A Global Enhanced Pharmacovigilance Pregnancy Surveillance Study of Pregnant Women Exposed to Yervoy® with 5-year Pediatric Follow-up (CA184-487)

Study identification

• EU PAS number:
  EUPAS18596
• Study ID:
  40257
• Official title and acronym:
  A Global Enhanced Pharmacovigilance Pregnancy Surveillance Study of Pregnant Women Exposed to Yervoy® with 5-year Pediatric Follow-up (CA184-487)
• DARWIN EU® study:
  No
• Study countries:
  Brazil

  Canada

  France

  Germany

  Italy

  Poland

  United Kingdom

  United States
• Study description:
  Although cancer during pregnancy is not common, melanoma is among the most common cancers observed in pregnant women. The incidence of melanoma among pregnant women is expected to continue to increase, as it has done in recent decades. Evidence suggests that pregnant women with melanoma have no worse a prognosis than non-pregnant women with melanoma, and that maternal and birth outcomes may be quite good depending upon the stage of disease. The data on Yervoy® (ipilimumab) exposure and human pregnancy available to date are very limited as pregnant women are excluded from clinical trials. The effects of exposure to ipilimumab during pregnancy on development of the fetal immune system and other organs that are susceptible to immune-mediated adverse reactions are unknown. The purpose of this study is to monitor pregnancies exposed to ipilimumab to evaluate the possible adverse effects of this immunotherapy on the pregnancy outcome and on delays in growth and development milestones, clinical signs of immune or endocrine dysfunction, autoimmune disorders, reactions to immunizations/vaccinations, hospitalizations for serious infection and malignancies in the first 5 years of life. The lack of human fetal safety data for ipilimumab makes such a monitoring system an important component of epidemiologic research on the safety of this drug when treating melanoma during pregnancy.
• Study status:
  Finalised

Research institutions and networks

Institutions

Bristol-Myers Squibb (BMS)

Multiple centres: 50 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 01/01/2017

Actual: 25/02/2016

Study start date

Planned: 30/09/2016

Actual: 26/09/2016

Date of final study report

Planned: 20/10/2020

Actual: 05/03/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Bristol-Myers Squibb

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable