NCT03199846

Brief Summary

This study will collect real-world data from advanced melanoma diagnosis through most recent visit and data sourced from patient medical records following a 2-part study design consisting of a random sample (Part 1) and an oversample (Part 2).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
650

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

1 active site

Status
completed

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

October 25, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 23, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 27, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

February 6, 2018

Status Verified

February 1, 2018

Enrollment Period

1 year

First QC Date

June 23, 2017

Last Update Submit

February 5, 2018

Conditions

Melanoma

Outcome Measures

Primary Outcomes (1)

  • Distribution of treatment patterns for advanced melanoma patients

    Distribution of treatment patterns for advanced melanoma patients including, treatment regimen selection and rationale, as well as time to initiation of therapy and type of therapy

    Aproximately 6 months

Secondary Outcomes (20)

  • Distribution of prescribing patterns

    Approximately 16 months

  • Distribution of Patient Age at index date

    at baseline

  • Distribution of Patient's Sex at Index Date

    At Baseline

  • Distribution of Comorbidities at index date

    At Baseline

  • Distribution of Healthcare Coverage type

    At Baseline

  • +15 more secondary outcomes

Study Arms (6)

advanced melanoma patients

Part 1 will consist of a representative sample of advanced melanoma patients, irrespective of date of diagnosis of stage III unresectable and metastatic/stage IV, to address information objectives on treatment patterns, clinical outcomes, and resource use after the start of treatment post-launch of new drugs, ie, since 2011 for ipi and 2015 for ipi + nivo in advanced melanoma

Other: Non-Interventional

Ipi monotherapy

Part 2: patients must have been prescribed Ipi monotherapy during the index period between 01-Jan-2015 and 31-May-2016.

Other: Non-Interventional

Ipi + nivo combination therapy

Part 2: patients must have been prescribed Ipi + nivo combination therapy during the index period between 01-Jan-2015 and 31-May-2016.

Other: Non-Interventional

Dabrafenib + trametinib combination therapy

Part 2: patients must have been prescribed Dabrafenib + trametinib combination therapy during the index period between 01-Jan-2015 and 31-May-2016.

Other: Non-Interventional

Pembro monotherapy

Part 2: patients must have been prescribed Pembro monotherapy during the index period between 01-Jan-2015 and 31-May-2016

Other: Non-Interventional

Nivo monotherapy

Part 2: patients must have been prescribed Nivo monotherapy during the index period between 01-Jan-2015 and 31-May-2016

Other: Non-Interventional

Interventions

Non-InterventionalOTHER

Non-Interventional

Dabrafenib + trametinib combination therapyIpi + nivo combination therapyIpi monotherapyNivo monotherapyPembro monotherapyadvanced melanoma patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients initiating a new line of therapy for unresectable stage III and/or metastatic (stage IV) melanoma during the index period between 01-Jan-2015 and 31-May-2016.

You may qualify if:

  • Adults 18 years or older
  • Diagnosis of unresectable stage III and/or metastatic (stage IV) melanoma before 01-Nov-2015
  • Initiating a new line of therapy during the index period between 01-Jan-2015 and 31-May-2016, irrespective of advanced melanoma diagnosis date
  • 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:

  • Physicians unwilling or unable to follow study instructions
  • Patients who were previously enrolled in a cancer treatment-related clinical trial since the diagnosis of unresectable stage III and/or metastatic (stage IV) melanoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Local Institution

Morristown, New Jersey, 07960, United States

Location

Related Links

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2017

First Posted

June 27, 2017

Study Start

October 25, 2016

Primary Completion

October 30, 2017

Study Completion

December 31, 2017

Last Updated

February 6, 2018

Record last verified: 2018-02

Locations

US(1)