Clinical trial · Interventional
Trial of Vemurafenib and Cobimetinib in Patients With Advanced BRAFV600 Mutant Melanoma
An Exploratory Study of the Immunological Effects of Vemurafenib and Cobimetinib, Administered Alone and in Combination, in Subjects With Advanced BRAF V600E/K Mutant Melanoma
NCT02427893CI-TRIAL-00024788withdrawnPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): no patients were enrolled
Summary
Brief summary (as posted)
This trial explores the immunologic effects of vemurafenib (BRAF inhibitor) and cobimetinib (MEK inhibitor), administered alone and in combination, to patients with advanced BRAF V600E/K mutant melanoma.
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 |
|---|---|---|---|
| Cobimetinib | Drug | Cobimetinib | ALIAS |
| Vemurafenib | Drug | Vemurafenib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Cohort 1
- description
- Ten patients begin Vemurafenib monotherapy, after 10 days, begin combination therapy by adding Cobimetinib.
- interventionNames
- Drug: Cobimetinib
- Drug: Vemurafenib
- type
- ACTIVE_COMPARATOR
- label
- Cohort 2
- description
- Ten patients begin Cobimetinib monotherapy, after 10 days, begin combination therapy by adding Vemurafenib.
- interventionNames
- Drug: Cobimetinib
- Drug: Vemurafenib
Primary outcomes (1)
- measure
- Safety and tolerability of cobimetinib monotherapy and combination vemurafenib/cobimetinib in subjects with advanced melanoma.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Signed informed consent * Signed HIV testing consent * Life expectancy ≥ 12 weeks * Able to swallow pills * ECOG performance status 2 or less * Adequate bone marrow function * Adequate renal function * Adequate liver function * Negative urine pregnancy test within 7 days prior to commencement of dosing in premenopausal women * Histological diagnosis of unresectable AJCC stage III or stage IV, BRAFV600E/K mutant melanoma * Measurable disease * Accessible tumor that can be biopsied * Naive to targeted therapy (Prior immune-based therapy in the adjuvant setting or for advanced disease will be allowed if \>2 weeks from study entry) Exclusion Criteria: * Active systemic infection * Active autoimmune disease or history of known or suspected autoimmune disease * Active brain metastases or leptomeningeal metastases * Treatment with any immunomodulatory medication within 4 weeks of initiation of study therapy. * Positive test for hepatitis B virus * Positive test for hepatitis C virus * Positive test for human immunodeficiency virus (HIV) * Pregnant, lactating or breast feeding women * Localized radiation therapy within the last 14 days * History of malabsorption * No consumption of the following within 7 days prior to start of treatment: * St. John's wort or hyperforin (potent cytochrome P450 CYP3A4 enzyme inducer) * Grapefruit juice (potent cytochrome P450 CYP3A4 enzyme inhibitor * History or evidence of cardiovascular risk * History or evidence of retinal pathology
References
Publications (0)
Data not yet available
No reference posted for this study.