Testing What Happens When an Immunotherapy Drug (Pembrolizumab) is Given by Itself Compared to the Usual Treatment of Chemotherapy With Radiation After Surgery for Recurrent Head and Neck Squamous Cell Carcinoma

NCT ID: NCT04671667

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

188 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-27

Study Completion Date

2029-06-30

Brief Summary

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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.

Detailed Description

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PRIMARY OBJECTIVE:

I. To evaluate overall survival (OS) of adjuvant pembrolizumab for 12 months compared to adjuvant reirradiation plus concurrent platinum chemotherapy in high risk head and neck squamous cell carcinoma (HNSCC) patients.

SECONDARY OBJECTIVES:

I. To evaluate the following endpoints in both arms: disease free survival (DFS), locoregional control, rates of distant metastasis, toxicity.

II. To evaluate whether high PD-L1 expression (defined as Combined Positive Score \[CPS\] \>= 20) is predictive of increased efficacy in the experimental group compared to control.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM B: Patients receive cisplatin or carboplatin intravenously (IV) on day 1. Treatment repeats every 7 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo intensity-modulated radiation therapy (IMRT) or proton beam radiation therapy (PBRT) once daily (QD) for a total of 30 fractions in the absence of disease progression or unacceptable toxicity.

ARM C: 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 in all arms undergo computed tomography (CT) or magnetic resonance imaging (MRI) throughout the trial.

After completion of study treatment, patients are followed up at 30 days, and then every 6 months for up to 5 years from the date of registration.

Conditions

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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 Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Carboplatin

Intervention Type DRUG

Given IV

Cisplatin

Intervention Type DRUG

Given IV

Computed Tomography

Intervention Type PROCEDURE

Undergo CT

Intensity-Modulated Radiation Therapy

Intervention Type RADIATION

Undergo IMRT

Magnetic Resonance Imaging

Intervention Type PROCEDURE

Undergo MRI

Proton Beam Radiation Therapy

Intervention Type RADIATION

Undergo PBRT

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.

Group Type EXPERIMENTAL

Computed Tomography

Intervention Type PROCEDURE

Undergo CT

Magnetic Resonance Imaging

Intervention Type PROCEDURE

Undergo MRI

Pembrolizumab

Intervention Type BIOLOGICAL

Given IV

Interventions

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Carboplatin

Given IV

Intervention Type DRUG

Cisplatin

Given IV

Intervention Type DRUG

Computed Tomography

Undergo CT

Intervention Type PROCEDURE

Intensity-Modulated Radiation Therapy

Undergo IMRT

Intervention Type RADIATION

Magnetic Resonance Imaging

Undergo MRI

Intervention Type PROCEDURE

Pembrolizumab

Given IV

Intervention Type BIOLOGICAL

Proton Beam Radiation Therapy

Undergo PBRT

Intervention Type RADIATION

Other Intervention Names

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Blastocarb Carboplat Carboplatin Hexal Carboplatino Carboplatinum Carbosin Carbosol Carbotec CBDCA Displata Ercar JM-8 JM8 Nealorin Novoplatinum Paraplatin Paraplatin AQ Paraplatine Platinwas Ribocarbo 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 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 IMRT Intensity modulated radiation therapy (procedure) Intensity Modulated RT Intensity-Modulated Radiotherapy Radiation, Intensity-Modulated Radiotherapy 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 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 External beam radiation therapy protons (procedure) External Beam Radiotherapy (protons) PBRT Proton Proton EBRT Proton External Beam Radiotherapy Proton Radiation Therapy PROTON Therapy Radiation, Proton Beam

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dan P Zandberg

Role: PRINCIPAL_INVESTIGATOR

ECOG-ACRIN Cancer Research Group

Locations

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University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, United States

Site Status SUSPENDED

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Site Status RECRUITING

Kaiser Permanente-Anaheim

Anaheim, California, United States

Site Status RECRUITING

Kaiser Permanente-Bellflower

Bellflower, California, United States

Site Status RECRUITING

UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

Irvine, California, United States

Site Status RECRUITING

UC San Diego Moores Cancer Center

La Jolla, California, United States

Site Status ACTIVE_NOT_RECRUITING

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, United States

Site Status RECRUITING

Kaiser Permanente-Ontario

Ontario, California, United States

Site Status RECRUITING

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, United States

Site Status RECRUITING

Sutter Cancer Centers Radiation Oncology Services-Roseville

Roseville, California, United States

Site Status ACTIVE_NOT_RECRUITING

Sutter Roseville Medical Center

Roseville, California, United States

Site Status ACTIVE_NOT_RECRUITING

California Protons Cancer Therapy Center

San Diego, California, United States

Site Status ACTIVE_NOT_RECRUITING

Smilow Cancer Center/Yale-New Haven Hospital

New Haven, Connecticut, United States

Site Status RECRUITING

Yale University

New Haven, Connecticut, United States

Site Status RECRUITING

Smilow Cancer Hospital Care Center-Trumbull

Trumbull, Connecticut, United States

Site Status RECRUITING

Smilow Cancer Hospital Care Center - Waterford

Waterford, Connecticut, United States

Site Status RECRUITING

MedStar Washington Hospital Center

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

Site Status ACTIVE_NOT_RECRUITING

UM Sylvester Comprehensive Cancer Center at Coral Gables

Coral Gables, Florida, United States

Site Status RECRUITING

UM Sylvester Comprehensive Cancer Center at Deerfield Beach

Deerfield Beach, Florida, United States

Site Status RECRUITING

University of Florida Health Science Center - Gainesville

Gainesville, Florida, United States

Site Status ACTIVE_NOT_RECRUITING

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, United States

Site Status RECRUITING

UM Sylvester Comprehensive Cancer Center at Plantation

Plantation, Florida, United States

Site Status RECRUITING

Moffitt Cancer Center-International Plaza

Tampa, Florida, United States

Site Status SUSPENDED

Moffitt Cancer Center - McKinley Campus

Tampa, Florida, United States

Site Status RECRUITING

Moffitt Cancer Center

Tampa, Florida, United States

Site Status RECRUITING

Emory Proton Therapy Center

Atlanta, Georgia, United States

Site Status RECRUITING

Emory University Hospital Midtown

Atlanta, Georgia, United States

Site Status RECRUITING

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

Site Status SUSPENDED

Memorial Health University Medical Center

Savannah, Georgia, United States

Site Status SUSPENDED

Northwestern University

Chicago, Illinois, United States

Site Status RECRUITING

John H Stroger Jr Hospital of Cook County

Chicago, Illinois, United States

Site Status RECRUITING

University of Illinois

Chicago, Illinois, United States

Site Status RECRUITING

Carle at The Riverfront

Danville, Illinois, United States

Site Status RECRUITING

Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, United States

Site Status SUSPENDED

Decatur Memorial Hospital

Decatur, Illinois, United States

Site Status RECRUITING

Northwestern Medicine Cancer Center Kishwaukee

DeKalb, Illinois, United States

