Clinical trial · Observational
Yervoy Pregnancy Surveillance Study
A Global Enhanced Pharmacovigilance Pregnancy Surveillance Study of Pregnant Women Exposed to Yervoy With 5 -Year Pediatric Follow-up
NCT02854488CI-TRIAL-00057426withdrawnClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): During the study period, no participants were enrolled in the study despite extensive recruitment methods.
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Yervoy | Drug | Ipilimumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Women Exposed to Yervoy (ipilimumab) During Pregnancy
- description
- Women Exposed to Yervoy (ipilimumab) During Pregnancy and the Children from These Pregnancies
- interventionNames
- Drug: Yervoy
Primary outcomes (7)
- measure
- Incidence of structural birth defects in infants born to mothers exposed to Yervoy while pregnant
- timeFrame
- Birth up to 12 months
- measure
- Incidence of chromosomal birth defects in infants born to mothers exposed to Yervoy while pregnant
- timeFrame
- Birth up to 12 months
- measure
- Delays in developmental milestones
- timeFrame
- Birth up to 5 Years
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.