Ipilimumab 12-month Intensive Pharmacovigilance Protocol

Bristol-Myers Squibb (BMS)

Status: Completed

Conditions: Melanoma

Treatments: Drug: Ipilimumab

Study type: Observational

Funder types: Industry

Identifiers

NCT02050594

CA184-366

Details and patient eligibility

About

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

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

6 participants in 1 patient group

Melanoma patients on Ipilimumab

Description:

All unresectable, recurrent or metastatic melanoma patients

Treatment:

Drug: Ipilimumab