Recruiting
Phase 2

Pembrolizumab vs. Chemotherapy

Sponsor:

National Cancer Institute (NCI)

Code:

NCT04671667

Conditions

Recurrent Head and Neck Squamous Cell Carcinoma

Recurrent Hypopharyngeal Squamous Cell Carcinoma

Recurrent Laryngeal Squamous Cell Carcinoma

Recurrent Oral Cavity Squamous Cell Carcinoma

Recurrent Oropharyngeal Squamous Cell Carcinoma

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Carboplatin

Cisplatin

Computed Tomography

Intensity-Modulated Radiation Therapy

Magnetic Resonance Imaging

Study Details

Brief summary:

This phase II trial studies the effect of pembrolizumab alone compared to the usual approach (chemotherapy \[cisplatin and carboplatin\] plus radiation therapy) after surgery in treating patients with head and neck squamous cell carcinoma that has come back (recurrent) or patients with a second head and neck cancer that is not from metastasis (primary). Radiation therapy uses high energy radiation or protons to kill tumor 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. Carboplatin is also 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. 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. Giving pembrolizumab alone after surgery may work better than the usual approach in shrinking recurrent or primary head and neck squamous cell carcinoma.

Conditions

Recurrent Head and Neck Squamous Cell Carcinoma

Recurrent Hypopharyngeal Squamous Cell Carcinoma

Recurrent Laryngeal Squamous Cell Carcinoma

Recurrent Oral Cavity Squamous Cell Carcinoma

Recurrent Oropharyngeal Squamous Cell Carcinoma

Study ID

NCT04671667

Start date

Apr 27, 2021

Status verified date

Mar, 2026

Completion date

Jun 30, 2029

Anticipated

Primary completion date

Jun 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patient must be between 18 and 79 years of age
  • Patient must have locoregionally recurrent or second primary HNSCC (oral cavity, oropharynx, larynx, hypopharynx) in a previously radiated field
  • Patient must have undergone surgery with gross total resection and must be randomized within 8 weeks of surgery
  • Patients must have high risk disease defined as:

  • Positive margins and/or extra nodal extension (ENE)

  • Positive margins are defined as malignancy at or within 1 mm of the margin. High grade dysplasia (i.e. carcinoma in situ) at the margin is also considered positive
  • ENE may be either gross or microscopic
  • Patient must have a PD-L1 Combined Positive Score (CPS) >= 1 in a Clinical Laboratory Improvement Act (CLIA) certified laboratory. Testing can be done locally as long as it is done in a CLIA certified laboratory. This testing must be on the tumor specimen from the resection of the patient's recurrent or second primary HNSCC
  • Patient must have had prior radiation to the area of recurrent or second primary tumor. This is defined as > 50% of the presurgical tumor volume having previously received a dose of > 45 Gy as determined by the treating radiation oncologist
  • Patient must have completed prior radiation a minimum of 6 months prior to randomization
  • Patient must not have any evidence of distant disease based on baseline imaging done within 28 days prior to randomization
  • Patient must not have received anti-PD-1/PD-L1 therapy for recurrent disease. If the patient received anti-PD-1/PD-L1 therapy as part of initial upfront curative intent treatment (either as part of definitive non-surgical therapy or in the adjuvant setting) in the past, the last dosage of anti-PD-1/PD-L1 therapy must have been given greater than one year prior to randomization
  • Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible
  • Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All patients of childbearing potential must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy. A urine or serum pregnancy test must be repeated within 72 hours prior to receiving the first dose of pembrolizumab or chemotherapy if the test done for eligibility/randomization is done outside of this 72 hour window. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. A patient of childbearing potential is someone, regardless of whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
  • Patient must not expect to conceive or father children by using by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse while on study treatment, and continue for 120 days after the last dose of study treatment
  • Absolute neutrophil count (ANC) >= 1,500/mcL (obtained =< 28 days prior to protocol randomization)
  • Platelets >= 100,000/mcL (obtained =< 28 days prior to protocol randomization)
  • Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (obtained =< 28 days prior to protocol randomization)
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) =< 3.0 x institutional ULN (obtained =< 28 days prior to protocol randomization)
  • Creatinine clearance > 30 ml/min using the Cockcroft-Gault formula (obtained =< 28 days prior to protocol randomization)
  • Patient must not have a current active infection that requires systemic treatment at time of randomization
  • Patient must not have a history of non-infectious pneumonitis requiring steroids within 3 years prior to randomization
  • Patient must not have a history of solid organ transplant or stem cell transplant
  • Patient must not be on immunosuppressive medication within 7 days prior to randomization, EXCEPT for the following: a) intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection); b) systemic corticosteroids at physiologic doses =< 10 mg/day of prednisone or equivalent; c) steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)
  • 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. Patients with New York Heart Association class III or IV heart failure are not eligible
  • Patient must not have received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist \[registered trademark\]) are live attenuated vaccines and are not allowed
  • Patient must not have severe hypersensitivity (>= grade 3) to pembrolizumab and/or any of its excipients
  • Patient must not have an 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
  • Patient must not have a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study
  • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial as long as they have not been HIV-infected with a history of Kaposi sarcoma and/or multicentric Castleman disease
  • Patient must not have a known history of hepatitis B (defined as hepatitis B surface antigen \[HBsAg\] reactive) or known active hepatitis C virus (defined as HCV ribonucleic acid \[RNA\] \[qualitative\] is detected) infection

  • NOTE: No testing for hepatitis B and hepatitis C is required unless mandated by a local health authority

Study Design

Enrollment

188 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Arm B (cisplatin, carboplatin, IMRT, PBRT)

Patients receive cisplatin or carboplatin IV on day 1. Treatment repeats every 7 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo IMRT or PBRT QD for a total of 30 fractions in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI throughout the trial.

experimental: Arm C (pembrolizumab)

Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 6 weeks for 9 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI throughout the trial.

Interventions

Carboplatin

Given IV

Cisplatin

Given IV

Computed Tomography

Undergo CT

Intensity-Modulated Radiation Therapy

Undergo IMRT

Magnetic Resonance Imaging

Undergo MRI

Pembrolizumab

Given IV

Proton Beam Radiation Therapy

Undergo PBRT

Primary outcome measure

  • Overall survival (OS) [ Time Frame: From randomization to date of death from any cause, measured at 2 years ]
  • Incidence of adverse events [ Time Frame: Up to 5 years from date of registration ]

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

Kaiser Permanente-Anaheim

Recruiting

Anaheim, California, United States, 92806

Contacts

Site Public Contact

800-398-3996clinical.trials@kp.org

Principal Investigator:

Aakash Batra

Kaiser Permanente-Bellflower

Recruiting

Bellflower, California, United States, 90706

Contacts

Site Public Contact

800-398-3996clinical.trials@kp.org

Principal Investigator:

Aakash Batra

UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

Recruiting

Irvine, California, United States, 92612

Contacts

Site Public Contact

877-827-8839ucstudy@uci.edu

Principal Investigator:

Shirin Attarian

Kaiser Permanente Los Angeles Medical Center

Recruiting

Los Angeles, California, United States, 90027

Contacts

Site Public Contact

800-398-3996clinical.trials@kp.org

Principal Investigator:

Aakash Batra

Kaiser Permanente-Ontario

Recruiting

Ontario, California, United States, 91761

Contacts

Site Public Contact

800-398-3996clinical.trials@kp.org

Principal Investigator:

Aakash Batra

UC Irvine Health/Chao Family Comprehensive Cancer Center

Recruiting

Orange, California, United States, 92868

Contacts

Site Public Contact

877-827-8839ucstudy@uci.edu

Principal Investigator:

Shirin Attarian

Smilow Cancer Center/Yale-New Haven Hospital

Recruiting

New Haven, Connecticut, United States, 06510

Contacts

Site Public Contact

203-785-5702canceranswers@yale.edu

Principal Investigator:

Aarti Bhatia

Yale University

Recruiting

New Haven, Connecticut, United States, 06520

Contacts

Site Public Contact

203-785-5702canceranswers@yale.edu

Principal Investigator:

Aarti Bhatia

Smilow Cancer Hospital Care Center-Trumbull

Recruiting

Trumbull, Connecticut, United States, 06611

Contacts

Site Public Contact

203-785-5702canceranswers@yale.edu

Principal Investigator:

Aarti Bhatia

Smilow Cancer Hospital Care Center - Waterford

Recruiting

Waterford, Connecticut, United States, 06385

Contacts

Site Public Contact

203-785-5702canceranswers@yale.edu

Principal Investigator:

Aarti Bhatia

MedStar Washington Hospital Center

Recruiting

Washington D.C., District of Columbia, United States, 20010

Contacts

Site Public Contact

202-877-8839

Principal Investigator:

Cristina Merkhofer

UM Sylvester Comprehensive Cancer Center at Coral Gables

Recruiting

Coral Gables, Florida, United States, 33146

Contacts

Site Public Contact

305-243-2647

Principal Investigator:

Elizabeth A. Nicolli

UM Sylvester Comprehensive Cancer Center at Deerfield Beach

Recruiting

Deerfield Beach, Florida, United States, 33442

Contacts

Site Public Contact

305-243-2647

Principal Investigator:

Elizabeth A. Nicolli

University of Miami Miller School of Medicine-Sylvester Cancer Center

Recruiting

Miami, Florida, United States, 33136

Contacts

Site Public Contact

305-243-2647

Principal Investigator:

Elizabeth A. Nicolli

UM Sylvester Comprehensive Cancer Center at Plantation

Recruiting

Plantation, Florida, United States, 33324

Contacts

Site Public Contact

305-243-2647

Principal Investigator:

Elizabeth A. Nicolli

Moffitt Cancer Center-International Plaza

Recruiting

Tampa, Florida, United States, 33607

Contacts

Site Public Contact

800-679-0775ClinicalTrials@moffitt.org

Principal Investigator:

Kedar Kirtane

Moffitt Cancer Center - McKinley Campus

Recruiting

Tampa, Florida, United States, 33612

Contacts

Site Public Contact

800-679-0775ClinicalTrials@moffitt.org

Principal Investigator:

Kedar Kirtane

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Contacts

Site Public Contact

800-679-0775ClinicalTrials@moffitt.org

Principal Investigator:

Kedar Kirtane

Moffitt Cancer Center at Wesley Chapel

Recruiting

Wesley Chapel, Florida, United States, 33544

Contacts

Site Public Contact

800-679-0775ClinicalTrials@moffitt.org

Principal Investigator:

Kedar Kirtane

Emory Proton Therapy Center

Recruiting

Atlanta, Georgia, United States, 30308

Contacts

Site Public Contact

404-251-2854allyson.anderson@emory.edu

Principal Investigator:

Sujith Baliga

Emory University Hospital Midtown

Recruiting

Atlanta, Georgia, United States, 30308

Contacts

Site Public Contact

888-946-7447

Principal Investigator:

Sujith Baliga

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Site Public Contact

312-695-1301cancer@northwestern.edu

Principal Investigator:

Jochen H. Lorch

John H Stroger Jr Hospital of Cook County

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Site Public Contact

312-864-5204

Principal Investigator:

Deimante M. Tamkus

University of Illinois

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Site Public Contact

312-355-3046

Principal Investigator:

Ameen Salahudeen

Carle at The Riverfront

Recruiting

Danville, Illinois, United States, 61832

Contacts

Site Public Contact

800-446-5532Research@Carle.com

Principal Investigator:

Tanmay Sahai

Decatur Memorial Hospital

Recruiting

Decatur, Illinois, United States, 62526

Contacts

Site Public Contact

217-876-4762morganthaler.jodi@mhsil.com

Principal Investigator:

Bryan A. Faller

Northwestern Medicine Cancer Center Kishwaukee

Recruiting

DeKalb, Illinois, United States, 60115

Contacts

Site Public Contact

630-352-5360Donald.Smith3@nm.org

Principal Investigator:

Jochen H. Lorch

Carle Physician Group-Effingham

Recruiting

Effingham, Illinois, United States, 62401

Contacts

Site Public Contact

800-446-5532Research@carle.com

Principal Investigator:

Tanmay Sahai

Crossroads Cancer Center

Recruiting

Effingham, Illinois, United States, 62401

Contacts

Site Public Contact

217-876-4762morganthaler.jodi@mhsil.com

Principal Investigator:

Bryan A. Faller

Northwestern Medicine Cancer Center Delnor

Recruiting

Geneva, Illinois, United States, 60134

Contacts

Site Public Contact

630-352-5360Donald.Smith3@nm.org

Principal Investigator:

Jochen H. Lorch

Carle Physician Group-Mattoon/Charleston

Recruiting

Mattoon, Illinois, United States, 61938

Contacts

Site Public Contact

800-446-5532Research@carle.com

Principal Investigator:

Tanmay Sahai

Loyola University Medical Center

Recruiting

Maywood, Illinois, United States, 60153

Contacts

Site Public Contact

708-226-4357

Principal Investigator:

Joseph I. Clark

HSHS Saint Elizabeth's Hospital

Recruiting

O'Fallon, Illinois, United States, 62269

Contacts

Site Public Contact

217-876-4762morganthaler.jodi@mhsil.com

Principal Investigator:

Bryan A. Faller

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

Site Public Contact

217-528-7541pallante.beth@mhsil.com

Principal Investigator:

Bryan A. Faller

Carle Cancer Center

Recruiting

Urbana, Illinois, United States, 61801

Contacts

Site Public Contact

800-446-5532Research@carle.com

Principal Investigator:

Tanmay Sahai

Northwestern Medicine Cancer Center Warrenville

Recruiting

Warrenville, Illinois, United States, 60555

Contacts

Site Public Contact

630-352-5360Donald.Smith3@nm.org

Principal Investigator:

Jochen H. Lorch

UI Health Care Mission Cancer and Blood - Ankeny Clinic

Recruiting

Ankeny, Iowa, United States, 50023

Contacts

Site Public Contact

515-241-3305

Principal Investigator:

Seema Harichand-Herdt

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

Recruiting

Clive, Iowa, United States, 50325

Contacts

Site Public Contact

515-241-3305

Principal Investigator:

Seema Harichand-Herdt

Heartland Oncology and Hematology LLP

Recruiting

Council Bluffs, Iowa, United States, 51503

Contacts

Site Public Contact

712-322-4136

Principal Investigator:

Yungpo B. Su

Methodist Jennie Edmundson Hospital

Recruiting

Council Bluffs, Iowa, United States, 51503

Contacts

Site Public Contact

402-354-7939kathryn.bartz@nmhs.org

Principal Investigator:

Yungpo B. Su

Iowa Methodist Medical Center

Recruiting

Des Moines, Iowa, United States, 50309

Contacts

Site Public Contact

515-241-6727

Principal Investigator:

Seema Harichand-Herdt

UI Health Care Mission Cancer and Blood - Des Moines Clinic

Recruiting

Des Moines, Iowa, United States, 50309

Contacts

Site Public Contact

515-241-3305

Principal Investigator:

Seema Harichand-Herdt

Broadlawns Medical Center

Recruiting

Des Moines, Iowa, United States, 50314

Contacts

Site Public Contact

515-282-2200

Principal Investigator:

Seema Harichand-Herdt

UI Health Care Mission Cancer and Blood - Laurel Clinic

Recruiting

Des Moines, Iowa, United States, 50314

Contacts

Site Public Contact

515-241-3305

Principal Investigator:

