Non-interventional post-marketing safety study (PMSS) to collect information on hepatic function disorders among Japanese patients with radically unresectable or metastatic renal cell carcinoma treated with pembrolizumab in combination with axitinib (MK-3475-A97)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/48486
• EU PAS number:
  EUPAS34319
• Study ID:
  48486
• Official title and acronym:
  Non-interventional post-marketing safety study (PMSS) to collect information on hepatic function disorders among Japanese patients with radically unresectable or metastatic renal cell carcinoma treated with pembrolizumab in combination with axitinib (MK-3475-A97)
• DARWIN EU® study:
  No
• Study countries:
  Japan
• Study description:
  The aim of this study is to collect information on hepatic disorders including clinical events and/or laboratory elevations with or without hepatic dysfunction in Japanese participants with radically unresectable or metastatic renal cell carcinoma (RCC) treated with pembrolizumab in combination with axitinib, and to describe treatment and resolution of these adverse events (AEs) in real-world clinical practice.
• Study status:
  Finalised

Research institutions and networks

Institutions

Merck & Co.

Merck Investigational Site Japan

Study timelines

Date when funding contract was signed

Actual: 05/11/2019

Study start date

Planned: 31/07/2020

Actual: 17/06/2020

Data analysis start date

Planned: 31/05/2023

Actual: 26/04/2023

Date of final study report

Planned: 11/07/2024

Actual: 08/07/2024

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Merck Sharp & Dohme LLC

Study protocol

Initial protocol

MK-3475-A97-00-v1-prot_final-redaction

Updated protocol

MK-3475-A97-04-v1-Protocol_final redaction

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Non-EU RMP only