Ipilimumab 12-month Intensive Pharmacovigilance Protocol

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02050594

Enrollment

Registered

2014-01-31

Start date

2014-02-28

Completion date

2015-02-28

Last updated

2015-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanoma

Brief summary

The primary objective of the protocol is to identify and describe observed adverse events (AEs) while on treatment with Ipilimumab for advanced melanoma in Venezuela during the study period

Interventions

DRUGIpilimumab

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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 * Subjects who received at least 1 dose of Ipilimumab for the treatment of unresectable, recurrent or metastatic melanoma in Venezuela

Exclusion criteria

* Subjects who received Ipilimumab as part of a clinical trial * Subjects who received Ipilimumab for any indication other than local approval (ie, unresectable or metastatic melanoma)

Design outcomes

Primary

Measure	Time frame
Descriptive statistics of observed adverse events (AEs) while on treatment with Ipilimumab for advanced melanoma in Venezuela	Up to 12 months of treatment

Countries

Venezuela

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026