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Clinical Trial Details — Status: Withdrawn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
• Status: Withdrawn
• 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
• 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• Status: Withdrawn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

Related Conditions & MeSH terms

• Melanoma

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

External Links

•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form