MelanomaNCT02854488
Yervoy Pregnancy Surveillance Study
An observational study of Melanoma, run by Bristol-Myers Squibb at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Melanoma
- What is being tested?
- Yervoy
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2016to 5 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Primary Care Clinic
Who may be able to join
- Documented exposure to Yervoy while pregnant or within 90 days of discontinuing treatment
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Melanoma
- Being tested
- Yervoy
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YervoyDrug
Also called ipilimumab
| Study group | Role | What they receive |
|---|---|---|
| Women Exposed to Yervoy (ipilimumab) During Pregnancy | Women Exposed to Yervoy (ipilimumab) During Pregnancy and the Children from These Pregnancies Receives: Drug: Yervoy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of structural birth defects in infants born to mothers exposed to Yervoy while pregnant
Measured: Birth up to 12 months
Incidence of chromosomal birth defects in infants born to mothers exposed to Yervoy while pregnant
Measured: Birth up to 12 months
Delays in developmental milestones
Measured: Birth up to 5 Years
Clinical Signs of Immune or Endocrine Dysfunction
Measured: Birth up to 5 Years
Clinical Signs of Autoimmune Disorders
Measured: Birth up to 5 Years
Clinical Signs of Serious Infections and Malignancy
Measured: Birth up to 5 Years
Adverse Pregnancy Outcomes
Elective or spontaneous abortion, fetal death/stillbirth, pre-term delivery, ectopic or molar pregnancy
Measured: Time of Conception up to Birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2016 (estimated)
- Study start30 Sep 2016
- Primary completion5 Feb 2021
- Study completion5 Mar 2021
Why it stopped: During the study period, no participants were enrolled in the study despite extensive recruitment methods.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02854488
- Sponsor's protocol ID
- CA184-487
- Status last verified
- Mar 2022
- First submitted
- 1 Aug 2016
- Last updated
- 31 Mar 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Global Enhanced Pharmacovigilance Pregnancy Surveillance Study of Pregnant Women Exposed to Yervoy With 5 -Year Pediatric Follow-up
- ClinicalTrials.gov ID
- NCT02854488
- Acronym / sponsor ID
- CA184-487
- Conditions
- Melanoma
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: During the study period, no participants were enrolled in the study despite extensive recruitment methods.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2016 (actual)
- Primary completion
- 5 Feb 2021 (actual)
- Study completion
- 5 Mar 2021 (actual)
- First posted
- 3 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women Exposed to Yervoy (ipilimumab) During Pregnancy | – | Drug: YervoyWomen Exposed to Yervoy (ipilimumab) During Pregnancy and the Children from These Pregnancies |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Primary Care Clinic
Key inclusion criteria (1 listed)
- Documented exposure to Yervoy while pregnant or within 90 days of discontinuing treatment
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YervoyAlso: ipilimumab | Drug | Women Exposed to Yervoy (ipilimumab) During Pregnancy |
Primary outcome
Incidence of structural birth defects in infants born to mothers exposed to Yervoy while pregnant
Time frame: 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
Delays in developmental milestones
Time frame: Birth up to 5 Years
Clinical Signs of Immune or Endocrine Dysfunction
Time frame: Birth up to 5 Years
Clinical Signs of Autoimmune Disorders
Time frame: Birth up to 5 Years
Clinical Signs of Serious Infections and Malignancy
Time frame: 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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- BMS Clinical Trial InformationLink provided by the sponsor.
- Investigator Inquiry FormLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma, run by Bristol-Myers Squibb at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of structural birth defects in infants born to mothers exposed to Yervoy while pregnant (time frame: Birth up to 12 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.