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Survival Study for Participants Treated With Ipilimumab-Nivolumab Combination Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03438279
Recruitment Status : Completed
First Posted : February 19, 2018
Last Update Posted : February 19, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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Brief Summary:
This study will review published trial literature and documents for Overall Survival (OS) to evaluate the association between the hazard of death and each baseline variable.

Condition or disease Intervention/treatment
Melanoma Other: Non-Interventional

Study Design
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Study Type : Observational
Actual Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Projecting Survival for Patients Treated With First-Line Ipilimumab-Nivolumab Combination Therapy Using a Prognostic Model and Cost Per Responder Model of Ipilimumab-Nivolumab Combination Therapy
Actual Study Start Date : June 23, 2015
Actual Primary Completion Date : December 28, 2017
Actual Study Completion Date : December 28, 2017

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
Drug Information available for: Ipilimumab

Groups and Cohorts
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Group/Cohort Intervention/treatment
First-Line Ipilimumab
patients who received ipilimumab as their first-line treatment
 Other: Non-Interventional
Non-Interventional


Outcome Measures
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Primary Outcome Measures :
  1. Prognostic Model of Overall Survival (OS) [ Time Frame: 10 years ]
    The OS prognostic model uses Individual patient data from a pooled analysis of 12 ipilimumab studies.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Individual patient data (IPD) from the ipilimumab pooled analysis of clinical trials and observational studies will be used to construct the prognostic model for OS in advanced melanoma patients.
Criteria

Inclusion Criteria:

  • Diagnosis of melanoma

Exclusion Criteria:

  • Age less than 18 years old
Contacts and Locations
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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): NCT03438279


Locations
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United States, Massachusetts
Local Institution
Boston, Massachusetts, United States, 02199
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03438279    
Other Study ID Numbers: CA209-437
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: February 19, 2018
Last Verified: February 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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