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Trial record 1 of 1 for:    NCT02952586
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Study To Compare Avelumab In Combination With Standard of Care Chemoradiotherapy (SoC CRT) Versus SoC CRT for Definitive Treatment In Patients With Locally Advanced Squamous Cell Carcinoma Of The Head And Neck (JAVELIN HEAD AND NECK 100)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02952586
Recruitment Status : Active, not recruiting
First Posted : November 2, 2016
Last Update Posted : January 29, 2020
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE October 31, 2016
First Posted Date  ICMJE November 2, 2016
Last Update Posted Date January 29, 2020
Actual Study Start Date  ICMJE November 28, 2016
Estimated Primary Completion Date April 8, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 31, 2016)
Progression Free Survival (PFS) [ Time Frame: Baseline up to 49 months ]
PFS per modified Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02952586 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 31, 2016)
  • Overall Survival (OS) [ Time Frame: Baseline up to 103 months ]
  • Trough plasma concentration (Ctrough) of avelumab [ Time Frame: Lead-in Day 1; and Days 8 and 25 of CRT phase ]
    Ctrough is defined as the trough plasma concentration of avelumab
  • Percentage of patients with positive anti-drug antibodies (ADA) and neutralizing antibodies [ Time Frame: Day 1 of the Lead-in Phase, and Days 8, and 25 of the CRT Phase ]
  • Tumor tissue biomarker status [ Time Frame: Lead-in Day 1 ]
    Tumor tissue biomarkers including, but not limited to PD-L1 expression and tumor-infiltrating CD8+ T-lymphocytes.
  • Maximum plasma concentration (Cmax) of Avelumab [ Time Frame: Lead-in Day 1; and Days 8 and 25 of CRT phase ]
  • Area under the concentration-time curve extrapolated to infinity (AUCinf) for cisplatin [ Time Frame: Day 1 of CRT phase ]
  • Cmax of Cisplatin [ Time Frame: Day 1 of CRT phase ]
  • Clearance (CL) of cisplatin [ Time Frame: Day 1 of CRT phase ]
  • Time to maximum plasma concentration (Tmax) and elimination half-life (t1/2)for cisplatin [ Time Frame: Day 1 of CRT phase ]
  • Volume of distribution (Vz) for cisplatin (total and free) [ Time Frame: Day 1 of CRT phase ]
  • Change from Baseline in the EuroQoL Group 5-Dimension 5- Level Self-Report Questionnaire (EQ-5D-5L) [ Time Frame: Lead-in Day 1 and CRT phase Day 1 and Day 29 ]
  • Change from baseline in National Cancer Comprehensive Network (NCCN) Head and Neck Symptom Index-22 items (FHNSI-22) [ Time Frame: Lead-in Day 1 and CRT phase Day 1 and Day 29 ]
  • Rate of pathologic complete response [ Time Frame: Baseline up to 49 months ]
    In any patients with resected specimens, neck dissection.
  • Locoregional tumor control [ Time Frame: Baseline up to 49 months ]
    Per modified RECIST v1.1
  • Distant metastatic failure [ Time Frame: Baseline up to 49 months ]
    Per modified RECIST v1.1
  • Objective Response Rate - Percentage of Participants With Objective Response [ Time Frame: Baseline up to 49 months ]
    Per modified RECIST v1.1
  • Duration of response [ Time Frame: Baseline up to 49 months ]
    Per modified RECIST v1.1
  • The incidence of pathologically-positive neck dissection versus the incidence of pathologically-negative neck dissection [ Time Frame: Baseline up to 49 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study To Compare Avelumab In Combination With Standard of Care Chemoradiotherapy (SoC CRT) Versus SoC CRT for Definitive Treatment In Patients With Locally Advanced Squamous Cell Carcinoma Of The Head And Neck (JAVELIN HEAD AND NECK 100)
Official Title  ICMJE A RANDOMIZED DOUBLE-BLIND PHASE 3 STUDY OF AVELUMAB IN COMBINATION WITH STANDARD OF CARE CHEMORADIOTHERAPY (CISPLATIN PLUS DEFINITIVE RADIATION THERAPY) VERSUS STANDARD OF CARE CHEMORADIOTHERAPY IN THE FRONT-LINE TREATMENT OF PATIENTS WITH LOCALLY ADVANCED SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK
Brief Summary This is a phase 3 randomized, placebo controlled study to evaluate the safety and anti-tumor activity of Avelumab in combination with standard of care chemoradiation (SoC CRT) versus SoC CRT alone in front-line treatment of patients with locally advanced head and neck cancer.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Squamous Cell Carcinoma of the Head and Neck
Intervention  ICMJE
  • Drug: Avelumab
    Avelumab + SOC Chemoradiation
  • Other: Chemoradiation
    Cisplatin + Radiation Therapy
Study Arms  ICMJE
  • Experimental: Avelumab + SOC Chemoradiation Therapy
    • Avelumab 10 mg/kg IV: Day 1 of the Lead-in Phase; Days 8, 25, and 39 of the CRT Phase; and Q2W for 12 months during the Maintenance Phase
    • Cisplatin 100 mg/m2 IV: Days 1, 22, and 43 of the CRT Phase
    • Intensity Modulated Radiation Therapy (IMRT) 70 Gy/35 fractions/7 weeks; 1 fraction per day, 5 fractions/week for 7 weeks during the CRT Phase
    Intervention: Drug: Avelumab
  • Placebo Comparator: Placebo + SOC CRT
    • Placebo IV matching avelumab: Days 1 of the Lead-in Phase; Days 8, 25, and 39 of the CRT Phase; Q2W for 12 months during the Maintenance Phase
    • Cisplatin 100 mg/m2 IV: Days 1, 22, and 43 of the CRT Phase
    • IMRT 70 Gy/35 fractions/7 weeks; 1 fraction per day, 5 fractions/week for 7 weeks during the CRT Phase
    Intervention: Other: Chemoradiation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 30, 2019)
697
Original Estimated Enrollment  ICMJE
 (submitted: October 31, 2016)
640
Estimated Study Completion Date  ICMJE May 18, 2022
Estimated Primary Completion Date April 8, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

INCLUSION CRITERIA

  • Histological diagnosis of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx
  • HPV negative disease, Stage III, IVa, IVb; non-oropharyngeal HPV positive disease Stage III, IVa, IVb, HPV positive oropharyngeal disease T4 or N2c or N3
  • No prior therapy for advanced stage SCCHN; eligible for definitive CRT with curative intent.
  • Available tumor samples for submission or willing to undergo further tumor biopsies:
  • Age ≥18 years (≥19 in Korea;20 years in Japan and Taiwan).
  • ECOG Performance Status 0 or 1
  • Adequate bone marrow function
  • Adequate renal function
  • Adequate liver function
  • Pregnancy test (for patients of childbearing potential) negative at screening

EXCLUSION CRITERIA

  • Prior immunotherapy with an anti PD 1, anti PD L1, anti PD L2, anti CD137, or anti CTLA 4 antibody (including ipilimumab), or any other antibody or drug specifically targeting T cell co stimulation or immune checkpoint pathways.
  • Major surgery 4 weeks prior to randomization.
  • Prior malignancy requiring tumor-directed therapy within the last 2 years prior to enrollment, or concurrent malignancy associated with clinical instability. Exceptions for disease within the 2 years are superficial esophageal cancer (TIS or T1a) fully resected by endoscopy, prostate cancer (Gleason score 6) either curatively treated or deemed to not require treatment, ductal IS carcinoma of the breast that has completed curative treatment, adequately treated basal cell or squamous cell skin cancer.
  • Active autoimmune disease
  • Any of the following in the 6 months prior to randomization: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack, or symptomatic pulmonary embolism.
  • Active infection requiring systemic therapy.
  • Use of immunosuppressive medication at time of randomization
  • Prior organ transplantation including allogenic stem-cell transplantation.
  • Diagnosis of prior immunodeficiency or known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related illness.
  • Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
  • Vaccination within 4 weeks prior to randomization.
  • Current use of or anticipated need for treatment with other anti-cancer drugs.
  • Pregnant female patients, breastfeeding female patients, and male patients able to father children and female patients of childbearing potential who are unwilling or unable to use 2 highly effective methods of contraception as outlined in the protocol for the duration of the study and for at least 6 months after the last dose of cisplatin and 60 days after the last dose of avelumab/placebo (whichever is later).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Austria,   Belgium,   Canada,   China,   France,   Germany,   Greece,   Hungary,   Ireland,   Israel,   Italy,   Japan,   Korea, Republic of,   Poland,   Portugal,   Russian Federation,   Spain,   Switzerland,   Taiwan,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02952586
Other Study ID Numbers  ICMJE B9991016
2016-001456-21 ( EudraCT Number )
LOCALLY ADVANCED HEAD AND NECK ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP