Clinical trial · Interventional
Continuous vs Intermittent Dabrafenib Plus Trametinib in BRAFV600 Mutant Stage 3 Unresectable or Metastatic Melanoma
INTERIM: a Randomised Phase II Feasibility Study of INTERmittent Versus Continuous Dosing or Oral Targeted Combination Therapy in Patients With BRAFV600 Mutant Stage 3 Unresectable or Metastatic Melanoma
- 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 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.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dabrafenib | Drug | Dabrafenib | ALIAS |
| Trametinib | Drug | Trametinib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Continuous (Standard)
- description
- Dabrafenib 150mg twice daily 12 hours apart, on days 1-28 of a 28 day cycle plus Trametinib 2mg once daily, on days 1-28 of a 28 day cycle
- interventionNames
- Drug: Dabrafenib
- Drug: Trametinib
- type
- EXPERIMENTAL
- label
- Intermittent (experimental)
- description
- Dabrafenib 150mg twice daily 12 hours apart, on days 1-21 of a 28 day cycle plus Trametinib 2mg once daily, on days 1-14 of a 28 day cycle
- interventionNames
- Drug: Dabrafenib
- Drug: Trametinib
Primary outcomes (4)
- measure
- Recruitment Rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available