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

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.

Study Overview

• Status: Completed
• Conditions: Melanoma

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.

• Study Type: Observational
• Enrollment (Actual): 408

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Muscle Shoals, Alabama, United States, 35661
      • Northwest Alabama Cancer Center
  • Arkansas
    • Hot Springs, Arkansas, United States, 71913
      • Genesis Cancer Center
  • California
    • Long Beach, California, United States, 90813
      • Pacific Shores Medical Group
    • Redondo Beach, California, United States, 90277
      • Cancer Care Associates
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado
  • Florida
    • Jacksonville, Florida, United States, 32204
      • 21st Century Oncology
    • Jacksonville, Florida, United States, 32256
      • Cancer Specialits, LLC D/B/A
    • Lakeland, Florida, United States, 33805
      • Lakeland Regional Health
    • Lakeland, Florida, United States, 33805
      • Watson Clinical Center for Research, INC
    • Longwood, Florida, United States, 32750
      • UF Health Cancer Center at Orlando Health
    • Miami Beach, Florida, United States, 33140
      • Mount Sinai Medical Center
    • Orange City, Florida, United States, 32763
      • Mid Florida Hematology and Oncology Centers
    • Pensacola, Florida, United States, 32504
      • Sacred Heart Medical Oncology Group
    • Tallahassee, Florida, United States, 32308
      • Tallahassee Memorial HealthCare
    • Tampa, Florida, United States, 33612
      • H. Lee Moffitt Cancer Center Moffitt Cancer Center
  • Georgia
    • Rome, Georgia, United States, 30165
      • Harbin Clinic
    • Savannah, Georgia, United States, 31405
      • Summit Cancer Care
  • Hawaii
    • Honolulu, Hawaii, United States, 96813
      • The Queen's Medical Center
  • Illinois
    • Evanston, Illinois, United States, 60201
      • North Shore University Health System
    • Harvey, Illinois, United States, 60426
      • Ingalls Cancer Research Center
    • Niles, Illinois, United States, 60714
      • Oncology Specialits, S.C.
    • Skokie, Illinois, United States, 60077
      • Orchard Healthcare Research Inc.
    • Springfield, Illinois, United States, 62702
      • Simmons Cancer Institute at SIU School of Medicine
  • Kansas
    • Topeka, Kansas, United States, 66606
      • Stormont-Vail Cancer Center
    • Westwood, Kansas, United States, 66205
      • University of Kansas Medical Center
  • Kentucky
    • Paducah, Kentucky, United States, 42003
      • West Ky Hematology & Oncology
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Clinic Foundation
    • Shreveport, Louisiana, United States, 71101
      • Christus Schumpert Cancer Treatment Center
  • Maryland
    • Baltimore, Maryland, United States, 21229
      • Saint Agnes Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Masonic Cancer Center
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic Cancer Center (MCCC)
  • Mississippi
    • Hattiesburg, Mississippi, United States, 39119
      • Forrest General Cancer Center
  • Missouri
    • Bolivar, Missouri, United States, 65613
      • Central Care Cancer Center
  • Nebraska
    • Lincoln, Nebraska, United States, 68506
      • Nebraska Hematology-Oncology, P.C.
    • Omaha, Nebraska, United States, 68130
      • Oncology Hematology West P.C.
  • New Jersey
    • Hackensack, New Jersey, United States, 76520
      • John Theurer Cancer Center at Hackensack University Medical Center
    • Morristown, New Jersey, United States, 07960
      • Atlantic Health, Morristown Medical Center
    • Neptune, New Jersey, United States, 07753
      • Meridian Health
  • New York
    • Buffalo, New York, United States, 14263
      • Rosewell Park Cancer Institute
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Center of Learning Healthcare
  • Ohio
    • Canton, Ohio, United States, 44710
      • Aultman Hospital
    • Canton, Ohio, United States, 44708
      • Hematolgoy and Oncology Associates, Inc.
    • Massillon, Ohio, United States, 44646
      • Tri-County Hematology and Oncology Associates, Inc
    • Zanesville, Ohio, United States, 43701
      • Genesis Cancer Care Center
  • Oregon
    • Bend, Oregon, United States, 97701
      • St. Charles Medical Center - Cancer Center
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • Network Office of Research & Innovation / Lehigh Valley Health Network
    • Bethlehem, Pennsylvania, United States, 18015
      • St. Luke's Hospital and Health Network
    • Erie, Pennsylvania, United States, 15505
      • The Regional Cancer Center
    • Lancaster, Pennsylvania, United States, 17604
      • Lancaster General Health
    • Philadelphia, Pennsylvania, United States, 19107
      • Jefferson Medical Oncology
    • Pittsburgh, Pennsylvania, United States, 15224
      • Allegheny Health Network
    • Pittsburgh, Pennsylvania, United States, 15232
      • UPCI - UPMC Cancer Center
  • Tennessee
    • Knoxville, Tennessee, United States, 37916
      • Thompson Cancer Survival Center
  • Texas
    • Austin, Texas, United States, 78731
      • Texas Oncology
    • El Paso, Texas, United States, 79902
      • Texas Oncology
    • Paris, Texas, United States, 75460
      • Texas Oncology
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Huntsman Cancer Institute at the University of Utah
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Inova Melanoma and Skin Cancer Center
  • Washington
    • Everett, Washington, United States, 98201
      • Providence Regional Medical Center Everett
    • Spokane, Washington, United States, 99216
      • Cancer Care Northwest
  • West Virginia
    • Bridgeport, West Virginia, United States, 26330
      • West Virginia University
    • Huntington, West Virginia, United States, 25702
      • West Virginia University
    • Martinsburg, West Virginia, United States, 25401
      • West Virginia University Hematolgoy & Oncology
    • Morgantown, West Virginia, United States, 26506
      • West Virginia University
  • Wisconsin
    • La Crosse, Wisconsin, United States, 54601
      • Gundersen Lutheran Medical Foundations, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with histologically-confirmed unresectable stage III or stage IV melanoma, (including mucosal, uveal, acral-lentiginous, leptomeningeal disease). Patients can be treatment-naïve or previously treated for unresectable or metastatic melanoma.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

8

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2015
• Primary Completion (Actual): September 8, 2020
• Study Completion (Actual): September 8, 2020

Study Registration Dates

• First Submitted: April 25, 2016
• First Submitted That Met QC Criteria: May 19, 2016
• First Posted (Estimate): May 23, 2016

Study Record Updates

• Last Update Posted (Actual): May 23, 2022
• Last Update Submitted That Met QC Criteria: May 17, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Metastatic; Unresectable
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma
• Other Study ID Numbers: CA209-357

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided