Clinical trial · Observational
Ipilimumab 60-month Pharmacovigilance Protocol for Advanced Melanoma Patients Who Are Hepatitis B and/or Hepatitis C Virus Positive in Taiwan
NCT02402699CI-TRIAL-00056175Yervoy RMPcompletedClinicalTrials.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)
This protocol is being conducted to comply with the direct request from the Taiwan Food and Drug Administration (TFDA) for a 60-month intensive pharmacovigilance protocol of patients with known hepatitis B (HBV) or hepatitis C (HCV) infection, regardless of control on antiviral therapy in Taiwan and who are treated with ipilimumab for advanced (unresectable, recurrent or metastatic) Melanoma.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Melanoma | Melanoma | CURATED_BROADER | 0.78 |
| Hepatitis B | — | UNRESOLVED | — |
| Hepatitis C | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Unresectable, recurrent or metastatic melanoma patients
- description
- All adult unresectable, recurrent, or metastatic melanoma patients with HBV or HCV treated with at least 1 dose of ipilimumab therapy in Taiwan
Primary outcomes (1)
- measure
- Identify and describe observed adverse events (AEs) based on liver function abnormalities and changes in hepatitis viral load
- timeFrame
- During 6months after enrollment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Age of 18 years or older on date of first dose of Ipilimumab * Patients who received at least 1 dose of Ipilimumab for the treatment of unresectable, recurrent or Metastatic Melanoma in Taiwan * Patients with advanced Melanoma and HBV or HCV who are initiating Ipilimumab under the discretion of their physician Exclusion Criteria: * Patients who received Ipilimumab as part of a clinical trial * Patients who are receiving Ipilimumab for any indication other than local approval (ie, unresectable or Metastatic Melanoma) * Patients who are not infected with HBV or HCV
References
Publications (0)
Data not yet available
No reference posted for this study.