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A Comparison of Nivolumab-based Treatments in a Real-world PD-L1 Positive Metastatic Melanoma Population in the US

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ClinicalTrials.gov Identifier: NCT03732560
Recruitment Status : Active, not recruiting
First Posted : November 6, 2018
Last Update Posted : November 8, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
The goal of this study is to describe patient characteristics, treatment outcomes and adverse events for patients with metastatic melanoma testing positive for PD-L1 expression treated first line (1L) with either nivolumab and ipilimumab in combination (NIVO + IPI) or nivolumab (NIVO) monotherapy

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

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Study Type : Observational
Actual Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Retrospective Observational Study Comparing Nivolumab + Ipilimumab Combination vs. Nivolumab Monotherapy as First Line Treatment of Metastatic PD-L1 Positive Melanoma in the US
Actual Study Start Date : July 31, 2018
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : October 29, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
Drug Information available for: Nivolumab

Group/Cohort Intervention/treatment
Patients undergoing treatment with nivolumab and ipilimumab Other: Non-Interventional
Non-Interventional

Patients undergoing treatment with nivolumab Other: Non-Interventional
Non-Interventional




Primary Outcome Measures :
  1. Overall Survival (OS) from Advanced Diagnosis [ Time Frame: Minimum follow up 1 year ]

Secondary Outcome Measures :
  1. Progression Free Survival (PFS) from Advanced Diagnosis [ Time Frame: Minimum follow up 1 year ]
  2. Overall Survival (OS) from 1L Therapy Initiation [ Time Frame: Minimum follow up 1 year ]
  3. Progression Free Survival (PFS) from Index Date [ Time Frame: Minimum follow up 1 year ]
  4. Objective Response Rate (ORR) [ Time Frame: Minimum follow up 1 year ]
  5. Best Therapy Response [ Time Frame: Minimum follow up 1 year ]
    Best response (complete response, CR or partial response, PR) will be measured from the start of index treatment to progression or recurrence. Outcome will be reported as the percent of patients achieving best response from the total population of patients in a study arm.

  6. Time to Best Therapy Response [ Time Frame: Minimum follow up 1 year ]
  7. Time to Loss of Peak Response [ Time Frame: Minimum follow up 1 year ]
  8. Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Minimum follow up 1 year ]
  9. Immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) criteria [ Time Frame: Minimum follow up 1 year ]
  10. Incidence of AE's [ Time Frame: Minimum follow up 1 year ]
  11. Incidence of SAE's [ Time Frame: Minimum follow up 1 year ]


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:   Probability Sample
Study Population
Adult metastatic melanoma patients with a positive PD-L1 expression level (above 1%) treated with nivolumab or nivolumab+ipilimumab in the first line setting in the US between Oct 1, 2015 and July 1, 2017
Criteria

Inclusion Criteria:

  • Adults 18 years or older
  • First advanced of diagnosis of metastatic/Stage IV) melanoma
  • Tested for PD-L1 expression with a tumor proportion score (TPS) greater than or equal to 1% (Phase 1 data collection)
  • Initiating a first line of therapy during the index period between October 1, 2015 through July 1, 2017
  • Medical history available for medical chart abstraction from date of diagnosis through most recent or current therapy (defined as end of data collection period)

Exclusion Criteria:

  • Patients enrolled in a cancer treatment-related clinical trial prior to first line therapy initiation for metastatic/Stage IV) melanoma

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): NCT03732560


Locations
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United States, New Jersey
Local Institution
Parsippany, New Jersey, United States, 07054
Sponsors and Collaborators
Bristol-Myers Squibb
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: NCT03732560     History of Changes
Other Study ID Numbers: CA209-8RW
First Posted: November 6, 2018    Key Record Dates
Last Update Posted: November 8, 2018
Last Verified: November 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
Nivolumab
Ipilimumab
Antineoplastic Agents, Immunological
Antineoplastic Agents