Study in Patients With Unresectable And Metastatic Melanoma: The Optimize Study
- Conditions
- Melanoma
- Registration Number
- NCT02780089
- Lead Sponsor
- Bristol-Myers Squibb
- Brief 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.
- Detailed 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 & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 408
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.
- 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.
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Patterns of Care Up to 5 years 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).
Demographics Up to 5 years Baseline characteristics (age, gender, race/ethnicity)
Overall Survival Up to 5 years To estimate overall survival in patients receiving therapy for unresectable or metastatic melanoma some statistical measurements and actual survival will be used.
Disease Characteristics Up to 5 years Disease characteristics (date of diagnosis, disease stage, performance status)
- Secondary Outcome Measures
Name Time Method Work Productivity and Activity Impairment: General Health (WPAI:GH) Up to 12 months Healthcare Resource up to 5 years 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.
Functional Assessments of Cancer Therapy-Melanoma (FACT-M) Up to 12 months European Quality of Life-5 Dimensions (EQ-5D) Up to 12 months The Caregiver Quality of Life Index - Cancer (CQOLC) Up to 12 months
Trial Locations
- Locations (62)
Central Care Cancer Center
🇺🇸Bolivar, Missouri, United States
Jefferson Medical Oncology
🇺🇸Philadelphia, Pennsylvania, United States
Harbin Clinic
🇺🇸Rome, Georgia, United States
Northwest Alabama Cancer Center
🇺🇸Muscle Shoals, Alabama, United States
Tallahassee Memorial Healthcare
🇺🇸Tallahassee, Florida, United States
UF Health Cancer Center at Orlando Health
🇺🇸Longwood, Florida, United States
Summit Cancer Care
🇺🇸Savannah, Georgia, United States
Genesis Cancer Center
🇺🇸Hot Springs, Arkansas, United States
Sacred Heart Medical Oncology Group
🇺🇸Pensacola, Florida, United States
Orchard Healthcare Research Inc.
🇺🇸Skokie, Illinois, United States
Lancaster General Health
🇺🇸Lancaster, Pennsylvania, United States
Nebraska Hematology-Oncology, P.C.
🇺🇸Lincoln, Nebraska, United States
Lakeland Regional Health
🇺🇸Lakeland, Florida, United States
Mount Sinai Medical Center
🇺🇸Miami Beach, Florida, United States
Aultman Hospital
🇺🇸Canton, Ohio, United States
Forrest General Cancer Center
🇺🇸Hattiesburg, Mississippi, United States
Cancer Specialits, LLC D/B/A
🇺🇸Jacksonville, Florida, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
North Shore University Health System
🇺🇸Evanston, Illinois, United States
Network Office of Research & Innovation / Lehigh Valley Health Network
🇺🇸Allentown, Pennsylvania, United States
Genesis Cancer Care Center
🇺🇸Zanesville, Ohio, United States
Simmons Cancer Institute at SIU School of Medicine
🇺🇸Springfield, Illinois, United States
Thompson Cancer Survival Center
🇺🇸Knoxville, Tennessee, United States
St. Luke's Hospital and Health Network
🇺🇸Bethlehem, Pennsylvania, United States
Saint Agnes Hospital
🇺🇸Baltimore, Maryland, United States
UPCI - UPMC Cancer Center
🇺🇸Pittsburgh, Pennsylvania, United States
Inova Melanoma and Skin Cancer Center
🇺🇸Fairfax, Virginia, United States
Gundersen Lutheran Medical Foundations, Inc.
🇺🇸La Crosse, Wisconsin, United States
Texas Oncology
🇺🇸Paris, Texas, United States
West Virginia University Hematolgoy & Oncology
🇺🇸Martinsburg, West Virginia, United States
Masonic Cancer Center
🇺🇸Minneapolis, Minnesota, United States
Center of Learning Healthcare
🇺🇸Durham, North Carolina, United States
Stormont-Vail Cancer Center
🇺🇸Topeka, Kansas, United States
Hematolgoy and Oncology Associates, Inc.
🇺🇸Canton, Ohio, United States
St. Charles Medical Center - Cancer Center
🇺🇸Bend, Oregon, United States
Allegheny Health Network
🇺🇸Pittsburgh, Pennsylvania, United States
Pacific Shores Medical Group
🇺🇸Long Beach, California, United States
Cancer Care Associates
🇺🇸Redondo Beach, California, United States
21st Century Oncology
🇺🇸Jacksonville, Florida, United States
Mid Florida Hematology and Oncology Centers
🇺🇸Orange City, Florida, United States
Ingalls Cancer Research Center
🇺🇸Harvey, Illinois, United States
Watson Clinical Center for Research, INC
🇺🇸Lakeland, Florida, United States
Oncology Specialits, S.C.
🇺🇸Niles, Illinois, United States
West Ky Hematology & Oncology
🇺🇸Paducah, Kentucky, United States
CHRISTUS Schumpert Cancer Treatment Center
🇺🇸Shreveport, Louisiana, United States
John Theurer Cancer Center at Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Rosewell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Meridian Health
🇺🇸Neptune, New Jersey, United States
Atlantic Health, Morristown Medical Center
🇺🇸Morristown, New Jersey, United States
The Regional Cancer Center
🇺🇸Erie, Pennsylvania, United States
Tri-County Hematology and Oncology Associates, Inc
🇺🇸Massillon, Ohio, United States
Cancer Care Northwest
🇺🇸Spokane, Washington, United States
Providence Regional Medical Center Everett
🇺🇸Everett, Washington, United States
West Virginia University
🇺🇸Morgantown, West Virginia, United States
University of Colorado
🇺🇸Aurora, Colorado, United States
Mayo Clinic Cancer Center (MCCC)
🇺🇸Rochester, Minnesota, United States
H. Lee Moffitt Cancer Center Moffitt Cancer Center
🇺🇸Tampa, Florida, United States
Oncology Hematology West P.C.
🇺🇸Omaha, Nebraska, United States
Huntsman Cancer Institute at the University of Utah
🇺🇸Salt Lake City, Utah, United States
Ochsner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States
The Queen's Medical Center
🇺🇸Honolulu, Hawaii, United States
University of Kansas Medical Center
🇺🇸Westwood, Kansas, United States