Ipilimumab 12-month Intensive Pharmacovigilance Protocol

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

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Key information

Conditions

Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution

Caracas, Venezuela

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Ipilimumab

Drug

Other names: Yervoy

Primary outcomes

Descriptive statistics of observed adverse events (AEs) while on treatment with Ipilimumab for advanced melanoma in Venezuela

Time frame: Up to 12 months of treatment

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Collaborators

JSS Medical Research Inc.

Registry information

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Jan 31, 2014
Registry last updated: Jul 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed