Metastatic eye melanoma Cancer Eye melanoma
Conditions
Interventions
This is a single arm phase II study. Stored tissue of primary ocular tumour and/or metastatic biopsies will be collected at baseline to determine eligibility and will be available for associated trans
Sponsors
Clatterbridge Centre for Oncology NHS Foundation Trust (UK)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with histologically or cytologically confirmed unresectable, metastatic uveal melanoma (c-kit positive on immunohistochemistry [IHC]) 2. Any prior therapy for advanced disease excluding agents targeting c-kit 3. Life expectancy greater than 12 weeks 4. World Health Organization (WHO) performance status 0, 1 or 2 5. Presence of one or more measurable lesions 6. Age greater than 18 years, either sex 7. Adequate haematological, renal and liver function 8. Written informed consent provided by the patient
Exclusion criteria
Exclusion criteria: 1. C-kit negative uveal melanoma 2. Any previous investigational agent within the last 12 weeks 3. Known leptomeningeal or brain metastases 4. Any other serious or uncontrolled illness which, in the opinion of the investigator, makes it undesirable for the patient to enter the trial 5. Any medical or psychiatric condition which would influence the ability to provide informed consent 6. Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival at 3 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Objective response rate, according to Response Evaluation Criteria In Solid Tumours (RECIST) criteria, assessed every 8 weeks 2. Overall survival (OS) assessed at date of first treatment to date of death and safety and toxicity, assessed every 28 days 3. Biomarker correlation with outcome measures 4. PET response (European Organisation for Research and Treatment of Cancer [EORTC] guidelines, Young, 1999) | — |
Countries
England, United Kingdom
Outcome results
None listed