Study in Patients With Unresectable And Metastatic Melanoma: The Optimize Study

Melanoma Clinical Trial

Official title:

A US Multi-Site Observational Study in Patients With Unresectable And Metastatic Melanoma: The OPTIMIzE Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02780089
• Other study ID #: CA209-357
• Status: Completed
• Start date: October 23, 2015
• Est. completion date: September 8, 2020

Study information

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

Clinical Trial Summary

This study evaluates the different patterns of care for patients who have unresectable or metastatic melanoma. The dosing, duration, regimen, indication, and treatments will be observed. The survival rate of these patients will also be observed.

Description:

This is a non-interventional, observational study with the primary objective to assess and describe "real world" patterns of care in the treatment of patients with unresectable or metastatic melanoma. A sample size of 1,600 prospective patients will provide sufficient information to explore this primary objective. There will be no forced number of patients enrolled into a specific treatment cohort. Setting or controlling specific treatment enrollment cohort counts would invalidate the results of the primary objective of the study. No primary hypothesis is being tested.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 408
• Est. completion date: September 8, 2020
• Est. primary completion date: September 8, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Prospective cohort patients:

• Diagnosis date must occur on or after March 24, 2011 (date of ipilimumab approval in US)

• Diagnosis of stage III (unresectable) or stage IV melanoma (includes mucosal, uveal acral-lentiginous, leptomeningeal disease)

• Age = 18 years at time of entry into study

• Patients must be actively receiving or scheduled to receive systemic treatment (any line, eg, first, second, third line [including investigational drugs]).

• For patients initiating new treatment, treatment must be started within 28 days after signing informed consent.

• For patients currently receiving treatment, patients must enroll within the first 21 days of starting new treatment

Retrospective cohort patients:

• Patients with diagnosis of confirmed unresectable stage III or stage IV melanoma (including mucosal, uveal, acral-lentiginous, leptomeningeal disease)

• Age = 18 years at time of unresectable or metastatic melanoma diagnosis

• Initiated therapy for unresectable or metastatic melanoma within 4 years prior to approval of ipilimumab (first immune checkpoint inhibitor therapy approved in US)

• March 25, 2007 - March 24, 2011

• One year of follow-up data is required from date of therapy initiation, if a patient passed away within the one year of follow-up; such patients are still eligible and the date of death will be collected.

1. If retrospective patients have at least one year of follow-up data and are then treated with immuno-oncology, immune checkpoint inhibitor therapy, or targeted therapy, these patients will be analyzed separately.

Exclusion Criteria:

Prospective patients:

• Patients participating in a clinical study that does not allow enrollment into a non interventional study or clinical studies in which the investigational treatment is blinded

• Patients who started new treatment > 21 days

• Patients who enrolled in study but did not initiate treatment before 28 days

• Patients with current malignancies (except non-melanoma skin cancer and the following in situ cancers: bladder, gastric, colon, endometrial, cervical/dysplasia, melanoma, or breast) that requires additional systemic therapy

Related Conditions & MeSH terms

• Melanoma

Locations

Country	Name	City	State
United States	Network Office of Research & Innovation / Lehigh Valley Health Network	Allentown	Pennsylvania
United States	University of Colorado	Aurora	Colorado
United States	Texas Oncology	Austin	Texas
United States	Saint Agnes Hospital	Baltimore	Maryland
United States	St. Charles Medical Center - Cancer Center	Bend	Oregon
United States	St. Luke's Hospital and Health Network	Bethlehem	Pennsylvania
United States	Central Care Cancer Center	Bolivar	Missouri
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	West Virginia University	Bridgeport	West Virginia
United States	Rosewell Park Cancer Institute	Buffalo	New York
United States	Aultman Hospital	Canton	Ohio
United States	Hematolgoy and Oncology Associates, Inc.	Canton	Ohio
United States	Center of Learning Healthcare	Durham	North Carolina
United States	Texas Oncology	El Paso	Texas
United States	The Regional Cancer Center	Erie	Pennsylvania
United States	North Shore University Health System	Evanston	Illinois
United States	Providence Regional Medical Center Everett	Everett	Washington
United States	Inova Melanoma and Skin Cancer Center	Fairfax	Virginia
United States	John Theurer Cancer Center at Hackensack University Medical Center	Hackensack	New Jersey
United States	Ingalls Cancer Research Center	Harvey	Illinois
United States	Forrest General Cancer Center	Hattiesburg	Mississippi
United States	The Queen's Medical Center	Honolulu	Hawaii
United States	Genesis Cancer Center	Hot Springs	Arkansas
United States	West Virginia University	Huntington	West Virginia
United States	21st Century Oncology	Jacksonville	Florida
United States	Cancer Specialits, LLC D/B/A	Jacksonville	Florida
United States	Thompson Cancer Survival Center	Knoxville	Tennessee
United States	Gundersen Lutheran Medical Foundations, Inc.	La Crosse	Wisconsin
United States	Lakeland Regional Health	Lakeland	Florida
United States	Watson Clinical Center for Research, INC	Lakeland	Florida
United States	Lancaster General Health	Lancaster	Pennsylvania
United States	Nebraska Hematology-Oncology, P.C.	Lincoln	Nebraska
United States	Pacific Shores Medical Group	Long Beach	California
United States	UF Health Cancer Center at Orlando Health	Longwood	Florida
United States	West Virginia University Hematolgoy & Oncology	Martinsburg	West Virginia
United States	Tri-County Hematology and Oncology Associates, Inc	Massillon	Ohio
United States	Mount Sinai Medical Center	Miami Beach	Florida
United States	Masonic Cancer Center	Minneapolis	Minnesota
United States	West Virginia University	Morgantown	West Virginia
United States	Atlantic Health, Morristown Medical Center	Morristown	New Jersey
United States	Northwest Alabama Cancer Center	Muscle Shoals	Alabama
United States	Meridian Health	Neptune	New Jersey
United States	Ochsner Clinic Foundation	New Orleans	Louisiana
United States	Oncology Specialits, S.C.	Niles	Illinois
United States	Oncology Hematology West P.C.	Omaha	Nebraska
United States	Mid Florida Hematology and Oncology Centers	Orange City	Florida
United States	West Ky Hematology & Oncology	Paducah	Kentucky
United States	Texas Oncology	Paris	Texas
United States	Sacred Heart Medical Oncology Group	Pensacola	Florida
United States	Jefferson Medical Oncology	Philadelphia	Pennsylvania
United States	Allegheny Health Network	Pittsburgh	Pennsylvania
United States	UPCI - UPMC Cancer Center	Pittsburgh	Pennsylvania
United States	Cancer Care Associates	Redondo Beach	California
United States	Mayo Clinic Cancer Center (MCCC)	Rochester	Minnesota
United States	Harbin Clinic	Rome	Georgia
United States	Huntsman Cancer Institute at the University of Utah	Salt Lake City	Utah
United States	Summit Cancer Care	Savannah	Georgia
United States	CHRISTUS Schumpert Cancer Treatment Center	Shreveport	Louisiana
United States	Orchard Healthcare Research Inc.	Skokie	Illinois
United States	Cancer Care Northwest	Spokane	Washington
United States	Simmons Cancer Institute at SIU School of Medicine	Springfield	Illinois
United States	Tallahassee Memorial Healthcare	Tallahassee	Florida
United States	H. Lee Moffitt Cancer Center Moffitt Cancer Center	Tampa	Florida
United States	Stormont-Vail Cancer Center	Topeka	Kansas
United States	University of Kansas Medical Center	Westwood	Kansas
United States	Genesis Cancer Care Center	Zanesville	Ohio

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	Patterns of Care	To assess the selection and sequencing of drugs and practice patterns used to treat unresectable and metastatic melanoma (e.g. immune checkpoint agents, targeted agents, or combination therapies) in a real-world setting. Reasons for initial treatment decisions across and between drug classes, changes in treatment, and discontinuation will be recorded (e.g. lack of benefit, safety, cost, or other barriers to care).	Up to 5 years
Primary	Demographics	Baseline characteristics (age, gender, race/ethnicity)	Up to 5 years
Primary	Overall Survival	To estimate overall survival in patients receiving therapy for unresectable or metastatic melanoma some statistical measurements and actual survival will be used.	Up to 5 years
Primary	Disease Characteristics	Disease characteristics (date of diagnosis, disease stage, performance status)	Up to 5 years
Secondary	Healthcare Resource	To compare and describe healthcare utilization, imputed costs, and impact of initial treatment choice on lifetime or periodic costs. Due to potential differences between in patterns of care among various regions, region-specific analyses may be conducted for healthcare resource utilization.	up to 5 years
Secondary	Functional Assessments of Cancer Therapy-Melanoma (FACT-M)		Up to 12 months
Secondary	European Quality of Life-5 Dimensions (EQ-5D)		Up to 12 months
Secondary	Work Productivity and Activity Impairment: General Health (WPAI:GH)		Up to 12 months
Secondary	The Caregiver Quality of Life Index - Cancer (CQOLC)		Up to 12 months

External Links

•   BMS Clinical Trial Information
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