Ipilimumab 12-month Intensive Pharmacovigilance Protocol

NCT02050594 | Completed

• 1 other identifier: CA184-366
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

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

Conditions

Melanoma

Outcome Measures

Primary Outcomes (1)

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

  Up to 12 months of treatment

Study Arms (1)

Melanoma patients on Ipilimumab

All unresectable, recurrent or metastatic melanoma patients

Drug: Ipilimumab

Interventions

Ipilimumab DRUG

Also known as: Yervoy

Melanoma patients on Ipilimumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Bristol Myers de Venezuela S.A.C. has in place a Customer Model registry, which tracks every Ipilimumab prescription in Venezuela. Therefore, any oncologist who treats a patient with Ipilimumab will be identified by BMS. Use of this registry will ensure all patients who are infused with Ipilimumab are included in this study

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bristol-Myers Squibb: lead
• JSS Medical Research Inc.: collaborator

Study Sites (1)

Local Institution

Caracas, Venezuela

Location

Related Links

• BMS clinical trial educational resource
• Investigator Inquiry form

MeSH Terms

Conditions

Melanoma

Interventions

Ipilimumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2014
• First Posted: January 31, 2014
• Study Start: February 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: July 7, 2015

Record last verified: 2015-07

Locations

VE (1)