Melanoma
Conditions
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
Interventions
DRUGYervoy
Sponsors
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of structural birth defects in infants born to mothers exposed to Yervoy while pregnant | Birth up to 12 months | — |
| Incidence of chromosomal 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 | — |
| Adverse Pregnancy Outcomes | Time of Conception up to Birth | Elective or spontaneous abortion, fetal death/stillbirth, pre-term delivery, ectopic or molar pregnancy |
Countries
United States
Outcome results
None listed