A Comparison of Nivolumab-based Treatments in a Real-world PD-L1 Positive Metastatic Melanoma Population in the US
A Retrospective Observational Study Comparing Nivolumab + Ipilimumab Combination vs. Nivolumab Monotherapy as First Line Treatment of Metastatic PD-L1 Positive Melanoma in the US
1 other identifier
observational
600
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2018
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 31, 2018
CompletedFirst Submitted
Initial submission to the registry
November 5, 2018
CompletedFirst Posted
Study publicly available on registry
November 6, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 25, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 25, 2021
CompletedDecember 8, 2022
December 1, 2022
2.7 years
November 5, 2018
December 6, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Overall Survival (OS) from Advanced Diagnosis
Minimum follow up 1 year
Secondary Outcomes (11)
Progression Free Survival (PFS) from Advanced Diagnosis
Minimum follow up 1 year
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
- +6 more secondary outcomes
Study Arms (2)
Patients undergoing treatment with nivolumab and ipilimumab
Patients undergoing treatment with nivolumab
Interventions
Non-Interventional
Eligibility Criteria
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
You may qualify if:
- 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)
You may not qualify if:
- Patients enrolled in a cancer treatment-related clinical trial prior to first line therapy initiation for metastatic/Stage IV) melanoma
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Local Institution
Parsippany, New Jersey, 07054, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 5, 2018
First Posted
November 6, 2018
Study Start
July 31, 2018
Primary Completion
March 25, 2021
Study Completion
March 25, 2021
Last Updated
December 8, 2022
Record last verified: 2022-12