Study Stopped
During the study period, no participants were enrolled in the study despite extensive recruitment methods.
Yervoy Pregnancy Surveillance Study
A Global Enhanced Pharmacovigilance Pregnancy Surveillance Study of Pregnant Women Exposed to Yervoy With 5 -Year Pediatric Follow-up
1 other identifier
observational
N/A
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Sep 2016
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 1, 2016
CompletedFirst Posted
Study publicly available on registry
August 3, 2016
CompletedStudy Start
First participant enrolled
September 30, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 5, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 5, 2021
CompletedMarch 31, 2022
March 1, 2022
4.4 years
August 1, 2016
March 16, 2022
Conditions
Outcome Measures
Primary Outcomes (7)
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
Elective or spontaneous abortion, fetal death/stillbirth, pre-term delivery, ectopic or molar pregnancy
Time of Conception up to Birth
Study Arms (1)
Women Exposed to Yervoy (ipilimumab) During Pregnancy
Women Exposed to Yervoy (ipilimumab) During Pregnancy and the Children from These Pregnancies
Interventions
Eligibility Criteria
Primary Care Clinic
You may qualify if:
- Documented exposure to Yervoy while pregnant or within 90 days of discontinuing treatment
You may not qualify if:
- Women whose ipilimumab exposure is outside the window of pregnancy exposure
- Pregnancies for which there is only paternal exposure to Yervoy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UBC
Baltimore, Maryland, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 1, 2016
First Posted
August 3, 2016
Study Start
September 30, 2016
Primary Completion
February 5, 2021
Study Completion
March 5, 2021
Last Updated
March 31, 2022
Record last verified: 2022-03