Yervoy Pregnancy Surveillance Study

NCT ID: NCT02854488

Last Updated: 2022-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-30

Study Completion Date

2021-03-05

Brief Summary

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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

Detailed Description

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Conditions

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Melanoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Women Exposed to Yervoy (ipilimumab) During Pregnancy

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

Yervoy

Intervention Type DRUG

Interventions

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Yervoy

Intervention Type DRUG

Other Intervention Names

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ipilimumab

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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UBC

Baltimore, Maryland, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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CA184-487

Identifier Type: -

Identifier Source: org_study_id

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