Seema Harichand-Herdt

UI Health Care Mission Cancer and Blood - Waukee Clinic

Recruiting

Waukee, Iowa, United States, 50263

Contacts

Site Public Contact

515-241-3305

Principal Investigator:

Seema Harichand-Herdt

University of Kentucky/Markey Cancer Center

Recruiting

Lexington, Kentucky, United States, 40536

Contacts

Site Public Contact

859-257-3379

Principal Investigator:

Susanne M. Arnold

The James Graham Brown Cancer Center at University of Louisville

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Site Public Contact

502-562-3429

Principal Investigator:

Neal E. Dunlap

UofL Health Medical Center Northeast

Recruiting

Louisville, Kentucky, United States, 40245

Contacts

Site Public Contact

502-852-2755ctoinfo@louisville.edu

Principal Investigator:

Neal E. Dunlap

University of Maryland/Greenebaum Cancer Center

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Site Public Contact

800-888-8823

Principal Investigator:

Matthew J. Ferris

Central Maryland Radiation Oncology in Howard County

Recruiting

Columbia, Maryland, United States, 21044

Contacts

Site Public Contact

443-546-1300

Principal Investigator:

Matthew J. Ferris

UM Baltimore Washington Medical Center/Tate Cancer Center

Recruiting

Glen Burnie, Maryland, United States, 21061

Contacts

Site Public Contact

410-553-8100

Principal Investigator:

Matthew J. Ferris

Tufts Medical Center

Recruiting

Boston, Massachusetts, United States, 02111

Contacts

Site Public Contact

617-636-5000ContactUsCancerCenter@TuftsMedicalCenter.org

Principal Investigator:

Francis W. Nugent

Sanford Joe Lueken Cancer Center

Recruiting

Bemidji, Minnesota, United States, 56601

Contacts

Site Public Contact

218-333-5000OncologyClinicalTrialsFargo@sanfordhealth.org

Principal Investigator:

Daniel Almquist

Mercy Hospital South

Recruiting

St Louis, Missouri, United States, 63128

Contacts

Site Public Contact

314-525-6042Danielle.Werle@mercy.net

Principal Investigator:

Jay W. Carlson

Mercy Hospital Saint Louis

Recruiting

St Louis, Missouri, United States, 63141

Contacts

Site Public Contact

314-251-7066

Principal Investigator:

Jay W. Carlson

Benefis Sletten Cancer Institute

Recruiting

Great Falls, Montana, United States, 59405

Contacts

Site Public Contact

406-969-6060mccinfo@mtcancer.org

Principal Investigator:

John M. Schallenkamp

Logan Health Medical Center

Recruiting

Kalispell, Montana, United States, 59901

Contacts

Site Public Contact

406-969-6060mccinfo@mtcancer.org

Principal Investigator:

John M. Schallenkamp

Community Medical Center

Recruiting

Missoula, Montana, United States, 59804

Contacts

Site Public Contact

406-969-6060mccinfo@mtcancer.org

Principal Investigator:

John M. Schallenkamp

Nebraska Methodist Hospital

Recruiting

Omaha, Nebraska, United States, 68114

Contacts

Site Public Contact

402-354-5144

Principal Investigator:

Yungpo B. Su

Memorial Sloan Kettering Basking Ridge

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

Michael Hwang

Memorial Sloan Kettering Monmouth

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

Michael Hwang

Memorial Sloan Kettering Bergen

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

Michael Hwang

Memorial Sloan Kettering Commack

Recruiting

Commack, New York, United States, 11725

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

Michael Hwang

Memorial Sloan Kettering Westchester

Recruiting

Harrison, New York, United States, 10604

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

Michael Hwang

Mount Sinai Union Square

Recruiting

New York, New York, United States, 10003

Contacts

Site Public Contact

212-824-7309CCTO@mssm.edu

Principal Investigator:

Richard L. Bakst

Mount Sinai Chelsea

Recruiting

New York, New York, United States, 10011

Contacts

Site Public Contact

212-824-7309CCTO@mssm.edu

Principal Investigator:

Richard L. Bakst

Mount Sinai Hospital

Recruiting

New York, New York, United States, 10029

Contacts

Site Public Contact

212-824-7309CCTO@mssm.edu

Principal Investigator:

Richard L. Bakst

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

Michael Hwang

University of Rochester

Recruiting

Rochester, New York, United States, 14642

Contacts

Site Public Contact

585-275-5830

Principal Investigator:

Monaliben Patel

Stony Brook University Medical Center

Recruiting

Stony Brook, New York, United States, 11794

Contacts

Site Public Contact

800-862-2215

Principal Investigator:

Amna Sher

Montefiore Medical Center-Einstein Campus

Recruiting

The Bronx, New York, United States, 10461

Contacts

Site Public Contact

718-379-6866eskwak@montefiore.org

Principal Investigator:

Rafi Kabarriti

Montefiore Medical Center - Moses Campus

Recruiting

The Bronx, New York, United States, 10467

Contacts

Site Public Contact

718-379-6866eskwak@montefiore.org

Principal Investigator:

Rafi Kabarriti

Memorial Sloan Kettering Nassau

Recruiting

Uniondale, New York, United States, 11553

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

Michael Hwang

Wilmot Cancer Institute at Webster

Recruiting

Webster, New York, United States, 14580

Contacts

Site Public Contact

WCICTOresearch@urmc.rochester.edu

Principal Investigator:

Monaliben Patel

UNC Lineberger Comprehensive Cancer Center

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Site Public Contact

877-668-0683cancerclinicaltrials@med.unc.edu

Principal Investigator:

Colette Shen

Cone Health Cancer Center

Recruiting

Greensboro, North Carolina, United States, 27403

Contacts

Site Public Contact

336-832-0836stacey.phelps@conehealth.com

Principal Investigator:

Vinay K. Gudena

Annie Penn Memorial Hospital

Recruiting

Reidsville, North Carolina, United States, 27320

Contacts

Site Public Contact

336-832-0836stacey.phelps@conehealth.com

Principal Investigator:

Vinay K. Gudena

Sanford Bismarck Medical Center

Recruiting

Bismarck, North Dakota, United States, 58501

Contacts

Site Public Contact

701-323-5760OncologyClinicalTrialsFargo@sanfordhealth.org

Principal Investigator:

Daniel Almquist

Sanford Roger Maris Cancer Center

Recruiting

Fargo, North Dakota, United States, 58122

Contacts

Site Public Contact

701-234-6161OncologyClinicalTrialsFargo@sanfordhealth.org

Principal Investigator:

Daniel Almquist

Miami Valley Hospital South

Recruiting

Centerville, Ohio, United States, 45459

Contacts

Site Public Contact

937-528-2900clinical.trials@daytonncorp.org

Principal Investigator:

Tarek M. Sabagh

Cleveland Clinic Foundation

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Site Public Contact

866-223-8100TaussigResearch@ccf.org

Principal Investigator:

Jessica L. Geiger

Premier Blood and Cancer Center

Recruiting

Dayton, Ohio, United States, 45409

Contacts

Site Public Contact

937-276-8320

Principal Investigator:

Tarek M. Sabagh

Miami Valley Hospital North

Recruiting

Dayton, Ohio, United States, 45415

Contacts

Site Public Contact

937-528-2900clinical.trials@daytonncorp.org

Principal Investigator:

Tarek M. Sabagh

Atrium Medical Center-Middletown Regional Hospital

Recruiting

Franklin, Ohio, United States, 45005-1066

Contacts

Site Public Contact

937-528-2900clinical.trials@daytonncorp.org

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

Upper Valley Medical Center

Recruiting

Troy, Ohio, United States, 45373

Contacts

Site Public Contact

937-528-2900clinical.trials@daytonncorp.org

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

Site Public Contact

405-271-8777ou-clinical-trials@ouhsc.edu

Principal Investigator:

Minh Phan

Providence Newberg Medical Center

Recruiting

Newberg, Oregon, United States, 97132

Contacts

Site Public Contact

503-215-2614CanRsrchStudies@providence.org

Principal Investigator:

Alison K. Conlin

Providence Portland Medical Center

Recruiting

Portland, Oregon, United States, 97213

Contacts

Site Public Contact

503-215-2614CanRsrchStudies@providence.org

Principal Investigator:

Alison K. Conlin

Providence Saint Vincent Medical Center

Recruiting

Portland, Oregon, United States, 97225

Contacts

Site Public Contact

503-215-2614CanRsrchStudies@providence.org

Principal Investigator:

Alison K. Conlin

UPMC Altoona

Recruiting

Altoona, Pennsylvania, United States, 16601

Contacts

Site Public Contact

ecog.rss@jimmy.harvard.edu

Principal Investigator:

Dan P. Zandberg

Geisinger Medical Center

Recruiting

Danville, Pennsylvania, United States, 17822

Contacts

Site Public Contact

570-271-5251cancerresearch@geisinger.edu

Principal Investigator:

Rajiv Panikkar

UPMC Hillman Cancer Center Erie

Recruiting

Erie, Pennsylvania, United States, 16505

Contacts

Site Public Contact

412-864-7716ClinicalResearchServices@upmc.edu

Principal Investigator:

Dan P. Zandberg

UPMC Cancer Center at UPMC Horizon

Recruiting

Farrell, Pennsylvania, United States, 16121

Contacts

Site Public Contact

ecog.rss@jimmy.harvard.edu

Principal Investigator:

Dan P. Zandberg

IRMC Cancer Center

Recruiting

Indiana, Pennsylvania, United States, 15701

Contacts

Site Public Contact

412-389-5208haneydl@upmc.edu

Principal Investigator:

Dan P. Zandberg

Geisinger Medical Oncology-Lewisburg

Recruiting

Lewisburg, Pennsylvania, United States, 17837

Contacts

Site Public Contact

570-523-9200cancerresearch@geisinger.edu

Principal Investigator:

Rajiv Panikkar

UPMC Hillman Cancer Center - New Castle

Recruiting

New Castle, Pennsylvania, United States, 16105

Contacts

Site Public Contact

412-389-5208haneydl@upmc.edu

Principal Investigator:

Dan P. Zandberg

Thomas Jefferson University Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Site Public Contact

215-600-9151ONCTrialNow@jefferson.edu

Principal Investigator:

Jennifer M. Johnson

Fox Chase Cancer Center

Recruiting

Philadelphia, Pennsylvania, United States, 19111

Contacts

Site Public Contact

215-728-4790

Principal Investigator:

Thomas J. Galloway

Jefferson Torresdale Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19114

Contacts

Site Public Contact

215-600-9151ONCTrialNow@jefferson.edu

Principal Investigator:

Jennifer M. Johnson

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

Geisinger Wyoming Valley/Henry Cancer Center

Recruiting

Wilkes-Barre, Pennsylvania, United States, 18711

Contacts

Site Public Contact

570-271-5251HemonCCTrials@geisinger.edu

Principal Investigator:

Rajiv Panikkar

UPMC Memorial

Recruiting

York, Pennsylvania, United States, 17408

Contacts

Site Public Contact

717-724-6760

Principal Investigator:

Dan P. Zandberg

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Site Public Contact

843-792-9321hcc-clinical-trials@musc.edu

Principal Investigator:

Jennifer L. Harper

Avera Cancer Institute

Recruiting

Sioux Falls, South Dakota, United States, 57105

Contacts

Site Public Contact

605-322-3095OncRegulatory@avera.org

Principal Investigator:

Benjamin M. Solomon

Sanford USD Medical Center - Sioux Falls

Recruiting

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

Contacts

Site Public Contact

605-312-3320OncologyClinicalTrialsSF@SanfordHealth.org

Principal Investigator:

Daniel Almquist

Avera Cancer Institute at Yankton

Recruiting

Yankton, South Dakota, United States, 57078

Contacts

Site Public Contact

605-655-1800OncRegulatory@avera.org

Principal Investigator:

Benjamin M. Solomon

Vanderbilt University/Ingram Cancer Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Site Public Contact

800-811-8480

Principal Investigator:

Jennifer H. Choe

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

Site Public Contact

804-628-6430CTOclinops@vcu.edu

Principal Investigator:

Erin R. Alesi

Aspirus Cancer Care-Antigo-Volm Cancer Center

Recruiting

Antigo, Wisconsin, United States, 54409

Contacts

Site Public Contact

715-623-9869Juli.Alford@aspirus.org

Principal Investigator:

Andrew J. Huang

ThedaCare Regional Cancer Center

Recruiting

Appleton, Wisconsin, United States, 54911

Contacts

Site Public Contact

920-364-3604ResearchDept@thedacare.org

Principal Investigator:

Matthias Weiss

Saint Vincent Hospital Cancer Center Green Bay

Recruiting

Green Bay, Wisconsin, United States, 54301

Contacts

Site Public Contact

920-433-8889WI_research_admin@hshs.org

Principal Investigator:

Brian L. Burnette

Saint Vincent Hospital Cancer Center at Saint Mary's

Recruiting

Green Bay, Wisconsin, United States, 54303

Contacts

Site Public Contact

920-433-8889wi_research_admin@hshs.org

Principal Investigator:

Brian L. Burnette

Froedtert Menomonee Falls Hospital

Recruiting

Menomonee Falls, Wisconsin, United States, 53051

Contacts

Site Public Contact

262-257-5100

Principal Investigator:

Stuart J. Wong

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Site Public Contact

414-805-3666

Principal Investigator:

Stuart J. Wong

Drexel Town Square Health Center

Recruiting

Oak Creek, Wisconsin, United States, 53154

Contacts

Site Public Contact

414-805-0505

Principal Investigator:

Stuart J. Wong

Aspirus Cancer Care-Rhinelander-James Beck Cancer Center

Recruiting

Rhinelander, Wisconsin, United States, 54501

Contacts

Site Public Contact

715-847-2353Beth.Knetter@aspirus.org

Principal Investigator:

Andrew J. Huang

Aspirus Cancer Care - Stevens Point

Recruiting

Stevens Point, Wisconsin, United States, 54481

Contacts

Site Public Contact

715-847-2353Beth.Knetter@aspirus.org

Principal Investigator:

Andrew J. Huang

Saint Vincent Hospital Cancer Center at Sturgeon Bay

Recruiting

Sturgeon Bay, Wisconsin, United States, 54235-1495

Contacts

Site Public Contact

920-433-8889wi_research_admin@hshs.org

Principal Investigator:

Brian L. Burnette

Aspirus Cancer Care-Wausau

Recruiting

Wausau, Wisconsin, United States, 54401

Contacts

Site Public Contact

877-405-6866

Principal Investigator:

Andrew J. Huang

Froedtert West Bend Hospital/Kraemer Cancer Center

Recruiting

West Bend, Wisconsin, United States, 53095

Contacts

Site Public Contact

414-805-0505

Principal Investigator:

Stuart J. Wong

Aspirus Cancer Care - Wisconsin Rapids

Recruiting

Wisconsin Rapids, Wisconsin, United States, 54494

Contacts

Site Public Contact

715-422-7718

Principal Investigator:

Andrew J. Huang

More Information

Sponsor

National Cancer Institute (NCI)

Last update posted

Aug 24, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-16. This information was provided to ClinicalTrials.gov by National Cancer Institute (NCI) on 2026-08-24.