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Trial record 1 of 14 for:    MK-3475 Pembrolizumab head and neck phase III
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Pembrolizumab (MK-3475) Versus Standard Treatment for Recurrent or Metastatic Head and Neck Cancer (MK-3475-040/KEYNOTE-040)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT02252042
First received: September 25, 2014
Last updated: September 18, 2017
Last verified: September 2017
  Purpose
This is a study of pembrolizumab (MK-3475, KEYTRUDA®) versus standard treatment (methotrexate, docetaxel or cetuximab) for the treatment of recurrent or metastatic head and neck squamous cell cancer (HNSCC). Participants will be randomly assigned to receive either pembrolizumab or Investigator's choice of standard treatment. The primary study hypothesis is that pembrolizumab treatment prolongs overall survival when compared to standard treatment.

Condition Intervention Phase
Head and Neck Squamous Cell Cancer Biological: pembrolizumab Drug: methotrexate Drug: docetaxel Biological: cetuximab Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III Randomized Trial of MK-3475 (Pembrolizumab) Versus Standard Treatment in Subjects With Recurrent or Metastatic Head and Neck Cancer

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Overall Survival (OS) for All Participants [ Time Frame: Up to approximately 2 years ]

Secondary Outcome Measures:
  • Progression-Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With Programmed Cell Death Ligand 1 (PD-L1)-Positive Expression defined by ≥1% Combined Positive Score (CPS)(PD-L1 1% CPS) [ Time Frame: Up to approximately 2 years ]
  • Objective Response Rate (ORR) per RECIST 1.1 in All Participants [ Time Frame: Up to approximately 2 years ]
  • ORR per RECIST 1.1 in Participants With PD-L1 1% CPS [ Time Frame: Up to approximately 2 years ]
  • PFS per RECIST 1.1 for All Participants [ Time Frame: Up to approximately 2 years ]
  • OS for Participants With PD-L1 1% CPS [ Time Frame: Up to approximately 2 years ]

Enrollment: 495
Actual Study Start Date: November 17, 2014
Estimated Study Completion Date: June 12, 2018
Primary Completion Date: May 15, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pembroliziumab
Participants receive pembrolizumab 200 mg intravenous (IV) on Day 1 of each 3-week cycle
Biological: pembrolizumab
Other Names:
  • MK-3475
  • KEYTRUDA®
Active Comparator: Active Comparator
Participants receive methotrexate 40 mg/m^2 IV (may be escalated to 60 mg/m^2 maximum dose) on Days 1, 8, and 15 of each 3-week cycle; or docetaxel 75 mg/m^2 IV on Day 1 of each 3- week cycle; or cetuximab 400 mg/m^2 IV loading dose on Day 1 and 250 mg/m^2 IV on Days 8 and 15 of Cycle 1, followed by cetuximab 250 mg/m^2 on Days 1, 8, and 15 of each subsequent 3-week cycle
Drug: methotrexate Drug: docetaxel Biological: cetuximab

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Has histologically- or cytologically-confirmed recurrent disease not amenable to curative treatment with local or systemic therapy, or metastatic (disseminated) head and neck squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, and larynx that is considered incurable by local therapies
  • Failure of prior platinum therapy
  • Radiographically-measurable disease based on RECIST 1.1
  • Tumor tissue available for PD-L1 biomarker analysis
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate organ function
  • Female participants of childbearing potential must be willing to use 2 methods of birth control or abstain from heterosexual activity for the course of the study through 120 days after last dose of pembrolizumab or through 120-180 days after the last dose of docetaxel, methotrexate or cetuximab, acccording to local standard of care
  • Male participants must agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after last dose of pembrolizumab or through 120-180 days after the last dose of docetaxel, methotrexate or cetuximab, acccording to local standard of care

Exclusion Criteria

  • Disease is suitable for local therapy administered with curative intent
  • Currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks prior to randomization
  • Previously treated with 3 or more systemic regimens given for recurrent and/or metastatic disease
  • Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study therapy
  • Not recovered from adverse events due to therapy more than 4 weeks earlier
  • Prior anti-cancer monoclonal antibody (mAb) therapy within 4 weeks prior to study Day 1, or not recovered from adverse events due to agents administered more than 4 weeks earlier
  • Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1
  • Diagnosed and/or treated additional malignancy within 5 years of randomization, with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin, and/or curatively-resected in situ cervical and/or breast cancers
  • Active autoimmune disease that has required systemic therapy in the past 2 years with modifying agents, corticosteroids, or immunosuppressive agents
  • Active central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Active, non-infectious pneumonitis
  • Active infection requiring systemic therapy
  • Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial therapy according to local standard of care
  • Prior therapy with an anti-PD-1 or anti-PD1-L1 or -L2 therapy or previously participated in a Merck pembrolizumab (MK-3475) trial
  • Human immunodeficiency virus (HIV)
  • Hepatitis B or C
  • Live vaccine within 30 days of planned start of study therapy
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02252042

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT02252042     History of Changes
Other Study ID Numbers: 3475-040
2014-001749-26 ( EudraCT Number )
Study First Received: September 25, 2014
Last Updated: September 18, 2017

Keywords provided by Merck Sharp & Dohme Corp.:
Squamous cell carcinoma
Head and neck carcinoma
PD1
PD-1
PDL1
PD-L1

Additional relevant MeSH terms:
Head and Neck Neoplasms
Pembrolizumab
Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Neoplasms by Site
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Carcinoma
Docetaxel
Methotrexate
Cetuximab
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on September 19, 2017