Treatment Outcomes in Japanese RCC Patients Treated With Avelumab Plus Axitinib as First-line Therapy: Retrospective Study (J-DART2)

Merck KGaA (EMD Serono)

Status: Completed

Conditions: Renal Cell Carcinoma

Treatments: Drug: axitinib; Drug: avelumab

Study type: Observational

Funder types: Industry

Identifiers

NCT05650164

J-DART2 (Other Identifier)

B9991052

Details and patient eligibility

About

This study is a multicenter, non-interventional, retrospective, medical chart review of participants with metastatic renal cell cancer(mRCC) treated with avelumab plus axitinib as a first-line therapy in Japan between 20 December 2019 and 17 October 2022. All decisions regarding clinical management and treatment of the participating patients were made by the investigator as part of standard care in real-world clinical setting and were not contingent upon the patient's participation in the study. Data will be collected if available per study site.

Enrollment: 171 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnoses of mRCC based on the General Rule for Clinical and Pathological Studies on RCC (Fifth Edition) before receiving avelumab plus axitinib as first-line therapy. Patients with mRCC who have unresectable disease, either unresectable locally advanced or metastatic disease.
2. Age over 18 years at the time of the first administration of avelumab plus axitinib as firstline therapy for mRCC (baseline).
3. Index date from 20 December 2019 to 17 October 2022.

Exclusion criteria

1. Patients participating in a prospective interventional clinical trial assessing an investigational product during the observation period.
2. Patients (or a patient's legally representative) refusing to provide patient data during the consent process.

Trial design

171 participants in 1 patient group

Participants with metastatic renal cell carcinoma

Description:

Participants with metastatic renal cell carcinoma

Treatment:

Drug: avelumab

Drug: axitinib