Study identification

PURI

https://redirect.ema.europa.eu/resource/1000000104

EU PAS number

EUPAS1000000104

Study ID

1000000104

Official title and acronym

Real-world treatment patterns and outcomes of patients with advanced renal cell carcinoma (aRCC) treated with first-line (1L) axitinib + pembrolizumab therapy

DARWIN EU® study

No

Study countries

United States

Study description

This is a cohort study that includes a cross-sectional physician survey and a retrospective, multi-site, oncology community-based, medical chart abstraction of patients with clear cell aRCC treated with 1L axitinib + pembrolizumab therapy. Cardinal Health will recruit physicians to participate in the study through a proprietary network of community oncologists. Primary data will be collected from participating physicians, who will be asked to complete a one-time survey on treatment management approaches for aRCC. Participating physicians will then be asked to complete electronic case report (eCRF) forms for patients meeting the study selection criteria based on their existing medical records. All patient-level data are secondary data that will be collected retrospectively from existing medical records originally collected as part of routine care by participating providers.

Study status

Ongoing
Research institutions and networks

Institutions

Pfizer
First published:
01/02/2024
Institution
Cardinal Health

Contact details

Yaa Ababio

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Pfizer
Study protocol
Initial protocol

A4061101_NIS_Protocol_V2.0_10Jun2024_R.pdf

English (995.06 KB - PDF)View document
Updated protocol

A4061101_NIS_Protocol_V3.0_5March2025_Redacted.pdf

English (433.1 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

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

Not applicable