Contact

319-363-2690

Principal Investigator:

Deborah W. Wilbur

McFarland Clinic - Trinity Cancer Center

Recruiting

Fort Dodge, Iowa, United States, 50501

Contacts

Site Public Contact

515-956-4132

Principal Investigator:

Joseph J. Merchant

McFarland Clinic - Marshalltown

Recruiting

Marshalltown, Iowa, United States, 50158

Contacts

Site Public Contact

515-956-4132

Principal Investigator:

Joseph J. Merchant

HaysMed

Recruiting

Hays, Kansas, United States, 67601

Contacts

Site Public Contact

785-623-5774

Principal Investigator:

Prakash C. Neupane

University of Kansas Cancer Center

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Principal Investigator:

Prakash C. Neupane

Lawrence Memorial Hospital

Recruiting

Lawrence, Kansas, United States, 66044

Contacts

Principal Investigator:

Prakash C. Neupane

The University of Kansas Cancer Center - Olathe

Recruiting

Olathe, Kansas, United States, 66061

Contacts

Principal Investigator:

Prakash C. Neupane

University of Kansas Cancer Center-Overland Park

Recruiting

Overland Park, Kansas, United States, 66210

Contacts

Principal Investigator:

Prakash C. Neupane

University of Kansas Hospital-Indian Creek Campus

Recruiting

Overland Park, Kansas, United States, 66211

Contacts

Principal Investigator:

Prakash C. Neupane

Salina Regional Health Center

Recruiting

Salina, Kansas, United States, 67401

Contacts

Principal Investigator:

Prakash C. Neupane

University of Kansas Health System Saint Francis Campus

Recruiting

Topeka, Kansas, United States, 66606

Contacts

Site Public Contact

785-295-8000

Principal Investigator:

Prakash C. Neupane

University of Kansas Hospital-Westwood Cancer Center

Recruiting

Westwood, Kansas, United States, 66205

Contacts

Principal Investigator:

Prakash C. Neupane

University of Maryland/Greenebaum Cancer Center

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Site Public Contact

800-888-8823

Principal Investigator:

Ranee Mehra

Boston Medical Center

Recruiting

Boston, Massachusetts, United States, 02118

Contacts

Site Public Contact

617-638-8265

Principal Investigator:

Peter C. Everett

Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Recruiting

Ann Arbor, Michigan, United States, 48106

Contacts

Principal Investigator:

Christopher M. Reynolds

Trinity Health IHA Medical Group Hematology Oncology - Brighton

Recruiting

Brighton, Michigan, United States, 48114

Contacts

Principal Investigator:

Christopher M. Reynolds

Trinity Health IHA Medical Group Hematology Oncology - Canton

Recruiting

Canton, Michigan, United States, 48188

Contacts

Principal Investigator:

Christopher M. Reynolds

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

Recruiting

Chelsea, Michigan, United States, 48118

Contacts

Principal Investigator:

Christopher M. Reynolds

Cancer Hematology Centers - Flint

Recruiting

Flint, Michigan, United States, 48503

Contacts

Principal Investigator:

Christopher M. Reynolds

Genesys Hurley Cancer Institute

Recruiting

Flint, Michigan, United States, 48503

Contacts

Principal Investigator:

Christopher M. Reynolds

Hurley Medical Center

Recruiting

Flint, Michigan, United States, 48503

Contacts

Principal Investigator:

Christopher M. Reynolds

University of Michigan Health - Sparrow Lansing

Recruiting

Lansing, Michigan, United States, 48912

Contacts

Principal Investigator:

Christopher M. Reynolds

Trinity Health Saint Mary Mercy Livonia Hospital

Recruiting

Livonia, Michigan, United States, 48154

Contacts

Principal Investigator:

Christopher M. Reynolds

Trinity Health Saint Joseph Mercy Oakland Hospital

Recruiting

Pontiac, Michigan, United States, 48341

Contacts

Principal Investigator:

Christopher M. Reynolds

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

Recruiting

Ypsilanti, Michigan, United States, 48197

Contacts

Principal Investigator:

Christopher M. Reynolds

Sanford Joe Lueken Cancer Center

Recruiting

Bemidji, Minnesota, United States, 56601

Contacts

Principal Investigator:

Daniel Almquist

Minnesota Oncology - Burnsville

Recruiting

Burnsville, Minnesota, United States, 55337

Contacts

Principal Investigator:

Yan Ji

Mercy Hospital

Recruiting

Coon Rapids, Minnesota, United States, 55433

Contacts

Principal Investigator:

Yan Ji

Fairview Southdale Hospital

Recruiting

Edina, Minnesota, United States, 55435

Contacts

Principal Investigator:

Yan Ji

Saint John's Hospital - Healtheast

Recruiting

Maplewood, Minnesota, United States, 55109

Contacts

Principal Investigator:

Yan Ji

Abbott-Northwestern Hospital

Recruiting

Minneapolis, Minnesota, United States, 55407

Contacts

Principal Investigator:

Yan Ji

Hennepin County Medical Center

Recruiting

Minneapolis, Minnesota, United States, 55415

Contacts

Principal Investigator:

Yan Ji

Park Nicollet Clinic - Saint Louis Park

Recruiting

Saint Louis Park, Minnesota, United States, 55416

Contacts

Principal Investigator:

Yan Ji

Regions Hospital

Recruiting

Saint Paul, Minnesota, United States, 55101

Contacts

Principal Investigator:

Yan Ji

United Hospital

Recruiting

Saint Paul, Minnesota, United States, 55102

Contacts

Principal Investigator:

Yan Ji

Saint Francis Medical Center

Recruiting

Cape Girardeau, Missouri, United States, 63703

Contacts

Site Public Contact

573-334-2230sfmc@sfmc.net

Principal Investigator:

Bryan A. Faller

Siteman Cancer Center at Saint Peters Hospital

Recruiting

City of Saint Peters, Missouri, United States, 63376

Contacts

Principal Investigator:

Christine Auberle

Siteman Cancer Center at West County Hospital

Recruiting

Creve Coeur, Missouri, United States, 63141

Contacts

Principal Investigator:

Christine Auberle

University Health Truman Medical Center

Recruiting

Kansas City, Missouri, United States, 64108

Contacts

Site Public Contact

816-404-4375

Principal Investigator:

Prakash C. Neupane

University of Kansas Cancer Center - Briarcliff

Recruiting

Kansas City, Missouri, United States, 64116

Contacts

Site Public Contact

913-588-3671

Principal Investigator:

Prakash C. Neupane

University of Kansas Cancer Center - North

Recruiting

Kansas City, Missouri, United States, 64154

Contacts

Principal Investigator:

Prakash C. Neupane

University of Kansas Cancer Center - Lee's Summit

Recruiting

Lee's Summit, Missouri, United States, 64064

Contacts

Principal Investigator:

Prakash C. Neupane

Liberty Hospital

Recruiting

Liberty, Missouri, United States, 64068

Contacts

Site Public Contact

913-588-1569

Principal Investigator:

Prakash C. Neupane

Lake Regional Hospital

Recruiting

Osage Beach, Missouri, United States, 65065

Contacts

Principal Investigator:

Jay W. Carlson

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Principal Investigator:

Christine Auberle

Mercy Hospital South

Recruiting

St Louis, Missouri, United States, 63128

Contacts

Principal Investigator:

Jay W. Carlson

Siteman Cancer Center-South County

Recruiting

St Louis, Missouri, United States, 63129

Contacts

Principal Investigator:

Christine Auberle

Siteman Cancer Center at Christian Hospital

Recruiting

St Louis, Missouri, United States, 63136

Contacts

Principal Investigator:

Christine Auberle

Community Hospital of Anaconda

Recruiting

Anaconda, Montana, United States, 59711

Contacts

Principal Investigator:

John M. Schallenkamp

Billings Clinic Cancer Center

Recruiting

Billings, Montana, United States, 59101

Contacts

Principal Investigator:

John M. Schallenkamp

Bozeman Health Deaconess Hospital

Recruiting

Bozeman, Montana, United States, 59715

Contacts

Principal Investigator:

John M. Schallenkamp

Benefis Sletten Cancer Institute

Recruiting

Great Falls, Montana, United States, 59405

Contacts

Principal Investigator:

John M. Schallenkamp

Logan Health Medical Center

Recruiting

Kalispell, Montana, United States, 59901

Contacts

Principal Investigator:

John M. Schallenkamp

Community Medical Center

Recruiting

Missoula, Montana, United States, 59804

Contacts

Principal Investigator:

John M. Schallenkamp

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

Recruiting

Lebanon, New Hampshire, United States, 03756

Contacts

Principal Investigator:

Joerg Rathmann

Memorial Sloan Kettering Basking Ridge

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

Alan L. Ho

Memorial Sloan Kettering Monmouth

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

Alan L. Ho

Memorial Sloan Kettering Bergen

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

Alan L. Ho

Memorial Sloan Kettering Commack

Recruiting

Commack, New York, United States, 11725

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

Alan L. Ho

Memorial Sloan Kettering Westchester

Recruiting

Harrison, New York, United States, 10604

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

Alan L. Ho

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

Alan L. Ho

State University of New York Upstate Medical University

Recruiting

Syracuse, New York, United States, 13210

Contacts

Site Public Contact

315-464-5476

Principal Investigator:

Komal Akhtar

SUNY Upstate Medical Center-Community Campus

Recruiting

Syracuse, New York, United States, 13215

Contacts

Site Public Contact

315-464-5476

Principal Investigator:

Komal Akhtar

Memorial Sloan Kettering Nassau

Recruiting

Uniondale, New York, United States, 11553

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

Alan L. Ho

Upstate Cancer Center at Verona

Recruiting

Verona, New York, United States, 13478

Contacts

Principal Investigator:

Komal Akhtar

UNC Lineberger Comprehensive Cancer Center

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Principal Investigator:

Siddharth Sheth

Margaret R Pardee Memorial Hospital

Recruiting

Hendersonville, North Carolina, United States, 28791

Contacts

Principal Investigator:

John K. Hill

FirstHealth of the Carolinas-Moore Regional Hospital

Recruiting

Pinehurst, North Carolina, United States, 28374

Contacts

Principal Investigator:

Charles S. Kuzma

Sanford Bismarck Medical Center

Recruiting

Bismarck, North Dakota, United States, 58501

Contacts

Principal Investigator:

Daniel Almquist

Sanford Broadway Medical Center

Recruiting

Fargo, North Dakota, United States, 58122

Contacts

Principal Investigator:

Daniel Almquist

Sanford Roger Maris Cancer Center

Recruiting

Fargo, North Dakota, United States, 58122

Contacts

Principal Investigator:

Daniel Almquist

Miami Valley Hospital South

Recruiting

Centerville, Ohio, United States, 45459

Contacts

Principal Investigator:

Tarek M. Sabagh

Miami Valley Hospital

Recruiting

Dayton, Ohio, United States, 45409

Contacts

Principal Investigator:

Tarek M. Sabagh

Miami Valley Hospital North

Recruiting

Dayton, Ohio, United States, 45415

Contacts

Principal Investigator:

Tarek M. Sabagh

Atrium Medical Center-Middletown Regional Hospital

Recruiting

Franklin, Ohio, United States, 45005-1066

Contacts

Principal Investigator:

Tarek M. Sabagh

Miami Valley Cancer Care and Infusion

Recruiting

Greenville, Ohio, United States, 45331

Contacts

Site Public Contact

937-569-7515

Principal Investigator:

Tarek M. Sabagh

ProMedica Flower Hospital

Recruiting

Sylvania, Ohio, United States, 43560

Contacts

Principal Investigator:

Chang Xia

Upper Valley Medical Center

Recruiting

Troy, Ohio, United States, 45373

Contacts

Principal Investigator:

Tarek M. Sabagh

Cancer Centers of Southwest Oklahoma Research

Recruiting

Lawton, Oklahoma, United States, 73505

Contacts

Site Public Contact

877-231-4440

Principal Investigator:

Minh Phan

University of Oklahoma Health Sciences Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Principal Investigator:

Minh Phan

Saint Alphonsus Cancer Care Center-Ontario

Recruiting

Ontario, Oregon, United States, 97914

Contacts

Principal Investigator:

Christopher M. Reynolds

Providence Willamette Falls Medical Center

Recruiting

Oregon City, Oregon, United States, 97045

Contacts

Principal Investigator:

Alison K. Conlin

Providence Portland Medical Center

Recruiting

Portland, Oregon, United States, 97213

Contacts

Principal Investigator:

Alison K. Conlin

Providence Saint Vincent Medical Center

Recruiting

Portland, Oregon, United States, 97225

Contacts

Principal Investigator:

Alison K. Conlin

Lehigh Valley Hospital-Cedar Crest

Recruiting

Allentown, Pennsylvania, United States, 18103

Contacts

Principal Investigator:

Christopher M. Reynolds

Lehigh Valley Hospital - Muhlenberg

Recruiting

Bethlehem, Pennsylvania, United States, 18017

Contacts

Principal Investigator:

Christopher M. Reynolds

Carlisle Regional Cancer Center

Recruiting

Carlisle, Pennsylvania, United States, 17015

Contacts

Principal Investigator:

Dan P. Zandberg

Pocono Medical Center

Recruiting

East Stroudsburg, Pennsylvania, United States, 18301

Contacts

Principal Investigator:

Christopher M. Reynolds

UPMC Hillman Cancer Center Erie

Recruiting

Erie, Pennsylvania, United States, 16505

Contacts

Principal Investigator:

Dan P. Zandberg

UPMC Cancer Centers - Arnold Palmer Pavilion

Recruiting

Greensburg, Pennsylvania, United States, 15601

Contacts

Site Public Contact

724-838-1900

Principal Investigator:

Dan P. Zandberg

UPMC Pinnacle Cancer Center/Community Osteopathic Campus

Recruiting

Harrisburg, Pennsylvania, United States, 17109

Contacts

Principal Investigator:

Dan P. Zandberg

IRMC Cancer Center

Recruiting

Indiana, Pennsylvania, United States, 15701

Contacts

Principal Investigator:

Dan P. Zandberg

UPMC-Johnstown/John P. Murtha Regional Cancer Center

Recruiting

Johnstown, Pennsylvania, United States, 15901

Contacts

Site Public Contact

814-534-4724

Principal Investigator:

Dan P. Zandberg

UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion

Recruiting

Mechanicsburg, Pennsylvania, United States, 17050

Contacts

Principal Investigator:

Dan P. Zandberg

UPMC Hillman Cancer Center - Monroeville

Recruiting

Monroeville, Pennsylvania, United States, 15146

Contacts

Principal Investigator:

Dan P. Zandberg

UPMC-Saint Margaret

Recruiting

Pittsburgh, Pennsylvania, United States, 15215

Contacts

Site Public Contact

412-784-4900

Principal Investigator:

Dan P. Zandberg

UPMC Hillman Cancer Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Contacts

Site Public Contact

412-647-8073

Principal Investigator:

Dan P. Zandberg

UPMC-Passavant Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15237

Contacts

Site Public Contact

412-367-6454

Principal Investigator:

Dan P. Zandberg

UPMC-Saint Clair Hospital Cancer Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15243

Contacts

Site Public Contact

412-502-3920

Principal Investigator:

Dan P. Zandberg

UPMC Cancer Center at UPMC Northwest

Recruiting

Seneca, Pennsylvania, United States, 16346

Contacts

Site Public Contact

814-676-7900

Principal Investigator:

Dan P. Zandberg

UPMC Cancer Center-Uniontown

Recruiting

Uniontown, Pennsylvania, United States, 15401

Contacts

Principal Investigator:

Dan P. Zandberg

UPMC Cancer Center-Washington

Recruiting

Washington, Pennsylvania, United States, 15301

Contacts

Principal Investigator:

Dan P. Zandberg

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Principal Investigator:

John M. Kaczmar

Avera Cancer Institute - Mitchell

Recruiting

Mitchell, South Dakota, United States, 57301

Contacts

Principal Investigator:

Benjamin M. Solomon

Avera Cancer Institute at Pierre

Recruiting

Pierre, South Dakota, United States, 57501

Contacts

Principal Investigator:

Benjamin M. Solomon

Sanford Cancer Center Oncology Clinic

Recruiting

Sioux Falls, South Dakota, United States, 57104

Contacts

Principal Investigator:

Daniel Almquist

Avera Cancer Institute

Recruiting

Sioux Falls, South Dakota, United States, 57105

Contacts

Principal Investigator:

Benjamin M. Solomon

Sanford USD Medical Center - Sioux Falls

Recruiting

Sioux Falls, South Dakota, United States, 57117-5134

Contacts

Principal Investigator:

Daniel Almquist

Avera Cancer Institute at Yankton

Recruiting

Yankton, South Dakota, United States, 57078

Contacts

Principal Investigator:

Benjamin M. Solomon

Dartmouth Cancer Center - North

Recruiting

Saint Johnsbury, Vermont, United States, 05819

Contacts

Principal Investigator:

Joerg Rathmann

VCU Massey Cancer Center at Stony Point

Recruiting

Richmond, Virginia, United States, 23235

Contacts

Site Public Contact

ctoclinops@vcu.edu

Principal Investigator:

Erin R. Alesi

VCU Massey Comprehensive Cancer Center

Recruiting

Richmond, Virginia, United States, 23298

Contacts

Principal Investigator:

Erin R. Alesi

West Virginia University Charleston Division

Recruiting

Charleston, West Virginia, United States, 25304

Contacts

Site Public Contact

304-388-9944

Principal Investigator:

Kok Hoe Chan

Aurora Cancer Care-Southern Lakes VLCC

Recruiting

Burlington, Wisconsin, United States, 53105

Contacts

Principal Investigator:

Peter J. Polewski

Aurora Saint Luke's South Shore

Recruiting

Cudahy, Wisconsin, United States, 53110

Contacts

Principal Investigator:

Peter J. Polewski

Marshfield Medical Center-EC Cancer Center

Recruiting

Eau Claire, Wisconsin, United States, 54701

Contacts

Principal Investigator:

Seth O. Fagbemi

Aurora Health Care Germantown Health Center

Recruiting

Germantown, Wisconsin, United States, 53022

Contacts

Principal Investigator:

Peter J. Polewski

Aurora Cancer Care-Grafton

Recruiting

Grafton, Wisconsin, United States, 53024

Contacts

Principal Investigator:

Peter J. Polewski

Aurora BayCare Medical Center

Recruiting

Green Bay, Wisconsin, United States, 54311

Contacts

Principal Investigator:

Peter J. Polewski

Aurora Cancer Care-Kenosha South

Recruiting

Kenosha, Wisconsin, United States, 53142

Contacts

Principal Investigator:

Peter J. Polewski

Gundersen Lutheran Medical Center

Recruiting

La Crosse, Wisconsin, United States, 54601

Contacts

Principal Investigator:

Michael O. Ojelabi

Aurora Bay Area Medical Group-Marinette

Recruiting

Marinette, Wisconsin, United States, 54143

Contacts

Principal Investigator:

Peter J. Polewski

Marshfield Medical Center-Marshfield

Recruiting

Marshfield, Wisconsin, United States, 54449

Contacts

Principal Investigator:

Seth O. Fagbemi

Aurora Cancer Care-Milwaukee

Recruiting

Milwaukee, Wisconsin, United States, 53209

Contacts

Principal Investigator:

Peter J. Polewski

Aurora Saint Luke's Medical Center

Recruiting

Milwaukee, Wisconsin, United States, 53215

Contacts

Principal Investigator:

Peter J. Polewski

Aurora Sinai Medical Center

Recruiting

Milwaukee, Wisconsin, United States, 53233

Contacts

Principal Investigator:

Peter J. Polewski

ProHealth D N Greenwald Center

Recruiting

Mukwonago, Wisconsin, United States, 53149

Contacts

Site Public Contact

research.institute@phci.org

Principal Investigator:

Timothy R. Wassenaar

ProHealth Oconomowoc Memorial Hospital

Recruiting

Oconomowoc, Wisconsin, United States, 53066

Contacts

Site Public Contact

262-928-7878

Principal Investigator:

Timothy R. Wassenaar

Vince Lombardi Cancer Clinic - Oshkosh

Recruiting

Oshkosh, Wisconsin, United States, 54904

Contacts

Principal Investigator:

Peter J. Polewski

Aurora Cancer Care-Racine

Recruiting

Racine, Wisconsin, United States, 53406

Contacts

Principal Investigator:

Peter J. Polewski

Vince Lombardi Cancer Clinic-Sheboygan

Recruiting

Sheboygan, Wisconsin, United States, 53081

Contacts

Principal Investigator:

Peter J. Polewski

Marshfield Medical Center-River Region at Stevens Point

Recruiting

Stevens Point, Wisconsin, United States, 54482

Contacts

Principal Investigator:

Seth O. Fagbemi

Aurora Medical Center in Summit

Recruiting

Summit, Wisconsin, United States, 53066

Contacts

Principal Investigator:

Peter J. Polewski

Vince Lombardi Cancer Clinic-Two Rivers

Recruiting

Two Rivers, Wisconsin, United States, 54241

Contacts

Principal Investigator:

Peter J. Polewski

ProHealth Waukesha Memorial Hospital

Recruiting

Waukesha, Wisconsin, United States, 53188

Contacts

Site Public Contact

262-928-7632

Principal Investigator:

Timothy R. Wassenaar

UW Cancer Center at ProHealth Care

Recruiting

Waukesha, Wisconsin, United States, 53188

Contacts

Principal Investigator:

Timothy R. Wassenaar

Aurora Cancer Care-Milwaukee West

Recruiting

Wauwatosa, Wisconsin, United States, 53226

Contacts

Principal Investigator:

Peter J. Polewski

Aurora West Allis Medical Center

Recruiting

West Allis, Wisconsin, United States, 53227

Contacts

Principal Investigator:

Peter J. Polewski

Marshfield Medical Center - Weston

Recruiting

Weston, Wisconsin, United States, 54476

Contacts

Principal Investigator:

Seth O. Fagbemi

More Information

Sponsor

National Cancer Institute (NCI)

Last update posted

Sep 3, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by National Cancer Institute (NCI) on 2026-09-03.