De-intensified Radiation Therapy With Chemotherapy (Cisplatin) or Immunotherapy (Nivolumab) in Treating Patients With Early-Stage, HPV-Positive, Non-Smoking Associated Oropharyngeal Cancer

NCT ID: NCT03952585

Last Updated: 2025-10-31

Study Results

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Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

384 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-09

Study Completion Date

2025-12-11

Brief Summary

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This phase II/III trial studies how well a reduced dose of radiation therapy works with nivolumab compared to cisplatin in treating patients with human papillomavirus (HPV)-positive oropharyngeal cancer that is early in its growth and may not have spread to other parts of the body (early-stage), and is not associated with smoking. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Chemotherapy drugs, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This trial is being done to see if a reduced dose of radiation therapy and nivolumab works as well as standard dose radiation therapy and cisplatin in treating patients with oropharyngeal cancer.

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Detailed Description

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PRIMARY OBJECTIVES:

I. To demonstrate non-inferiority in terms of progression-free survival (PFS) of concurrent reduced-dose radiation therapy (RT) with cisplatin or concurrent reduced-dose radiation therapy with nivolumab to the current standard of care (standard-dose RT with cisplatin). (Phase II) (Arm 2 \[concurrent reduced-dose RT with cisplatin\] was dropped after interim futility analysis in phase II.) II. To demonstrate non-inferiority in terms of progression-free survival (PFS) of concurrent reduced-dose radiation therapy (RT) with nivolumab to the current standard of care (standard-dose RT with cisplatin). (Phase II) III. To demonstrate co-primary endpoints of non-inferiority of PFS and superiority of quality of life (QOL) as measured by the MD Anderson Dysphagia Inventory (MDADI) of concurrent reduced-dose radiation with cisplatin or concurrent reduced-dose radiation with nivolumab to the current standard of care (standard-dose RT with cisplatin). (Phase III) (Arm 2 \[concurrent reduced-dose RT with cisplatin\] was dropped after interim futility analysis in phase II.) IV. To demonstrate co-primary endpoints of non-inferiority of PFS and superiority of quality of life (QOL) as measured by the MD Anderson Dysphagia Inventory \[MDADI\] of concurrent reduced-dose radiation with nivolumab to the current standard of care (standard-dose RT with cisplatin). (Phase III)

SECONDARY OBJECTIVES:

I. To compare patterns of failure (local and regional relapse versus distant) and overall survival between the experimental arm and the control arm.

II. To assess long term PFS, overall survival, and toxicity between the experimental arm and the control arm.

III. To determine acute and late toxicity profiles as measured by the Common Terminology Criteria for Adverse Events (CTCAE).

IV. To explore the symptomatic adverse events (AEs) for tolerability of each treatment arm as measured by the Patient-Reported Outcomes (PRO)-CTCAE.

V. To compare changes in patient-reported outcomes (Hearing Handicap Inventory for Adults-Screening \[HHIA-S\], European Organization for Research and Treatment of Cancer \[EORTC\]-Quality of Life Questionnaire \[QLQ\]30) between the experimental arm and the control arm.

VI. To assess the association of fludeoxyglucose F-18 (FDG)-positron emission tomography (PET)/computed tomography (CT) at baseline with locoregional control and PFS.

VII. To estimate the negative predictive value of the 12-14 weeks post-radiation therapy (RT) FDG-PET/CT in terms of locoregional control rates and PFS rates at 1 and 2 years.

EXPLORATORY OBJECTIVES:

I. To collect blood and tissue specimens for future translation research. II. To optimize radiotherapy treatment plan quality assurance methodology for radiotherapy planning and imaging.

III. To compare changes in patient-reported outcomes (European Quality of Life Five Dimension Five Level Scale \[EQ-5D-5L\]) between the experimental arm and the control arm.

IV. To collect Modified Barium Swallow (MBS) data for future review and analysis.

OUTLINE:

PHASE II: Patients are randomized to 1 of 3 arms.

ARM I: Patients undergo standard dose RT as 70 Gy intensity modulated radiation therapy (IMRT) or image-guided radiation therapy (IGRT) over 6 fractions per week and receive 100 mg/m\^2/day cisplatin intravenously (IV) over 30-60 minutes on days 1 and 22. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients receive fludeoxyglucose F-18 (FDG) and undergo positron emission tomography (PET)/computed tomography (CT) or CT during screening and during follow up, and undergo magnetic resonance imaging (MRI) during follow up. Patients may also undergo tissue biopsy and blood sample collection throughout the study.

ARM II (CLOSED TO ACCRUAL 03-FEB-2023): Patients undergo reduced dose RT as 60 Gy IMRT or IGRT once daily (QD) over 5 fractions per week and receive 100 mg/m\^2/day cisplatin IV over 30-60 minutes on days 1 and 22. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients receive FDG and undergo PET/CT or CT during screening and during follow up, and undergo MRI during follow up. Patients may also undergo tissue biopsy and blood sample collection throughout the study.

ARM III: Beginning 1 week prior to radiation, patients receive 240 mg fixed dose nivolumab IV over 30 minutes on day 1. Treatment repeats every 2 weeks (14 days) for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo reduced dose RT as 60 Gy IMRT or IGRT over 6 fractions per week for 5 weeks in the absence of disease progression or unacceptable toxicity. Patients receive FDG and undergo PET/CT or CT during screening and during follow up, and undergo MRI during follow up. Patients may also undergo tissue biopsy and blood sample collection throughout the study.

PHASE III: Patients are randomized to Arm I and/or Arm III.

After completion of study treatment, patients are followed up at 12-14 weeks, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Conditions

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Basaloid Squamous Cell Carcinoma Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 Oropharyngeal Squamous Cell Carcinoma Papillary Squamous Cell Carcinoma Pathologic Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 Pathologic Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 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 I (Standard RT + cisplatin)

Patients undergo standard dose RT as 70 Gy IMRT or IGRT over 6 fractions per week and receive 100 mg/m\^2/day cisplatin IV over 30-60 minutes on days 1 and 22. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients receive FDG and undergo PET/CT or CT during screening and during follow up, and undergo MRI during follow up. Patients may also undergo tissue biopsy and blood sample collection throughout the study.

Group Type ACTIVE_COMPARATOR

Biopsy Procedure

Intervention Type PROCEDURE

Undergo tissue biopsy

Biospecimen Collection

Intervention Type PROCEDURE

Undergo blood sample collection

Cisplatin

Intervention Type DRUG

Given IV

Computed Tomography

Intervention Type PROCEDURE

Undergo CT

Fludeoxyglucose F-18

Intervention Type OTHER

Receive FDG

Image Guided Radiation Therapy

Intervention Type RADIATION

Undergo IGRT

Intensity-Modulated Radiation Therapy

Intervention Type RADIATION

Undergo IMRT

Magnetic Resonance Imaging

Intervention Type PROCEDURE

Undergo MRI

Positron Emission Tomography

Intervention Type PROCEDURE

Undergo PET

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Arm II (Reduced RT + cisplatin)

Patients undergo reduced dose RT as 60 Gy IMRT or IGRT QD over 5 fractions per week and receive 100 mg/m\^2/day cisplatin IV over 30-60 minutes on days 1 and 22. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients receive FDG and undergo PET/CT or CT during screening and during follow up, and undergo MRI during follow up. Patients may also undergo tissue biopsy and blood sample collection throughout the study.

Group Type EXPERIMENTAL

Biopsy Procedure

Intervention Type PROCEDURE

Undergo tissue biopsy

Biospecimen Collection

Intervention Type PROCEDURE

Undergo blood sample collection

Cisplatin

Intervention Type DRUG

Given IV

Computed Tomography

Intervention Type PROCEDURE

Undergo CT

Fludeoxyglucose F-18

Intervention Type OTHER

Receive FDG

Image Guided Radiation Therapy

Intervention Type RADIATION

Undergo IGRT

Intensity-Modulated Radiation Therapy

Intervention Type RADIATION

Undergo IMRT

Magnetic Resonance Imaging

Intervention Type PROCEDURE

Undergo MRI

Positron Emission Tomography

Intervention Type PROCEDURE

Undergo PET

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Arm III (Reduced RT + nivolumab)

Beginning 1 week prior to radiation, patients receive 240 mg fixed dose nivolumab IV over 30 minutes on day 1. Treatment repeats every 2 weeks (14 days) for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo reduced dose RT as 60 Gy IMRT or IGRT over 6 fractions per week for 5 weeks in the absence of disease progression or unacceptable toxicity. Patients receive FDG and undergo PET/CT or CT during screening and during follow up, and undergo MRI during follow up. Patients may also undergo tissue biopsy and blood sample collection throughout the study.

Group Type EXPERIMENTAL

Biopsy Procedure

Intervention Type PROCEDURE

Undergo tissue biopsy

Biospecimen Collection

Intervention Type PROCEDURE

Undergo blood sample collection

Computed Tomography

Intervention Type PROCEDURE

Undergo CT

Fludeoxyglucose F-18

Intervention Type OTHER

Receive FDG

Image Guided Radiation Therapy

Intervention Type RADIATION

Undergo IGRT

Intensity-Modulated Radiation Therapy

Intervention Type RADIATION

Undergo IMRT

Nivolumab

Intervention Type BIOLOGICAL

Given IV

Positron Emission Tomography

Intervention Type PROCEDURE

Undergo PET

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Biopsy Procedure

Undergo tissue biopsy

Intervention Type PROCEDURE

Biospecimen Collection

Undergo blood sample collection

Intervention Type PROCEDURE

Cisplatin

Given IV

Intervention Type DRUG

Computed Tomography

Undergo CT

Intervention Type PROCEDURE

Fludeoxyglucose F-18

Receive FDG

Intervention Type OTHER

Image Guided Radiation Therapy

Undergo IGRT

Intervention Type RADIATION

Intensity-Modulated Radiation Therapy

Undergo IMRT

Intervention Type RADIATION

Magnetic Resonance Imaging

Undergo MRI

Intervention Type PROCEDURE

Nivolumab

Given IV

Intervention Type BIOLOGICAL

Positron Emission Tomography

Undergo PET

Intervention Type PROCEDURE

Quality-of-Life Assessment

Ancillary studies

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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Biopsy BIOPSY_TYPE Bx Biological Sample Collection Biospecimen Collected Specimen Collection 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 18FDG FDG Fludeoxyglucose (18F) fludeoxyglucose F 18 Fludeoxyglucose F18 Fluorine-18 2-Fluoro-2-deoxy-D-Glucose Fluorodeoxyglucose F18 IGRT Image Guided Radiotherapy image-guided radiation therapy Image-Guided Radiotherapy 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 ABP 206 BCD-263 BMS 936558 BMS-936558 BMS936558 CMAB819 MDX 1106 MDX-1106 MDX1106 NIVO Nivolumab Biosimilar ABP 206 Nivolumab Biosimilar BCD-263 Nivolumab Biosimilar CMAB819 ONO 4538 ONO-4538 ONO4538 Opdivo Medical Imaging, Positron Emission Tomography PET PET Scan Positron emission tomography (procedure) Positron Emission Tomography Scan Positron-Emission Tomography PT Quality of Life Assessment

Eligibility Criteria

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Inclusion Criteria

* Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma (including the histological variants papillary squamous cell carcinoma and basaloid squamous cell carcinoma but not neuroendocrine phenotype) of the oropharynx (tonsil, base of tongue, soft palate, or oropharyngeal walls); cytologic diagnosis from a cervical lymph node is sufficient in the presence of clinical evidence of a primary tumor in the oropharynx. Clinical evidence should be documented, may consist of palpation, imaging, or endoscopic evaluation, and should be sufficient to estimate the size of the primary (for T stage)
* Patients must have clinically or radiographically evident measurable disease at the primary site or at nodal stations. Simple tonsillectomy or local excision of the primary without removal of nodal disease is permitted, as is excision removing gross nodal disease but with intact primary site. Limited neck dissections retrieving =\< 4 nodes are permitted and considered as non-therapeutic nodal excisions
* P16-positive based on local site immunohistochemical tissue staining (defined as greater than 70% strong diffuse nuclear or nuclear and cytoplasmic staining of tumor cells). Fine needle aspiration (FNA) biopsy specimens may be used as the sole diagnostic tissue. Centers are encouraged to contact the pathology chair for clarification

* Note: Institutions must screen patients, whose tumors must be p16-positive by immunohistochemistry (IHC) in order to be eligible for the trial using a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory. A rigorous laboratory accreditation process similar to the United States (U.S.) CLIA certification, such as the provincial accreditation status offered by the Ontario Laboratory Accreditation (OLA) Program in Canada, the College of American Pathologists (CAP), or an equivalent accreditation in other countries, is acceptable. The p16-positive results must be reported on the pathology report being submitted
* Note: If p16 result is equivocal, positive HPV deoxyribonucleic acid (DNA) test of tumor specimen is acceptable and fulfills the eligibility criteria
* Clinical stage T1-2, N1, M0 (American Joint Committee on Cancer \[AJCC\], 8th edition \[ed.\]) or T3, N0-N1, M0 (AJCC, 8th ed.) including no distant metastases based on the following diagnostic workup:

* General history and physical examination within 56 days prior to registration;
* Exam with laryngopharyngoscopy (mirror or in office direct procedure acceptable) within 70 days prior to registration;
* One of the following imaging studies is required within 56 days prior to registration:

* FDG-PET/CT of the neck and chest (with or without contrast); FDG-PET/CT scan is strongly preferred and highly recommended to be used for eligibility OR
* Chest CT (with or without contrast)
* One of the following imaging studies is required within 28 days prior to registration:

* A diagnostic CT scan of neck (with contrast and of diagnostic quality) OR
* An magnetic resonance imaging (MRI) of the neck (with contrast and of diagnostic quality)
* Note: A diagnostic quality CT or MRI with contrast or FDG-PET/CT scan of neck performed for the purposes of radiation planning may serve as both staging and planning tools
* Patients must provide their personal smoking history prior to registration. The lifetime cumulative history cannot exceed 10 pack-years. The following formula is used to calculate the pack-years during the periods of smoking in the patient's life; the cumulative total of the number of pack-years during each period of active smoking is the lifetime cumulative history

* Number of pack-years = \[Frequency of smoking (number of cigarettes per day) x duration of cigarette smoking (years)\] / 20
* Note: Twenty cigarettes is considered equivalent to one pack. The effect of non-cigarette tobacco products on the survival of patients with p16-positive oropharyngeal cancers is undefined. While there are reportedly increased risks of head and neck cancer associated with sustained heavy cigar and pipe use (Wyss 2013), such sustained use of non-cigarette products is unusual and does not appear to convey added risk with synchronous cigarette smoking. Cigar and pipe tobacco consumption is therefore not included in calculating the lifetime pack-years. Marijuana consumption is likewise not considered in this calculation. There is no clear scientific evidence regarding the role of chewing tobacco-containing products in this disease, although this is possibly more concerning given the proximity of the oral cavity and oropharynx. In any case, investigators are discouraged from enrolling patients with a history of very sustained use (such as several years or more) of non-cigarette tobacco products alone
* Zubrod performance status of 0-1 within 14 days prior to registration
* Age \>= 18
* Absolute neutrophil count \>= 1,500/mcL (within 14 days prior to registration)
* Platelets \>= 100,000/mcL (within 14 days prior to registration)
* Hemoglobin \>= 8.0 g/dL (within 14 days prior to registration) (Note: use of transfusion or other intervention to achieve hemoglobin \[Hgb\] \>= 8.0 g/dL is acceptable)
* Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN) (within 14 days prior to registration)
* Aspartate aminotransferase (AST)(serum glutamic-oxaloacetic transaminase \[SGOT\]) or alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase \[SGPT\]) =\< 3.0 x institutional ULN (within 14 days prior to registration)
* Serum creatinine =\< 1.5 x ULN OR creatinine clearance (CrCl) \>= 50 mL/min (if using the Cockcroft-Gault formula) (within 14 days prior to registration)
* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated

* Note: Known positive test for hepatitis B virus surface antigen (HBV sAg) indicating acute or chronic infection would make the patient ineligible unless the viral load becomes undetectable on suppressive therapy. Patients who are immune to hepatitis B (anti-hepatitis B surface antibody positive) are eligible (e.g. patients immunized against hepatitis B)
* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment for the hepatitis, they are eligible if they have an undetectable HCV viral load.

* Note: Known positive test for hepatitis C virus ribonucleic acid (HCV RNA) indicating acute or chronic infection would make the patient ineligible unless the viral load becomes undetectable on suppressive therapy
* For women of childbearing potential (WOCBP), negative serum or urine pregnancy test within 24 hours prior to registration

* Women of childbearing potential (WOCBP) is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal. Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes. In addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU/mL
* Women of childbearing potential (WOCBP) and men who are sexually active with WOCBP must be willing to use an adequate method of contraception during and after treatment
* The patient or a legally authorized representative must provide study-specific informed consent prior to study entry
* Only English, Spanish, or French speaking patients are eligible to participate as these are the only languages for which the mandatory dysphagia-related patient reported instrument (MDADI) is available

Exclusion Criteria

* Clinical stages T0; T4; T1-2, N0; or any N2 (AJCC, 8th ed)
* Recurrent disease
* Definitive clinical or radiologic evidence of metastatic disease or adenopathy below the clavicles
* Cancers considered to be from an oral cavity site (oral tongue, floor mouth, alveolar ridge, buccal or lip), or the nasopharynx, hypopharynx, or larynx, even if p16-positive, or histologies of adenosquamous, verrucous, or spindle cell carcinomas
* Carcinoma of the neck of unknown primary site origin (T0 is ineligible, even if p16-positive)
* Radiographically matted nodes, defined as 3 abutting nodes with loss of the intervening fat plane
* Supraclavicular nodes, defined as nodes centered below the level of the cricoid cartilage
* Gross total excision of both primary and nodal disease; this includes tonsillectomy, local excision of primary site, and nodal excision that removes all clinically and radiographically evident disease. In other words, to participate in this protocol, the patient must have clinically or radiographically evident gross disease for which disease response can be assessed
* Patients with simultaneous primary cancers or separate bilateral primary tumor sites are excluded with the exception of patients with bilateral tonsil cancers
* Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 1095 days (3 years) (of note, the exclusion applies only for invasive cancers such that carcinoma in situ of the breast, oral cavity, or cervix are all permissible)
* Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable
* Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
* Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways
* History of severe hypersensitivity reaction to any monoclonal antibody.
* Severe, active co-morbidity defined as follows:

* Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
* Transmural myocardial infarction within the last 6 months
* Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
* Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration
* Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
* Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition with immune compromise greater than that noted; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immuno-compromised patients
* Condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of registration. Inhaled or topical steroids and adrenal replacement doses \< 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease
* Patients with active autoimmune disease requiring systemic treatment (i.e. disease modifying agents, corticosteroids, or immunosuppressive drugs) should be excluded. These include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), rheumatoid arthritis, connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn's, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded because of the risk of recurrence or exacerbation of disease
* Note: Patients are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger (precipitating event)
* Patients who are pregnant, nursing, or expecting to conceive or father children
* Prior allergic reaction to cisplatin
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NRG Oncology

OTHER

Sponsor Role collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sue S Yom

Role: PRINCIPAL_INVESTIGATOR

NRG Oncology

Locations

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University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, United States

