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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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 79 Years
Gender All
More Inclusion & Exclusion Criteria

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 defined as anyone, regardless of sexual orientation or 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04671667
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

National Cancer Institute (NCI)
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Dan P Zandberg
Principal Investigator Affiliation ECOG-ACRIN Cancer Research Group
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

NIH
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

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
Additional Details

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.

Arms & Interventions

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

Drug: - Carboplatin

Given IV

Drug: - Cisplatin

Given IV

Procedure: - Computed Tomography

Undergo CT

Radiation: - Intensity-Modulated Radiation Therapy

Undergo IMRT

Procedure: - Magnetic Resonance Imaging

Undergo MRI

Biological: - Pembrolizumab

Given IV

Radiation: - Proton Beam Radiation Therapy

Undergo PBRT

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Birmingham, Alabama

Status

Suspended

Address

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, 35233

Little Rock, Arkansas

Status

Recruiting

Address

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205

Site Contact

Site Public Contact

501-686-8274

Kaiser Permanente-Anaheim, Anaheim, California

Status

Recruiting

Address

Kaiser Permanente-Anaheim

Anaheim, California, 92806

Site Contact

Site Public Contact

[email protected]

800-398-3996

Kaiser Permanente-Bellflower, Bellflower, California

Status

Recruiting

Address

Kaiser Permanente-Bellflower

Bellflower, California, 90706

Site Contact

Site Public Contact

[email protected]

800-398-3996

UC San Diego Moores Cancer Center, La Jolla, California

Status

Recruiting

Address

UC San Diego Moores Cancer Center

La Jolla, California, 92093

Site Contact

Site Public Contact

[email protected]

858-822-5354

Los Angeles, California

Status

Recruiting

Address

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, 90027

Site Contact

Site Public Contact

[email protected]

800-398-3996

Kaiser Permanente-Ontario, Ontario, California

Status

Recruiting

Address

Kaiser Permanente-Ontario

Ontario, California, 91761

Site Contact

Site Public Contact

[email protected]

800-398-3996

Roseville, California

Status

Active, not recruiting

Address

Sutter Cancer Centers Radiation Oncology Services-Roseville

Roseville, California, 95661

Sutter Roseville Medical Center, Roseville, California

Status

Active, not recruiting

Address

Sutter Roseville Medical Center

Roseville, California, 95661

California Protons Cancer Therapy Center, San Diego, California

Status

Recruiting

Address

California Protons Cancer Therapy Center

San Diego, California, 92121

Site Contact

Site Public Contact

858-299-5982

New Haven, Connecticut

Status

Recruiting

Address

Smilow Cancer Center/Yale-New Haven Hospital

New Haven, Connecticut, 06510

Site Contact

Site Public Contact

[email protected]

203-785-5702

Yale University, New Haven, Connecticut

Status

Recruiting

Address

Yale University

New Haven, Connecticut, 06520

Site Contact

Site Public Contact

[email protected]

203-785-5702

Trumbull, Connecticut

Status

Recruiting

Address

Smilow Cancer Hospital Care Center-Trumbull

Trumbull, Connecticut, 06611

Site Contact

Site Public Contact

[email protected]

203-785-5702

Waterford, Connecticut

Status

Recruiting

Address

Smilow Cancer Hospital Care Center - Waterford

Waterford, Connecticut, 06385

Site Contact

Site Public Contact

[email protected]

203-785-5702

MedStar Washington Hospital Center, Washington, District of Columbia

Status

Recruiting

Address

MedStar Washington Hospital Center

Washington, District of Columbia, 20010

Site Contact

Site Public Contact

202-877-8839

Coral Gables, Florida

Status

Recruiting

Address

UM Sylvester Comprehensive Cancer Center at Coral Gables

Coral Gables, Florida, 33146

Site Contact

Site Public Contact

305-243-2647

Deerfield Beach, Florida

Status

Recruiting

Address

UM Sylvester Comprehensive Cancer Center at Deerfield Beach

Deerfield Beach, Florida, 33442

Site Contact

Site Public Contact

305-243-2647

Gainesville, Florida

Status

Active, not recruiting

Address

University of Florida Health Science Center - Gainesville

Gainesville, Florida, 32610

Miami, Florida

Status

Active, not recruiting

Address

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, 33136

Plantation, Florida

Status

Recruiting

Address

UM Sylvester Comprehensive Cancer Center at Plantation

Plantation, Florida, 33324

Site Contact

Site Public Contact

305-243-2647

Tampa, Florida

Status

Suspended

Address

Moffitt Cancer Center-International Plaza

Tampa, Florida, 33607

Moffitt Cancer Center - McKinley Campus, Tampa, Florida

Status

Recruiting

Address

Moffitt Cancer Center - McKinley Campus

Tampa, Florida, 33612

Site Contact

Site Public Contact

[email protected]

800-679-0775

Moffitt Cancer Center, Tampa, Florida

Status

Recruiting

Address

Moffitt Cancer Center

Tampa, Florida, 33612

Site Contact

Site Public Contact

[email protected]

800-679-0775

Emory Proton Therapy Center, Atlanta, Georgia

Status

Recruiting

Address

Emory Proton Therapy Center

Atlanta, Georgia, 30308

Site Contact

Site Public Contact

[email protected]

404-251-2854

Emory University Hospital Midtown, Atlanta, Georgia

Status

Recruiting

Address

Emory University Hospital Midtown

Atlanta, Georgia, 30308

Site Contact

Site Public Contact

888-946-7447

Atlanta, Georgia

Status

Suspended

Address

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322

Savannah, Georgia

Status

Suspended

Address

Memorial Health University Medical Center

Savannah, Georgia, 31404

Northwestern University, Chicago, Illinois

Status

Recruiting

Address

Northwestern University

Chicago, Illinois, 60611

Site Contact

Site Public Contact

[email protected]

312-695-1301

Chicago, Illinois

Status

Recruiting

Address

John H Stroger Jr Hospital of Cook County

Chicago, Illinois, 60612

Site Contact

Site Public Contact

312-864-5204

University of Illinois, Chicago, Illinois

Status

Recruiting

Address

University of Illinois

Chicago, Illinois, 60612

Site Contact

Site Public Contact

312-355-3046

Carle at The Riverfront, Danville, Illinois

Status

Recruiting

Address

Carle at The Riverfront

Danville, Illinois, 61832

Site Contact

Site Public Contact

[email protected]

800-446-5532

Decatur, Illinois

Status

Suspended

Address

Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, 62526

Decatur Memorial Hospital, Decatur, Illinois

Status

Recruiting

Address

Decatur Memorial Hospital

Decatur, Illinois, 62526

Site Contact

Site Public Contact

[email protected]

217-876-4762

DeKalb, Illinois

Status

Recruiting

Address

Northwestern Medicine Cancer Center Kishwaukee

DeKalb, Illinois, 60115

Site Contact

Site Public Contact

[email protected]

630-352-5360

Carle Physician Group-Effingham, Effingham, Illinois

Status

Recruiting

Address

Carle Physician Group-Effingham

Effingham, Illinois, 62401

Site Contact

Site Public Contact

[email protected]

800-446-5532

Crossroads Cancer Center, Effingham, Illinois

Status

Recruiting

Address

Crossroads Cancer Center

Effingham, Illinois, 62401

Site Contact

Site Public Contact

[email protected]

217-876-4762

Geneva, Illinois

Status

Recruiting

Address

Northwestern Medicine Cancer Center Delnor

Geneva, Illinois, 60134

Site Contact

Site Public Contact

[email protected]

630-352-5360

Lake Forest, Illinois

Status

Active, not recruiting

Address

Northwestern Medicine Lake Forest Hospital

Lake Forest, Illinois, 60045

Carle Physician Group-Mattoon/Charleston, Mattoon, Illinois

Status

Recruiting

Address

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, 61938

Site Contact

Site Public Contact

[email protected]

800-446-5532

Loyola University Medical Center, Maywood, Illinois

Status

Recruiting

Address

Loyola University Medical Center

Maywood, Illinois, 60153

Site Contact

Site Public Contact

708-226-4357

HSHS Saint Elizabeth's Hospital, O'Fallon, Illinois

Status

Recruiting

Address

HSHS Saint Elizabeth's Hospital

O'Fallon, Illinois, 62269

Site Contact

Site Public Contact

[email protected]

217-876-4762

Springfield, Illinois

Status

Recruiting

Address

Southern Illinois University School of Medicine

Springfield, Illinois, 62702

Site Contact

Site Public Contact

217-545-7929

Springfield Clinic, Springfield, Illinois

Status

Recruiting

Address

Springfield Clinic

Springfield, Illinois, 62702

Site Contact

Site Public Contact

800-444-7541

Springfield Memorial Hospital, Springfield, Illinois

Status

Recruiting

Address

Springfield Memorial Hospital

Springfield, Illinois, 62781

Site Contact

Site Public Contact

[email protected]

217-528-7541

Carle Cancer Center, Urbana, Illinois

Status

Recruiting

Address

Carle Cancer Center

Urbana, Illinois, 61801

Site Contact

Site Public Contact

[email protected]

800-446-5532

The Carle Foundation Hospital, Urbana, Illinois

Status

Suspended

Address

The Carle Foundation Hospital

Urbana, Illinois, 61801

Warrenville, Illinois

Status

Recruiting

Address

Northwestern Medicine Cancer Center Warrenville

Warrenville, Illinois, 60555

Site Contact

Site Public Contact

[email protected]

630-352-5360

Reid Health, Richmond, Indiana

Status

Recruiting

Address

Reid Health

Richmond, Indiana, 47374

Site Contact

Site Public Contact

[email protected]

937-528-2900

Ankeny, Iowa

Status

Recruiting

Address

UI Health Care Mission Cancer and Blood - Ankeny Clinic

Ankeny, Iowa, 50023

Site Contact

Site Public Contact

515-241-3305

Heartland Oncology and Hematology LLP, Council Bluffs, Iowa

Status

Recruiting

Address

Heartland Oncology and Hematology LLP

Council Bluffs, Iowa, 51503

Site Contact

Site Public Contact

712-322-4136

Methodist Jennie Edmundson Hospital, Council Bluffs, Iowa

Status

Recruiting

Address

Methodist Jennie Edmundson Hospital

Council Bluffs, Iowa, 51503

Site Contact

Site Public Contact

[email protected]

402-354-7939

Iowa Methodist Medical Center, Des Moines, Iowa

Status

Recruiting

Address

Iowa Methodist Medical Center

Des Moines, Iowa, 50309

Site Contact

Site Public Contact

515-241-6727

Des Moines, Iowa

Status

Recruiting

Address

UI Health Care Mission Cancer and Blood - Des Moines Clinic

Des Moines, Iowa, 50309

Site Contact

Site Public Contact

515-241-3305

Broadlawns Medical Center, Des Moines, Iowa

Status

Recruiting

Address

Broadlawns Medical Center

Des Moines, Iowa, 50314

Site Contact

Site Public Contact

515-282-2200

Iowa Lutheran Hospital, Des Moines, Iowa

Status

Suspended

Address

Iowa Lutheran Hospital

Des Moines, Iowa, 50316

Waukee, Iowa

Status

Recruiting

Address

UI Health Care Mission Cancer and Blood - Waukee Clinic

Waukee, Iowa, 50263

Site Contact

Site Public Contact

515-241-3305

Methodist West Hospital, West Des Moines, Iowa

Status

Suspended

Address

Methodist West Hospital

West Des Moines, Iowa, 50266-7700

University of Kansas Cancer Center, Kansas City, Kansas

Status

Active, not recruiting

Address

University of Kansas Cancer Center

Kansas City, Kansas, 66160

Overland Park, Kansas

Status

Active, not recruiting

Address

University of Kansas Cancer Center-Overland Park

Overland Park, Kansas, 66210

Overland Park, Kansas

Status

Active, not recruiting

Address

University of Kansas Hospital-Indian Creek Campus

Overland Park, Kansas, 66211

Westwood, Kansas

Status

Active, not recruiting

Address

University of Kansas Hospital-Westwood Cancer Center

Westwood, Kansas, 66205

Lexington, Kentucky

Status

Recruiting

Address

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, 40536

Site Contact

Site Public Contact

859-257-3379

Louisville, Kentucky

Status

Recruiting

Address

The James Graham Brown Cancer Center at University of Louisville

Louisville, Kentucky, 40202

Site Contact

Site Public Contact

502-562-3429

UofL Health Medical Center Northeast, Louisville, Kentucky

Status

Recruiting

Address

UofL Health Medical Center Northeast

Louisville, Kentucky, 40245

Site Contact

Site Public Contact

[email protected]

502-852-2755

Maryland Proton Treatment Center, Baltimore, Maryland

Status

Suspended

Address

Maryland Proton Treatment Center

Baltimore, Maryland, 21201

Baltimore, Maryland

Status

Recruiting

Address

University of Maryland/Greenebaum Cancer Center

Baltimore, Maryland, 21201

Site Contact

Site Public Contact

800-888-8823

Columbia, Maryland

Status

Recruiting

Address

Central Maryland Radiation Oncology in Howard County

Columbia, Maryland, 21044

Site Contact

Site Public Contact

443-546-1300

Glen Burnie, Maryland

Status

Recruiting

Address

UM Baltimore Washington Medical Center/Tate Cancer Center

Glen Burnie, Maryland, 21061

Site Contact

Site Public Contact

410-553-8100

Tufts Medical Center, Boston, Massachusetts

Status

Recruiting

Address

Tufts Medical Center

Boston, Massachusetts, 02111

Site Contact

Site Public Contact

[email protected]

617-636-5000

Ann Arbor, Michigan

Status

Recruiting

Address

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109

Site Contact

Site Public Contact

[email protected]

800-865-1125

Detroit, Michigan

Status

Active, not recruiting

Address

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, 48201

Weisberg Cancer Treatment Center, Farmington Hills, Michigan

Status

Active, not recruiting

Address

Weisberg Cancer Treatment Center

Farmington Hills, Michigan, 48334

Sanford Joe Lueken Cancer Center, Bemidji, Minnesota

Status

Recruiting

Address

Sanford Joe Lueken Cancer Center

Bemidji, Minnesota, 56601

Site Contact

Site Public Contact

[email protected]

218-333-5000

University of Mississippi Medical Center, Jackson, Mississippi

Status

Recruiting

Address

University of Mississippi Medical Center

Jackson, Mississippi, 39216

Site Contact

Site Public Contact

601-815-6700

Saint Francis Medical Center, Cape Girardeau, Missouri

Status

Suspended

Address

Saint Francis Medical Center

Cape Girardeau, Missouri, 63703

Creve Coeur, Missouri

Status

Active, not recruiting

Address

Siteman Cancer Center at West County Hospital

Creve Coeur, Missouri, 63141

Kansas City, Missouri

Status

Active, not recruiting

Address

University of Kansas Cancer Center - North

Kansas City, Missouri, 64154

Lee's Summit, Missouri

Status

Active, not recruiting

Address

University of Kansas Cancer Center - Lee's Summit

Lee's Summit, Missouri, 64064

North Kansas City, Missouri

Status

Active, not recruiting

Address

University of Kansas Cancer Center at North Kansas City Hospital

North Kansas City, Missouri, 64116

Washington University School of Medicine, Saint Louis, Missouri

Status

Active, not recruiting

Address

Washington University School of Medicine

Saint Louis, Missouri, 63110

Mercy Hospital South, Saint Louis, Missouri

Status

Recruiting

Address

Mercy Hospital South

Saint Louis, Missouri, 63128

Site Contact

Site Public Contact

[email protected]

314-525-6042

Siteman Cancer Center-South County, Saint Louis, Missouri

Status

Active, not recruiting

Address

Siteman Cancer Center-South County

Saint Louis, Missouri, 63129

Saint Louis, Missouri

Status

Active, not recruiting

Address

Siteman Cancer Center at Christian Hospital

Saint Louis, Missouri, 63136

Mercy Hospital Saint Louis, Saint Louis, Missouri

Status

Recruiting

Address

Mercy Hospital Saint Louis

Saint Louis, Missouri, 63141

Site Contact

Site Public Contact

314-251-7066

Saint Peters, Missouri

Status

Active, not recruiting

Address

Siteman Cancer Center at Saint Peters Hospital

Saint Peters, Missouri, 63376

Mercy Hospital Springfield, Springfield, Missouri

Status

Suspended

Address

Mercy Hospital Springfield

Springfield, Missouri, 65804

Benefis Sletten Cancer Institute, Great Falls, Montana

Status

Recruiting

Address

Benefis Sletten Cancer Institute

Great Falls, Montana, 59405

Site Contact

Site Public Contact

[email protected]

406-969-6060

Logan Health Medical Center, Kalispell, Montana

Status

Recruiting

Address

Logan Health Medical Center

Kalispell, Montana, 59901

Site Contact

Site Public Contact

[email protected]

406-969-6060

Community Medical Center, Missoula, Montana

Status

Recruiting

Address

Community Medical Center

Missoula, Montana, 59804

Site Contact

Site Public Contact

[email protected]

406-969-6060

Omaha, Nebraska

Status

Recruiting

Address

Nebraska Cancer Specialists/Oncology Hematology West PC - MECC

Omaha, Nebraska, 68114

Site Contact

Site Public Contact

402-334-4773

Nebraska Methodist Hospital, Omaha, Nebraska

Status

Recruiting

Address

Nebraska Methodist Hospital

Omaha, Nebraska, 68114

Site Contact

Site Public Contact

402-354-5144

Oncology Associates PC, Omaha, Nebraska

Status

Recruiting

Address

Oncology Associates PC

Omaha, Nebraska, 68114

Site Contact

Site Public Contact

[email protected]

402-354-5860

University of New Mexico Cancer Center, Albuquerque, New Mexico

Status

Recruiting

Address

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87106

Site Contact

Site Public Contact

[email protected]

505-925-0348

Bronx, New York

Status

Recruiting

Address

Montefiore Medical Center-Einstein Campus

Bronx, New York, 10461

Site Contact

Site Public Contact

[email protected]

718-379-6866

Montefiore Medical Center - Moses Campus, Bronx, New York

Status

Recruiting

Address

Montefiore Medical Center - Moses Campus

Bronx, New York, 10467

Site Contact

Site Public Contact

[email protected]

718-379-6866

Mount Sinai Union Square, New York, New York

Status

Recruiting

Address

Mount Sinai Union Square

New York, New York, 10003

Site Contact

Site Public Contact

[email protected]

212-824-7309

Mount Sinai Chelsea, New York, New York

Status

Recruiting

Address

Mount Sinai Chelsea

New York, New York, 10011

Site Contact

Site Public Contact

[email protected]

212-824-7309

Mount Sinai Hospital, New York, New York

Status

Recruiting

Address

Mount Sinai Hospital

New York, New York, 10029

Site Contact

Site Public Contact

[email protected]

212-824-7309

Stony Brook University Medical Center, Stony Brook, New York

Status

Recruiting

Address

Stony Brook University Medical Center

Stony Brook, New York, 11794

Site Contact

Site Public Contact

800-862-2215

Randolph Hospital, Asheboro, North Carolina

Status

Suspended

Address

Randolph Hospital

Asheboro, North Carolina, 27203

Cone Health Cancer Center, Greensboro, North Carolina

Status

Recruiting

Address

Cone Health Cancer Center

Greensboro, North Carolina, 27403

Site Contact

Site Public Contact

[email protected]

336-832-0836

Annie Penn Memorial Hospital, Reidsville, North Carolina

Status

Recruiting

Address

Annie Penn Memorial Hospital

Reidsville, North Carolina, 27320

Site Contact

Site Public Contact

[email protected]

336-832-0836

Sanford Bismarck Medical Center, Bismarck, North Dakota

Status

Recruiting

Address

Sanford Bismarck Medical Center

Bismarck, North Dakota, 58501

Site Contact

Site Public Contact

[email protected]

701-323-5760

Sanford Roger Maris Cancer Center, Fargo, North Dakota

Status

Recruiting

Address

Sanford Roger Maris Cancer Center

Fargo, North Dakota, 58122

Site Contact

Site Public Contact

[email protected]

701-234-6161

Indu and Raj Soin Medical Center, Beavercreek, Ohio

Status

Recruiting

Address

Indu and Raj Soin Medical Center

Beavercreek, Ohio, 45431

Site Contact

Site Public Contact

[email protected]

937-528-2900

Dayton Physicians LLC-Miami Valley South, Centerville, Ohio

Status

Recruiting

Address

Dayton Physicians LLC-Miami Valley South

Centerville, Ohio, 45459

Site Contact

Site Public Contact

[email protected]

937-528-2900

Miami Valley Hospital South, Centerville, Ohio

Status

Recruiting

Address

Miami Valley Hospital South

Centerville, Ohio, 45459

Site Contact

Site Public Contact

[email protected]

937-528-2900

Cleveland Clinic Foundation, Cleveland, Ohio

Status

Recruiting

Address

Cleveland Clinic Foundation

Cleveland, Ohio, 44195

Site Contact

Site Public Contact

[email protected]

866-223-8100

Premier Blood and Cancer Center, Dayton, Ohio

Status

Recruiting

Address

Premier Blood and Cancer Center

Dayton, Ohio, 45409

Site Contact

Site Public Contact

937-276-8320

Dayton Physician LLC - Englewood, Dayton, Ohio

Status

Recruiting

Address

Dayton Physician LLC - Englewood

Dayton, Ohio, 45415

Site Contact

Site Public Contact

[email protected]

937-528-2900

Miami Valley Hospital North, Dayton, Ohio

Status

Recruiting

Address

Miami Valley Hospital North

Dayton, Ohio, 45415

Site Contact

Site Public Contact

[email protected]

937-528-2900

Franklin, Ohio

Status

Recruiting

Address

Atrium Medical Center-Middletown Regional Hospital

Franklin, Ohio, 45005-1066

Site Contact

Site Public Contact

[email protected]

937-528-2900

Dayton Physicians LLC-Atrium, Franklin, Ohio

Status

Recruiting

Address

Dayton Physicians LLC-Atrium

Franklin, Ohio, 45005

Site Contact

Site Public Contact

[email protected]

937-528-2900

Miami Valley Cancer Care and Infusion, Greenville, Ohio

Status

Recruiting

Address

Miami Valley Cancer Care and Infusion

Greenville, Ohio, 45331

Site Contact

Site Public Contact

937-569-7515

Greater Dayton Cancer Center, Kettering, Ohio

Status

Recruiting

Address

Greater Dayton Cancer Center

Kettering, Ohio, 45409

Site Contact

Site Public Contact

[email protected]

937-528-2900

Kettering Medical Center, Kettering, Ohio

Status

Recruiting

Address

Kettering Medical Center

Kettering, Ohio, 45429

Site Contact

Site Public Contact

[email protected]

937-528-2900

Upper Valley Medical Center, Troy, Ohio

Status

Recruiting

Address

Upper Valley Medical Center

Troy, Ohio, 45373

Site Contact

Site Public Contact

[email protected]

937-528-2900

Lawton, Oklahoma

Status

Recruiting

Address

Cancer Centers of Southwest Oklahoma Research

Lawton, Oklahoma, 73505

Site Contact

Site Public Contact

877-231-4440

Oklahoma City, Oklahoma

Status

Recruiting

Address

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104

Site Contact

Site Public Contact

[email protected]

405-271-8777

Clackamas Radiation Oncology Center, Clackamas, Oregon

Status

Suspended

Address

Clackamas Radiation Oncology Center

Clackamas, Oregon, 97015

Clackamas, Oregon

Status

Suspended

Address

Providence Cancer Institute Clackamas Clinic

Clackamas, Oregon, 97015

Providence Newberg Medical Center, Newberg, Oregon

Status

Recruiting

Address

Providence Newberg Medical Center

Newberg, Oregon, 97132

Site Contact

Site Public Contact

[email protected]

503-215-2614

Providence Portland Medical Center, Portland, Oregon

Status

Recruiting

Address

Providence Portland Medical Center

Portland, Oregon, 97213

Site Contact

Site Public Contact

[email protected]

503-215-2614

Providence Saint Vincent Medical Center, Portland, Oregon

Status

Recruiting

Address

Providence Saint Vincent Medical Center

Portland, Oregon, 97225

Site Contact

Site Public Contact

[email protected]

503-215-2614

UPMC Altoona, Altoona, Pennsylvania

Status

Recruiting

Address

UPMC Altoona

Altoona, Pennsylvania, 16601

Site Contact

Site Public Contact

[email protected]

Geisinger Medical Center, Danville, Pennsylvania

Status

Recruiting

Address

Geisinger Medical Center

Danville, Pennsylvania, 17822

Site Contact

Site Public Contact

[email protected]

570-271-5251

Geisinger Medical Oncology-Lewisburg, Lewisburg, Pennsylvania

Status

Recruiting

Address

Geisinger Medical Oncology-Lewisburg

Lewisburg, Pennsylvania, 17837

Site Contact

Site Public Contact

[email protected]

570-374-8555

Thomas Jefferson University Hospital, Philadelphia, Pennsylvania

Status

Recruiting

Address

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107

Site Contact

Site Public Contact

[email protected]

215-600-9151

Fox Chase Cancer Center, Philadelphia, Pennsylvania

Status

Recruiting

Address

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111

Site Contact

Site Public Contact

215-728-4790

Jefferson Torresdale Hospital, Philadelphia, Pennsylvania

Status

Recruiting

Address

Jefferson Torresdale Hospital

Philadelphia, Pennsylvania, 19114

Site Contact

Site Public Contact

[email protected]

215-600-9151

Temple University Hospital, Philadelphia, Pennsylvania

Status

Active, not recruiting

Address

Temple University Hospital

Philadelphia, Pennsylvania, 19140

UPMC-Saint Margaret, Pittsburgh, Pennsylvania

Status

Recruiting

Address

UPMC-Saint Margaret

Pittsburgh, Pennsylvania, 15215

Site Contact

Site Public Contact

412-784-4900

Pittsburgh, Pennsylvania

Status

Recruiting

Address

University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, Pennsylvania, 15232

Site Contact

Site Public Contact

412-647-8073

UPMC-Shadyside Hospital, Pittsburgh, Pennsylvania

Status

Active, not recruiting

Address

UPMC-Shadyside Hospital

Pittsburgh, Pennsylvania, 15232

UPMC-Passavant Hospital, Pittsburgh, Pennsylvania

Status

Recruiting

Address

UPMC-Passavant Hospital

Pittsburgh, Pennsylvania, 15237

Site Contact

Site Public Contact

412-367-6454

Wilkes-Barre, Pennsylvania

Status

Recruiting

Address

Geisinger Wyoming Valley/Henry Cancer Center

Wilkes-Barre, Pennsylvania, 18711

Site Contact

Site Public Contact

[email protected]

570-271-5251

UPMC Memorial, York, Pennsylvania

Status

Recruiting

Address

UPMC Memorial

York, Pennsylvania, 17408

Site Contact

Site Public Contact

717-724-6760

Medical University of South Carolina, Charleston, South Carolina

Status

Recruiting

Address

Medical University of South Carolina

Charleston, South Carolina, 29425

Site Contact

Site Public Contact

[email protected]

843-792-9321

Avera Cancer Institute, Sioux Falls, South Dakota

Status

Recruiting

Address

Avera Cancer Institute

Sioux Falls, South Dakota, 57105

Site Contact

Site Public Contact

[email protected]

605-322-3095

Sanford USD Medical Center - Sioux Falls, Sioux Falls, South Dakota

Status

Recruiting

Address

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, 57117-5134

Site Contact

Site Public Contact

[email protected]

605-312-3320

Avera Cancer Institute at Yankton, Yankton, South Dakota

Status

Recruiting

Address

Avera Cancer Institute at Yankton

Yankton, South Dakota, 57078

Site Contact

Site Public Contact

[email protected]

605-322-3095

Nashville, Tennessee

Status

Recruiting

Address

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, 37232

Site Contact

Site Public Contact

800-811-8480

Salt Lake City, Utah

Status

Active, not recruiting

Address

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, 84112

VCU Massey Cancer Center at Stony Point, Richmond, Virginia

Status

Recruiting

Address

VCU Massey Cancer Center at Stony Point

Richmond, Virginia, 23235

Site Contact

Site Public Contact

[email protected]

Richmond, Virginia

Status

Recruiting

Address

Virginia Commonwealth University/Massey Cancer Center

Richmond, Virginia, 23298

Site Contact

Site Public Contact

[email protected]

ThedaCare Regional Cancer Center, Appleton, Wisconsin

Status

Recruiting

Address

ThedaCare Regional Cancer Center

Appleton, Wisconsin, 54911

Site Contact

Site Public Contact

[email protected]

920-364-3604

HSHS Sacred Heart Hospital, Eau Claire, Wisconsin

Status

Suspended

Address

HSHS Sacred Heart Hospital

Eau Claire, Wisconsin, 54701

Green Bay, Wisconsin

Status

Recruiting

Address

Saint Vincent Hospital Cancer Center Green Bay

Green Bay, Wisconsin, 54301

Site Contact

Site Public Contact

[email protected]

920-433-8889

Green Bay, Wisconsin

Status

Recruiting

Address

Saint Vincent Hospital Cancer Center at Saint Mary's

Green Bay, Wisconsin, 54303

Site Contact

Site Public Contact

[email protected]

920-433-8889

Froedtert Menomonee Falls Hospital, Menomonee Falls, Wisconsin

Status

Recruiting

Address

Froedtert Menomonee Falls Hospital

Menomonee Falls, Wisconsin, 53051

Site Contact

Site Public Contact

262-257-5100

Medical College of Wisconsin, Milwaukee, Wisconsin

Status

Recruiting

Address

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226

Site Contact

Site Public Contact

414-805-3666

Drexel Town Square Health Center, Oak Creek, Wisconsin

Status

Recruiting

Address

Drexel Town Square Health Center

Oak Creek, Wisconsin, 53154

Site Contact

Site Public Contact

414-805-0505

Sturgeon Bay, Wisconsin

Status

Recruiting

Address

Saint Vincent Hospital Cancer Center at Sturgeon Bay

Sturgeon Bay, Wisconsin, 54235-1495

Site Contact

Site Public Contact

[email protected]

920-433-8889

West Bend, Wisconsin

Status

Recruiting

Address

Froedtert West Bend Hospital/Kraemer Cancer Center

West Bend, Wisconsin, 53095

Site Contact

Site Public Contact

414-805-0505

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