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

Sponsor

Pfizer (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05650164

Collaborator

(none)

150

Enrollment

2.8

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This study is a multicenter, non-interventional, retrospective, medical chart review of patients 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.

Condition or Disease	Intervention/Treatment	Phase
Renal Cell Carcinoma	Drug: avelumab Drug: axitinib

Study Design

Study Type:

Observational

Anticipated Enrollment :

150 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

A Multicenter, NI, Retrospective, Observational Study Evaluating Real-World Treatment Outcomes in Japanese Patients With Metastatic Renal Cell Carcinoma (mRCC) Treated With Avelumab Plus Axitinib as First-line Therapy: J-DART2

Anticipated Study Start Date :

Feb 3, 2023

Anticipated Primary Completion Date :

Apr 30, 2023

Anticipated Study Completion Date :

Apr 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Patients with metastatic renal cell carcinoma Patients with metastatic renal cell carcinoma	Drug: avelumab as provided in real world practice Drug: axitinib as provided in real world practice

Arm

Intervention/Treatment

Patients with metastatic renal cell carcinoma

Drug: avelumab

as provided in real world practice

Drug: axitinib

as provided in real world practice

Outcome Measures

Primary Outcome Measures

Description of patient characteristics at baseline [20 December 2019 to 17 October 2022]

Secondary Outcome Measures

Time to treatment discontinuation (TTD) [20 December 2019 to 31 October 2022]
TTD is defined as the time from the start of treatment with avelumab plus axitinib to the end of treatment due to any cause except the effectiveness of the treatment.
Real-World Progression-Free Survival (PFS) [20 December 2019 to 31 October 2022]
Real-world PFS, defined as time from start of avelumab/axitinib treatment to date of first disease progression (as clinically assessed by local investigator based on radiology, laboratory evidence, pathology, or other assessments) or death due to any cause, which ever came first. If there were no clinical records of death or disease progression, they were censored at the date of initiation of the next line of therapy for the patients undertaking two or more lines of therapy based on the record, or at their last visit date during the study period for the patients undertaking only one line of therapy based on the record.
Overall Survival (OS) [20 December 2019 to 31 October 2022]
OS is defined as the time from the start of treatment with avelumab plus axitinib to the date of death due to any cause. If there are no clinical records of death, the date when the patient was last documented to be alive will be confirmed based on medical records. The data will be censored at the date of last contact.
Objective response rate (ORR) [20 December 2019 to 31 October 2022]
The ORR is defined as the proportion of patients with a documented BOR (complete response (CR) or partial response (PR)) by the invesetigator during treatment with avelumab plus axitinib as firstline therapy. The BOR is defined as the best tumor response recorded during the observation period. The definitions of tumor responses are as follows: Complete or PR as the best adjudication result (CR > PR > stable disease [SD] > progressive disease [PD], not Evaluable[NE]) complies with the RECIST tumor assessment guidelines as closely as possible in clinical practice.
Best overall response (BOR) for primary lesions [20 December 2019 to 31 October 2022]
The BOR is defined as the best tumor response recorded during the observation period.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.
Age over 18 years at the time of the first administration of avelumab plus axitinib as firstline therapy for mRCC (baseline).
Index date from 20 December 2019 to 17 October 2022.

Exclusion Criteria:

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