Yervoy Pregnancy Surveillance Study
- Registration Number
- NCT02854488
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The study is a global safety surveillance study of pregnancy outcomes in women who were exposed to ipilimumab during pregnancy and pediatric outcomes up to 5 years of age
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Female
- Target Recruitment
- Not specified
Inclusion Criteria
- Documented exposure to Yervoy while pregnant or within 90 days of discontinuing treatment
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Exclusion Criteria
- Women whose ipilimumab exposure is outside the window of pregnancy exposure
- Pregnancies for which there is only paternal exposure to Yervoy
Other protocol defined inclusion/exclusion criteria could apply
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Women Exposed to Yervoy (ipilimumab) During Pregnancy Yervoy Women Exposed to Yervoy (ipilimumab) During Pregnancy and the Children from These Pregnancies
- Primary Outcome Measures
Name Time Method Adverse Pregnancy Outcomes Time of Conception up to Birth Elective or spontaneous abortion, fetal death/stillbirth, pre-term delivery, ectopic or molar pregnancy
Incidence of chromosomal birth defects in infants born to mothers exposed to Yervoy while pregnant Birth up to 12 months Incidence of structural birth defects in infants born to mothers exposed to Yervoy while pregnant Birth up to 12 months Delays in developmental milestones Birth up to 5 Years Clinical Signs of Immune or Endocrine Dysfunction Birth up to 5 Years Clinical Signs of Autoimmune Disorders Birth up to 5 Years Clinical Signs of Serious Infections and Malignancy Birth up to 5 Years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
UBC
🇺🇸Baltimore, Maryland, United States