N/A
Completed N=48
Current Treatment Outcomes in Japanese RCC Patients Treated With Avelumab Plus Axitinib as First-line Therapy: Retrospective Study (J-DART)
Source: ClinicalTrials.gov NCT05012865 ↗Enrolled (actual)
48
Serious AEs
—
Results posted
Dec 2023
Primary outcomePrimary: Number of Participants Categorized According to Eastern Cooperative Oncology Group Performance Status (ECOG-PS) — 29; 9; 3; 0 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Categorized According to Eastern Cooperative Oncology Group Performance Status (ECOG-PS) |
29; 9; 3; 0; 0; 7 | — |
| PRIMARY Number of Participants Categorized According to International Metastatic RCC Database Consortium (IMDC) Risk Score |
8; 26; 14 | — |
| PRIMARY Number of Participants Categorized According to Fuhrman Grade |
2; 14; 12; 8; 12 | — |
| PRIMARY Number of Participants Categorized According to Histological Type |
39; 1; 1; 7 | — |
| PRIMARY Number of Participants Categorized According to Presence of Sarcomatoid Component |
5; 43 | — |
| PRIMARY Number of Participants Categorized According to Tumor-node-metastases (TNM) Classification |
3; 17; 3; 20; 2; 3 | — |
| PRIMARY Number of Participants Categorized According to Number of Metastatic Organs |
22; 21 | — |
| PRIMARY Number of Participants Categorized According to Type of Site of Metastases |
25; 5; 14; 1; 11; 4 | — |
| PRIMARY Number of Participants According to Presence of Complications |
34; 14 | — |
| PRIMARY Number of Participants Who Underwent Nephrectomy Previously |
32; 16 | — |
| PRIMARY Estimated Glomerular Filtration Rate (eGFR) |
49.62 | — |
| PRIMARY Number of Participants With Proteinuria |
19; 8; 3; 2; 2 | — |
| PRIMARY C-reactive Protein (CRP) |
1.779 | — |
| PRIMARY Number of Participants Categorized According to Smoking Status |
16; 21; 5; 6 | — |
| PRIMARY Number of Participants Who Took Concomitant Drugs |
37; 11 | — |
| SECONDARY Time to Treatment Failure (TTF) of Avelumab Plus Axitinib as a First-line Therapy |
15.2 | — |
| SECONDARY Real-world Progression Free Survival (PFS) |
15.3 | — |
| SECONDARY Percentage of Participants With Objective Response |
48.8 | — |
| SECONDARY Time to Treatment Failure in Participants With Avelumab and Axitinib Treatment |
NA; 10.5 | — |
| SECONDARY Number of Participants With Discontinuation and Interruption of Avelumab and Axitinib Treatment |
8; 25; 11; 28 | — |
| SECONDARY Number of Participants With Reason for Discontinuation of Avelumab Treatment |
4; 1; 1; 3 | — |
| SECONDARY Number of Participants With Reason for Discontinuation of Axitinib Treatment |
3; 3; 2; 3 | — |
| SECONDARY Number of Participants With Reason for Interruption of Avelumab Treatment |
19; 2; 10 | — |
| SECONDARY Number of Participants With Reason for Interruption of Axitinib Treatment |
24; 2; 9 | — |
| SECONDARY Number of Participants With Dose Modification of Axitinib Treatment |
24; 24 | — |
| SECONDARY Number of Participants According to Reason for Dose Modification of Axitinib Treatment |
19; 8 | — |
| SECONDARY Cumulative Dose of Corticosteroid for Immune-related Adverse Events (irAE) During Avelumab Plus Axitinib Treatment |
15.00; 234.38; 50.00 | — |
| SECONDARY Duration of Corticosteroid Treatment for irAE During Avelumab Plus Axitinib Treatment |
25.0; 1.0; 1.0 | — |
| SECONDARY Number of Corticosteroid Doses for irAE During Avelumab Plus Axitinib Treatment |
2; 2; 1 | — |
| SECONDARY Number of Participants With Presence of Pre-medication for Potential Infusion-related Reaction of Avelumab |
45; 3 | — |
| SECONDARY Number of Participants Categorized According to Type of Pre-medication for Infusion-related Reaction of Avelumab |
39; 22; 22; 4; 1; 1 | — |
| SECONDARY Number of Participants Who Received Treatment for Infusion-related Reaction of Avelumab |
8 | — |
| SECONDARY Number of Participants by Type of Received Subsequent Treatment After Avelumab Plus Axitinib |
1; 7; 3; 1 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
- Over 20 years of age at the time of metastatic renal cell cancer(mRCC) diagnosis.
- 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.
- 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.
- Deceased patients are also included for inclusion criteria 1-3.
Exclusion Criteria
There are no exclusion criteria for this study.
Data sourced from ClinicalTrials.gov (NCT05012865). 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.