Clinical trial NCT05012865: Current Treatment Outcomes in Japanese RCC Patients Treated With Avelumab Plus Axitinib as First-line Therapy: Retrospective Study (J-DART)
Official title: Retrospective, Multicenter, Observational Study to Evaluate Current Treatment Outcomes in Japanese Patients With Metastatic Renal Cell Carcinoma Treated With Avelumab Plus Axitinib as a First-line Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Cell Carcinoma
Keywords: 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
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2021-08-19
Enrollment: 48
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with metastatic renal cell cancer(mRCC) treated with avelumab plus axitinib as a first-line therapy in Japan between 20 December 2019 and 20 December 2020

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 20 December 2020. 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.


Eligibility criteria: Inclusion Criteria:

1. Diagnosed with metastatic renal cell cancer(mRCC) based on the General Rule for Clinical and Pathological Studies on Renal Cell Carcinoma (4th Edition) before receiving avelumab plus axitinib as a first-line therapy.
2. Over 20 years of age at the time of metastatic renal cell cancer(mRCC) diagnosis.
3. Start treatment with avelumab plus axitinib as a first-line therapy for metastatic renal cell cancer(mRCC) from 20 December 2019 to 20 December 2020.
4. For patients who are still alive and have routine visits to the study site, evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study. For patients who are still alive and had been transferred to another hospital, evidence that the patient has been informed of all pertinent aspects of the study and oral or written informed consent is obtained.
5. Deceased patients are also included for inclusion criteria 1-3.

Exclusion Criteria:

There are no exclusion criteria for this study.

