問卷
Log In
繁中 EN
TPIDB
TPIDB Outstanding PI
TPIDB > Search Result > Clinical Trials List

Clinical Trials List

Protocol NumberMK-3475-975
NCT Number(ClinicalTrials.gov Identfier)NCT04210115
Active

2020-01-01 - 2029-12-31

Phase III

Not yet recruiting1

Recruiting6

ICD-10C15.9

Malignant neoplasm of esophagus, unspecified

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9150.9

Malignant neoplasm of esophagus, unspecified

A Randomized, Double-blind, Placebo-controlled Phase 3 Trial of Pembrolizumab (MK-3475) Versus Placebo in Participants With Esophageal Carcinoma Receiving Concurrent Definitive Chemoradiotherapy (KEYNOTE 975)

  • Trial Applicant

    Merck Sharp & Dohme (I.A.) LLC

  • Sponsor

    Merck Sharp & Dohme Corp.

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Hsien-Kun Chang Division of Hematology & Oncology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

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 Recruiting

Principal Investigator 邱倫瑋 Division of Hematology & Oncology
Koo Foundation Sun Yat-Sen Cancer Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Shang-Yin Wu Division of General Internal Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chen-Yuan Lin Division of Hematology & Oncology
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Chih-Hung Hsu Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

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

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Esophageal Squamous Cell Carcinoma (ESCC)、 Gastroesophageal Junction Carcinoma (GEJC)、 Esophageal Adenocarcinoma (EAC)

Objectives

The purpose of this study is to assess the efficacy and safety of treatment with definitive chemoradiotherapy (dCRT) + pembrolizumab (MK-3475) compared to treatment with dCRT + placebo with respect to Overall Survival (OS) and Event-free survival (EFS) in: participants with esophageal squamous cell carcinoma (ESCC), participants whose tumors express Programmed Death-Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10, and all participants. The primary study hypotheses are that dCRT+ pembrolizumab is better than dCRT + placebo with respect to: OS in participants with ESCC, OS in participants whose tumors express PD-L1 CPS ≥10, OS in all participants, EFS in participants with ESCC, EFS in participants whose tumors express PD-L1 CPS ≥10, and EFS in all participants.

Test Drug

Pembrolizumab (MK-3475)
KEYTRUDA®

Active Ingredient

Pembrolizumab

Dosage Form

IVT

Dosage

100 mg/ 4 mL

Endpoints

Primary Outcome Measures :
Overall Survival (OS) [ Time Frame: Up to ~72 months ]
OS is defined as the time from randomization to death from any cause.

Event-free Survival (EFS) [ Time Frame: Up to ~60 months ]
EFS is defined as the time from randomization to an event defined as local, regional, or distant recurrence as assessed by blinded independent central review (BICR) based on imaging or biopsy if indicated (if biopsy is accompanied with radiological recurrence of primary disease as evaluated by investigator); or death from any cause.

Inclution Criteria

Inclusion Criteria:

Has histologically or cytologically confirmed diagnosis of CTX N+ M0 or cT2-T4a NX M0 ESCC, GEJC, EAC, or histologically or cytologically confirmed diagnosis of cTX N+ M1 cervical or upper thoracic esophageal carcinoma with supraclavicular lymph node metastases only
Is deemed suitable for dCRT
Is ineligible for curative surgery based on the documented opinion of a qualified medical/surgical/radiation oncologist
Is not expected to require tumor resection during the course of the study
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 3 days of the first dose of study treatment.
Has adequate organ function
Male participants must use adequate contraception (a male condom plus partner use of an additional contraceptive method) unless confirmed to be azoospermic (vasectomized or secondary to medical cause) during the study treatment period and through 90 days after the last dose of chemotherapy
Female participants who are a Woman of Childbearing Potential (WOCBP) must use contraception that is highly effective (with a failure rate of <1% per year), with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle, during the study treatment period through 180 days after the last dose of chemotherapy or 120 days after the last dose of pembrolizumab, whichever is greater, and agree not to donate eggs to others or freeze/store for her own use for the purpose of reproduction during this period
Female participants must not be pregnant or breastfeeding

Exclusion Criteria

Exclusion Criteria:

Has direct invasion of tumor into adjacent organs such as the aorta or trachea
Has had major surgery other than for insertion of a feeding tube, open biopsy, or significant traumatic injury within 28 days prior to randomization, or anticipates the need for major surgery during study treatment; participants with gastric or esophageal fistulae are excluded
Has had weight loss of >20% in the previous 3 months
Has had prior chemotherapy or radiotherapy for esophageal cancer
Has had a myocardial infarction within the past 6 months
Has severe congestive heart failure
Has received prior therapy with an anti-programmed cell death-1 (anti PD-1), anti-programmed cell death-ligand 1 (anti-PD-L1), or anti-programmed cell death-ligand 2 (anti-PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], OX-40, CD137)
Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention; administration of killed vaccines is allowed
Has received any prior systemic anticancer therapy for esophageal cancer including investigational agents
Has not recovered from all adverse events (AEs) due to previous non-anticancer therapies to ≤Grade 1 or Baseline
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study treatment
Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded from the study. Participants with localized prostate cancer that has undergone potentially curative treatment can be enrolled in the study.
Has severe hypersensitivity (≥Grade 3) to pembrolizumab, any of the study chemotherapy agents, or their excipients
Has an active autoimmune disease that has required systemic treatment in past 2 years
Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
Has an active infection requiring systemic therapy
Has a known history of human immunodeficiency virus (HIV) infection
Has a known history of Hepatitis B or known active Hepatitis C virus infection
Has a known history of active tuberculosis (TB; Bacillus tuberculosis)
Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment (180 days for participants receiving cisplatin who are breastfeeding)
Has had an allogenic tissue/solid organ transplant

The Estimated Number of Participants

  • Taiwan

    30 participants

  • Global

    700 participants

聯絡我們

台灣臨床試驗主持人資料庫 TPIDB

All Contents Copyright 2020 台灣臨床試驗主持人資料庫TPIDB