Pembrolizumab (MK-3475) Versus Standard Treatment for Recurrent or Metastatic Head and Neck Cancer (MK-3475-040/KEYNOTE-040)
Conditions
Head and Neck Squamous Cell Cancer
Conditions: official terms
Carcinoma, Squamous Cell - Head and Neck Neoplasms - Neoplasms, Squamous Cell
Conditions: Keywords
Squamous cell carcinoma, Head and neck carcinoma, PD1
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: pembrolizumab Type: Biological
Name: methotrexate Type: Drug
Name: docetaxel Type: Drug
Name: cetuximab Type: Biological
Overall Status
Recruiting
Summary
This is a study of pembrolizumab 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 progression-free survival and overall survival when compared to standard treatment.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Have 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 120-180 days after the last dose of study therapy 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 120-180 days after the last dose of study therapy according 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 the first dose of study therapy

- 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 therapy within 4 weeks prior to study Day 1, or not recovered from adverse events

- 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 carcinoma

- 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 -180 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 trial

- Human immunodeficiency virus (HIV)

- Hepatitis B or C

- Live vaccine within 30 days of planned start of study therapy
Locations
Call for Information (Investigational Site 0011)
La Jolla, California, United States
Status: Recruiting
Call for Information (Investigational Site 0008)
Los Angeles, California, United States
Status: Recruiting
Call for Information (Investigational Site 0026)
San Francisco, California, United States
Status: Recruiting
Call for Information (Investigational Site 0006)
Aurora, Colorado, United States
Status: Recruiting
Call for Information (Investigational Site 0010)
New Haven, Connecticut, United States
Status: Recruiting
Call for Information (Investigational Site 0007)
Harvey, Illinois, United States
Status: Recruiting
Call for Information (Investigational Site 0001)
St. Louis, Missouri, United States
Status: Recruiting
Call for Information (Investigational Site 0019)
Cincinnati, Ohio, United States
Status: Recruiting
Call for Information (Investigational Site 0018)
Portland, Oregon, United States
Status: Recruiting
Call for Information (Investigational Site 0020)
Hershey, Pennsylvania, United States
Status: Recruiting
Call for Information (Investigational Site 0014)
Philadelphia, Pennsylvania, United States
Status: Recruiting
MSD Belgium BVBA/SPRL
Brussels, Belgium
Status: Recruiting
Contact: Marc Denayer - 32 2 776 60 28
Merck Canada
Kirkland, Quebec, Canada
Status: Recruiting
Contact: Medical Information Centre Centre de l'information mýcale de Merck Canada - 514-428-8600 / 1-800-567-2594
MSD France
Paris, France
Status: Recruiting
Contact: Dominique Blazy - 33 147548990
Merck Sharp & Dohme GmbH
Haar, Germany
Status: Recruiting
Contact: German Medical Information Center - 49 800 673 673 673
MSD Pharma Hungary Kft.
Budapest, Hungary
Status: Recruiting
Contact: Simona Martinkova - 36 1 457 8522
MSD Ireland (Human Health) Ltd.
Dublin, Ireland
Status: Recruiting
Contact: Colm Galligan - 353 12998700
MSD Italia S.r.l.
Rome, Italy
Status: Recruiting
Contact: Patrizia Nardini - 39 06 361911
MSD Korea LTD
Seoul, Korea, Republic of
Status: Recruiting
Contact: Cem Ozesen - 90 212 3361260
UAB "Merck Sharp & Dohme"
Vilnius, Lithuania
Status: Recruiting
Contact: Andrius Bacevicius - 370 52780243
Merck Sharp & Dohme BV
Haarlem, Netherlands
Status: Recruiting
Contact: Caroline Doornebos - 31 23 515 3362
MSD Polska Sp. Z o.o.
Warsaw, Poland
Status: Recruiting
Contact: Adam Czernik - 48 22 4784324
Merck Sharp & Dohme Lda.
Paco D'arcos, Portugal
Status: Recruiting
Contact: Ana Maria Nogueira - 351-21-4465890
Call for Information (Investigational Site 0096)
Ponce, Puerto Rico
Status: Recruiting
Call for Information (Investigational Site 0098)
San Juan, Puerto Rico
Status: Recruiting
Call for Information (Investigational Site 0101)
San Juan, Puerto Rico
Status: Recruiting
Merck Sharp & Dohme IDEA, Inc.
Moscow, Russian Federation
Status: Recruiting
Contact: Tatiana Serebriakova - 74959167100, EXT.366
Merck Sharp and Dohme de Espana S.A.
Madrid, Spain
Status: Recruiting
Contact: Joaquin Mateos Chacon - ensayos_clinicos@merck.com
MSD International GmbH
Lucerne 6, Switzerland
Status: Recruiting
Contact: Erik Mossdorf - 41 58 618 33 79
Merck Sharp & Dohme Ltd.
Hoddesdon, United Kingdom
Status: Recruiting
Contact: Mark Toms - 44 199 242 7272
Start Date
November 2014
Completion Date
April 2017
Sponsors
Merck Sharp & Dohme Corp.
Source
Merck Sharp & Dohme Corp.
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page