Site Status RECRUITING

Carle Physician Group-Effingham

Effingham, Illinois, United States

Site Status RECRUITING

Crossroads Cancer Center

Effingham, Illinois, United States

Site Status RECRUITING

Northwestern Medicine Cancer Center Delnor

Geneva, Illinois, United States

Site Status RECRUITING

Northwestern Medicine Lake Forest Hospital

Lake Forest, Illinois, United States

Site Status ACTIVE_NOT_RECRUITING

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, United States

Site Status RECRUITING

Loyola University Medical Center

Maywood, Illinois, United States

Site Status RECRUITING

HSHS Saint Elizabeth's Hospital

O'Fallon, Illinois, United States

Site Status RECRUITING

Southern Illinois University School of Medicine

Springfield, Illinois, United States

Site Status RECRUITING

Springfield Clinic

Springfield, Illinois, United States

Site Status RECRUITING

Springfield Memorial Hospital

Springfield, Illinois, United States

Site Status RECRUITING

Carle Cancer Center

Urbana, Illinois, United States

Site Status RECRUITING

The Carle Foundation Hospital

Urbana, Illinois, United States

Site Status SUSPENDED

Northwestern Medicine Cancer Center Warrenville

Warrenville, Illinois, United States

Site Status RECRUITING

Reid Health

Richmond, Indiana, United States

Site Status ACTIVE_NOT_RECRUITING

UI Health Care Mission Cancer and Blood - Ankeny Clinic

Ankeny, Iowa, United States

Site Status RECRUITING

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

Clive, Iowa, United States

Site Status RECRUITING

Heartland Oncology and Hematology LLP

Council Bluffs, Iowa, United States

Site Status RECRUITING

Methodist Jennie Edmundson Hospital

Council Bluffs, Iowa, United States

Site Status RECRUITING

Iowa Methodist Medical Center

Des Moines, Iowa, United States

Site Status RECRUITING

UI Health Care Mission Cancer and Blood - Des Moines Clinic

Des Moines, Iowa, United States

Site Status RECRUITING

Broadlawns Medical Center

Des Moines, Iowa, United States

Site Status RECRUITING

UI Health Care Mission Cancer and Blood - Laurel Clinic

Des Moines, Iowa, United States

Site Status RECRUITING

Iowa Lutheran Hospital

Des Moines, Iowa, United States

Site Status SUSPENDED

UI Health Care Mission Cancer and Blood - Waukee Clinic

Waukee, Iowa, United States

Site Status RECRUITING

Methodist West Hospital

West Des Moines, Iowa, United States

Site Status SUSPENDED

University of Kansas Cancer Center

Kansas City, Kansas, United States

Site Status ACTIVE_NOT_RECRUITING

University of Kansas Cancer Center-Overland Park

Overland Park, Kansas, United States

Site Status ACTIVE_NOT_RECRUITING

University of Kansas Hospital-Indian Creek Campus

Overland Park, Kansas, United States

Site Status ACTIVE_NOT_RECRUITING

University of Kansas Hospital-Westwood Cancer Center

Westwood, Kansas, United States

Site Status ACTIVE_NOT_RECRUITING

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, United States

Site Status RECRUITING

The James Graham Brown Cancer Center at University of Louisville

Louisville, Kentucky, United States

Site Status RECRUITING

UofL Health Medical Center Northeast

Louisville, Kentucky, United States

Site Status RECRUITING

Maryland Proton Treatment Center

Baltimore, Maryland, United States

Site Status SUSPENDED

University of Maryland/Greenebaum Cancer Center

Baltimore, Maryland, United States

Site Status RECRUITING

Central Maryland Radiation Oncology in Howard County

Columbia, Maryland, United States

Site Status RECRUITING

UM Baltimore Washington Medical Center/Tate Cancer Center

Glen Burnie, Maryland, United States

Site Status RECRUITING

Tufts Medical Center

Boston, Massachusetts, United States

Site Status RECRUITING

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Site Status SUSPENDED

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, United States

Site Status ACTIVE_NOT_RECRUITING

Weisberg Cancer Treatment Center

Farmington Hills, Michigan, United States

Site Status ACTIVE_NOT_RECRUITING

Sanford Joe Lueken Cancer Center

Bemidji, Minnesota, United States

Site Status RECRUITING

University of Mississippi Medical Center

Jackson, Mississippi, United States

Site Status SUSPENDED

Saint Francis Medical Center

Cape Girardeau, Missouri, United States

Site Status SUSPENDED

Siteman Cancer Center at Saint Peters Hospital

City of Saint Peters, Missouri, United States

Site Status ACTIVE_NOT_RECRUITING

Siteman Cancer Center at West County Hospital

Creve Coeur, Missouri, United States

Site Status ACTIVE_NOT_RECRUITING

University of Kansas Cancer Center - North

Kansas City, Missouri, United States

Site Status ACTIVE_NOT_RECRUITING

University of Kansas Cancer Center - Lee's Summit

Lee's Summit, Missouri, United States

Site Status ACTIVE_NOT_RECRUITING

University of Kansas Cancer Center at North Kansas City Hospital

North Kansas City, Missouri, United States

Site Status ACTIVE_NOT_RECRUITING

Mercy Hospital Springfield

Springfield, Missouri, United States

Site Status SUSPENDED

Washington University School of Medicine

St Louis, Missouri, United States

Site Status ACTIVE_NOT_RECRUITING

Mercy Hospital South

St Louis, Missouri, United States

Site Status RECRUITING

Siteman Cancer Center-South County

St Louis, Missouri, United States

Site Status ACTIVE_NOT_RECRUITING

Siteman Cancer Center at Christian Hospital

St Louis, Missouri, United States

Site Status ACTIVE_NOT_RECRUITING

Mercy Hospital Saint Louis

St Louis, Missouri, United States

Site Status RECRUITING

Benefis Sletten Cancer Institute

Great Falls, Montana, United States

Site Status RECRUITING

Logan Health Medical Center

Kalispell, Montana, United States

Site Status RECRUITING

Community Medical Center

Missoula, Montana, United States

Site Status RECRUITING

Nebraska Cancer Specialists/Oncology Hematology West PC - MECC

Omaha, Nebraska, United States

Site Status RECRUITING

Nebraska Methodist Hospital

Omaha, Nebraska, United States

Site Status RECRUITING

Oncology Associates PC

Omaha, Nebraska, United States

Site Status SUSPENDED

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, United States

Site Status RECRUITING

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, United States

Site Status RECRUITING

Memorial Sloan Kettering Bergen

Montvale, New Jersey, United States

Site Status RECRUITING

University of New Mexico Cancer Center

Albuquerque, New Mexico, United States

Site Status ACTIVE_NOT_RECRUITING

Memorial Sloan Kettering Commack

Commack, New York, United States

Site Status RECRUITING

Memorial Sloan Kettering Westchester

Harrison, New York, United States

Site Status RECRUITING

Mount Sinai Union Square

New York, New York, United States

Site Status RECRUITING

Mount Sinai Chelsea

New York, New York, United States

Site Status RECRUITING

Mount Sinai Hospital

New York, New York, United States

Site Status RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status RECRUITING

University of Rochester

Rochester, New York, United States

Site Status RECRUITING

Stony Brook University Medical Center

Stony Brook, New York, United States

Site Status RECRUITING

Montefiore Medical Center-Einstein Campus

The Bronx, New York, United States

Site Status RECRUITING

Montefiore Medical Center - Moses Campus

The Bronx, New York, United States

Site Status RECRUITING

Memorial Sloan Kettering Nassau

Uniondale, New York, United States

Site Status RECRUITING

Wilmot Cancer Institute at Webster

Webster, New York, United States

Site Status RECRUITING

Randolph Hospital

Asheboro, North Carolina, United States

Site Status SUSPENDED

Cone Health Cancer Center

Greensboro, North Carolina, United States

Site Status RECRUITING

Annie Penn Memorial Hospital

Reidsville, North Carolina, United States

Site Status RECRUITING

Sanford Bismarck Medical Center

Bismarck, North Dakota, United States

Site Status RECRUITING

Sanford Roger Maris Cancer Center

Fargo, North Dakota, United States

Site Status RECRUITING

Indu and Raj Soin Medical Center

Beavercreek, Ohio, United States

Site Status ACTIVE_NOT_RECRUITING

Dayton Physicians LLC-Miami Valley South

Centerville, Ohio, United States

Site Status ACTIVE_NOT_RECRUITING

Miami Valley Hospital South

Centerville, Ohio, United States

Site Status RECRUITING

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status RECRUITING

Premier Blood and Cancer Center

Dayton, Ohio, United States

Site Status RECRUITING

Dayton Physician LLC - Englewood

Dayton, Ohio, United States

Site Status ACTIVE_NOT_RECRUITING

Miami Valley Hospital North

Dayton, Ohio, United States

Site Status RECRUITING

Atrium Medical Center-Middletown Regional Hospital

Franklin, Ohio, United States

Site Status RECRUITING

Dayton Physicians LLC-Atrium

Franklin, Ohio, United States

Site Status ACTIVE_NOT_RECRUITING

Miami Valley Cancer Care and Infusion

Greenville, Ohio, United States

Site Status RECRUITING

Greater Dayton Cancer Center

Kettering, Ohio, United States

Site Status ACTIVE_NOT_RECRUITING

Kettering Medical Center

Kettering, Ohio, United States

Site Status ACTIVE_NOT_RECRUITING

Upper Valley Medical Center

Troy, Ohio, United States

Site Status RECRUITING

Cancer Centers of Southwest Oklahoma Research

Lawton, Oklahoma, United States

Site Status RECRUITING

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Site Status RECRUITING

Clackamas Radiation Oncology Center

Clackamas, Oregon, United States

Site Status SUSPENDED

Providence Cancer Institute Clackamas Clinic

Clackamas, Oregon, United States

Site Status SUSPENDED

Providence Newberg Medical Center

Newberg, Oregon, United States

Site Status RECRUITING

Providence Portland Medical Center

Portland, Oregon, United States

Site Status RECRUITING

Providence Saint Vincent Medical Center

Portland, Oregon, United States

Site Status RECRUITING

UPMC Altoona

Altoona, Pennsylvania, United States

Site Status RECRUITING

Geisinger Medical Center

Danville, Pennsylvania, United States

Site Status RECRUITING

UPMC Hillman Cancer Center Erie

Erie, Pennsylvania, United States

Site Status RECRUITING

UPMC Cancer Center at UPMC Horizon

Farrell, Pennsylvania, United States

Site Status RECRUITING

Geisinger Medical Oncology-Lewisburg

Lewisburg, Pennsylvania, United States

Site Status RECRUITING

UPMC Hillman Cancer Center - New Castle

New Castle, Pennsylvania, United States

Site Status RECRUITING

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Jefferson Torresdale Hospital

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Temple University Hospital

Philadelphia, Pennsylvania, United States

Site Status ACTIVE_NOT_RECRUITING

UPMC-Saint Margaret

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

UPMC-Shadyside Hospital

Pittsburgh, Pennsylvania, United States

Site Status ACTIVE_NOT_RECRUITING

UPMC-Passavant Hospital

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

Geisinger Wyoming Valley/Henry Cancer Center

Wilkes-Barre, Pennsylvania, United States

Site Status RECRUITING

UPMC Memorial

York, Pennsylvania, United States

Site Status RECRUITING

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status RECRUITING

Avera Cancer Institute

Sioux Falls, South Dakota, United States

Site Status RECRUITING

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, United States

Site Status RECRUITING

Avera Cancer Institute at Yankton

Yankton, South Dakota, United States

Site Status RECRUITING

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, United States

Site Status RECRUITING

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, United States

Site Status ACTIVE_NOT_RECRUITING

VCU Massey Cancer Center at Stony Point

Richmond, Virginia, United States

Site Status RECRUITING

VCU Massey Comprehensive Cancer Center

Richmond, Virginia, United States

Site Status RECRUITING

ThedaCare Regional Cancer Center

Appleton, Wisconsin, United States

Site Status RECRUITING

HSHS Sacred Heart Hospital

Eau Claire, Wisconsin, United States

Site Status ACTIVE_NOT_RECRUITING

Saint Vincent Hospital Cancer Center Green Bay

Green Bay, Wisconsin, United States

Site Status RECRUITING

Saint Vincent Hospital Cancer Center at Saint Mary's

Green Bay, Wisconsin, United States

Site Status RECRUITING

Froedtert Menomonee Falls Hospital

Menomonee Falls, Wisconsin, United States

Site Status RECRUITING

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status RECRUITING

Drexel Town Square Health Center

Oak Creek, Wisconsin, United States

Site Status RECRUITING

Saint Vincent Hospital Cancer Center at Sturgeon Bay

Sturgeon Bay, Wisconsin, United States

Site Status RECRUITING

Froedtert West Bend Hospital/Kraemer Cancer Center

West Bend, Wisconsin, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

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Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NCI-2020-13174

Identifier Type: REGISTRY

Identifier Source: secondary_id

EA3191

Identifier Type: OTHER

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EA3191

Identifier Type: OTHER

Identifier Source: secondary_id

U10CA180820

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2020-13174

Identifier Type: -

Identifier Source: org_study_id