A post-licensure prospective observational registry study in real-world Taiwanese cancer patients with microsatellite instability-high (MSI-H) or deficient mismatch repair (dMMR) genes

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/47306
• EU PAS number:
  EUPAS33807
• Study ID:
  47306
• Official title and acronym:
  A post-licensure prospective observational registry study in real-world Taiwanese cancer patients with microsatellite instability-high (MSI-H) or deficient mismatch repair (dMMR) genes
• DARWIN EU® study:
  No
• Study countries:
  Taiwan
• Study description:
  In major cancer centers in Taiwan, participants with a diagnosis of advanced unresectable or metastatic solid tumors and have progressed on prior standard therapy following index diagnosis will be screened for microsatellite instability (MSI)/deoxyribonucleic (DNA) mismatch repair (MMR) status. Participants that test MSI-H (including deficient mismatch repair dMMR) positive and receive at least one dose of pembrolizumab will be enrolled following consent and prospectively followed through a registry. The primary objectives of the study are to measure objective response rate (ORR) and duration of response (DOR) in participants who have received at least 1 dose of pembrolizumab.
• Study status:
  Discontinued

Research institutions and networks

Institutions

Merck & Co.

Study timelines

Date when funding contract was signed

Planned: 21/04/2020

Actual: 21/01/2020

Study start date

Planned: 01/10/2021

Actual: 01/10/2021

Data analysis start date

Actual: 15/09/2023

Date of final study report

Planned: 13/12/2024

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Merck Sharp & Dohme LLC

Study protocol

Initial protocol

MK-3475-A80-00-v1-Protocol_Final Redaction

Updated protocol

3475-A80-01-V2-Protocol_L1-final-redaction

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable