Clinical trial NCT03732560: A Comparison of Nivolumab-based Treatments in a Real-world PD-L1 Positive Metastatic Melanoma Population in the US
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Melanoma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2018-11-06
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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


Eligibility 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

Primary outcomes:
measure: Overall Survival (OS) from Advanced Diagnosis
timeFrame: Minimum follow up 1 year
Secondary outcomes:
measure: Progression Free Survival (PFS) from Advanced Diagnosis
timeFrame: Minimum follow up 1 year
measure: Overall Survival (OS) from 1L Therapy Initiation
timeFrame: Minimum follow up 1 year
measure: Progression Free Survival (PFS) from Index Date
timeFrame: Minimum follow up 1 year
measure: Objective Response Rate (ORR)
timeFrame: Minimum follow up 1 year
measure: Best Therapy Response
timeFrame: Minimum follow up 1 year
measure: Time to Best Therapy Response
timeFrame: Minimum follow up 1 year
measure: Time to Loss of Peak Response
timeFrame: Minimum follow up 1 year
measure: Response Evaluation Criteria in Solid Tumors (RECIST)
timeFrame: Minimum follow up 1 year
measure: Immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) criteria
timeFrame: Minimum follow up 1 year
measure: Incidence of AE's
timeFrame: Minimum follow up 1 year
measure: Incidence of SAE's
timeFrame: Minimum follow up 1 year
Other outcomes:
Locations:
city: Parsippany
country: United States
facility: Local Institution
state: New Jersey
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: