Clinical trial · Observational
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
NCT02780089CI-TRIAL-00058667completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (8)
- label
- Prospective Patients
- description
- 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.
- label
- Treatment Group No. 1
- description
- 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.
- label
- Treatment Group No. 2
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDKirkwood 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 37937397