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

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/1000000542
• 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 & Co.

Networks

Flatiron

Study timelines

Date when funding contract was signed

Planned: 20/11/2024

Actual: 20/11/2024

Study start date

Planned: 02/05/2025

Actual: 02/05/2025

Data analysis start date

Planned: 31/12/2026

Date of final study report

Planned: 15/12/2027

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