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NCT02854488 Clinical Trial

Yervoy Pregnancy Surveillance Study

Melanoma Clinical Trial

Official title:
A Global Enhanced Pharmacovigilance Pregnancy Surveillance Study of Pregnant Women Exposed to Yervoy With 5 -Year Pediatric Follow-up

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT02854488
Other study ID # CA184-487
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date September 30, 2016
Est. completion date March 5, 2021

Study information
Verified date March 2022
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date March 5, 2021
Est. primary completion date February 5, 2021
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Yervoy

Locations
Country Name City State
United States UBC Baltimore Maryland

Sponsors (1)
Lead Sponsor Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

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