Clinical trial · Observational
Treatment Outcomes in Japanese RCC Patients Treated With Avelumab Plus Axitinib as First-line Therapy: Retrospective Study (J-DART2)
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
Design
Arms and outcomes
Arms (1)
- label
- Participants with metastatic renal cell carcinoma
- description
- Participants with metastatic renal cell carcinoma
- interventionNames
- Drug: avelumab
- Drug: axitinib
Primary outcomes (26)
- measure
- Age of Participants at Baseline
- timeFrame
- At Baseline (prior to initial treatment with avelumab plus axitinib)
- description
- The age of participants at baseline was reported.
- measure
- Height of Participants at Baseline
- timeFrame
- At Baseline (prior to initial treatment with avelumab plus axitinib)
- description
- The height of participants at baseline was reported.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available