N/A
Completed N=171
Treatment Outcomes in Japanese RCC Patients Treated With Avelumab Plus Axitinib as First-line Therapy: Retrospective Study (J-DART2)
Source: ClinicalTrials.gov NCT05650164 ↗Enrolled (actual)
171
Serious AEs
—
Results posted
Mar 2025
Primary outcomePrimary: Age of Participants at Baseline — 71.0 years
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Age of Participants at Baseline |
71.0 | — |
| PRIMARY Height of Participants at Baseline |
163.23 | — |
| PRIMARY Body Weight of Participants at Baseline |
63.117 | — |
| PRIMARY Body Mass Index of Participants at Baseline |
23.593 | — |
| PRIMARY C-Reactive Protein Levels of Participants at Baseline |
1.575 | — |
| PRIMARY Estimated Glomerular Filtration Rate of Participants at Baseline |
124; 45; 1 | — |
| PRIMARY Smoking History Status of Participants at Baseline |
67; 62; 26; 15 | — |
| PRIMARY Eastern Cooperative Oncology Group (ECOG) Performance Scale Score Status of Participants at Baseline |
132; 25; 5; 6; 1 | — |
| PRIMARY Number of Participants With Metastatic Organs at Baseline |
101; 13; 28; 3; 22; 19 | — |
| PRIMARY Invasion Depth (T Factor) of Participants at Baseline |
6; 0; 1; 26; 29; 2 | — |
| PRIMARY Lymph Node Metastasis (N Factor) Status of Participants at Baseline |
7; 127; 30; 6 | — |
| PRIMARY Distant Metastasis (M Factor) Status of Participants at Baseline |
0; 20; 150; 0 | — |
| PRIMARY Tumor Histological Type of Participants at Baseline |
154; 4; 2; 4; 6 | — |
| PRIMARY Number of Participants With Presence or Absence of Sarcomatoid Component in Participants at Baseline |
11; 158 | — |
| PRIMARY Fuhrman Grade Status of Participants at Baseline |
57; 0; 33; 16; 64 | — |
| PRIMARY Availability of Proteinuria in Participants at Baseline |
92; 22; 17; 6; 6; 27 | — |
| PRIMARY Performance of Nephrectomy in Participants |
45; 125; 0 | — |
| PRIMARY Number of Participants With Presence or Absence of Clinically Important Comorbidities of Participants at Baseline |
59; 111; 0 | — |
| PRIMARY Number of Participants With Presence or Absence of Clinically Important Concomitant Drugs in Participants at Baseline |
75; 95; 0 | — |
| PRIMARY Number of Participants With Initiation of Systemic Therapy Within One Year of Diagnosis |
81; 89 | — |
| PRIMARY Number of Participants With Karnofsky Performance Status Less Than (<) 80 Percent (%) at Baseline |
157; 13 | — |
| PRIMARY Number of Participants With Hemoglobin Value Below the Lower Normal Limit at Baseline |
85; 85 | — |
| PRIMARY Number of Participants With Corrected Calcium Value Above the Upper Normal Limit in Participants at Baseline |
150; 20 | — |
| PRIMARY Number of Participants With Neutrophil Count Above the Upper Normal Limit in Participants at Baseline |
146; 24 | — |
| PRIMARY International Metastatic RCC Database Consortium (IMDC) Risk Group in Participants at Baseline |
44; 92; 34 | — |
| PRIMARY Number of Risk Factors in Participants at Baseline |
44; 50; 42; 21; 12; 1 | — |
| SECONDARY Real-World Progression-Free Survival (Rw-PFS) |
13.8 | — |
| SECONDARY Time to Treatment Discontinuation (TTD) |
17.2 | — |
| SECONDARY Overall Survival (OS) |
18.7 | — |
| SECONDARY Percentage of Participants With Best Overall Response of CR or PR (Objective Response Rate) |
53.3 | — |
| SECONDARY Number of Participants With Best Overall Response (BOR) for Primary Lesions |
12; 60; 48; 14; 1 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT05650164). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.