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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Renal Cell Carcinoma

Intervention / Treatment
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* Drug: avelumab
* Drug: axitinib


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with metastatic renal cell carcinoma<br>Patients with metastatic renal cell carcinoma | Drug: avelumab<br>* as provided in real world practice<br>Drug: axitinib<br>* as provided in real world practice<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description of patient characteristics at baseline |  | 20 December 2019 to 17 October 2022 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to treatment discontinuation (TTD) | 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. | 20 December 2019 to 31 October 2022 | 
| Real-World Progression-Free Survival (PFS) | 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. | 20 December 2019 to 31 October 2022 | 
| Overall Survival (OS) | 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. | 20 December 2019 to 31 October 2022 | 
| Objective response rate (ORR) | 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. | 20 December 2019 to 31 October 2022 | 
| Best overall response (BOR) for primary lesions | The BOR is defined as the best tumor response recorded during the observation period. | 20 December 2019 to 31 October 2022 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Retrospective, Multicenter, Non-interventional, Medical chart review, Japan, Metastatic renal cell cancer(mRCC), Avelumab, Axitinib, First-line therapy, Standard care in real-world clinical setting