Melanoma
Conditions
Keywords
Metastatic, Unresectable
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.
Interventions
None listed
Sponsors
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| The Caregiver Quality of Life Index - Cancer (CQOLC) | Up to 12 months | — |
| 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 | — |
Countries
United States
Outcome results
None listed