Yervoy Pregnancy Surveillance Study

Withdrawn

• Conditions: Melanoma
• Interventions: Drug: Yervoy

• 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

Study Timeline

• Study First Submitted: 2016-08-01
• Study First Submitted QC: 2016-08-01
• Study First Posted: 2016-08-03
• Study Start: 2016-09-30
• Primary Completion: 2021-02-05
• Study Completion: 2021-03-05
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-16
• Last Update Posted: 2022-03-31

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• Status: WITHDRAWN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

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

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

Trial Locations

Locations (1)

UBC; 🇺🇸 Baltimore, Maryland, United States