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

Renal Cell Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05650164
• Other study ID #: B9991052
• Secondary ID: J-DART2
• Status: Completed
• Start date: January 25, 2023
• Est. completion date: October 13, 2023

Study information

• Verified date: January 2024
• Source: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 171
• Est. completion date: October 13, 2023
• Est. primary completion date: October 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Renal Cell Carcinoma

Intervention

Drug:
• avelumab
as provided in real world practice
• axitinib
as provided in real world practice

Locations

Country	Name	City	State
Japan	Asahikawa Medical University Hospital	Asahikawa	Hokkaido
Japan	Kyushu University Hospital	Fukuoka
Japan	Hirosaki University Hospital	Hirosaki	Aomori
Japan	Hiroshima University Hospital	Hiroshima
Japan	Kanazawa University Hospital	Kanazawa-shi	Ishikawa
Japan	Kobe University Hospital	Kobe	Hyogo
Japan	Kobe City Medical Center General Hospital	Kobe-city	Hyogo
Japan	Kurume University Hospital	Kurume-shi	Fukuoka
Japan	University Hospital Kyoto Prefectural University of Medicine	Kyoto
Japan	National Hospital Organization Kyoto Medical Center	Kyoto-shi	Kyoto
Japan	Nagoya University Hospital	Nagoya	Aichi
Japan	Kochi Medical School Hospital	Nankoku	Kochi
Japan	Kindai University Hospital	Osakasayama	Osaka
Japan	Jichi Medical University Saitama Medical Center	Saitama City	Saitama
Japan	Sapporo Medical University Hospital	Sapporo	Hokkaido
Japan	Keio University Hospital	Shinjuku-ku	Tokyo
Japan	Osaka University Hospital	Suita-city	Osaka
Japan	Wakayama Medical University Hospital	Wakayama-shi	Wakayama
Japan	Yamagata University Hospital	Yamagata-Shi	Yamagata

Sponsors (1)

Lead Sponsor	Collaborator
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Description of patient characteristics at baseline		20 December 2019 to 17 October 2022
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Trial Awareness and Transparency website