Clinical trial · Observational
A Study to Observe the Onset of Immune-related Adverse Reactions in Patients With Non-surgical or Renal Cell Carcinoma (RCC) That Has Spread
Drug Use Investigation on Combination Therapy With Yervoy and Opdivo (Unresectable or Metastatic Renal Cell Carcinoma)
NCT03663946CI-TRIAL-00056759completedClinicalTrials.gov clinicaltrialsProvenance
- 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)
Patients with non-surgical or renal cell carcinoma that has spread who are starting treatment for the first time with Yervoy and Opdivo in the real world
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Kidney Cancer | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
| Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Non-Interventional | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients taking combination therapy with Yervoy and Opdivo
- description
- Medical records will be reviewed for safety and treatments for specific ADR
- interventionNames
- Other: Non-Interventional
Primary outcomes (2)
- measure
- Incidence of immune-related AE's
- timeFrame
- Approximately 13 weeks
- measure
- Incidence of immune related SAE's
- timeFrame
- Approximately 13 weeks
Secondary outcomes (3)
- measure
- Incidence of treatment for immune-related adverse reactions
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Patients with unresectable or metastatic renal cell carcinoma who are initiating treatment for the first time with Yervoy and Opdivo in accordance with the Japanese package insert will be included in this PMS Exclusion Criteria: * Patients receiving combination therapy with Yervoy and Opdivo for non RCC indication will be excluded from this PMS Other protocol defined inclusion/exclusion criteria could apply
References
Publications (0)
Data not yet available
No reference posted for this study.