Status:
COMPLETED
Continuous vs Intermittent Dabrafenib Plus Trametinib in BRAFV600 Mutant Stage 3 Unresectable or Metastatic Melanoma
Lead Sponsor:
Cambridge University Hospitals NHS Foundation Trust
Collaborating Sponsors:
National Institute for Health Research, United Kingdom
Oxford University Hospitals NHS Trust
Conditions:
Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 standar...
Detailed Description
Metastatic melanoma has a very poor prognosis: median overall survival is 8 months untreated and around 2 years even with optimal systemic therapies. A gene called BRAF is abnormal in about half of me...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 3 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 27 2020
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT03352947
Start Date
November 3 2017
End Date
November 27 2020
Last Update
December 8 2020
Active Locations (1)
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1
Addenbrooke's Hospital
Cambridge, England, United Kingdom, CB2 2QQ