Study identification

EU PAS number

EUPAS1000000542

Study ID

1000000542

Official title and acronym

Real-world effectiveness of pembrolizumab among patients with TMB-H advanced solid tumors (MK-3475-G34)

DARWIN EU® study

No

Study countries

United States

Study description

The main objective of the study is to understand the real-world effectiveness of pembrolizumab monotherapy among patients with advanced solid tumors with Tumor Mutational Burden-High (TMB-H) assayed by F1/F1CDx. This study will describe the real-world effectiveness of pembrolizumab monotherapy among adult patients with advanced solid tumors with TMB-H in 2nd line or 2nd line+ (2L/2L+) setting.

Study status

Ongoing
Research institutions and networks

Institutions

Merck Sharp & Dohme LLC
United States
First published:
08/07/2025
Institution Pharmaceutical company

Networks

Flatiron

Contact details

Clinical Trials Disclosure Merck Sharp & Dohme LLC

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Merck Sharp & Dohme LLC
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable