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Clinical Trials List

Protocol NumberMK-3475-06A
NCT Number(ClinicalTrials.gov Identfier)NCT05342636
Active

2022-06-16 - 2026-06-30

Phase I/II

Recruiting7

ICD-10C15.9

Malignant neoplasm of esophagus, unspecified

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9150.9

Malignant neoplasm of esophagus, unspecified

A Phase 1/2 Open-Label, Umbrella Platform Design Study of Investigational Agents With or Without Pembrolizumab (MK-3475) and/or Chemotherapy in Participants With Advanced Esophageal Cancer naïve to PD-1/PD-L1 Treatment (KEYMAKER-U06): Substudy 06A.

  • Trial Applicant

    Merck Sharp & Dohme (I.A.) LLC

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Ming-Huang Chen Division of Hematology & Oncology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 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 Chi-Ting Liau 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 Chen-Yuan Lin Division of Hematology & Oncology
China Medical 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

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

Condition/Disease

Esophageal Squamous Cell Carcinoma (ESCC)

Objectives

This trial will not conduct formal hypothesis testing. Objectives will be assessed in each treatment group. For men and women with advanced ESCC who have failed prior first-line therapy and who have not received prior PD-1/PD-L1 therapy. Primary Objectives: - Safety Run-in Phase: To evaluate the safety and tolerability of the combination that has not been evaluated in other trials. - To estimate the objective response rate (ORR) as assessed by a blinded independent central review committee (BICR) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). Secondary Objectives: - Efficacy Phase: To evaluate progression-free survival (PFS) as assessed by BICR according to RECIST 1.1. - Efficacy Phase: To evaluate the duration of response (DOR) as assessed by BICR according to RECIST 1.1. - Efficacy Phase: To evaluate overall survival (OS). - Efficacy Phase: To evaluate the safety and tolerability of the investigational treatment combination based on the proportion of subjects experiencing AEs.

Test Drug

Keytruda injection RMK-4830MK-4280A Lenvima capsule R Lenvima capsule R Intaxel Injection R Irinotel Intravenous Infusion Concentrate

Active Ingredient

Pembrolizumab (Humanized anti-PD-1 mAb)
Fully human anti-ILT4 IgG4 monoclonal antibody
Favezelimab (MK-4280) (Humanized IgG4 mAb) + Pembrolizumab (MK-3475) (Humanized anti-PD-1 mAb)
Lenvatinib mesilate
Lenvatinib mesilate
Paclitaxel
Irinotecan Hydro

Dosage Form

Injection
Injection
Injection
capsule
capsule
Injection
Injection

Dosage

100 mg/ 4mL
800 mg/16mL
800mg+200mg/40mL
4mg
10 mg
100mg/16.7mL
100mg/5mL

Endpoints

Main outcome measures:
- Dose-limiting toxicity (DLT).
- Adverse events (AEs).
- Discontinuation of trial treatment due to AEs.
- Objective response: confirmed complete response (CR) or partial response (PR).

Inclution Criteria

The main inclusion and exclusion criteria include but are not limited to the following:

Inclusion Criteria:

Histologically or cytologically confirmed diagnosis of metastatic or locally advanced unresectable ESCC
Has experienced investigator documented radiographic or clinical disease progression on one prior line of standard therapy.
Has an evaluable baseline tumor sample (newly obtained or archival) for analysis
Has adequately controlled blood pressure (BP) with or without antihypertensive medications
Participants who have adverse events (AEs) due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤Grade 2 neuropathy are eligible

Exclusion Criteria

Exclusion Criteria:

Direct invasion into adjacent organs such as the aorta or trachea
Has experienced weight loss >10% over approximately 2 months prior to first dose of study therapy
Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medication
Known additional malignancy that is progressing or has required active treatment within the past 3 years, except basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ that has undergone potentially curative therapy
Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
Active autoimmune disease that has required systemic treatment in past 2 years
History of human immunodeficiency virus (HIV) infection
History of Hepatitis B or known active Hepatitis C virus infection
History of allogenic tissue/solid organ transplant
Clinically significant cardiovascular disease within 12 months from first dose of study intervention
Participants with known gastrointestinal (GI) malabsorption or any other condition that may affect the absorption of lenvatinib
Has risk for significant GI bleeding, such as:
Has had a serious nonhealing wound, peptic ulcer, or bone fracture within 28 days prior to allocation/randomization
Has significant bleeding disorders, vasculitis, or has had a significant bleeding episode from the GI tract within 12 weeks prior to allocation/randomization

The Estimated Number of Participants

  • Taiwan

    54 participants

  • Global

    120 participants

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