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

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT02780089
Collaborator
(none)
408
Enrollment
66
Locations
58.5
Actual Duration (Months)
6.2
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    408 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    Official Title:
    A US Multi-Site Observational Study in Patients With Unresectable And Metastatic Melanoma: The OPTIMIzE Study
    Actual Study Start Date :
    Oct 23, 2015
    Actual Primary Completion Date :
    Sep 8, 2020
    Actual Study Completion Date :
    Sep 8, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. 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).

    2. Demographics [Up to 5 years]

      Baseline characteristics (age, gender, race/ethnicity)

    3. 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.

    4. Disease Characteristics [Up to 5 years]

      Disease characteristics (date of diagnosis, disease stage, performance status)

    Secondary Outcome Measures

    1. 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.

    2. Functional Assessments of Cancer Therapy-Melanoma (FACT-M) [Up to 12 months]

    3. European Quality of Life-5 Dimensions (EQ-5D) [Up to 12 months]

    4. Work Productivity and Activity Impairment: General Health (WPAI:GH) [Up to 12 months]

    5. The Caregiver Quality of Life Index - Cancer (CQOLC) [Up to 12 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Northwest Alabama Cancer Center Muscle Shoals Alabama United States 35661
    2 Genesis Cancer Center Hot Springs Arkansas United States 71913
    3 Pacific Shores Medical Group Long Beach California United States 90813
    4 Cancer Care Associates Redondo Beach California United States 90277
    5 University of Colorado Aurora Colorado United States 80045
    6 21st Century Oncology Jacksonville Florida United States 32204
    7 Cancer Specialits, LLC D/B/A Jacksonville Florida United States 32256
    8 Lakeland Regional Health Lakeland Florida United States 33805
    9 Watson Clinical Center for Research, INC Lakeland Florida United States 33805
    10 UF Health Cancer Center at Orlando Health Longwood Florida United States 32750
    11 Mount Sinai Medical Center Miami Beach Florida United States 33140
    12 Mid Florida Hematology and Oncology Centers Orange City Florida United States 32763
    13 Sacred Heart Medical Oncology Group Pensacola Florida United States 32504
    14 Tallahassee Memorial Healthcare Tallahassee Florida United States 32308
    15 H. Lee Moffitt Cancer Center Moffitt Cancer Center Tampa Florida United States 33612
    16 Harbin Clinic Rome Georgia United States 30165
    17 Summit Cancer Care Savannah Georgia United States 31405
    18 The Queen's Medical Center Honolulu Hawaii United States 96813
    19 North Shore University Health System Evanston Illinois United States 60201
    20 Ingalls Cancer Research Center Harvey Illinois United States 60426
    21 Oncology Specialits, S.C. Niles Illinois United States 60714
    22 Orchard Healthcare Research Inc. Skokie Illinois United States 60077
    23 Simmons Cancer Institute at SIU School of Medicine Springfield Illinois United States 62702
    24 Stormont-Vail Cancer Center Topeka Kansas United States 66606
    25 University of Kansas Medical Center Westwood Kansas United States 66205
    26 West Ky Hematology & Oncology Paducah Kentucky United States 42003
    27 Ochsner Clinic Foundation New Orleans Louisiana United States 70121
    28 CHRISTUS Schumpert Cancer Treatment Center Shreveport Louisiana United States 71101
    29 Saint Agnes Hospital Baltimore Maryland United States 21229
    30 Beth Israel Deaconess Medical Center Boston Massachusetts United States 02215
    31 Masonic Cancer Center Minneapolis Minnesota United States 55455
    32 Mayo Clinic Cancer Center (MCCC) Rochester Minnesota United States 55905
    33 Forrest General Cancer Center Hattiesburg Mississippi United States 39119
    34 Central Care Cancer Center Bolivar Missouri United States 65613
    35 Nebraska Hematology-Oncology, P.C. Lincoln Nebraska United States 68506
    36 Oncology Hematology West P.C. Omaha Nebraska United States 68130
    37 John Theurer Cancer Center at Hackensack University Medical Center Hackensack New Jersey United States 76520
    38 Atlantic Health, Morristown Medical Center Morristown New Jersey United States 07960
    39 Meridian Health Neptune New Jersey United States 07753
    40 Rosewell Park Cancer Institute Buffalo New York United States 14263
    41 Center of Learning Healthcare Durham North Carolina United States 27705
    42 Hematolgoy and Oncology Associates, Inc. Canton Ohio United States 44708
    43 Aultman Hospital Canton Ohio United States 44710
    44 Tri-County Hematology and Oncology Associates, Inc Massillon Ohio United States 44646
    45 Genesis Cancer Care Center Zanesville Ohio United States 43701
    46 St. Charles Medical Center - Cancer Center Bend Oregon United States 97701
    47 Network Office of Research & Innovation / Lehigh Valley Health Network Allentown Pennsylvania United States 18103
    48 St. Luke's Hospital and Health Network Bethlehem Pennsylvania United States 18015
    49 The Regional Cancer Center Erie Pennsylvania United States 15505
    50 Lancaster General Health Lancaster Pennsylvania United States 17604
    51 Jefferson Medical Oncology Philadelphia Pennsylvania United States 19107
    52 Allegheny Health Network Pittsburgh Pennsylvania United States 15224
    53 UPCI - UPMC Cancer Center Pittsburgh Pennsylvania United States 15232
    54 Thompson Cancer Survival Center Knoxville Tennessee United States 37916
    55 Texas Oncology Austin Texas United States 78731
    56 Texas Oncology El Paso Texas United States 79902
    57 Texas Oncology Paris Texas United States 75460
    58 Huntsman Cancer Institute at the University of Utah Salt Lake City Utah United States 84112
    59 Inova Melanoma and Skin Cancer Center Fairfax Virginia United States 22031
    60 Providence Regional Medical Center Everett Everett Washington United States 98201
    61 Cancer Care Northwest Spokane Washington United States 99216
    62 West Virginia University Bridgeport West Virginia United States 26330
    63 West Virginia University Huntington West Virginia United States 25702
    64 West Virginia University Hematolgoy & Oncology Martinsburg West Virginia United States 25401
    65 West Virginia University Morgantown West Virginia United States 26506
    66 Gundersen Lutheran Medical Foundations, Inc. La Crosse Wisconsin United States 54601

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT02780089
    Other Study ID Numbers:
    • CA209-357
    First Posted:
    May 23, 2016
    Last Update Posted:
    May 23, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by Bristol-Myers Squibb
    Metastatic
    Unresectable
    Additional relevant MeSH terms:
    Melanoma

    Study Results

    No Results Posted as of May 23, 2022