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NCT02050594 Clinical Trial

Ipilimumab 12-month Intensive Pharmacovigilance Protocol

Melanoma Clinical Trial

Official title:
Ipilimumab 12-month Intensive Pharmacovigilance Protocol

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02050594
Other study ID # CA184-366
Secondary ID
Status Completed
Phase N/A
First received January 14, 2014
Last updated July 3, 2015
Start date February 2014
Est. completion date February 2015

Study information
Verified date July 2015
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority Venezuela: CENAVIF (National Center for Pharmacovigilance)
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 6
Est. completion date February 2015
Est. primary completion date February 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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)

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• Ipilimumab

Locations
Country Name City State
Venezuela Local Institution Caracas

Sponsors (2)
Lead Sponsor Collaborator
Bristol-Myers Squibb JSS Medical Research Inc.

Country where clinical trial is conducted

Venezuela, 

Outcome
Type Measure Description Time frame Safety issue
Primary Descriptive statistics of observed adverse events (AEs) while on treatment with Ipilimumab for advanced melanoma in Venezuela Up to 12 months of treatment Yes
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