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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03952585
Recruitment Status : Recruiting
First Posted : May 16, 2019
Last Update Posted : November 6, 2019
Sponsor:
Collaborator:
NRG Oncology
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Brief Summary:
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. Drugs used in chemotherapy, 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.

Condition or disease Intervention/treatment Phase
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 Drug: Cisplatin Radiation: Image Guided Radiation Therapy Radiation: Intensity-Modulated Radiation Therapy Biological: Nivolumab Other: Quality-of-Life Assessment Other: Questionnaire Administration Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 711 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase II/III Trial of De-Intensified Radiation Therapy for Patients With Early-Stage, P16-Positive, Non-Smoking Associated Oropharyngeal Cancer
Actual Study Start Date : July 10, 2019
Estimated Primary Completion Date : February 28, 2025
Estimated Study Completion Date : February 28, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Arm I (IMRT, IGRT, cisplatin)
Patients undergo IMRT or IGRT over 6 fractions per week and receive 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.
Drug: Cisplatin
Given IV
Other Names:
  • 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

Radiation: Image Guided Radiation Therapy
Undergo IGRT
Other Names:
  • IGRT
  • image-guided radiation therapy
  • Image-Guided Radiotherapy

Radiation: Intensity-Modulated Radiation Therapy
Undergo IMRT
Other Names:
  • IMRT
  • Intensity Modulated RT
  • Intensity-Modulated Radiotherapy

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Experimental: Arm II (IMRT, IGRT, cisplatin)
Patients undergo reduced dose IMRT or IGRT QD over 5 fractions per week and receive 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.
Drug: Cisplatin
Given IV
Other Names:
  • 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

Radiation: Image Guided Radiation Therapy
Undergo IGRT
Other Names:
  • IGRT
  • image-guided radiation therapy
  • Image-Guided Radiotherapy

Radiation: Intensity-Modulated Radiation Therapy
Undergo IMRT
Other Names:
  • IMRT
  • Intensity Modulated RT
  • Intensity-Modulated Radiotherapy

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Experimental: Arm III (IMRT, IGRT, nivolumab)
Beginning 1 week prior to radiation, patients receive 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 IMRT or IGRT over 6 fractions per week for 5 weeks in the absence of disease progression or unacceptable toxicity.
Radiation: Image Guided Radiation Therapy
Undergo IGRT
Other Names:
  • IGRT
  • image-guided radiation therapy
  • Image-Guided Radiotherapy

Radiation: Intensity-Modulated Radiation Therapy
Undergo IMRT
Other Names:
  • IMRT
  • Intensity Modulated RT
  • Intensity-Modulated Radiotherapy

Biological: Nivolumab
Given IV
Other Names:
  • BMS-936558
  • MDX-1106
  • NIVO
  • ONO-4538
  • Opdivo

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies




Primary Outcome Measures :
  1. Progression-free survival (PFS) (Phase II) [ Time Frame: Up to 6 years ]
    Will be estimated for all treatment arms using the Kaplan-Meier method (1958). The primary phase IIR endpoint will be tested using a confidence interval (CI) approach.

  2. PFS (Phase III) [ Time Frame: Up to 6 years ]
    Will be estimated for all treatment arms using the Kaplan-Meier method (1958). The co-primary phase III endpoint will be tested using a confidence interval (CI) approach.

  3. Quality of life [ Time Frame: Baseline up to 6 years ]
    Measured by the MD Anderson Dysphagia Inventory (MDADI) global quality of life (QOL) score. Will be compared between arms using a two-sample independent t-test at a one-sided significance level of 0.05 for each experimental arm comparison. MDADI global score and change from baseline will be summarized using mean and standard deviation at each time point for each arm.


Secondary Outcome Measures :
  1. Locoregional failure [ Time Frame: From the time of randomization to the date of failure, date of precluding event, or last known follow-up date, assessed up to 6 years ]
    The cumulative incidence estimator will be used to estimate time to event distributions for locoregional failure between arm differences tested using cause-specific log-rank test.

  2. Distant failure [ Time Frame: Up to 6 years ]
  3. Overall survival [ Time Frame: From the date of randomization to the date of death or last known follow-up date, with patients alive at the last known follow-up time treated as censored, assessed up to 6 years ]
    Will be estimated using the Kaplan-Meier method and treatment arms compared using the log-rank test (Kaplan 1958).

  4. Incidence of adverse events [ Time Frame: Up to 6 years ]
    Measured by the Common Terminology Criteria for Adverse Events (CTCAE). Adverse events (AEs) will be graded using CTCAE version (v)5.0. Counts of all AEs by grade will be provided by treatment arm. Counts and frequencies will be provided for the worst grade AE experienced by the patient by treatment arm. The number of patients with at least 1 grade 3 or higher AE will be compared between the treatment arms. A comparison between treatment arms of grade 3 and higher AEs related to treatment will also be tested. A comparison of grade 3 and higher events will be compared between treatment arms. All comparisons will be tested using a Chi-Square test, or Fisher's exact test if cell frequencies are < 5, with a significance level of 0.05.

  5. Hearing [ Time Frame: Baseline up to 24 months from end of radiation therapy (RT) ]
    Measured as Hearing Handicap Inventory for Adults-Screening (HHIA-S).

  6. Quality of life [ Time Frame: Baseline up to 24 months from end of RT ]
    Measured by the European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire (QLQ)30.

  7. Fludeoxyglucose F-18 (FDG)-positron emission tomography (PET)/computed tomography (CT) locoregional control [ Time Frame: Up to 6 years ]
    Will be associated with PFS.

  8. Negative predictive value of post-RT FDG-PET/CT for locoregional control [ Time Frame: At 1 and 2 years ]
    The negative predictive value of FDG-PET/CT for locoregional control will be estimated using binomial proportions and confidence intervals based on normal approximation.

  9. Negative predictive value of post-RT FDG-PET/CT for PFS [ Time Frame: At 1 and 2 years ]
    The negative predictive value of FDG-PET/CT PFS will be estimated using binomial proportions and confidence intervals based on normal approximation.

  10. Incidence of adverse events [ Time Frame: Up to 6 years ]
    Measured using Patient-Reported Outcomes (PRO)-CTCAE. For each symptom, counts and frequencies will be provided for the worst score experienced by the patient by treatment arm. The proportion of patients with scores >= 1 and >= 3 will be compared between groups using a Chi-square test, or Fisher's exact test if cell frequencies are < 5, using a significance level of 0.05. Analysis of changes in patient reported outcomes over time will analyzed by fitting generalized estimating equations (GEE) models using a logit link (dichotomizing the symptom scores as 0 vs. > 1 and 0-2 vs. 3-4) with time of assessment, treatment arm, and treatment-by-time interaction terms in the model.


Other Outcome Measures:
  1. Quality of life [ Time Frame: Baseline up to 24 months from end of RT ]
    Measured by EuroQol-5 Dimensional- 5 Level (EQ-5D-5L).

  2. Swallowing physiology [ Time Frame: Up to 6 years ]
    Measured by a Modified Barium Swallow (MBS) test. The proportion of aspiration for each arm will be estimated assuming a binomial distribution and between arm comparison will be performed using a Fisher's exact test.

  3. Locoregional control for patients with post-RT FDG-PET/CT [ Time Frame: At 12-14 weeks post-RT ]
    Locoregional control rates will be compared between negative and positive/undetermined patients. Cox proportional hazards models will be used to determine whether there are differences between these two groups, while adjusting for treatment arm and other covariates (cause-specific Cox models for locoregional failure).

  4. PFS for patients with post-RT FDG-PET/CT [ Time Frame: At 12-14 weeks post-RT ]
    PFS rates will be compared between negative and positive/undetermined patients. Cox proportional hazards models will be used to determine whether there are differences between these two groups, while adjusting for treatment arm and other covariates (cause-specific Cox models for locoregional failure).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  • 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 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
  • 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, 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 visualized on the same axial imaging slice as the clavicle
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03952585


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Locations
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United States, California
Stanford Cancer Institute Palo Alto Recruiting
Palo Alto, California, United States, 94304
Contact: Site Public Contact    650-498-7061    ccto-office@stanford.edu   
Principal Investigator: Quynh-Thu X. Le         
Sutter Medical Center Sacramento Recruiting
Sacramento, California, United States, 95816
Contact: Site Public Contact    415-209-2686    bernicl@sutterhealth.org   
Principal Investigator: Christopher U. Jones         
UCSF Medical Center-Mission Bay Recruiting
San Francisco, California, United States, 94158
Contact: Site Public Contact    877-827-3222      
Principal Investigator: Sue S. Yom         
United States, Delaware
Delaware Clinical and Laboratory Physicians PA Recruiting
Newark, Delaware, United States, 19713
Contact: Site Public Contact    302-623-4450    KDempsey@christianacare.org   
Principal Investigator: Gregory A. Masters         
Helen F Graham Cancer Center Recruiting
Newark, Delaware, United States, 19713
Contact: Site Public Contact    302-623-4450    KDempsey@christianacare.org   
Principal Investigator: Gregory A. Masters         
Medical Oncology Hematology Consultants PA Recruiting
Newark, Delaware, United States, 19713
Contact: Site Public Contact    302-623-4450    KDempsey@christianacare.org   
Principal Investigator: Gregory A. Masters         
Christiana Care Health System-Christiana Hospital Recruiting
Newark, Delaware, United States, 19718
Contact: Site Public Contact    302-623-4450    KDempsey@christianacare.org   
Principal Investigator: Gregory A. Masters         
United States, Florida
UF Cancer Center at Orlando Health Recruiting
Orlando, Florida, United States, 32806
Contact: Site Public Contact    321-841-7246    CancerClinicalTrials@orlandohealth.com   
Principal Investigator: Jennifer E. Tseng         
Moffitt Cancer Center - McKinley Campus Recruiting
Tampa, Florida, United States, 33612
Contact: Site Public Contact    800-679-0775    canceranswers@moffitt.org   
Principal Investigator: Jimmy J. Caudell         
Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Site Public Contact    800-679-0775    canceranswers@moffitt.org   
Principal Investigator: Jimmy J. Caudell         
United States, Georgia
Grady Health System Recruiting
Atlanta, Georgia, United States, 30303
Contact: Site Public Contact    404-489-9164      
Principal Investigator: Jonathan J. Beitler         
Emory University Hospital Midtown Recruiting
Atlanta, Georgia, United States, 30308
Contact: Site Public Contact    888-946-7447      
Principal Investigator: Jonathan J. Beitler         
United States, Illinois
Illinois CancerCare-Bloomington Recruiting
Bloomington, Illinois, United States, 61704
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: Bryan A. Faller         
Illinois CancerCare-Canton Recruiting
Canton, Illinois, United States, 61520
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: Bryan A. Faller         
Illinois CancerCare-Carthage Recruiting
Carthage, Illinois, United States, 62321
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: Bryan A. Faller         
Centralia Oncology Clinic Recruiting
Centralia, Illinois, United States, 62801
Contact: Site Public Contact    217-876-4740    rhamrick@dmhhs.org   
Principal Investigator: Bryan A. Faller         
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Site Public Contact    312-695-1301    cancer@northwestern.edu   
Principal Investigator: Michelle S. Gentile         
Cancer Care Specialists of Illinois - Decatur Recruiting
Decatur, Illinois, United States, 62526
Contact: Site Public Contact    217-876-4740    rhamrick@dmhhs.org   
Principal Investigator: Bryan A. Faller         
Decatur Memorial Hospital Recruiting
Decatur, Illinois, United States, 62526
Contact: Site Public Contact    217-876-4740    rhamrick@dmhhs.org   
Principal Investigator: Bryan A. Faller         
Crossroads Cancer Center Recruiting
Effingham, Illinois, United States, 62401
Contact: Site Public Contact    217-876-4740    rhamrick@dmhhs.org   
Principal Investigator: Bryan A. Faller         
Illinois CancerCare-Eureka Recruiting
Eureka, Illinois, United States, 61530
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: Bryan A. Faller         
Illinois CancerCare-Galesburg Recruiting
Galesburg, Illinois, United States, 61401
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: Bryan A. Faller         
Illinois CancerCare-Kewanee Clinic Recruiting
Kewanee, Illinois, United States, 61443
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: Bryan A. Faller         
Illinois CancerCare-Macomb Recruiting
Macomb, Illinois, United States, 61455
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: Bryan A. Faller         
Illinois CancerCare-Ottawa Clinic Recruiting
Ottawa, Illinois, United States, 61350
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: Bryan A. Faller         
Illinois CancerCare-Pekin Recruiting
Pekin, Illinois, United States, 61554
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: Bryan A. Faller         
Illinois CancerCare-Peoria Recruiting
Peoria, Illinois, United States, 61615
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: Bryan A. Faller         
Methodist Medical Center of Illinois Recruiting
Peoria, Illinois, United States, 61636
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: Bryan A. Faller         
Illinois CancerCare-Peru Recruiting
Peru, Illinois, United States, 61354
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: Bryan A. Faller         
Illinois CancerCare-Princeton Recruiting
Princeton, Illinois, United States, 61356
Contact: Site Public Contact    309-243-3605    andersonj@illinoiscancercare.com   
Principal Investigator: Bryan A. Faller         
Southern Illinois University School of Medicine Recruiting
Springfield, Illinois, United States, 62702
Contact: Site Public Contact    217-545-7929      
Principal Investigator: Bryan A. Faller         
Springfield Clinic Recruiting
Springfield, Illinois, United States, 62702
Contact: Site Public Contact    800-444-7541      
Principal Investigator: Bryan A. Faller         
Memorial Medical Center Recruiting
Springfield, Illinois, United States, 62781
Contact: Site Public Contact    217-788-3528      
Principal Investigator: Bryan A. Faller         
United States, Iowa
Medical Oncology and Hematology Associates-West Des Moines Recruiting
Clive, Iowa, United States, 50325
Contact: Site Public Contact    308-398-6518    clinicaltrials@sfmc-gi.org   
Principal Investigator: Richard L. Deming         
Mercy Cancer Center-West Lakes Recruiting
Clive, Iowa, United States, 50325
Contact: Site Public Contact    308-398-6518    clinicaltrials@sfmc-gi.org   
Principal Investigator: Richard L. Deming         
Iowa Methodist Medical Center Recruiting
Des Moines, Iowa, United States, 50309
Contact: Site Public Contact    515-241-6727      
Principal Investigator: Robert J. Behrens         
Medical Oncology and Hematology Associates-Des Moines Recruiting
Des Moines, Iowa, United States, 50309
Contact: Site Public Contact    515-282-2921      
Principal Investigator: Robert J. Behrens         
Broadlawns Medical Center Recruiting
Des Moines, Iowa, United States, 50314
Contact: Site Public Contact    515-282-2200      
Principal Investigator: Robert J. Behrens         
Medical Oncology and Hematology Associates-Laurel Recruiting
Des Moines, Iowa, United States, 50314
Contact: Site Public Contact    308-398-6518    clinicaltrials@sfmc-gi.org   
Principal Investigator: Richard L. Deming         
Mercy Medical Center - Des Moines Recruiting
Des Moines, Iowa, United States, 50314
Contact: Site Public Contact    308-398-6518    clinicaltrials@sfmc-gi.org   
Principal Investigator: Richard L. Deming         
Iowa Lutheran Hospital Recruiting
Des Moines, Iowa, United States, 50316
Contact: Site Public Contact    515-241-8704      
Principal Investigator: Robert J. Behrens         
Methodist West Hospital Recruiting
West Des Moines, Iowa, United States, 50266-7700
Contact: Site Public Contact    515-343-1000      
Principal Investigator: Robert J. Behrens         
Mercy Medical Center-West Lakes Recruiting
West Des Moines, Iowa, United States, 50266
Contact: Site Public Contact    308-398-6518    clinicaltrials@sfmc-gi.org   
Principal Investigator: Richard L. Deming         
United States, Kansas
University of Kansas Cancer Center Recruiting
Kansas City, Kansas, United States, 66160
Contact: Site Public Contact    913-945-7552    ctnursenav@kumc.edu   
Principal Investigator: Christopher Lominska         
University of Kansas Cancer Center-Overland Park Recruiting
Overland Park, Kansas, United States, 66210
Contact: Site Public Contact    913-945-7552    ctnursenav@kumc.edu   
Principal Investigator: Christopher Lominska         
University of Kansas Hospital-Westwood Cancer Center Recruiting
Westwood, Kansas, United States, 66205
Contact: Site Public Contact    913-945-7552    ctnursenav@kumc.edu   
Principal Investigator: Christopher Lominska         
United States, Kentucky
Jewish Hospital Recruiting
Louisville, Kentucky, United States, 40202
Contact: Site Public Contact    308-398-6518    clinicaltrials@sfmc-gi.org   
Principal Investigator: Richard L. Deming         
Norton Hospital Pavilion and Medical Campus Recruiting
Louisville, Kentucky, United States, 40202
Contact: Site Public Contact    502-629-2500      
Principal Investigator: Aaron C. Spalding         
The James Graham Brown Cancer Center at University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
Contact: Site Public Contact    502-562-3429      
Principal Investigator: Neal E. Dunlap         
United States, Louisiana
LSU Health Baton Rouge-North Clinic Recruiting
Baton Rouge, Louisiana, United States, 70805
Contact: Site Public Contact    225-215-1353    clinicalresearch@marybird.com   
Principal Investigator: David S. Hanson         
Louisiana Hematology Oncology Associates LLC Recruiting
Baton Rouge, Louisiana, United States, 70809
Contact: Site Public Contact    225-215-1353    clinicalresearch@marybird.com   
Principal Investigator: David S. Hanson         
Mary Bird Perkins Cancer Center Recruiting
Baton Rouge, Louisiana, United States, 70809
Contact: Site Public Contact    225-215-1353    clinicalresearch@marybird.com   
Principal Investigator: David S. Hanson         
Our Lady of the Lake Physicians Group - Medical Oncology Recruiting
Baton Rouge, Louisiana, United States, 70809
Contact: Site Public Contact    225-215-1353    clinicalresearch@marybird.com   
Principal Investigator: David S. Hanson         
United States, Maryland
Greater Baltimore Medical Center Recruiting
Baltimore, Maryland, United States, 21204
Contact: Site Public Contact    443-849-3706      
Principal Investigator: Kruti Patel         
United States, Michigan
Saint Joseph Mercy Hospital Recruiting
Ann Arbor, Michigan, United States, 48106
Contact: Site Public Contact    734-712-3671    stephanie.couch@stjoeshealth.org   
Principal Investigator: Samir Narayan         
Saint Joseph Mercy Brighton Recruiting
Brighton, Michigan, United States, 48114
Contact: Site Public Contact    734-712-3671    stephanie.couch@stjoeshealth.org   
Principal Investigator: Samir Narayan         
Saint Joseph Mercy Canton Recruiting
Canton, Michigan, United States, 48188
Contact: Site Public Contact    734-712-3671    stephanie.couch@stjoeshealth.org   
Principal Investigator: Samir Narayan         
Saint Joseph Mercy Chelsea Recruiting
Chelsea, Michigan, United States, 48118
Contact: Site Public Contact    734-712-3671    stephanie.couch@stjoeshealth.org   
Principal Investigator: Samir Narayan         
United States, Minnesota
Coborn Cancer Center at Saint Cloud Hospital Recruiting
Saint Cloud, Minnesota, United States, 56303
Contact: Site Public Contact    877-229-4907    coborncancercenter@centracare.com   
Principal Investigator: Donald J. Jurgens         
United States, Missouri
Saint Francis Medical Center Recruiting
Cape Girardeau, Missouri, United States, 63703
Contact: Site Public Contact    573-334-2230    sfmc@sfmc.net   
Principal Investigator: Bryan A. Faller         
Siteman Cancer Center at West County Hospital Recruiting
Creve Coeur, Missouri, United States, 63141
Contact: Site Public Contact    800-600-3606    info@siteman.wustl.edu   
Principal Investigator: Wade L. Thorstad         
The University of Kansas Cancer Center-North Recruiting
Kansas City, Missouri, United States, 64154
Contact: Site Public Contact    913-945-7552    ctnursenav@kumc.edu   
Principal Investigator: Christopher Lominska         
Delbert Day Cancer Institute at PCRMC Recruiting
Rolla, Missouri, United States, 65401
Contact: Site Public Contact    573-458-7504    jrichards@research.pcrmc.com   
Principal Investigator: Jay W. Carlson         
Mercy Clinic-Rolla-Cancer and Hematology Recruiting
Rolla, Missouri, United States, 65401
Contact: Site Public Contact    573-458-7504    jrichards@research.pcrmc.com   
Principal Investigator: Jay W. Carlson         
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Site Public Contact    800-600-3606    info@siteman.wustl.edu   
Principal Investigator: Wade L. Thorstad         
Siteman Cancer Center-South County Recruiting
Saint Louis, Missouri, United States, 63129
Contact: Site Public Contact    800-600-3606    info@siteman.wustl.edu   
Principal Investigator: Wade L. Thorstad         
Siteman Cancer Center at Saint Peters Hospital Recruiting
Saint Peters, Missouri, United States, 63376
Contact: Site Public Contact    800-600-3606    info@siteman.wustl.edu   
Principal Investigator: Wade L. Thorstad         
United States, Montana
Benefis Healthcare- Sletten Cancer Institute Recruiting
Great Falls, Montana, United States, 59405
Contact: Site Public Contact    406-969-6060    mccinfo@mtcancer.org   
Principal Investigator: John M. Schallenkamp         
United States, New York
Stony Brook University Medical Center Recruiting
Stony Brook, New York, United States, 11794
Contact: Site Public Contact    800-862-2215      
Principal Investigator: Kartik M. Mani         
United States, North Carolina
CaroMont Regional Medical Center Recruiting
Gastonia, North Carolina, United States, 28054
Contact: Site Public Contact    704-834-2810    tammy.cozad@caromonthealth.org   
Principal Investigator: Robert M. Doline         
United States, Ohio
Geauga Hospital Recruiting
Chardon, Ohio, United States, 44024
Contact: Site Public Contact    800-641-2422    CTUReferral@UHhospitals.org   
Principal Investigator: Min Yao         
University of Cincinnati/Barrett Cancer Center Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Site Public Contact    513-558-4553    uchealthnews@uc.edu   
Principal Investigator: Vinita Takiar         
Case Western Reserve University Recruiting
Cleveland, Ohio, United States, 44106
Contact: Site Public Contact    800-641-2422    CTUReferral@UHhospitals.org   
Principal Investigator: Min Yao         
Cleveland Clinic Cancer Center/Fairview Hospital Recruiting
Cleveland, Ohio, United States, 44111
Contact: Site Public Contact    866-223-8100    CancerAnswer@ccf.org   
Principal Investigator: Jessica L. Geiger         
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Site Public Contact    866-223-8100    CancerAnswer@ccf.org   
Principal Investigator: Jessica L. Geiger         
Cleveland Clinic Cancer Center Mansfield Recruiting
Mansfield, Ohio, United States, 44906
Contact: Site Public Contact    866-223-8100    CancerAnswer@ccf.org   
Principal Investigator: Jessica L. Geiger         
Hillcrest Hospital Cancer Center Recruiting
Mayfield Heights, Ohio, United States, 44124
Contact: Site Public Contact    866-223-8100    CancerAnswer@ccf.org   
Principal Investigator: Jessica L. Geiger         
UH Seidman Cancer Center at Lake Health Mentor Campus Recruiting
Mentor, Ohio, United States, 44060
Contact: Site Public Contact    800-641-2422    CTUReferral@UHhospitals.org   
Principal Investigator: Min Yao         
UH Seidman Cancer Center at Southwest General Hospital Recruiting
Middleburg Heights, Ohio, United States, 44130
Contact: Site Public Contact    800-641-2422    CTUReferral@UHhospitals.org   
Principal Investigator: Min Yao         
North Coast Cancer Care Recruiting
Sandusky, Ohio, United States, 44870
Contact: Site Public Contact    866-223-8100    CancerAnswer@ccf.org   
Principal Investigator: Jessica L. Geiger         
Cleveland Clinic Cancer Center Strongsville Recruiting
Strongsville, Ohio, United States, 44136
Contact: Site Public Contact    866-223-8100    CancerAnswer@ccf.org   
Principal Investigator: Jessica L. Geiger         
ProMedica Flower Hospital Recruiting
Sylvania, Ohio, United States, 43560
Contact: Site Public Contact    419-824-1842      
Principal Investigator: Jeffrey A. Forquer         
University Pointe Recruiting
West Chester, Ohio, United States, 45069
Contact: Site Public Contact       clinicaltrials@ucphysicians.com   
Principal Investigator: Vinita Takiar         
United States, Oklahoma
University of Oklahoma Health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Site Public Contact    405-271-8777    ou-clinical-trials@ouhsc.edu   
Principal Investigator: Christina Henson         
United States, Oregon
Clackamas Radiation Oncology Center Recruiting
Clackamas, Oregon, United States, 97015
Contact: Site Public Contact    503-215-2614    CanRsrchStudies@providence.org   
Principal Investigator: Dan S. Zuckerman         
Providence Newberg Medical Center Recruiting
Newberg, Oregon, United States, 97132
Contact: Site Public Contact    503-215-2614    CanRsrchStudies@providence.org   
Principal Investigator: Dan S. Zuckerman         
Providence Portland Medical Center Recruiting
Portland, Oregon, United States, 97213
Contact: Site Public Contact    503-215-2614    CanRsrchStudies@providence.org   
Principal Investigator: Dan S. Zuckerman         
Providence Saint Vincent Medical Center Recruiting
Portland, Oregon, United States, 97225
Contact: Site Public Contact    503-215-2614    CanRsrchStudies@providence.org   
Principal Investigator: Dan S. Zuckerman         
United States, Pennsylvania
Christiana Care Health System-Concord Health Center Recruiting
Chadds Ford, Pennsylvania, United States, 19317
Contact: Site Public Contact    302-623-4450    KDempsey@christianacare.org   
Principal Investigator: Gregory A. Masters         
Adams Cancer Center Recruiting
Gettysburg, Pennsylvania, United States, 17325
Contact: Site Public Contact    877-441-7957      
Principal Investigator: Chanh T. Huynh         
Fox Chase Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19111
Contact: Site Public Contact    215-728-4790      
Principal Investigator: Thomas J. Galloway         
WellSpan Health-York Cancer Center Recruiting
York, Pennsylvania, United States, 17403
Contact: Site Public Contact    877-441-7957      
Principal Investigator: Chanh T. Huynh         
WellSpan Health-York Hospital Recruiting
York, Pennsylvania, United States, 17403
Contact: Site Public Contact    877-441-7957      
Principal Investigator: Chanh T. Huynh         
United States, Utah
Farmington Health Center Recruiting
Farmington, Utah, United States, 84025
Contact: Site Public Contact    888-424-2100    cancerinfo@hci.utah.edu   
Principal Investigator: Ying J. Hitchcock         
Huntsman Cancer Institute/University of Utah Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Site Public Contact    888-424-2100    cancerinfo@hci.utah.edu   
Principal Investigator: Ying J. Hitchcock         
United States, Wisconsin
Gundersen Lutheran Medical Center Recruiting
La Crosse, Wisconsin, United States, 54601
Contact: Site Public Contact    608-775-2385    cancerctr@gundersenhealth.org   
Principal Investigator: Collin D. Driscoll         
University of Wisconsin Hospital and Clinics Recruiting
Madison, Wisconsin, United States, 53792
Contact: Site Public Contact    800-622-8922      
Principal Investigator: Randall J. Kimple         
Community Memorial Hospital Recruiting
Menomonee Falls, Wisconsin, United States, 53051
Contact: Site Public Contact    262-257-5100      
Principal Investigator: Musaddiq J. Awan         
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Site Public Contact    414-805-3666      
Principal Investigator: Musaddiq J. Awan         
The Alyce and Elmore Kraemer Cancer Care Center Recruiting
West Bend, Wisconsin, United States, 53095
Contact: Site Public Contact    866-680-0505      
Principal Investigator: Musaddiq J. Awan         
Sponsors and Collaborators
National Cancer Institute (NCI)
NRG Oncology
Investigators
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Principal Investigator: Sue S Yom NRG Oncology

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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT03952585     History of Changes
Other Study ID Numbers: NCI-2019-03015
NCI-2019-03015 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
NRG-HN005 ( Other Identifier: NRG Oncology )
NRG-HN005 ( Other Identifier: CTEP )
U10CA180868 ( U.S. NIH Grant/Contract )
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: November 6, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page
URL: https://grants.nih.gov/policy/sharing.htm

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Oropharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Cisplatin
Nivolumab
Antineoplastic Agents
Antineoplastic Agents, Immunological