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

Melanoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03732560
• Other study ID #: CA209-8RW
• Status: Completed
• Start date: July 31, 2018
• Est. completion date: March 25, 2021

Study information

• Verified date: December 2022
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: March 25, 2021
• Est. primary completion date: March 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Melanoma

Intervention

Other:
• Non-Interventional
Non-Interventional

Locations

Country	Name	City	State
United States	Local Institution	Parsippany	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival (OS) from Advanced Diagnosis		Minimum follow up 1 year
Secondary	Progression Free Survival (PFS) from Advanced Diagnosis		Minimum follow up 1 year
Secondary	Overall Survival (OS) from 1L Therapy Initiation		Minimum follow up 1 year
Secondary	Progression Free Survival (PFS) from Index Date		Minimum follow up 1 year
Secondary	Objective Response Rate (ORR)		Minimum follow up 1 year
Secondary	Best Therapy Response	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.	Minimum follow up 1 year
Secondary	Time to Best Therapy Response		Minimum follow up 1 year
Secondary	Time to Loss of Peak Response		Minimum follow up 1 year
Secondary	Response Evaluation Criteria in Solid Tumors (RECIST)		Minimum follow up 1 year
Secondary	Immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) criteria		Minimum follow up 1 year
Secondary	Incidence of AE's		Minimum follow up 1 year
Secondary	Incidence of SAE's		Minimum follow up 1 year

External Links

•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls