Clinical trial · Observational
Axitinib Therapy Management Study
Retrospective Analysis of Axitinib Treatment Optimization and Management of Selected Immune Related Adverse Events of Checkpoints Inhibitors
NCT04555603CI-TRIAL-00071545withdrawnClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Failed at data quality assurance process before any analyses would be performed
Summary
Brief summary (as posted)
The objectives of the study is to describe axitinib therapy management through use of the data to be generated by ConcertAI
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bavencio | Drug | Avelumab | ALIAS |
| Inlyta | Drug | Axitinib | ALIAS |
| Keytruda | Drug | Pembrolizumab | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (7)
- measure
- To describe type of immune related adverse events and adverse events related to axitinib
- timeFrame
- during treatment period
- description
- describe type of immune related adverse events and adverse events related to axitinib
- measure
- To describe the percentage of patients with documentation of dose modifications
- timeFrame
- during treatment period
- description
- describe dose modifications
- measure
- To describe the percentage of patients with usage of concomitant high-dose corticosteroid
- timeFrame
- during treatment period
- description
- descriptive assessment
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Confirmed diagnosis of aRCC (Stage III, Stage IV (M0) or Stage IV (M1)) at any point * Age 18 years or older at the time of aRCC diagnosis * Received a qualifying IO-containing combination (nivolumab and ipilimumab, axitinib and pembrolizumab, or axitinib and avelumab) in the first regimen after aRCC diagnosis or axitinib monotherapy in any line Exclusion Criteria: * none
References
Publications (0)
Data not yet available
No reference posted for this study.