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Clinical Trials List

Protocol NumberMK3475-412
NCT Number(ClinicalTrials.gov Identfier)NCT03040999
Completed

2017-01-20 - 2025-08-15

Phase III

Terminated7

ICD-10C44.42

Squamous cell carcinoma of skin of scalp and neck

ICD-9146.0

Malignant neoplasm of tonsil

A Randomized Phase III study of pembrolizumab given concomitantly with chemoradiation and as maintenance therapy versus chemoradiation alone in subjects with locally advanced head and neck squamous cell carcinoma (KEYNOTE-412)

  • Trial Applicant

    Merck Sharp & Dohme (I.A.) LLC

  • Sponsor

    Merck Sharp & Dohme LLC

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/08/24

Investigators and Locations

Principal Investigator Chia-Jui Yen Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Audit

None

Principal Investigator Shau-Hsuan Li Division of Hematology & Oncology
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 張義芳 Division of Hematology & Oncology
MacKay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator RUEY-LONG HONG Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Audit

None

Principal Investigator Muh-Hwa Yang Division of Radiation Therapy
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

5 Terminated

Audit

None

Principal Investigator YI-CHUN LIU Division of Radiation Therapy
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Hung-Ming Wang
Linkou Chang Gung Medical Foundation

Taiwan National PI

王宏銘

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

5 Terminated

Audit

None

Condition/Disease

Head and Neck Neoplasms

Objectives

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).

Test Drug

Keytruda

Active Ingredient

Pembrolizumab

Dosage Form

Dosage

200mg

Endpoints

Event-free Survival (EFS)
Overall Survival (OS)

Inclution Criteria

Inclusion Criteria:

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

Exclusion Criteria

Exclusion Criteria:

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

The Estimated Number of Participants

  • Taiwan

    33 participants

  • Global

    780 participants

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