Clinical trial NCT05650164: Treatment Outcomes in Japanese RCC Patients Treated With Avelumab Plus Axitinib as First-line Therapy: Retrospective Study (J-DART2)
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
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: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
First posted: 2022-12-14
Enrollment: 171
Sex: ALL
Minimum age (years): 18
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 17 October 2022

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Age of Participants at Baseline
timeFrame: At Baseline (prior to initial treatment with avelumab plus axitinib)
measure: Height of Participants at Baseline
timeFrame: At Baseline (prior to initial treatment with avelumab plus axitinib)
measure: Body Weight of Participants at Baseline
timeFrame: At Baseline (prior to initial treatment with avelumab plus axitinib)
measure: Body Mass Index of Participants at Baseline
timeFrame: At Baseline (prior to initial treatment with avelumab plus axitinib)
measure: C-Reactive Protein Levels of Participants at Baseline
timeFrame: At Baseline (prior to initial treatment with avelumab plus axitinib)
measure: Estimated Glomerular Filtration Rate of Participants at Baseline
timeFrame: At Baseline (prior to initial treatment with avelumab plus axitinib)
measure: Smoking History Status of Participants at Baseline
timeFrame: At Baseline (prior to initial treatment with avelumab plus axitinib)
measure: Eastern Cooperative Oncology Group (ECOG) Performance Scale Score Status of Participants at Baseline
timeFrame: At Baseline (prior to initial treatment with avelumab plus axitinib)
measure: Number of Participants With Metastatic Organs at Baseline
timeFrame: At Baseline (prior to initial treatment with avelumab plus axitinib)
measure: Invasion Depth (T Factor) of Participants at Baseline
timeFrame: At Baseline (prior to initial treatment with avelumab plus axitinib)
measure: Lymph Node Metastasis (N Factor) Status of Participants at Baseline
timeFrame: At Baseline (prior to initial treatment with avelumab plus axitinib)
measure: Distant Metastasis (M Factor) Status of Participants at Baseline
timeFrame: At Baseline (prior to initial treatment with avelumab plus axitinib)
measure: Tumor Histological Type of Participants at Baseline
timeFrame: At Baseline (prior to initial treatment with avelumab plus axitinib)
measure: Number of Participants With Presence or Absence of Sarcomatoid Component in Participants at Baseline
timeFrame: At Baseline (prior to initial treatment with avelumab plus axitinib)
measure: Fuhrman Grade Status of Participants at Baseline
timeFrame: At Baseline (prior to initial treatment with avelumab plus axitinib)
measure: Availability of Proteinuria in Participants at Baseline
timeFrame: At Baseline (prior to initial treatment with avelumab plus axitinib)
measure: Performance of Nephrectomy in Participants
timeFrame: At Baseline (prior to initial treatment with avelumab plus axitinib)
measure: Number of Participants With Presence or Absence of Clinically Important Comorbidities of Participants at Baseline
timeFrame: At Baseline (prior to initial treatment with avelumab plus axitinib)
measure: Number of Participants With Presence or Absence of Clinically Important Concomitant Drugs in Participants at Baseline
timeFrame: At Baseline (prior to initial treatment with avelumab plus axitinib)
measure: Number of Participants With Initiation of Systemic Therapy Within One Year of Diagnosis
timeFrame: At Baseline (prior to initial treatment with avelumab plus axitinib)
measure: Number of Participants With Karnofsky Performance Status Less Than (<) 80 Percent (%) at Baseline
timeFrame: At Baseline (prior to initial treatment with avelumab plus axitinib)
measure: Number of Participants With Hemoglobin Value Below the Lower Normal Limit at Baseline
timeFrame: At Baseline (prior to initial treatment with avelumab plus axitinib)
measure: Number of Participants With Corrected Calcium Value Above the Upper Normal Limit in Participants at Baseline
timeFrame: At Baseline (prior to initial treatment with avelumab plus axitinib)
measure: Number of Participants With Neutrophil Count Above the Upper Normal Limit in Participants at Baseline
timeFrame: At Baseline (prior to initial treatment with avelumab plus axitinib)
measure: International Metastatic RCC Database Consortium (IMDC) Risk Group in Participants at Baseline
timeFrame: At Baseline (prior to initial treatment with avelumab plus axitinib)
measure: Number of Risk Factors in Participants at Baseline
timeFrame: At Baseline (prior to initial treatment with avelumab plus axitinib)
Secondary outcomes:
measure: Real-World Progression-Free Survival (Rw-PFS)
timeFrame: From index date up to 31 Oct 2022, where index date was date of first prescription for avelumab plus axitinib between 20 December 2019 and 17 October 2022 (maximum observation period was of 34 months approximately)
measure: Time to Treatment Discontinuation (TTD)
timeFrame: From index date up to 31 Oct 2022, where index date was date of first prescription for avelumab plus axitinib between 20 December 2019 and 17 October 2022 (maximum observation period was of 34 months approximately)
measure: Overall Survival (OS)
timeFrame: From index date up to 31 Oct 2022, where index date was date of first prescription for avelumab plus axitinib between 20 December 2019 and 17 October 2022 (maximum observation period was of 34 months approximately)
measure: Percentage of Participants With Best Overall Response of CR or PR (Objective Response Rate)
timeFrame: From index date up to 31 Oct 2022, where index date was date of first prescription for avelumab plus axitinib between 20 December 2019 and 17 October 2022 (maximum observation period was of 34 months approximately)
measure: Number of Participants With Best Overall Response (BOR) for Primary Lesions
timeFrame: From index date up to 31 Oct 2022, where index date was date of first prescription for avelumab plus axitinib between 20 December 2019 and 17 October 2022 (maximum observation period was of 34 months approximately)
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Nagoya University Hospital
state: Aichi
city: Hirosaki
country: Japan
facility: Hirosaki University Hospital
state: Aomori
city: Kurume-shi
country: Japan
facility: Kurume University Hospital
state: Fukuoka
city: Asahikawa
country: Japan
facility: Asahikawa Medical University Hospital
state: Hokkaido
city: Sapporo
country: Japan
facility: Sapporo Medical University Hospital
state: Hokkaido
city: Kobe-city
country: Japan
facility: Kobe City Medical Center General Hospital
state: Hyogo
city: Kobe
country: Japan
facility: Kobe University Hospital
state: Hyogo
city: Kanazawa-shi
country: Japan
facility: Kanazawa University Hospital
state: Ishikawa
city: Kyoto-shi
country: Japan
facility: National Hospital Organization Kyoto Medical Center
state: Kyoto
city: Nankoku
country: Japan
facility: Kochi Medical School Hospital
state: Kōchi
city: Osakasayama
country: Japan
facility: Kindai University Hospital
state: Osaka
city: Suita-city
country: Japan
facility: Osaka University Hospital
state: Osaka
city: Saitama City
country: Japan
facility: Jichi Medical University Saitama Medical Center
state: Saitama
city: Shinjuku-ku
country: Japan
facility: Keio University Hospital
state: Tokyo
city: Wakayama-shi
country: Japan
facility: Wakayama Medical University Hospital
state: Wakayama
city: Yamagata-Shi
country: Japan
facility: Yamagata University Hospital
state: Yamagata
city: Fukuoka
country: Japan
facility: Kyushu University Hospital
city: Hiroshima
country: Japan
facility: Hiroshima University Hospital
city: Kyoto
country: Japan
facility: University Hospital Kyoto Prefectural University of Medicine
Study officials:
affiliation: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
name: Medical Responsible
role: STUDY_DIRECTOR
References: