Yervoy Pregnancy Surveillance Study

Overview

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

Full Title of Study: “A Global Enhanced Pharmacovigilance Pregnancy Surveillance Study of Pregnant Women Exposed to Yervoy With 5 -Year Pediatric Follow-up”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Other
  • Study Primary Completion Date: February 5, 2021

Interventions

  • Drug: Yervoy

Arms, Groups and Cohorts

  • Women Exposed to Yervoy (ipilimumab) During Pregnancy
    • Women Exposed to Yervoy (ipilimumab) During Pregnancy and the Children from These Pregnancies

Clinical Trial Outcome Measures

Primary Measures

  • Incidence of structural birth defects in infants born to mothers exposed to Yervoy while pregnant
    • Time Frame: Birth up to 12 months
  • Incidence of chromosomal birth defects in infants born to mothers exposed to Yervoy while pregnant
    • Time Frame: Birth up to 12 months
  • Delays in developmental milestones
    • Time Frame: Birth up to 5 Years
  • Clinical Signs of Immune or Endocrine Dysfunction
    • Time Frame: Birth up to 5 Years
  • Clinical Signs of Autoimmune Disorders
    • Time Frame: Birth up to 5 Years
  • Clinical Signs of Serious Infections and Malignancy
    • Time Frame: Birth up to 5 Years
  • Adverse Pregnancy Outcomes
    • Time Frame: Time of Conception up to Birth
    • Elective or spontaneous abortion, fetal death/stillbirth, pre-term delivery, ectopic or molar pregnancy

Participating in This Clinical Trial

Inclusion Criteria

  • Documented exposure to Yervoy while pregnant or within 90 days of discontinuing treatment 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

Gender Eligibility: Female

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Bristol-Myers Squibb
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Bristol-Myers Squibb, Study Director, Bristol-Myers Squibb

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