Primary outcomes:
measure: Number of Participants Categorized According to Eastern Cooperative Oncology Group Performance Status (ECOG-PS)
timeFrame: Baseline (before first dose of avelumab plus axitinib, during data identification period from 20-Dec-2019 to 20-Dec-2020 [approximately 1 year]) retrieved data was analyzed during 4.5 months of this observational study
measure: Number of Participants Categorized According to International Metastatic RCC Database Consortium (IMDC) Risk Score
timeFrame: Baseline (before first dose of avelumab plus axitinib, during data identification period from 20-Dec-2019 to 20-Dec-2020 [approximately 1 year]) retrieved data was analyzed during 4.5 months of this observational study
measure: Number of Participants Categorized According to Fuhrman Grade
timeFrame: Baseline (before first dose of avelumab plus axitinib, during data identification period from 20-Dec-2019 to 20-Dec-2020 [approximately 1 year]) retrieved data was analyzed during 4.5 months of this observational study
measure: Number of Participants Categorized According to Histological Type
timeFrame: Baseline (before first dose of avelumab plus axitinib, during data identification period from 20-Dec-2019 to 20-Dec-2020 [approximately 1 year]) retrieved data was analyzed during 4.5 months of this observational study
measure: Number of Participants Categorized According to Presence of Sarcomatoid Component
timeFrame: Baseline (before first dose of avelumab plus axitinib, during data identification period from 20-Dec-2019 to 20-Dec-2020 [approximately 1 year]) retrieved data was analyzed during 4.5 months of this observational study
measure: Number of Participants Categorized According to Tumor-node-metastases (TNM) Classification
timeFrame: Baseline (before first dose of avelumab plus axitinib, during data identification period from 20-Dec-2019 to 20-Dec-2020 [approximately 1 year]) retrieved data was analyzed during 4.5 months of this observational study
measure: Number of Participants Categorized According to Number of Metastatic Organs
timeFrame: Baseline (before first dose of avelumab plus axitinib, during data identification period from 20-Dec-2019 to 20-Dec-2020 [approximately 1 year]) retrieved data was analyzed during 4.5 months of this observational study
measure: Number of Participants Categorized According to Type of Site of Metastases
timeFrame: Baseline (before first dose of avelumab plus axitinib, during data identification period from 20-Dec-2019 to 20-Dec-2020 [approximately 1 year]) retrieved data was analyzed during 4.5 months of this observational study
measure: Number of Participants According to Presence of Complications
timeFrame: Baseline (before first dose of avelumab plus axitinib, during data identification period from 20-Dec-2019 to 20-Dec-2020 [approximately 1 year]) retrieved data was analyzed during 4.5 months of this observational study
measure: Number of Participants Who Underwent Nephrectomy Previously
timeFrame: Baseline (before first dose of avelumab plus axitinib, during data identification period from 20-Dec-2019 to 20-Dec-2020 [approximately 1 year]) retrieved data was analyzed during 4.5 months of this observational study
measure: Estimated Glomerular Filtration Rate (eGFR)
timeFrame: Baseline (before first dose of avelumab plus axitinib, during data identification period from 20-Dec-2019 to 20-Dec-2020 [approximately 1 year]) retrieved data was analyzed during 4.5 months of this observational study
measure: Number of Participants With Proteinuria
timeFrame: Baseline (before first dose of avelumab plus axitinib, during data identification period from 20-Dec-2019 to 20-Dec-2020 [approximately 1 year]) retrieved data was analyzed during 4.5 months of this observational study
measure: C-reactive Protein (CRP)
timeFrame: Baseline (before first dose of avelumab plus axitinib, during data identification period from 20-Dec-2019 to 20-Dec-2020 [approximately 1 year]) retrieved data was analyzed during 4.5 months of this observational study
measure: Number of Participants Categorized According to Smoking Status
timeFrame: Baseline (before first dose of avelumab plus axitinib, during data identification period from 20-Dec-2019 to 20-Dec-2020 [approximately 1 year]) retrieved data was analyzed during 4.5 months of this observational study
measure: Number of Participants Who Took Concomitant Drugs
timeFrame: Baseline (before first dose of avelumab plus axitinib, during data identification period from 20-Dec-2019 to 20-Dec-2020 [approximately 1 year]) retrieved data was analyzed during 4.5 months of this observational study
Secondary outcomes:
measure: Time to Treatment Failure (TTF) of Avelumab Plus Axitinib as a First-line Therapy
timeFrame: From index date up to 20-June-2021, where index date was date of first prescription for avelumab plus axitinib between 20-Dec-2019 and 20 December 2020 (maximum observation period was of 1.5 years approximately).
measure: Real-world Progression Free Survival (PFS)
timeFrame: From avelumab plus axitinib initiation to disease progression or death due to any cause/censored date (during data identification period from 20-Dec-2019 to 20-Jun-2021 [approx 1.6 years]); retrieved data was analyzed during 4.5 months of this OS
measure: Percentage of Participants With Objective Response
timeFrame: From avelumab plus axitinib initiation to CR or PR (during data identification period from 20-Dec-2019 to 20-Jun-2021 [approximately 1.6 years]) retrieved data was analyzed during 4.5 months of this observational study
measure: Time to Treatment Failure in Participants With Avelumab and Axitinib Treatment
timeFrame: From avelumab plus axitinib initiation to end of treatment (during data identification period from 20-Dec-2019 to 20-Jun-2021 [approximately 1.6 years]) retrieved data was analyzed during 4.5 months of this observational study
measure: Number of Participants With Discontinuation and Interruption of Avelumab and Axitinib Treatment
timeFrame: From avelumab plus axitinib initiation to end of treatment (during data identification period from 20-Dec-2019 to 20-Jun-2021 [approximately 1.6 years]); retrieved data was analyzed during 4.5 months of this observational study
measure: Number of Participants With Reason for Discontinuation of Avelumab Treatment
timeFrame: From avelumab plus axitinib initiation to end of treatment (during data identification period from 20-Dec-2019 to 20-Jun-2021 [approximately 1.5 years]); retrieved data was analyzed during 4.5 months of this observational study
measure: Number of Participants With Reason for Discontinuation of Axitinib Treatment
timeFrame: From avelumab plus axitinib initiation to end of treatment (during data identification period from 20-Dec-2019 to 20-Jun-2021 [approximately 1.5 years]); retrieved data was analyzed during 4.5 months of this observational study
measure: Number of Participants With Reason for Interruption of Avelumab Treatment
timeFrame: From avelumab plus axitinib initiation to end of treatment (during data identification period from 20-Dec-2019 to 20-Jun-2021 [approximately 1.5 years]); retrieved data was analyzed during 4.5 months of this observational study
measure: Number of Participants With Reason for Interruption of Axitinib Treatment
timeFrame: From avelumab plus axitinib initiation to end of treatment (during data identification period from 20-Dec-2019 to 20-Jun-2021 [approximately 1.5 years]); retrieved data was analyzed during 4.5 months of this observational study
measure: Number of Participants With Dose Modification of Axitinib Treatment
timeFrame: From avelumab plus axitinib initiation to end of treatment (during data identification period from 20-Dec-2019 to 20-Jun-2021 [approximately 1.5 years]); retrieved data was analyzed during 4.5 months of this observational study
measure: Number of Participants According to Reason for Dose Modification of Axitinib Treatment
timeFrame: From avelumab plus axitinib initiation to end of treatment (during data identification period from 20-Dec-2019 to 20-Jun-2021 [approximately 1.5 years]); retrieved data was analyzed during 4.5 months of this observational study
measure: Cumulative Dose of Corticosteroid for Immune-related Adverse Events (irAE) During Avelumab Plus Axitinib Treatment
timeFrame: From avelumab plus axitinib initiation to end of treatment (during data identification period from 20-Dec-2019 to 20-Jun-2021 [approximately 1.5 years]); retrieved data was analyzed during 4.5 months of this observational study
measure: Duration of Corticosteroid Treatment for irAE During Avelumab Plus Axitinib Treatment
timeFrame: From avelumab plus axitinib initiation to end of treatment (during data identification period from 20-Dec-2019 to 20-Jun-2021 [approximately 1.5 years]); retrieved data was analyzed during 4.5 months of this observational study
measure: Number of Corticosteroid Doses for irAE During Avelumab Plus Axitinib Treatment
timeFrame: From avelumab plus axitinib initiation to end of treatment (during data identification period from 20-Dec-2019 to 20-Jun-2021 [approximately 1.5 years]); retrieved data was analyzed during 4.5 months of this observational study
measure: Number of Participants With Presence of Pre-medication for Potential Infusion-related Reaction of Avelumab
timeFrame: From avelumab plus axitinib initiation to end of treatment (during data identification period from 20-Dec-2019 to 20-Jun-2021 [approximately 1.5 years]); retrieved data was analyzed during 4.5 months of this observational study
measure: Number of Participants Categorized According to Type of Pre-medication for Infusion-related Reaction of Avelumab
timeFrame: From avelumab plus axitinib initiation to end of treatment (during data identification period from 20-Dec-2019 to 20-Jun-2021 [approximately 1.5 years]); retrieved data was analyzed during 4.5 months of this observational study
measure: Number of Participants Who Received Treatment for Infusion-related Reaction of Avelumab
timeFrame: From avelumab plus axitinib initiation to end of treatment (during data identification period from 20-Dec-2019 to 20-Jun-2021 [approximately 1.5 years]); retrieved data was analyzed during 4.5 months of this observational study
measure: Number of Participants by Type of Received Subsequent Treatment After Avelumab Plus Axitinib
timeFrame: From avelumab plus axitinib end of treatment to end of study observation (during data identification period from 20-Dec-2019 to 20-Jun-2021 [approximately 1.5 years]); retrieved data was analyzed during 4.5 months of this observational study
Other outcomes:
Locations:
city: Kurume
country: Japan
facility: Kurume University Hospital
state: Fukuoka
city: Ota
country: Japan
facility: Gunma Prefectural Cancer Center
state: Gunma
city: Asahikawa
country: Japan
facility: Asahikawa Medical University Hospital
state: Hokkaido
city: Iwamizawa City
country: Japan
facility: Iwamizawa Municipal General Hospital
state: Hokkaido
city: Kobe-shi
country: Japan
facility: Kobe University Hospital
state: Hyogo
city: Kamigyo-ku
country: Japan
facility: University Hospital,Kyoto Prefectural University of Medicine
state: Kyoto
city: Osakasayama
country: Japan
facility: Kindai University Hospital
state: Osaka
city: Suita-city
country: Japan
facility: Osaka University Hospital
state: Osaka
city: Takatsuki
country: Japan
facility: Osaka Medical and Pharmaceutical University Hospital
state: Osaka
city: Saitama City
country: Japan
facility: Jichi Medical University Saitama Medical Center
state: Saitama
city: Hiroshima
country: Japan
facility: Hiroshima University Hospital
city: Osaka
country: Japan
facility: Osaka City University Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: