Study in Patients With Unresectable And Metastatic Melanoma: The Optimize Study
A US Multi-Site Observational Study in Patients With Unresectable And Metastatic Melanoma: The OPTIMIzE Study
1 other identifier
observational
408
1 country
66
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2015
Longer than P75 for all trials
66 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 23, 2015
CompletedFirst Submitted
Initial submission to the registry
April 25, 2016
CompletedFirst Posted
Study publicly available on registry
May 23, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 8, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 8, 2020
CompletedMay 23, 2022
May 1, 2022
4.9 years
April 25, 2016
May 17, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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
Demographics
Baseline characteristics (age, gender, race/ethnicity)
Up to 5 years
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
Disease Characteristics
Disease characteristics (date of diagnosis, disease stage, performance status)
Up to 5 years
Secondary Outcomes (5)
Healthcare Resource
up to 5 years
Functional Assessments of Cancer Therapy-Melanoma (FACT-M)
Up to 12 months
European Quality of Life-5 Dimensions (EQ-5D)
Up to 12 months
Work Productivity and Activity Impairment: General Health (WPAI:GH)
Up to 12 months
The Caregiver Quality of Life Index - Cancer (CQOLC)
Up to 12 months
Study Arms (8)
Prospective Patients
There will be 1,600 prospective patients recruited over a period of two years and followed-up for a planned minimum of three years. For the prospective cohort, patients will be recruited after the course of treatment has been decided by the physician and prior to the start of treatment.Prior advanced melanoma treatment information will be collected from patient charts for pre-treated patients. Patients will be followed for a minimum of 3 years from their study index date until death, withdrawal of consent, lost to follow-up/record, or end of study, whichever comes first. Study index date will be the date when first study therapy is initiated.
Treatment Group No. 1
Immune checkpoint inhibitor patients who remain on an immune checkpoint inhibitor therapy. Defined as immune checkpoint inhibitor therapy patients who either remained on their initial (index) immune checkpoint inhibitor therapy or switched to another immune checkpoint inhibitor therapy during the study period. Patients in this group remained on an immune checkpoint inhibitor therapy and did not switch to a non-immune checkpoint inhibitor therapy anytime during the study period.
Treatment Group No. 2
Immune checkpoint inhibitor patients who switched to a non-immune checkpoint inhibitor therapy. Defined as patients who switched from their index immune checkpoint inhibitor therapy to a non-immune checkpoint inhibitor therapy anytime during the study period.
Treatment Group No. 3
Targeted therapy patients who remain on a targeted therapy. Defined as targeted therapy patients who either remained on their initial (index) targeted therapy or switched to another targeted therapy during the study period. Patients in this group remained on a targeted therapy and did not switch to a non-targeted therapy anytime during the study period.
Treatment Group No. 4
Targeted therapy patients who switched to a non-targeted therapy. Defined as patients who switched from their index targeted therapy to a non-targeted therapy anytime during the study period.
Treatment Group No. 5
Chemotherapy/other therapy patients who remain on a chemotherapy/other therapy. Defined as chemotherapy/other therapy patients who either remained on their initial (index) chemotherapy/other therapy or switched to another chemotherapy/other therapy during the study period. Patients in this group remained on a chemotherapy/other therapy and did not switch to an immune checkpoint inhibitor therapy or targeted therapy anytime during the study period.
Treatment Group No. 6
Chemotherapy/other patients who switched to an immune checkpoint inhibitor therapy or targeted therapy. Defined as patients who switched from their index chemotherapy/other therapy to an immune checkpoint inhibitor therapy or targeted therapy anytime during the study period.
Retrospective Patients
Retrospective cohort of 600 patients with unresectable or metastatic melanoma, receiving therapies other than immune checkpoint inhibitor or targeted therapies during the four year period prior to the release of ipilimumab (March 25, 2007 -March 24, 2011), will be identified. The data for these 600 retrospective patients will be used as a benchmark for treatment patterns and outcomes prior to the marketed availability of immune checkpoint inhibitors or targeted therapies.
Eligibility Criteria
Patients diagnosed with histologically-confirmed unresectable stage III or stage IV melanoma, (including mucosal, uveal, acral-lentiginous, leptomeningeal disease). Patients can be treatment-naĂ¯ve or previously treated for unresectable or metastatic melanoma.
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (66)
Northwest Alabama Cancer Center
Muscle Shoals, Alabama, 35661, United States
Genesis Cancer Center
Hot Springs, Arkansas, 71913, United States
Pacific Shores Medical Group
Long Beach, California, 90813, United States
Cancer Care Associates
Redondo Beach, California, 90277, United States
University of Colorado
Aurora, Colorado, 80045, United States
21st Century Oncology
Jacksonville, Florida, 32204, United States
Cancer Specialits, LLC D/B/A
Jacksonville, Florida, 32256, United States
Lakeland Regional Health
Lakeland, Florida, 33805, United States
Watson Clinical Center for Research, INC
Lakeland, Florida, 33805, United States
UF Health Cancer Center at Orlando Health
Longwood, Florida, 32750, United States
Mount Sinai Medical Center
Miami Beach, Florida, 33140, United States
Mid Florida Hematology and Oncology Centers
Orange City, Florida, 32763, United States
Sacred Heart Medical Oncology Group
Pensacola, Florida, 32504, United States
Tallahassee Memorial Healthcare
Tallahassee, Florida, 32308, United States
H. Lee Moffitt Cancer Center Moffitt Cancer Center
Tampa, Florida, 33612, United States
Harbin Clinic
Rome, Georgia, 30165, United States
Summit Cancer Care
Savannah, Georgia, 31405, United States
The Queen's Medical Center
Honolulu, Hawaii, 96813, United States
North Shore University Health System
Evanston, Illinois, 60201, United States
Ingalls Cancer Research Center
Harvey, Illinois, 60426, United States
Oncology Specialits, S.C.
Niles, Illinois, 60714, United States
Orchard Healthcare Research Inc.
Skokie, Illinois, 60077, United States
Simmons Cancer Institute at SIU School of Medicine
Springfield, Illinois, 62702, United States
Stormont-Vail Cancer Center
Topeka, Kansas, 66606, United States
University of Kansas Medical Center
Westwood, Kansas, 66205, United States
West Ky Hematology & Oncology
Paducah, Kentucky, 42003, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
CHRISTUS Schumpert Cancer Treatment Center
Shreveport, Louisiana, 71101, United States
Saint Agnes Hospital
Baltimore, Maryland, 21229, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Masonic Cancer Center
Minneapolis, Minnesota, 55455, United States
Mayo Clinic Cancer Center (MCCC)
Rochester, Minnesota, 55905, United States
Forrest General Cancer Center
Hattiesburg, Mississippi, 39119, United States
Central Care Cancer Center
Bolivar, Missouri, 65613, United States
Nebraska Hematology-Oncology, P.C.
Lincoln, Nebraska, 68506, United States
Oncology Hematology West P.C.
Omaha, Nebraska, 68130, United States
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 76520, United States
Atlantic Health, Morristown Medical Center
Morristown, New Jersey, 07960, United States
Meridian Health
Neptune City, New Jersey, 07753, United States
Rosewell Park Cancer Institute
Buffalo, New York, 14263, United States
Center of Learning Healthcare
Durham, North Carolina, 27705, United States
Hematolgoy and Oncology Associates, Inc.
Canton, Ohio, 44708, United States
Aultman Hospital
Canton, Ohio, 44710, United States
Tri-County Hematology and Oncology Associates, Inc
Massillon, Ohio, 44646, United States
Genesis Cancer Care Center
Zanesville, Ohio, 43701, United States
St. Charles Medical Center - Cancer Center
Bend, Oregon, 97701, United States
Network Office of Research & Innovation / Lehigh Valley Health Network
Allentown, Pennsylvania, 18103, United States
St. Luke's Hospital and Health Network
Bethlehem, Pennsylvania, 18015, United States
The Regional Cancer Center
Erie, Pennsylvania, 15505, United States
Lancaster General Health
Lancaster, Pennsylvania, 17604, United States
Jefferson Medical Oncology
Philadelphia, Pennsylvania, 19107, United States
Allegheny Health Network
Pittsburgh, Pennsylvania, 15224, United States
UPCI - UPMC Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
Thompson Cancer Survival Center
Knoxville, Tennessee, 37916, United States
Texas Oncology
Austin, Texas, 78731, United States
Texas Oncology
El Paso, Texas, 79902, United States
Texas Oncology
Paris, Texas, 75460, United States
Huntsman Cancer Institute at the University of Utah
Salt Lake City, Utah, 84112, United States
Inova Melanoma and Skin Cancer Center
Fairfax, Virginia, 22031, United States
Providence Regional Medical Center Everett
Everett, Washington, 98201, United States
Cancer Care Northwest
Spokane, Washington, 99216, United States
West Virginia University
Bridgeport, West Virginia, 26330, United States
West Virginia University
Huntington, West Virginia, 25702, United States
West Virginia University Hematolgoy & Oncology
Martinsburg, West Virginia, 25401, United States
West Virginia University
Morgantown, West Virginia, 26506, United States
Gundersen Lutheran Medical Foundations, Inc.
La Crosse, Wisconsin, 54601, United States
Related Publications (1)
Kirkwood JM, Kottschade LA, McWilliams RR, Khushalani NI, Jang S, Hallmeyer S, McDermott DF, Tawbi H, Che M, Lee CH, Ritchings C, Le TK, Park B, Ramsey S. Real-world outcomes with immuno-oncology therapies in advanced melanoma: final results of the OPTIMIzE registry study. Immunotherapy. 2024 Jan;16(1):29-42. doi: 10.2217/imt-2022-0292. Epub 2023 Nov 8.
PMID: 37937397DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 25, 2016
First Posted
May 23, 2016
Study Start
October 23, 2015
Primary Completion
September 8, 2020
Study Completion
September 8, 2020
Last Updated
May 23, 2022
Record last verified: 2022-05