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Ipilimumab 60-month Pharmacovigilance Protocol for Advanced Melanoma Patients Who Are Hepatitis B and/or Hepatitis C Virus Positive in Taiwan (Yervoy RMP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb Identifier:
First received: March 16, 2015
Last updated: August 19, 2016
Last verified: August 2016
This protocol is being conducted to comply with the direct request from the Taiwan Food and Drug Administration (TFDA) for a 60-month intensive pharmacovigilance protocol of patients with known hepatitis B (HBV) or hepatitis C (HCV) infection, regardless of control on antiviral therapy in Taiwan and who are treated with ipilimumab for advanced (unresectable, recurrent or metastatic) Melanoma.

Advanced Melanoma
Hepatitis B
Hepatitis C

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Ipilimumab 60-month Pharmacovigilance Protocol for Advanced Melanoma Patients Who Are Hepatitis B and/or Hepatitis C Virus Positive in Taiwan

Resource links provided by NLM:

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Identify and describe observed adverse events (AEs) based on liver function abnormalities and changes in hepatitis viral load [ Time Frame: During 6months after enrollment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 2
Study Start Date: May 2015
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Unresectable, recurrent or metastatic melanoma patients
All adult unresectable, recurrent, or metastatic melanoma patients with HBV or HCV treated with at least 1 dose of ipilimumab therapy in Taiwan


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All adult unresectable, recurrent, or Metastatic Melanoma patients with HBV or HCV treated with at least 1 dose of Ipilimumab therapy in Taiwan

For more information regarding BMS clinical trial participation, please visit

Inclusion Criteria:

  • Age of 18 years or older on date of first dose of Ipilimumab
  • Patients who received at least 1 dose of Ipilimumab for the treatment of unresectable, recurrent or Metastatic Melanoma in Taiwan
  • Patients with advanced Melanoma and HBV or HCV who are initiating Ipilimumab under the discretion of their physician

Exclusion Criteria:

  • Patients who received Ipilimumab as part of a clinical trial
  • Patients who are receiving Ipilimumab for any indication other than local approval (ie, unresectable or Metastatic Melanoma)
  • Patients who are not infected with HBV or HCV
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02402699

Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email:
Contact: First line of the email MUST contain NCT# and Site #.

Local Institution Recruiting
Taipei 105, Taiwan
Contact: Site 0004         
Sponsors and Collaborators
Bristol-Myers Squibb
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Responsible Party: Bristol-Myers Squibb Identifier: NCT02402699     History of Changes
Other Study ID Numbers: CA184-414 
Study First Received: March 16, 2015
Last Updated: August 19, 2016
Health Authority: Taiwan : Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:

Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Hepatitis B
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Flaviviridae Infections
Hepadnaviridae Infections
DNA Virus Infections processed this record on December 02, 2016