Yervoy Pregnancy Surveillance Study

March 16, 2022 updated by: Bristol-Myers Squibb

A Global Enhanced Pharmacovigilance Pregnancy Surveillance Study of Pregnant Women Exposed to Yervoy With 5 -Year Pediatric Follow-up

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Primary Care Clinic

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Women Exposed to Yervoy (ipilimumab) During Pregnancy
Women Exposed to Yervoy (ipilimumab) During Pregnancy and the Children from These Pregnancies
Drug: Yervoy
Other Names:
  • ipilimumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of structural birth defects in infants born to mothers exposed to Yervoy while pregnant
Time Frame: Birth up to 12 months
Birth up to 12 months
Incidence of chromosomal birth defects in infants born to mothers exposed to Yervoy while pregnant
Time Frame: Birth up to 12 months
Birth up to 12 months
Delays in developmental milestones
Time Frame: Birth up to 5 Years
Birth up to 5 Years
Clinical Signs of Immune or Endocrine Dysfunction
Time Frame: Birth up to 5 Years
Birth up to 5 Years
Clinical Signs of Autoimmune Disorders
Time Frame: Birth up to 5 Years
Birth up to 5 Years
Clinical Signs of Serious Infections and Malignancy
Time Frame: Birth up to 5 Years
Birth up to 5 Years
Adverse Pregnancy Outcomes
Time Frame: Time of Conception up to Birth
Elective or spontaneous abortion, fetal death/stillbirth, pre-term delivery, ectopic or molar pregnancy
Time of Conception up to Birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2016

Primary Completion (Actual)

February 5, 2021

Study Completion (Actual)

March 5, 2021

Study Registration Dates

First Submitted

August 1, 2016

First Submitted That Met QC Criteria

August 1, 2016

First Posted (Estimate)

August 3, 2016

Study Record Updates

Last Update Posted (Actual)

March 31, 2022

Last Update Submitted That Met QC Criteria

March 16, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA184-487

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Melanoma

Clinical Trials on Yervoy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malaysia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe