Clinical Trials /

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

NCT03952585

Description:

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.

Related Conditions:
  • Oropharyngeal Squamous Cell Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2/Phase 3

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: NCI-2019-03015
  • SECONDARY ID: NCI-2019-03015
  • SECONDARY ID: NRG-HN005
  • SECONDARY ID: NRG-HN005
  • SECONDARY ID: U10CA180868
  • NCT ID: NCT03952585

Conditions

  • Basaloid Squamous Cell Carcinoma
  • CDKN2A-p16 Positive
  • 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

Interventions

DrugSynonymsArms
CisplatinAbiplatin, 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, PlatosinArm I (IMRT, IGRT, cisplatin)
NivolumabBMS-936558, MDX-1106, NIVO, ONO-4538, OpdivoArm III (IMRT, IGRT, nivolumab)

Purpose

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.

Detailed Description

      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) II. 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)

      SECONDARY OBJECTIVES:

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

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

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

      V. To assess the locoregional control rates and PFS for patients with FDG-PET/CT at 12-14
      weeks post-radiation.

      OUTLINE:

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

      ARM I: Patients undergo intensity modulated radiation therapy (IMRT) or image-guided
      radiation therapy (IGRT) over 6 fractions per week and receive 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.

      ARM II: Patients undergo reduced dose IMRT or IGRT once daily (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.

      ARM III: 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.

      PHASE III: Patients are randomized to Arm I, Arm II, 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.
    

Trial Arms

NameTypeDescriptionInterventions
Arm I (IMRT, IGRT, cisplatin)Active ComparatorPatients 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.
  • Cisplatin
Arm II (IMRT, IGRT, cisplatin)ExperimentalPatients 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.
  • Cisplatin
Arm III (IMRT, IGRT, nivolumab)ExperimentalBeginning 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.
  • Nivolumab

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Progression-free survival (PFS) (Phase II)
Time Frame:Up to 6 years
Safety Issue:
Description: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.

Secondary Outcome Measures

Measure: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
Safety Issue:
Description: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.
Measure:Distant failure
Time Frame:Up to 6 years
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:Will be estimated using the Kaplan-Meier method and treatment arms compared using the log-rank test (Kaplan 1958).
Measure:Incidence of adverse events
Time Frame:Up to 6 years
Safety Issue:
Description: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.
Measure:Hearing
Time Frame:Baseline up to 24 months from end of radiation therapy (RT)
Safety Issue:
Description:Measured as Hearing Handicap Inventory for Adults-Screening (HHIA-S).
Measure:Quality of life
Time Frame:Baseline up to 24 months from end of RT
Safety Issue:
Description:Measured by the European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire (QLQ)30.
Measure:Fludeoxyglucose F-18 (FDG)-positron emission tomography (PET)/computed tomography (CT) locoregional control
Time Frame:Up to 6 years
Safety Issue:
Description:Will be associated with PFS.
Measure:Negative predictive value of post-RT FDG-PET/CT for locoregional control
Time Frame:At 1 and 2 years
Safety Issue:
Description:The negative predictive value of FDG-PET/CT for locoregional control will be estimated using binomial proportions and confidence intervals based on normal approximation.
Measure:Negative predictive value of post-RT FDG-PET/CT for PFS
Time Frame:At 1 and 2 years
Safety Issue:
Description:The negative predictive value of FDG-PET/CT PFS will be estimated using binomial proportions and confidence intervals based on normal approximation.
Measure:Incidence of adverse events
Time Frame:Up to 6 years
Safety Issue:
Description: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.

Details

Phase:Phase 2/Phase 3
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:National Cancer Institute (NCI)

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