Melanoma
Conditions
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
Interventions
OTHERNon-Interventional
Non-Interventional
Sponsors
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival (OS) from Advanced Diagnosis | Minimum follow up 1 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) from 1L Therapy Initiation | Minimum follow up 1 year | — |
| Progression Free Survival (PFS) from Index Date | Minimum follow up 1 year | — |
| Objective Response Rate (ORR) | Minimum follow up 1 year | — |
| Best Therapy Response | 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. |
| Time to Best Therapy Response | Minimum follow up 1 year | — |
| Progression Free Survival (PFS) from Advanced Diagnosis | Minimum follow up 1 year | — |
| Response Evaluation Criteria in Solid Tumors (RECIST) | Minimum follow up 1 year | — |
| Immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) criteria | Minimum follow up 1 year | — |
| Incidence of AE's | Minimum follow up 1 year | — |
| Incidence of SAE's | Minimum follow up 1 year | — |
| Time to Loss of Peak Response | Minimum follow up 1 year | — |
Countries
United States
Outcome results
None listed