Overview

Yervoy Pregnancy Surveillance Study

Status:
Recruiting
Trial end date:
2024-08-31
Target enrollment:
0
Participant gender:
Female
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
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Bristol-Myers Squibb
Treatments:
Ipilimumab
Criteria
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