Melanoma Cancer Melanoma
Conditions
Interventions
All participants receive standard Dabrafenib+Trametinib, either taken continuously every day (continuous arm), or with planned treatment breaks in each 28 day cycle (intermittent arm).
Eligible pat
Sponsors
Cambridge University Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed informed consent 2. Age =18 years old 3. Histologically or cytologically confirmed BRAFV600 mutant stage 3 unresectable or metastatic melanoma 4. Measurable disease by RECIST 5. ECOG performance status 0-2 6. Minimum life expectancy 12 weeks 7. Adequate bone marrow, renal and liver function 8. Received no prior BRAF or MEK inhibitor therapy for metastatic disease 9. Willing and able to comply with the scheduled visits, treatment plans, laboratory tests, completion of QoL questionnaires and other study procedures 10. Archival tumour tissue sample available 11. Women of child-bearing potential and all sexually active male patients must agree to use effective contraception methods throughout treatment
Exclusion criteria
Exclusion criteria: 1. Concomitant immunotherapy being administered to treat advanced melanoma 2. Other invasive malignancies diagnosed within the last year which are not in complete remission, or for which additional therapy is required 3. Significant acute or chronic medical or psychiatric condition, disease or laboratory abnormality which in the judgment of the investigator would place the patient at undue risk or interfere with the trial 4. Women who are pregnant, plan to become pregnant or are lactating during the trial period 5. Other investigational anti-cancer drugs 6. Use of strong inducers and inhibitors of CYP3A or CYP2C8
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Recruitment rate will be measured as the average number of patients recruited per site per two months. To be assessed once the trial has been recruiting for 15 months, or when 15 sites have been open for 6 months whichever is sooner 2. Treatment compliance is the percentage of patients completing the allocated treatment at 6 months from randomisation 3. Overall Quality of Life, defined as the global health status score derived from European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire at 6 months from randomisation 4. Progression Free Survival (assessed according to standard Response Criteria In Solid Tumours (RECIST v1.1), calculated as the duration from the date of randomisation to the date of first progression or death from any cause, which ever occurs first | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Safety is assessed using the standard cancer National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) V4.03 criteria thoughout the trial 2. Objective Response Rate will be assessed according to RECIST v1.1 T3. ime to treatment failure will be the time from starting drug treatment on day 1 of cycle 1 until the date of day 1 of the last cycle +28 days 3. Overall survival will be calculated as the duration from the date of randomisation to the date of death from any cause 4. Patient Reported outcomes focussing on skin toxicity evaluation will be assessed using skin-specific patient reported oucome measures throughout the trial 5. Patient experience will be assessed by a survey of patients in each arm of the trial, 9 months from randomisation. Also, semi-structured interviews in a subset of patients who have volunteered at a later time point 6. Quality of Life and Health Economics Evaluation using the EORTC QLQ-C30 and EQ5D questionnaires throughout the trial | — |
Countries
England, Scotland, United Kingdom
Contacts
Public ContactClaire Mather
Outcome results
None listed