Skip to main content
OpenTrials
Completed

NCT Number: NCT03732560

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution

Parsippany, New Jersey, 07054, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-Interventional

Other

Non-Interventional

Primary outcomes

  1. Overall Survival (OS) from Advanced Diagnosis

    Time frame: Minimum follow up 1 year

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Nov 6, 2018
Registry last updated
Dec 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.