Study of Pembrolizumab (MK-3475) or Placebo With Chemoradiation in Participants With Locally Advanced Head and Neck Squamous Cell Carcinoma (MK-3475-412/KEYNOTE-412)

Completed · Phase 3 · Has a placebo group

Conditions studied: Head and Neck Neoplasms

In brief

The purpose of this study is to determine the efficacy and safety of pembrolizumab given concomitantly with chemoradiation (CRT) and as maintenance therapy versus placebo plus CRT in participants with locally advanced head and neck squamous cell carcinoma (LA HNSCC). The primary hypothesis is that pembrolizumab in combination with CRT is superior to placebo in combination with CRT with respect to event-free survival (EFS).

Key facts

Study ID

NCT03040999

Run by

Merck Sharp & Dohme LLC

People needed

804

Starts

2017-04-05

Expected to finish

2024-08-21

Last updated by the study team

2026-02-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Has a pathologically proven new diagnosis of oropharyngeal p16 positive, oropharyngeal p16 negative, or larynx/hypopharynx/oral cavity (independent of p16) squamous cell carcinoma. Participants with oral cavity tumors need to have unresectable disease. Participants with multiple synchronous tumors are not eligible for the study.
• Has provided tissue for Programmed Cell Death Receptor Ligand 1 (PD-L1) biomarker analysis from a core or excisional biopsy. If an excisional or incisional biopsy has been performed, participants remain eligible for the study provided the residual disease meets the staging criteria required for the trial (e.g., excisional biopsy of a lymph node with residual T4 primary). Prior surgical debulking, including tonsillectomy, for the head and neck cancer under study is not allowed.
• Has evaluable tumor burden (measurable and/or non-measurable tumor lesions) assessed by computed tomography scan or magnetic resonance imaging, based on RECIST version 1.1
• Is eligible for definitive CRT and not considered for primary surgery based on investigator decision
• Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 performed within 10 days prior to receiving the first dose of study therapy
• Female participants of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study therapy
• Female and male participants of reproductive potential must agree to use adequate contraception throughout the study period and for up to 180 days after the last dose of study therapy

You may not qualify if…

• Is currently participating or has participated in a study with an investigational agent or using an investigational device within 4 weeks of the first dose of study therapy
• Has received prior therapy with an anti-Programmed Cell Death Receptor 1 (PD-1), anti-PD-L1, anti-Programmed Cell Death Receptor Ligand 2 (PD-L2) agent or with an agent directed to another co-inhibitory T-cell receptor or has previously participated in clinical studies with pembrolizumab
• Has received a live vaccine within 30 days prior to the first dose of study therapy
• Has cancer outside of the oropharynx, larynx, and hypopharynx or oral cavity, such as nasopharyngeal, sinus, other para-nasal, or other unknown primary head and neck cancer
• Has had prior systemic therapy, targeted therapy, radiotherapy treatment or radical surgery for head and neck cancer under study
• Has not recovered from major surgery prior to starting study therapy
• Has known active Hepatitis B or C
• Has known history of Human Immunodeficiency Virus (HIV)
• Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study therapy
• Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis
• Has an active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy is not considered a form of systemic treatment.
• Has history of a diagnosed and/or treated hematologic or primary solid tumor malignancy, unless in remission for at least 5 years prior to randomization
• Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
• Has had previous allogeneic tissue/solid organ transplant
• Has active infection requiring systemic therapy
• Has a history of severe hypersensitivity reaction to pembrolizumab, Cisplatin or radiotherapy or their analogs
• Is pregnant or breast feeding or expecting to conceive or father children throughout the study period and for up to 180 days after the last dose of study therapy

Where it is running

• University of California San Francisco ( Site 0274) — San Francisco, California, United States
• St. Joseph Heritage Healthcare ( Site 0254) — Santa Rosa, California, United States
• Smilow Cancer Hospital at Yale New Haven ( Site 0256) — New Haven, Connecticut, United States
• Rush University Medical Center ( Site 0260) — Chicago, Illinois, United States
• Indiana University ( Site 0264) — Indianapolis, Indiana, United States
• Mary Bird Perkins Cancer Center at St. Tammany Parish Hospital ( Site 0281) — Baton Rouge, Louisiana, United States
• University of Massachusetts Memorial Medical Center ( Site 0285) — Worcester, Massachusetts, United States
• University of Michigan Hospital and Health Systems ( Site 0267) — Ann Arbor, Michigan, United States
• Barbara Ann Karmanos Cancer Institute ( Site 0272) — Detroit, Michigan, United States
• Mercy Clinic Cancer and Hematology - Chub O'Reilly Cancer Center ( Site 0290) — Springfield, Missouri, United States
• St. Vincent Healthcare Frontier Cancer Center ( Site 0286) — Billings, Montana, United States
• Comprehensive Cancer Centers of Nevada ( Site 8004) — Las Vegas, Nevada, United States
• University of Rochester - James P. Wilmot Cancer Center ( Site 0255) — Rochester, New York, United States
• Oncology Hematology Care, Inc. ( Site 8003) — Cincinnati, Ohio, United States
• Willamette Valley Cancer Institute and Research Center ( Site 8000) — Eugene, Oregon, United States
• St. Luke's Cancer Center - Anderson ( Site 0251) — Easton, Pennsylvania, United States
• St. Francis Hospital Cancer Center ( Site 1461) — Greenville, South Carolina, United States
• Texas Oncology-Arlington North ( Site 8005) — Arlington, Texas, United States
• Texas Oncology-Austin Central ( Site 8002) — Austin, Texas, United States
• Texas Oncology PA ( Site 8001) — Longview, Texas, United States
• University of Virginia Health System ( Site 0261) — Charlottesville, Virginia, United States
• Seattle Cancer Care Alliance/Univ of Washington Medical Center ( Site 0269) — Seattle, Washington, United States
• Medical Oncology Associates (Summit Cancer Centers) ( Site 0257) — Spokane, Washington, United States
• Blacktown Hospital Western Sydney Local Health District ( Site 0304) — Blacktown, New South Wales, Australia
• UCLA Medical Center ( Site 0273) — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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