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WithdrawnNCT02854488Updated Mar 31, 2022

Yervoy Pregnancy Surveillance Study

An observational study in Melanoma, sponsored by Bristol-Myers Squibb. Withdrawn at 1 site in United States. Open to female participants. Per ClinicalTrials.gov, last updated 2022-03-31.

Sponsored by Bristol-Myers Squibb · Observational

Why this study was withdrawn
During the study period, no participants were enrolled in the study despite extensive recruitment methods.
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
0
Sex
Female
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Study 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

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Conditions studied

  • Melanoma

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03

In context

Melanoma

3,006 studies on the registry are indexed under Melanoma; 519 are open to participants now.

Browse Melanoma studies →

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.

Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Primary Care Clinic

Inclusion criteria

  • Documented exposure to Yervoy while pregnant or within 90 days of discontinuing treatment

Exclusion criteria

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

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Study design

Observational model
Cohort
Time perspective
Other
Enrollment
0 participants (actual)
Patient registry
No

Groups and cohorts

  • Women Exposed to Yervoy (ipilimumab) During Pregnancy

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

    Drug: Yervoy

Interventions

  • DrugYervoy

    Also known as: ipilimumab

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What researchers measure

Primary outcomes

  1. Incidence of structural birth defects in infants born to mothers exposed to Yervoy while pregnant

    Time frame: Birth up to 12 months

  2. Incidence of chromosomal birth defects in infants born to mothers exposed to Yervoy while pregnant

    Time frame: Birth up to 12 months

  3. Delays in developmental milestones

    Time frame: Birth up to 5 Years

  4. Clinical Signs of Immune or Endocrine Dysfunction

    Time frame: Birth up to 5 Years

  5. Clinical Signs of Autoimmune Disorders

    Time frame: Birth up to 5 Years

  6. Clinical Signs of Serious Infections and Malignancy

    Time frame: Birth up to 5 Years

  7. Adverse Pregnancy Outcomes

    Elective or spontaneous abortion, fetal death/stillbirth, pre-term delivery, ectopic or molar pregnancy

    Time frame: Time of Conception up to Birth

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Study locations

1 site
  • UBC
    Baltimore, Maryland, United States
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References and documents

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 31, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02854488
Lead sponsor
Bristol-Myers Squibb
Responsible party
Sponsor
First posted
Aug 3, 2016
Start date
Sep 30, 2016
Primary completion
Feb 5, 2021
Completion
Mar 5, 2021
Last update
Mar 31, 2022

Study contacts

Bristol-Myers Squibb
study director · Bristol-Myers Squibb
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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