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Clinical Trials List

Protocol NumberMK-3475-06B
NCT Number(ClinicalTrials.gov Identfier)NCT05319730
Active

2022-12-15 - 2027-12-31

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 Previously Exposed to PD-1/PD-L1 Treatment (KEYMAKER-U06): Substudy 06B

  • 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 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 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 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 Shang-Yin Wu Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Esophageal Squamous Cell Carcinoma

Objectives

main purpose: (1) Safety lead-in period: Evaluate the safety and tolerability of a combination treatment that has not been evaluated in another trial. (2) Estimated objective response rate (ORR) as assessed by a Blinded Independent Central Review Committee (BICR) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). Secondary purpose: (1) Efficacy period: Evaluated by BICR based on RECIST 1.1 to evaluate progression-free survival (PFS). (2) Efficacy period: Evaluated by BICR based on RECIST 1.1 to evaluate the duration of response (DOR). (3) Efficacy period: evaluate overall survival (OS). (4) Efficacy period: Evaluate the safety and tolerability of the investigational treatment combination based on the proportion of subjects who develop AEs.

Test Drug

Lenvima capsule 4 mgR/ Lenvima capsule 4 mgR KeytrudaR/ KeytrudaR Lenvima capsule 10 mgR/ Lenvima capsule 10 mgRMK-4830 IntaxelR Cancer Treatment Intravenous Infusion Concentrate/ IrinotelR

Active Ingredient

Lenvatinib mesilate
Pembrolizumab (Humanized anti-PD-1 mAb)
Lenvatinib mesilate
Fully human anti-ILT4 IgG4 monoclonal antibody
Paclitaxel
Irinotecan Hydrochloride

Dosage Form

capsule
Injection
Capsule
Injection
Injection
Injection

Dosage

4 mg/capsule
100 mg/ 4 mL
10 mg/capsule
800 mg/16mL/vial
100mg/16.7mL
100mg/5mL

Endpoints

1. Dose-limiting toxicity (DLT)
2. Adverse events (AE)
3. Trial discontinuation of treatment due to AEs
4. Objective response rate (ORR)

Inclution Criteria

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, that includes a platinum agent and previous exposure to an anti-PD1/PD-L1 based 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 history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or corneal disease that prevents/delays corneal healing.
Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease.
Currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention.
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.
Known GI malabsorption or any other condition that may affect the absorption of lenvatinib. (Not applicable to actively enrolling arms as of Amendment 5)
Has risk for significant GI bleeding such as a serious nonhealing wound, peptic ulcer, or bone fracture within 28 days prior to allocation/randomization, significant bleeding disorders, vasculitis, or has had a significant bleeding episode from the GI tract within 12 weeks prior to allocation/randomization. (Not applicable to actively enrolling arms as of Amendment 5)

The Estimated Number of Participants

  • Taiwan

    32 participants

  • Global

    90 participants

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