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Yervoy® Postmarketing Surveillance for Patients in Japan With Unresectable, Malignant Melanoma

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ClinicalTrials.gov Identifier: NCT02717364
Recruitment Status : Recruiting
First Posted : March 23, 2016
Last Update Posted : September 19, 2018
Sponsor:
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
This study is a local, prospective, non-interventional, non-controlled, multicenter, observational study (regulatory postmarketing surveillance). Each physician will enroll patients who have received at least 1 dose of Yervoy, and each patient will be followed for up to 12 months. All patients will be evaluated for safety and effectiveness during Yervoy use (4 doses) and for 12 months from the first dose of Yervoy to confirm the safety profile of Yervoy under routine, daily practice

Condition or disease Intervention/treatment
Melanoma Drug: Yervoy

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Yervoy® Postmarketing Surveillance for Patients in Japan With Unresectable, Malignant Melanoma
Actual Study Start Date : August 31, 2015
Estimated Primary Completion Date : June 24, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
Drug Information available for: Ipilimumab

Group/Cohort Intervention/treatment
Population With Yervoy Exposure
Population With Yervoy Exposure
Drug: Yervoy



Primary Outcome Measures :
  1. The incidence of adverse events (AEs) by types among the analysis population [ Time Frame: 12 months ]
  2. The Overall Survival (OS) Rate [ Time Frame: 12 months ]
  3. The factors that potentially affect safety or effectiveness [ Time Frame: 12 months ]
    Stratified analysis on the incidence of adverse events (AEs) and effectiveness by patient background



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Primary Care Clinic
Criteria

Inclusion Criteria:

  • All patients who are initiating treatment with Yervoy

Exclusion Criteria:

  • Not Applicable

Other protocol defined inclusion/exclusion criteria could apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02717364


Contacts
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Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #

Locations
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Japan
Local Institution Recruiting
Tokyo, Japan
Contact: Site 0001         
Sponsors and Collaborators
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02717364     History of Changes
Other Study ID Numbers: CA184-438
First Posted: March 23, 2016    Key Record Dates
Last Update Posted: September 19, 2018
Last Verified: September 2018

Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Ipilimumab
Antineoplastic Agents, Immunological
Antineoplastic Agents