Continuous vs Intermittent Dabrafenib Plus Trametinib in BRAFV600 Mutant Stage 3 Unresectable or Metastatic Melanoma

• Status: Completed
• Trial end date: 2020-11-27
• Target enrollment: 0
• Participant gender: All

Summary

This feasibility study aims to determine if intermittent dosing is deliverable, based on patient and professional willingness to take part in a randomised trial evaluating less rather than the standard durations of treatment. The trial will evaluate treatment compliance, Progression Free Survival and Quality of Life, to inform whether a subsequent definitive trial is justified and how it should be designed.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust
• Collaborators: National Institute for Health Research, United Kingdom; Oxford University Hospitals NHS Trust; University of Oxford
• Treatments: Dabrafenib; Trametinib

Criteria

Inclusion Criteria:

• Signed informed consent

• Age ≥18 years old

• Histologically or cytologically confirmed BRAFV600 mutant stage 3 unresectable or metastatic melanoma

• Measurable disease by RECIST

• ECOG performance status 0-2

• Minimum life expectancy 12 weeks

• Adequate bone marrow, renal and liver function

• Received no prior BRAF or MEK inhibitor therapy for metastatic disease

• Willing and able to comply with the scheduled visits, treatment plans, laboratory tests, completion of QoL questionnaires and other study procedures

• Archival tumour tissue sample available

• Women of child-bearing potential and all sexually active male patients must agree to use effective contraception methods throughout treatment

Exclusion Criteria:

• Concomitant immunotherapy being administered to treat advanced melanoma

• Other invasive malignancies diagnosed within the last year which are not in complete remission, or for which additional therapy is required

• 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

• Women who are pregnant, plan to become pregnant or are lactating during the trial period

• Other investigational anti-cancer drugs

• Use of strong inducers and inhibitors of CYP3A or CYP2C8