Clinical Trial 18922

Cancer Type: Cutaneous
Interventions:Not Applicable

Study Type: Other
Phase of Study: Phase IV
Investigators:


    Overview

    Study Title

    A US Multisite Observational Study in Patients with Unresectable and Metastatic Melanoma: the OPTIMIzE Study

    Summary

    The purpose of this study is to collect information about post-approval or "real world" experience on the treatment and management of unresectable or metastatic melanoma. This observational study will follow the regulator medical care of patients who have unresectable or metastatic melanoma and related conditions, the treatments given for this disease, and document the burden of disease on those who provide care to those patients.

    Objective

    Primary Objectives: 1) To describe patterns of care for patients receiving therapy for unresectable or metastatic melanoma (dosing, duration, regimen, indication, treatment rationales, switching rate, and reasons for treatment discontinuation). 2) To describe the patient demographic and clinical characteristics of patients receiving therapy for unresectable or metastatic melanoma. 3) To estimate overall survival (OS) in patients receiving therapy for unresectable or metastatic melanoma. Secondary Objectives: 1) To describe real-world use of healthcare resources in the treatment of unresectable or metastatic melanoma (ie, identify resource utilization across the treatment strategies). 2) To measure patient-reported outcomes using the European Quality of Life-5 Dimensions (EQ-5D), Functional Assessment of Cancer Therapy -Melanoma (FACT-M), and work productivity specific questions. 3) To characterize caregiver burden, described as number of hours spent by caregivers providing informal medical care and other services related to the patient's illness, and impact on caregiver quality of life. Exploratory Objectives: 1) Describe the occurrence and severity of treatment-related adverse events (AEs) and serious adverse events (SAEs) to characterize changes in treatment patterns, as well as their treatment/management and outcomes, in a real world setting. 2) Assess the influence of patient demographic and clinical characteristics on the incidence and severity of treatment-related AEs.

    Inclusion Criteria

  • Prospective cohort patients: (1) Diagnosis date must occur on or after March 24, 2011 (date of ipilimumab approval in US). (2) Diagnosis of stage III (unresectable) or stage IV melanoma (includes mucosal, uveal acral-lentiginous, leptomeningeal disease). (3) Age ≥ 18 years at time of entry into study. (4) Patients must be actively receiving or scheduled to receive systemic treatment (any line, e.g., 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: (1) Patients with diagnosis of confirmed unresectable stage III or stage IV melanoma (including mucosal, uveal, acral-lentiginous, leptomeningeal disease). (2) Age ≥ 18 years at time of unresectable or metastatic melanoma diagnosis. (3) 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. (4) One year of follow-up data is required from date of therapy initiation.

  • Exclusion Criteria

  • Prospective patients: (1) 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. (2) Patients who started new treatment > 21 days. (3) Patients who enrolled in study but did not initiate treatment before 28 days. (4) 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.