Site Status

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

Site Status

Banner University Medical Center - Tucson

Tucson, Arizona, United States

Site Status

University of Arizona Cancer Center-North Campus

Tucson, Arizona, United States

Site Status

Kaiser Permanente-Deer Valley Medical Center

Antioch, California, United States

Site Status

PCR Oncology

Arroyo Grande, California, United States

Site Status

Sutter Auburn Faith Hospital

Auburn, California, United States

Site Status

Sutter Cancer Centers Radiation Oncology Services-Auburn

Auburn, California, United States

Site Status

AIS Cancer Center at San Joaquin Community Hospital

Bakersfield, California, United States

Site Status

Tower Cancer Research Foundation

Beverly Hills, California, United States

Site Status

Sutter Cancer Centers Radiation Oncology Services-Cameron Park

Cameron Park, California, United States

Site Status

City of Hope Comprehensive Cancer Center

Duarte, California, United States

Site Status

Kaiser Permanente Dublin

Dublin, California, United States

Site Status

UC San Diego Health System - Encinitas

Encinitas, California, United States

Site Status

Kaiser Permanente-Fremont

Fremont, California, United States

Site Status

Fresno Cancer Center

Fresno, California, United States

Site Status

Kaiser Permanente-Fresno

Fresno, California, United States

Site Status

City of Hope at Irvine Lennar

Irvine, California, United States

Site Status

UC San Diego Moores Cancer Center

La Jolla, California, United States

Site Status

City of Hope Antelope Valley

Lancaster, California, United States

Site Status

Los Angeles General Medical Center

Los Angeles, California, United States

Site Status

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States

Site Status

Cedars Sinai Medical Center

Los Angeles, California, United States

Site Status

Fremont - Rideout Cancer Center

Marysville, California, United States

Site Status

Kaiser Permanente-Modesto

Modesto, California, United States

Site Status

Palo Alto Medical Foundation-Camino Division

Mountain View, California, United States

Site Status

Kaiser Permanente Oakland-Broadway

Oakland, California, United States

Site Status

Kaiser Permanente-Oakland

Oakland, California, United States

Site Status

Palo Alto Medical Foundation Health Care

Palo Alto, California, United States

Site Status

Stanford Cancer Institute Palo Alto

Palo Alto, California, United States

Site Status

Kaiser Permanente-Rancho Cordova Cancer Center

Rancho Cordova, California, United States

Site Status

Kaiser Permanente- Marshall Medical Offices

Redwood City, California, United States

Site Status

Kaiser Permanente-Richmond

Richmond, California, United States

Site Status

Rohnert Park Cancer Center

Rohnert Park, California, United States

Site Status

Kaiser Permanente-Roseville

Roseville, California, United States

Site Status

Sutter Cancer Centers Radiation Oncology Services-Roseville

Roseville, California, United States

Site Status

Sutter Roseville Medical Center

Roseville, California, United States

Site Status

The Permanente Medical Group-Roseville Radiation Oncology

Roseville, California, United States

Site Status

Kaiser Permanente Downtown Commons

Sacramento, California, United States

Site Status

Sutter Medical Center Sacramento

Sacramento, California, United States

Site Status

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

Site Status

Kaiser Permanente-South Sacramento

Sacramento, California, United States

Site Status

South Sacramento Cancer Center

Sacramento, California, United States

Site Status

UC San Diego Medical Center - Hillcrest

San Diego, California, United States

Site Status

Naval Medical Center -San Diego

San Diego, California, United States

Site Status

Kaiser Permanente-San Francisco

San Francisco, California, United States

Site Status

UCSF Medical Center-Mission Bay

San Francisco, California, United States

Site Status

Kaiser Permanente-Santa Teresa-San Jose

San Jose, California, United States

Site Status

Stanford Cancer Center South Bay

San Jose, California, United States

Site Status

Kaiser Permanente San Leandro

San Leandro, California, United States

Site Status

Pacific Central Coast Health Center-San Luis Obispo

San Luis Obispo, California, United States

Site Status

Kaiser San Rafael-Gallinas

San Rafael, California, United States

Site Status

Kaiser Permanente Medical Center - Santa Clara

Santa Clara, California, United States

Site Status

Kaiser Permanente-Santa Rosa

Santa Rosa, California, United States

Site Status

City of Hope South Pasadena

South Pasadena, California, United States

Site Status

Kaiser Permanente Cancer Treatment Center

South San Francisco, California, United States

Site Status

Kaiser Permanente-South San Francisco

South San Francisco, California, United States

Site Status

Kaiser Permanente-Stockton

Stockton, California, United States

Site Status

Palo Alto Medical Foundation-Sunnyvale

Sunnyvale, California, United States

Site Status

City of Hope South Bay

Torrance, California, United States

Site Status

Torrance Memorial Physician Network - Cancer Care

Torrance, California, United States

Site Status

Torrance Memorial Medical Center

Torrance, California, United States

Site Status

City of Hope Upland

Upland, California, United States

Site Status

Kaiser Permanente Medical Center-Vacaville

Vacaville, California, United States

Site Status

Kaiser Permanente-Vallejo

Vallejo, California, United States

Site Status

Kaiser Permanente-Walnut Creek

Walnut Creek, California, United States

Site Status

Rocky Mountain Regional VA Medical Center

Aurora, Colorado, United States

Site Status

UCHealth University of Colorado Hospital

Aurora, Colorado, United States

Site Status

Rocky Mountain Cancer Centers-Boulder

Boulder, Colorado, United States

Site Status

Rocky Mountain Cancer Centers-Penrose

Colorado Springs, Colorado, United States

Site Status

UCHealth Memorial Hospital Central

Colorado Springs, Colorado, United States

Site Status

Memorial Hospital North

Colorado Springs, Colorado, United States

Site Status

AdventHealth Porter

Denver, Colorado, United States

Site Status

Poudre Valley Hospital

Fort Collins, Colorado, United States

Site Status

Cancer Care and Hematology-Fort Collins

Fort Collins, Colorado, United States

Site Status

UCHealth Greeley Hospital

Greeley, Colorado, United States

Site Status

AdventHealth Littleton

Littleton, Colorado, United States

Site Status

Medical Center of the Rockies

Loveland, Colorado, United States

Site Status

AdventHealth Parker

Parker, Colorado, United States

Site Status

Hartford Hospital

Hartford, Connecticut, United States

Site Status

Delaware Clinical and Laboratory Physicians PA

Newark, Delaware, United States

Site Status

Helen F Graham Cancer Center

Newark, Delaware, United States

Site Status

Medical Oncology Hematology Consultants PA

Newark, Delaware, United States

Site Status

Christiana Care Health System-Christiana Hospital

Newark, Delaware, United States

Site Status

UM Sylvester Comprehensive Cancer Center at Coral Gables

Coral Gables, Florida, United States

Site Status

UM Sylvester Comprehensive Cancer Center at Coral Springs

Coral Springs, Florida, United States

Site Status

UM Sylvester Comprehensive Cancer Center at Deerfield Beach

Deerfield Beach, Florida, United States

Site Status

Jupiter Medical Center

Jupiter, Florida, United States

Site Status

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, United States

Site Status

Miami Cancer Institute

Miami, Florida, United States

Site Status

UM Sylvester Comprehensive Cancer Center at Kendall

Miami, Florida, United States

Site Status

Orlando Health Cancer Institute

Orlando, Florida, United States

Site Status

Moffitt Cancer Center-International Plaza

Tampa, Florida, United States

Site Status

Moffitt Cancer Center - McKinley Campus

Tampa, Florida, United States

Site Status

Moffitt Cancer Center

Tampa, Florida, United States

Site Status

Moffitt Cancer Center at Wesley Chapel

Wesley Chapel, Florida, United States

Site Status

Grady Health System

Atlanta, Georgia, United States

Site Status

Emory University Hospital Midtown

Atlanta, Georgia, United States

Site Status

Hawaii Cancer Care Inc - Waterfront Plaza

Honolulu, Hawaii, United States

Site Status

Queen's Cancer Cenrer - POB I

Honolulu, Hawaii, United States

Site Status

Queen's Medical Center

Honolulu, Hawaii, United States

Site Status

Straub Clinic and Hospital

Honolulu, Hawaii, United States

Site Status

University of Hawaii Cancer Center

Honolulu, Hawaii, United States

Site Status

Hawaii Cancer Care Inc-Liliha

Honolulu, Hawaii, United States

Site Status

Kuakini Medical Center

Honolulu, Hawaii, United States

Site Status

Queen's Cancer Center - Kuakini

Honolulu, Hawaii, United States

Site Status

The Cancer Center of Hawaii-Liliha

Honolulu, Hawaii, United States

Site Status

Kaiser Permanente Moanalua Medical Center

Honolulu, Hawaii, United States

Site Status

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, United States

Site Status

Wilcox Memorial Hospital and Kauai Medical Clinic

Lihue, Hawaii, United States

Site Status

Hawaii Cancer Care - Westridge

‘Aiea, Hawaii, United States

Site Status

Pali Momi Medical Center

‘Aiea, Hawaii, United States

Site Status

Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho, United States

Site Status

Saint Luke's Cancer Institute - Boise

Boise, Idaho, United States

Site Status

Saint Alphonsus Cancer Care Center-Caldwell

Caldwell, Idaho, United States

Site Status

Saint Luke's Cancer Institute - Fruitland

Fruitland, Idaho, United States

Site Status

Saint Luke's Cancer Institute - Meridian

Meridian, Idaho, United States

Site Status

Saint Alphonsus Cancer Care Center-Nampa

Nampa, Idaho, United States

Site Status

Saint Luke's Cancer Institute - Nampa

Nampa, Idaho, United States

Site Status

Saint Luke's Cancer Institute - Twin Falls

Twin Falls, Idaho, United States

Site Status

Rush-Copley Medical Center

Aurora, Illinois, United States

Site Status

Advocate Good Shepherd Hospital

Barrington, Illinois, United States

Site Status

Illinois CancerCare-Bloomington

Bloomington, Illinois, United States

Site Status

Illinois CancerCare-Canton

Canton, Illinois, United States

Site Status

Illinois CancerCare-Carthage

Carthage, Illinois, United States

Site Status

Centralia Oncology Clinic

Centralia, Illinois, United States

Site Status

Northwestern University

Chicago, Illinois, United States

Site Status

Rush MD Anderson Cancer Center

Chicago, Illinois, United States

Site Status

Advocate Illinois Masonic Medical Center

Chicago, Illinois, United States

Site Status

AMG Crystal Lake - Oncology

Crystal Lake, Illinois, United States

Site Status

Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, United States

Site Status

Decatur Memorial Hospital

Decatur, Illinois, United States

Site Status

Northwestern Medicine Cancer Center Kishwaukee

DeKalb, Illinois, United States

Site Status

Advocate Good Samaritan Hospital

Downers Grove, Illinois, United States

Site Status

Crossroads Cancer Center

Effingham, Illinois, United States

Site Status

Advocate Sherman Hospital

Elgin, Illinois, United States

Site Status

Illinois CancerCare-Eureka

Eureka, Illinois, United States

Site Status

NorthShore University HealthSystem-Evanston Hospital

Evanston, Illinois, United States

Site Status

Illinois CancerCare-Galesburg

Galesburg, Illinois, United States

Site Status

Western Illinois Cancer Treatment Center

Galesburg, Illinois, United States

Site Status

Northwestern Medicine Cancer Center Delnor

Geneva, Illinois, United States

Site Status

NorthShore University HealthSystem-Glenbrook Hospital

Glenview, Illinois, United States

Site Status

NorthShore University HealthSystem-Highland Park Hospital

Highland Park, Illinois, United States

Site Status

Illinois CancerCare-Kewanee Clinic

Kewanee, Illinois, United States

Site Status

Illinois CancerCare-Macomb

Macomb, Illinois, United States

Site Status

Loyola University Medical Center

Maywood, Illinois, United States

Site Status

Cancer Care Center of O'Fallon

O'Fallon, Illinois, United States

Site Status

Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois, United States

Site Status

Advocate Lutheran General Hospital

Park Ridge, Illinois, United States

Site Status

Illinois CancerCare-Pekin

Pekin, Illinois, United States

Site Status

Illinois CancerCare-Peoria

Peoria, Illinois, United States

Site Status

Methodist Medical Center of Illinois

Peoria, Illinois, United States

Site Status

OSF Saint Francis Medical Center

Peoria, Illinois, United States

Site Status

Illinois CancerCare-Peru

Peru, Illinois, United States

Site Status

Illinois CancerCare-Princeton

Princeton, Illinois, United States

Site Status

UW Health Carbone Cancer Center Rockford

Rockford, Illinois, United States

Site Status

Memorial Hospital East

Shiloh, Illinois, United States

Site Status

Southern Illinois University School of Medicine

Springfield, Illinois, United States

Site Status

Springfield Clinic

Springfield, Illinois, United States

Site Status

Springfield Memorial Hospital

Springfield, Illinois, United States

Site Status

Northwestern Medicine Cancer Center Warrenville

Warrenville, Illinois, United States

Site Status

Illinois CancerCare - Washington

Washington, Illinois, United States

Site Status

IU Health North Hospital

Carmel, Indiana, United States

Site Status

Indiana University/Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, United States

Site Status

Sidney and Lois Eskenazi Hospital

Indianapolis, Indiana, United States

Site Status

Mercy Cancer Center-West Lakes

Clive, Iowa, United States

Site Status

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

Clive, Iowa, United States

Site Status

Greater Regional Medical Center

Creston, Iowa, United States

Site Status

Iowa Methodist Medical Center

Des Moines, Iowa, United States

Site Status

UI Health Care Mission Cancer and Blood - Des Moines Clinic

Des Moines, Iowa, United States

Site Status

Broadlawns Medical Center

Des Moines, Iowa, United States

Site Status

Mercy Medical Center - Des Moines

Des Moines, Iowa, United States

Site Status

UI Health Care Mission Cancer and Blood - Laurel Clinic

Des Moines, Iowa, United States

Site Status

Iowa Lutheran Hospital

Des Moines, Iowa, United States

Site Status

Methodist West Hospital

West Des Moines, Iowa, United States

Site Status

Mercy Medical Center-West Lakes

West Des Moines, Iowa, United States

Site Status

University of Kansas Cancer Center

Kansas City, Kansas, United States

Site Status

Lawrence Memorial Hospital

Lawrence, Kansas, United States

Site Status

The University of Kansas Cancer Center - Olathe

Olathe, Kansas, United States

Site Status

University of Kansas Cancer Center-Overland Park

Overland Park, Kansas, United States

Site Status

Salina Regional Health Center

Salina, Kansas, United States

Site Status

University of Kansas Health System Saint Francis Campus

Topeka, Kansas, United States

Site Status

University of Kansas Hospital-Westwood Cancer Center

Westwood, Kansas, United States

Site Status

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, United States

Site Status

Jewish Hospital

Louisville, Kentucky, United States

Site Status

Norton Hospital Pavilion and Medical Campus

Louisville, Kentucky, United States

Site Status

The James Graham Brown Cancer Center at University of Louisville

Louisville, Kentucky, United States

Site Status

Norton Brownsboro Hospital and Medical Campus

Louisville, Kentucky, United States

Site Status

LSU Health Baton Rouge-North Clinic

Baton Rouge, Louisiana, United States

Site Status

Our Lady of the Lake Physician Group

Baton Rouge, Louisiana, United States

Site Status

Louisiana Hematology Oncology Associates LLC

Baton Rouge, Louisiana, United States

Site Status

Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana, United States

Site Status

East Jefferson General Hospital

Metairie, Louisiana, United States

Site Status

MaineHealth Coastal Cancer Treatment Center

Bath, Maine, United States

Site Status

MaineHealth Maine Medical Center - Biddeford

Biddeford, Maine, United States

Site Status

MaineHealth Maine Medical Center - Portland

Portland, Maine, United States

Site Status

Penobscot Bay Medical Center

Rockport, Maine, United States

Site Status

MaineHealth Cancer Care and IV Therapy - Sanford

Sanford, Maine, United States

Site Status

MaineHealth Cancer Care Center of York County

Sanford, Maine, United States

Site Status

MaineHealth Maine Medical Center- Scarborough

Scarborough, Maine, United States

Site Status

MaineHealth Cancer Care and IV Therapy - South Portland

South Portland, Maine, United States

Site Status

University of Maryland/Greenebaum Cancer Center

Baltimore, Maryland, United States

Site Status

Greater Baltimore Medical Center

Baltimore, Maryland, United States

Site Status

UM Upper Chesapeake Medical Center

Bel Air, Maryland, United States

Site Status

Boston Medical Center

Boston, Massachusetts, United States

Site Status

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Ann Arbor, Michigan, United States

Site Status

McLaren Cancer Institute-Bay City

Bay City, Michigan, United States

Site Status

Trinity Health IHA Medical Group Hematology Oncology - Brighton

Brighton, Michigan, United States

Site Status

Trinity Health Medical Center - Brighton

Brighton, Michigan, United States

Site Status

Henry Ford Cancer Institute-Downriver

Brownstown, Michigan, United States

Site Status

Trinity Health IHA Medical Group Hematology Oncology - Canton

Canton, Michigan, United States

Site Status

Trinity Health Medical Center - Canton

Canton, Michigan, United States

Site Status

Caro Cancer Center

Caro, Michigan, United States

Site Status

Chelsea Hospital

Chelsea, Michigan, United States

Site Status

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

Chelsea, Michigan, United States

Site Status

McLaren Cancer Institute-Clarkston

Clarkston, Michigan, United States

Site Status

Henry Ford Macomb Hospital-Clinton Township

Clinton Township, Michigan, United States

Site Status

Henry Ford Medical Center-Fairlane

Dearborn, Michigan, United States

Site Status

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, United States

Site Status

Henry Ford Hospital

Detroit, Michigan, United States

Site Status

Weisberg Cancer Treatment Center

Farmington Hills, Michigan, United States

Site Status

McLaren Cancer Institute-Flint

Flint, Michigan, United States

Site Status

Singh and Arora Hematology Oncology PC

Flint, Michigan, United States

Site Status

Corewell Health Grand Rapids Hospitals - Butterworth Hospital

Grand Rapids, Michigan, United States

Site Status

Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital

Grand Rapids, Michigan, United States

Site Status

Trinity Health Grand Rapids Hospital

Grand Rapids, Michigan, United States

Site Status

Karmanos Cancer Institute at McLaren Greater Lansing

Lansing, Michigan, United States

Site Status

Mid-Michigan Physicians-Lansing

Lansing, Michigan, United States

Site Status

University of Michigan Health - Sparrow Lansing

Lansing, Michigan, United States

Site Status

McLaren Cancer Institute-Lapeer Region

Lapeer, Michigan, United States

Site Status

Trinity Health Saint Mary Mercy Livonia Hospital

Livonia, Michigan, United States

Site Status

Saint Mary's Oncology/Hematology Associates of Marlette

Marlette, Michigan, United States

Site Status

McLaren Cancer Institute-Macomb

Mount Clemens, Michigan, United States

Site Status

Corewell Health Lakeland Hospitals - Niles Hospital

Niles, Michigan, United States

Site Status

Henry Ford Medical Center-Columbus

Novi, Michigan, United States

Site Status

McLaren Cancer Institute-Northern Michigan

Petoskey, Michigan, United States

Site Status

McLaren-Port Huron

Port Huron, Michigan, United States

Site Status

MyMichigan Medical Center Saginaw

Saginaw, Michigan, United States

Site Status

Oncology Hematology Associates of Saginaw Valley PC

Saginaw, Michigan, United States

Site Status

Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center

Saint Joseph, Michigan, United States

Site Status

Corewell Health Lakeland Hospitals - Saint Joseph Hospital

Saint Joseph, Michigan, United States

Site Status

Henry Ford Macomb Health Center - Shelby Township

Shelby, Michigan, United States

Site Status

MyMichigan Medical Center Tawas

Tawas City, Michigan, United States

Site Status

Henry Ford West Bloomfield Hospital

West Bloomfield, Michigan, United States

Site Status

Saint Mary's Oncology/Hematology Associates of West Branch

West Branch, Michigan, United States

Site Status

University of Michigan Health - West

Wyoming, Michigan, United States

Site Status

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

Ypsilanti, Michigan, United States

Site Status

Sanford Joe Lueken Cancer Center

Bemidji, Minnesota, United States

Site Status

Essentia Health Saint Joseph's Medical Center

Brainerd, Minnesota, United States

Site Status

Essentia Health - Deer River Clinic

Deer River, Minnesota, United States

Site Status

Essentia Health Cancer Center

Duluth, Minnesota, United States

Site Status

Essentia Health Saint Mary's Medical Center

Duluth, Minnesota, United States

Site Status

Miller-Dwan Hospital

Duluth, Minnesota, United States

Site Status

Essentia Health Hibbing Clinic

Hibbing, Minnesota, United States

Site Status

Coborn Cancer Center at Saint Cloud Hospital

Saint Cloud, Minnesota, United States

Site Status

Essentia Health Sandstone

Sandstone, Minnesota, United States

Site Status

Essentia Health Virginia Clinic

Virginia, Minnesota, United States

Site Status

Saint Francis Medical Center

Cape Girardeau, Missouri, United States

Site Status

Siteman Cancer Center at Saint Peters Hospital

City of Saint Peters, Missouri, United States

Site Status

Siteman Cancer Center at West County Hospital

Creve Coeur, Missouri, United States

Site Status

Parkland Health Center - Farmington

Farmington, Missouri, United States

Site Status

Freeman Health System

Joplin, Missouri, United States

Site Status

University of Kansas Cancer Center - North

Kansas City, Missouri, United States

Site Status

University of Kansas Cancer Center - Lee's Summit

Lee's Summit, Missouri, United States

Site Status

University of Kansas Cancer Center at North Kansas City Hospital

North Kansas City, Missouri, United States

Site Status

Mercy Clinic-Rolla-Cancer and Hematology

Rolla, Missouri, United States

Site Status

Phelps Health Delbert Day Cancer Institute

Rolla, Missouri, United States

Site Status

Mercy Hospital Springfield

Springfield, Missouri, United States

Site Status

Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Siteman Cancer Center-South County

