Yervoy Pregnancy Surveillance Study

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages N/A and Over
Gender Female
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02854488
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Bristol-Myers Squibb
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Bristol-Myers Squibb
Principal Investigator Affiliation Bristol-Myers Squibb
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Melanoma
Study Website: View Trial Website
Arms & Interventions

Arms

: Women Exposed to Yervoy (ipilimumab) During Pregnancy

Women Exposed to Yervoy (ipilimumab) During Pregnancy and the Children from These Pregnancies

Interventions

Drug: - Yervoy

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

UBC, Morgantown, West Virginia

Status

Recruiting

Address

UBC

Morgantown, West Virginia, 26505-8065

Site Contact

Amy Miller, Site 0001

Clinical.Trials@bms.com

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