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Clinical Trials List

Protocol NumberMK-3475-587
NCT Number(ClinicalTrials.gov Identfier)NCT03486873
Active

2019-10-01 - 2046-12-31

Phase III

Recruiting12

ICD-10C7A.1

Malignant poorly differentiated neuroendocrine tumors

ICD-10C7A.8

Other malignant neuroendocrine tumors

ICD-10C7B.09

Secondary carcinoid tumors of other sites

ICD-10C7B.1

Secondary Merkel cell carcinoma

ICD-10C7B.8

Other secondary neuroendocrine tumors

ICD-10C80.0

Disseminated malignant neoplasm, unspecified

ICD-10D3A.8

Other benign neuroendocrine tumors

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9199.0

Disseminated malignant neoplasm

A Multicenter, Open label, Phase III Extension Trial to Study the Long-term Safety and Efficacy in Participants with Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab Trial.

  • 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 James Chih-Hsin Yang Division of Hematology & Oncology
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 Recruiting

Principal Investigator Mu-Hsin Chang Division of Hematology & Oncology
Taipei Veterans General Hospital

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 Wu-Chou Su Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Cheng-Ta Yang Division of Hematology & Oncology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

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

Co-Principal Investigator

  • 蘇健 Division of Thoracic Medicine
  • 張源清 Division of General Surgery

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 鍾奇峰 Division of Hematology & Oncology
Koo Foundation Sun Yat-Sen Cancer Center

Co-Principal Investigator

  • 陳鵬宇 Division of Hematology & Oncology

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Jih-Hsiang Lee Division of Hematology & Oncology
National Taiwan University Hospital Hsin-Chu Branch

Co-Principal Investigator

  • 李明璟 Division of Hematology & Oncology

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator TSUNG -YING YANG Division of Thoracic Medicine
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chao-Hua Chiu Division of Thoracic Medicine
Taipei Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 林聖皓 Division of Thoracic Medicine
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Advanced Solid Tumors

Objectives

The purpose of this study is to evaluate the long-term safety and efficacy of pembrolizumab (MK-3475) in participants from previous Merck pembrolizumab-based parent studies who roll-over into this extension study. This study will consist of three phases: 1) First Course Phase, 2) Survival Follow-up Phase or 3) Second Course Phase. Each participant will roll-over to this extension study in one of the following three phases, depending on the study phase they were in at the completion of the parent study. Participants who were in the First Course Phase of study treatment in their parent study will enter the First Course Phase of this study and complete up to 35 doses or more every 3 weeks (Q3W) or 17 doses or more every 6 weeks (Q6W) of study treatment with pembrolizumab or a pembrolizumab-based combination according to arm assignment. Participants who were in the Follow-up Phase in the parent study (post-treatment or Survival Follow-up Phase) will enter the Survival Follow-up Phase of this study. Participants who were in the Second Course Phase in their parent study will enter Second Course Phase of this study and complete up to 17 doses Q3W or 8 doses Q6W of study treatment with pembrolizumab or a pembrolizumab-based combination according to arm assignment.

Test Drug

Pembrolizumab

Active Ingredient

Pembrolizumab (Humanized anti-PD-1 mAb)

Dosage Form

Injection

Dosage

100 mg/ 4 mL vial

Endpoints

Overall Survival (OS)

Inclution Criteria

1.Advanced unresectable or metastatic tumor(s)
2.Currently enrolled in a Merck-sponsored pembrolizumab study and is receiving study treatment or in a Follow-up Phase at the time MK-3475-587 is open. The parent studies must have completed all regulatory requirements and submissions, if any, or have fully addressed their primary endpoint(s) before all their participants roll over into this MK-3475-587 extension study

Exclusion Criteria

There are no exclusion criteria to participate in MK-3475-587

The Estimated Number of Participants

  • Taiwan

    30 participants

  • Global

    3500 participants

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