St Louis, Missouri, United States

Site Status

Bozeman Health Deaconess Hospital

Bozeman, Montana, United States

Site Status

Benefis Sletten Cancer Institute

Great Falls, Montana, United States

Site Status

CHI Health Good Samaritan

Kearney, Nebraska, United States

Site Status

University of Nebraska Medical Center

Omaha, Nebraska, United States

Site Status

Renown Regional Medical Center

Reno, Nevada, United States

Site Status

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

Lebanon, New Hampshire, United States

Site Status

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Site Status

Community Medical Center

Toms River, New Jersey, United States

Site Status

University of New Mexico Cancer Center

Albuquerque, New Mexico, United States

Site Status

New Mexico Oncology Hematology Consultants

Albuquerque, New Mexico, United States

Site Status

Sands Cancer Center

Canandaigua, New York, United States

Site Status

Noyes Memorial Hospital/Myers Cancer Center

Dansville, New York, United States

Site Status

Upstate Cancer Center at Oswego

Oswego, New York, United States

Site Status

Highland Hospital

Rochester, New York, United States

Site Status

University of Rochester

Rochester, New York, United States

Site Status

Stony Brook University Medical Center

Stony Brook, New York, United States

Site Status

State University of New York Upstate Medical University

Syracuse, New York, United States

Site Status

SUNY Upstate Medical Center-Community Campus

Syracuse, New York, United States

Site Status

Upstate Cancer Center at Verona

Verona, New York, United States

Site Status

Wilmot Cancer Institute at Webster

Webster, New York, United States

Site Status

Carolinas Medical Center/Levine Cancer Institute

Charlotte, North Carolina, United States

Site Status

Novant Health Presbyterian Medical Center

Charlotte, North Carolina, United States

Site Status

Atrium Health Pineville/LCI-Pineville

Charlotte, North Carolina, United States

Site Status

Atrium Health University City/LCI-University

Charlotte, North Carolina, United States

Site Status

Levine Cancer Institute-Ballantyne

Charlotte, North Carolina, United States

Site Status

Wake Forest University at Clemmons

Clemmons, North Carolina, United States

Site Status

Atrium Health Cabarrus/LCI-Concord

Concord, North Carolina, United States

Site Status

CaroMont Regional Medical Center

Gastonia, North Carolina, United States

Site Status

East Carolina University

Greenville, North Carolina, United States

Site Status

Novant Health Cancer Institute - Huntersville

Huntersville, North Carolina, United States

Site Status

Novant Health Presbyterian Medical Center Huntersville

Huntersville, North Carolina, United States

Site Status

Novant Health Cancer Institute - Kernersville

Kernersville, North Carolina, United States

Site Status

Novant Health Cancer Institute - Matthews

Matthews, North Carolina, United States

Site Status

Atrium Health Union/LCI-Union

Monroe, North Carolina, United States

Site Status

Novant Health Cancer Institute - Mooresville

Mooresville, North Carolina, United States

Site Status

Novant Health Cancer Institute - Mount Airy

Mount Airy, North Carolina, United States

Site Status

Novant Health Cancer Institute - Wilkesboro

North Wilkesboro, North Carolina, United States

Site Status

FirstHealth of the Carolinas-Moore Regional Hospital

Pinehurst, North Carolina, United States

Site Status

Novant Health Cancer Institute - Rowan

Salisbury, North Carolina, United States

Site Status

Novant Health Cancer Institute - Statesville

Statesville, North Carolina, United States

Site Status

Wake Forest Baptist Health - Hematology Oncology - Statesville

Statesville, North Carolina, United States

Site Status

Novant Cancer Institute Radiation Oncology - Supply

Supply, North Carolina, United States

Site Status

Novant Health Cancer Institute - Thomasville

Thomasville, North Carolina, United States

Site Status

Wake Forest Baptist Health - Wilkes Medical Center

Wilkesboro, North Carolina, United States

Site Status

Novant Health Cancer Institute Radiation Oncology - Wilmington

Wilmington, North Carolina, United States

Site Status

Novant Health New Hanover Regional Medical Center

Wilmington, North Carolina, United States

Site Status

Novant Health Forsyth Medical Center

Winston-Salem, North Carolina, United States

Site Status

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Site Status

Sanford Bismarck Medical Center

Bismarck, North Dakota, United States

Site Status

Sanford Broadway Medical Center

Fargo, North Dakota, United States

Site Status

Sanford Roger Maris Cancer Center

Fargo, North Dakota, United States

Site Status

Summa Health System - Akron Campus

Akron, Ohio, United States

Site Status

UH Seidman Cancer Center at UH Avon Health Center

Avon, Ohio, United States

Site Status

Summa Health System - Barberton Campus

Barberton, Ohio, United States

Site Status

Geauga Hospital

Chardon, Ohio, United States

Site Status

University of Cincinnati Cancer Center-UC Medical Center

Cincinnati, Ohio, United States

Site Status

Case Western Reserve University

Cleveland, Ohio, United States

Site Status

MetroHealth Medical Center

Cleveland, Ohio, United States

Site Status

Cleveland Clinic Cancer Center/Fairview Hospital

Cleveland, Ohio, United States

Site Status

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Site Status

Cleveland Clinic Cancer Center Mansfield

Mansfield, Ohio, United States

Site Status

Hillcrest Hospital Cancer Center

Mayfield Heights, Ohio, United States

Site Status

Summa Health Medina Medical Center

Medina, Ohio, United States

Site Status

UH Seidman Cancer Center at Lake Health Mentor Campus

Mentor, Ohio, United States

Site Status

UH Seidman Cancer Center at Southwest General Hospital

Middleburg Heights, Ohio, United States

Site Status

University Hospitals Parma Medical Center

Parma, Ohio, United States

Site Status

Mercy Health - Perrysburg Hospital

Perrysburg, Ohio, United States

Site Status

University Hospitals Portage Medical Center

Ravenna, Ohio, United States

Site Status

North Coast Cancer Care

Sandusky, Ohio, United States

Site Status

Cleveland Clinic Cancer Center Strongsville

Strongsville, Ohio, United States

Site Status

ProMedica Flower Hospital

Sylvania, Ohio, United States

Site Status

Mercy Health - Saint Vincent Hospital

Toledo, Ohio, United States

Site Status

Mercy Health - Saint Anne Hospital

Toledo, Ohio, United States

Site Status

Mercy Health Sylvania Radiation Oncology Center

Toledo, Ohio, United States

Site Status

University of Cincinnati Cancer Center-West Chester

West Chester, Ohio, United States

Site Status

UH Seidman Cancer Center at Saint John Medical Center

Westlake, Ohio, United States

Site Status

UHHS-Westlake Medical Center

Westlake, Ohio, United States

Site Status

Cleveland Clinic Wooster Family Health and Surgery Center

Wooster, Ohio, United States

Site Status

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Site Status

Clackamas Radiation Oncology Center

Clackamas, Oregon, United States

Site Status

Providence Cancer Institute Clackamas Clinic

Clackamas, Oregon, United States

Site Status

Providence Newberg Medical Center

Newberg, Oregon, United States

Site Status

Providence Willamette Falls Medical Center

Oregon City, Oregon, United States

Site Status

Providence Portland Medical Center

Portland, Oregon, United States

Site Status

Providence Saint Vincent Medical Center

Portland, Oregon, United States

Site Status

Kaiser Permanente Northwest

Portland, Oregon, United States

Site Status

Lehigh Valley Hospital-Cedar Crest

Allentown, Pennsylvania, United States

Site Status

UPMC Altoona

Altoona, Pennsylvania, United States

Site Status

UPMC-Heritage Valley Health System Beaver

Beaver, Pennsylvania, United States

Site Status

Carlisle Regional Cancer Center

Carlisle, Pennsylvania, United States

Site Status

Christiana Care Health System-Concord Health Center

Chadds Ford, Pennsylvania, United States

Site Status

Chambersburg Hospital

Chambersburg, Pennsylvania, United States

Site Status

Geisinger Medical Center

Danville, Pennsylvania, United States

Site Status

Fox Chase Cancer Center - East Norriton Hospital Outpatient Center

East Norriton, Pennsylvania, United States

Site Status

Ephrata Cancer Center

Ephrata, Pennsylvania, United States

Site Status

UPMC Hillman Cancer Center Erie

Erie, Pennsylvania, United States

Site Status

UPMC Cancer Center at UPMC Horizon

Farrell, Pennsylvania, United States

Site Status

Fox Chase Cancer Center Buckingham

Furlong, Pennsylvania, United States

Site Status

Adams Cancer Center

Gettysburg, Pennsylvania, United States

Site Status

UPMC Cancer Centers - Arnold Palmer Pavilion

Greensburg, Pennsylvania, United States

Site Status

UPMC Pinnacle Cancer Center/Community Osteopathic Campus

Harrisburg, Pennsylvania, United States

Site Status

Penn State Milton S Hershey Medical Center

Hershey, Pennsylvania, United States

Site Status

UPMC-Johnstown/John P. Murtha Regional Cancer Center

Johnstown, Pennsylvania, United States

Site Status

Geisinger Medical Oncology-Lewisburg

Lewisburg, Pennsylvania, United States

Site Status

Lewistown Hospital

Lewistown, Pennsylvania, United States

Site Status

UPMC Cancer Center at UPMC McKeesport

McKeesport, Pennsylvania, United States

Site Status

UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion

Mechanicsburg, Pennsylvania, United States

Site Status

Forbes Hospital

Monroeville, Pennsylvania, United States

Site Status

UPMC Cancer Center - Monroeville

Monroeville, Pennsylvania, United States

Site Status

UPMC Hillman Cancer Center in Coraopolis

Moon Township, Pennsylvania, United States

Site Status

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Site Status

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Site Status

Jefferson Torresdale Hospital

Philadelphia, Pennsylvania, United States

Site Status

Temple University Hospital

Philadelphia, Pennsylvania, United States

Site Status

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

Site Status

UPMC-Magee Womens Hospital

Pittsburgh, Pennsylvania, United States

Site Status

UPMC-Saint Margaret

Pittsburgh, Pennsylvania, United States

Site Status

UPMC-Shadyside Hospital

Pittsburgh, Pennsylvania, United States

Site Status

UPMC-Passavant Hospital

Pittsburgh, Pennsylvania, United States

Site Status

UPMC-Saint Clair Hospital Cancer Center

Pittsburgh, Pennsylvania, United States

Site Status

Geisinger Cancer Services-Pottsville

Pottsville, Pennsylvania, United States

Site Status

UPMC Cancer Center at UPMC Northwest

Seneca, Pennsylvania, United States

Site Status

UPMC Uniontown Hospital Radiation Oncology

Uniontown, Pennsylvania, United States

Site Status

UPMC Washington Hospital Radiation Oncology

Washington, Pennsylvania, United States

Site Status

Reading Hospital

West Reading, Pennsylvania, United States

Site Status

Wexford Health and Wellness Pavilion

Wexford, Pennsylvania, United States

Site Status

Geisinger Wyoming Valley/Henry Cancer Center

Wilkes-Barre, Pennsylvania, United States

Site Status

Divine Providence Hospital

Williamsport, Pennsylvania, United States

Site Status

Asplundh Cancer Pavilion

Willow Grove, Pennsylvania, United States

Site Status

WellSpan Health-York Cancer Center

York, Pennsylvania, United States

Site Status

WellSpan Health-York Hospital

York, Pennsylvania, United States

Site Status

UPMC Memorial

York, Pennsylvania, United States

Site Status

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Gibbs Cancer Center-Gaffney

Gaffney, South Carolina, United States

Site Status

Tidelands Georgetown Memorial Hospital

Georgetown, South Carolina, United States

Site Status

Saint Francis Hospital

Greenville, South Carolina, United States

Site Status

Prisma Health Cancer Institute - Faris

Greenville, South Carolina, United States

Site Status

Saint Francis Cancer Center

Greenville, South Carolina, United States

Site Status

Prisma Health Cancer Institute - Eastside

Greenville, South Carolina, United States

Site Status

Prisma Health Cancer Institute - Greer

Greer, South Carolina, United States

Site Status

Gibbs Cancer Center-Pelham

Greer, South Carolina, United States

Site Status

Rock Hill Radiation Therapy Center

Rock Hill, South Carolina, United States

Site Status

Levine Cancer Institute-Rock Hill

Rock Hill, South Carolina, United States

Site Status

Prisma Health Cancer Institute - Seneca

Seneca, South Carolina, United States

Site Status

Spartanburg Medical Center

Spartanburg, South Carolina, United States

Site Status

SMC Center for Hematology Oncology Union

Union, South Carolina, United States

Site Status

Sanford Cancer Center Oncology Clinic

Sioux Falls, South Dakota, United States

Site Status

Avera Cancer Institute

Sioux Falls, South Dakota, United States

Site Status

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, United States

Site Status

The West Clinic - Wolf River

Germantown, Tennessee, United States

Site Status

University of Tennessee - Knoxville

Knoxville, Tennessee, United States

Site Status

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, United States

Site Status

The Don and Sybil Harrington Cancer Center

Amarillo, Texas, United States

Site Status

American Fork Hospital / Huntsman Intermountain Cancer Center

American Fork, Utah, United States

Site Status

Farmington Health Center

Farmington, Utah, United States

Site Status

Logan Regional Hospital

Logan, Utah, United States

Site Status

Intermountain Medical Center

Murray, Utah, United States

Site Status

McKay-Dee Hospital Center

Ogden, Utah, United States

Site Status

Utah Valley Regional Medical Center

Provo, Utah, United States

Site Status

Riverton Hospital

Riverton, Utah, United States

Site Status

Utah Cancer Specialists-Salt Lake City

Salt Lake City, Utah, United States

Site Status

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, United States

Site Status

LDS Hospital

Salt Lake City, Utah, United States

Site Status

Saint George Regional Medical Center

St. George, Utah, United States

Site Status

Dartmouth Cancer Center - North

Saint Johnsbury, Vermont, United States

Site Status

Inova Schar Cancer Institute

Fairfax, Virginia, United States

Site Status

Inova Fair Oaks Hospital

Fairfax, Virginia, United States

Site Status

Naval Medical Center - Portsmouth

Portsmouth, Virginia, United States

Site Status

VCU Massey Cancer Center at Stony Point

Richmond, Virginia, United States

Site Status

VCU Massey Comprehensive Cancer Center

Richmond, Virginia, United States

Site Status

Valley Medical Center

Renton, Washington, United States

Site Status

Swedish Medical Center-Ballard Campus

Seattle, Washington, United States

Site Status

Swedish Medical Center-First Hill

Seattle, Washington, United States

Site Status

Providence Saint Mary Regional Cancer Center

Walla Walla, Washington, United States

Site Status

Langlade Hospital and Cancer Center

Antigo, Wisconsin, United States

Site Status

Ascension Saint Elizabeth Hospital

Appleton, Wisconsin, United States

Site Status

Duluth Clinic Ashland

Ashland, Wisconsin, United States

Site Status

Northwest Wisconsin Cancer Center

Ashland, Wisconsin, United States

Site Status

Ascension Southeast Wisconsin Hospital - Elmbrook Campus

Brookfield, Wisconsin, United States

Site Status

Aurora Cancer Care-Southern Lakes VLCC

Burlington, Wisconsin, United States

Site Status

Ascension Calumet Hospital

Chilton, Wisconsin, United States

Site Status

HSHS Sacred Heart Hospital

Eau Claire, Wisconsin, United States

Site Status

Ascension Saint Francis - Reiman Cancer Center

Franklin, Wisconsin, United States

Site Status

Ascension Southeast Wisconsin Hospital - Franklin

Franklin, Wisconsin, United States

Site Status

Aurora Health Care Germantown Health Center

Germantown, Wisconsin, United States

Site Status

Aurora Cancer Care-Grafton

Grafton, Wisconsin, United States

Site Status

Saint Vincent Hospital Cancer Center Green Bay

Green Bay, Wisconsin, United States

Site Status

Saint Vincent Hospital Cancer Center at Saint Mary's

Green Bay, Wisconsin, United States

Site Status

Aurora BayCare Medical Center

Green Bay, Wisconsin, United States

Site Status

Essentia Health-Hayward Clinic

Hayward, Wisconsin, United States

Site Status

University of Wisconsin Carbone Cancer Center - Johnson Creek

Johnson Creek, Wisconsin, United States

Site Status

Aurora Cancer Care-Kenosha South

Kenosha, Wisconsin, United States

Site Status

Gundersen Lutheran Medical Center

La Crosse, Wisconsin, United States

Site Status

University of Wisconsin Carbone Cancer Center - University Hospital

Madison, Wisconsin, United States

Site Status

Aurora Bay Area Medical Group-Marinette

Marinette, Wisconsin, United States

Site Status

Froedtert Menomonee Falls Hospital

Menomonee Falls, Wisconsin, United States

Site Status

Ascension Columbia Saint Mary's Hospital Ozaukee

Mequon, Wisconsin, United States

Site Status

Aurora Cancer Care-Milwaukee

Milwaukee, Wisconsin, United States

Site Status

Ascension Southeast Wisconsin Hospital - Saint Joseph Campus

Milwaukee, Wisconsin, United States

Site Status

Ascension Columbia Saint Mary's Hospital - Milwaukee

Milwaukee, Wisconsin, United States

Site Status

Ascension Saint Francis Hospital

Milwaukee, Wisconsin, United States

Site Status

Aurora Saint Luke's Medical Center

Milwaukee, Wisconsin, United States

Site Status

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status

Aurora Sinai Medical Center

Milwaukee, Wisconsin, United States

Site Status

Ascension Mercy Hospital

Oshkosh, Wisconsin, United States

Site Status

Vince Lombardi Cancer Clinic - Oshkosh

Oshkosh, Wisconsin, United States

Site Status

Ascension All Saints Hospital

Racine, Wisconsin, United States

Site Status

Aurora Cancer Care-Racine

Racine, Wisconsin, United States

Site Status

Aspirus Cancer Care - James Beck Cancer Center

Rhinelander, Wisconsin, United States

Site Status

Vince Lombardi Cancer Clinic-Sheboygan

Sheboygan, Wisconsin, United States

Site Status

Essentia Health-Spooner Clinic

Spooner, Wisconsin, United States

Site Status

Aspirus Cancer Care - Stevens Point

Stevens Point, Wisconsin, United States

Site Status

Aurora Medical Center in Summit

Summit, Wisconsin, United States

Site Status

Essentia Health Saint Mary's Hospital - Superior

Superior, Wisconsin, United States

Site Status

Vince Lombardi Cancer Clinic-Two Rivers

Two Rivers, Wisconsin, United States

Site Status

Aspirus Regional Cancer Center

Wausau, Wisconsin, United States

Site Status

Ascension Medical Group Southeast Wisconsin - Mayfair Road

Wauwatosa, Wisconsin, United States

Site Status

Aurora Cancer Care-Milwaukee West

Wauwatosa, Wisconsin, United States

Site Status

Aurora West Allis Medical Center

West Allis, Wisconsin, United States

Site Status

Froedtert West Bend Hospital/Kraemer Cancer Center

West Bend, Wisconsin, United States

Site Status

Aspirus Cancer Care - Wisconsin Rapids

Wisconsin Rapids, Wisconsin, United States

Site Status

University Health Network-Princess Margaret Hospital

Toronto, Ontario, Canada

Site Status

Countries

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United States Canada

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form: Phase II Consent Document

View Document

Document Type: Informed Consent Form: Phase III Consent Document

View Document

Other Identifiers

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NCI-2019-03015

Identifier Type: REGISTRY

Identifier Source: secondary_id

NRG-HN005

Identifier Type: OTHER

Identifier Source: secondary_id

NRG-HN005

Identifier Type: OTHER

Identifier Source: secondary_id

U10CA180868

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2019-03015

Identifier Type: -

Identifier Source: org_study_id

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