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Vemurafenib Plus Cobimetinib in Metastatic Melanoma

TerminatedPhase 2

Sponsor: Netherlands Working Group on Immunotherapy of Oncology

Conditions: Metastatic Melanoma

Interventions: Vemurafenib plus cobimetinib, Positron Emission Tomography, Tissue sampling, Blood sampling

Countries: Netherlands

This is a single arm explorative phase II clinical trial in 90 subjects with advanced stage melanoma harbouring a BRAFV600 mutation. PET imaging and molecular diagnostics are combined in order to monitor response to treatment with vemurafenib plus cobimetinib, examine development of resistance and correlate changes in metabolic/proliferative activity with extend of target inhibition.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Patients with histologically confirmed melanoma, either unresectable stage IIIc or stage IV metastatic melanoma, as defined by AJCC 7th edition.
* Patients must be naïve to treatment for locally advanced unresectable or metastatic disease. Prior immunotherapy (including ipilimumab) is allowed.
* Documentation of BRAFV600E or BRAFV600K mutation-positive status in melanoma tumor tissue (archival or newly obtained tumor samples).
* Measurable disease per RECIST v1.1, which are accessible to biopsies.
* Biopsy lesion is within scan reach of diagnostic CT and PET-CT (thorax- abdomen-pelvis)
* ECOG performance status of 0 or 1.
* Male or female patient aged ≥ 18 years.
* Life expectancy ≥ 12 weeks.
* Adequate hematologic and end organ function within 14 days prior to first dose of study drug treatment.

Exclusion Criteria:

* History of prior RAF or MEK pathway inhibitor treatment.
* Palliative radiotherapy, major surgery or traumatic injury within 14 days prior to the first dose of study treatment.
* Active malignancy within the past 3 years other than melanoma that could potentially interfere with the interpretation of efficacy measures, except for patients with resected BCC or SCC of the skin, melanoma in-situ, carcinoma in-situ of the cervix, and carcinoma in-situ of the breast.
* History of or evidence of retinal pathology, clinically significant cardiac dysfunction, patients with active CNS lesions, renal or liver dysfunction as described in main protocol (REPOSIT NL48639.031.14).
* Pregnant, lactating, or breast-feeding.
* Unwillingness or inability to comply with study and follow-up procedures (i.e. severe anxiety disorder preventing PET/CT imaging.

Locations (10)

Amsterdam, Netherlands
Amsterdam, Netherlands
Enschede, Netherlands
Groningen, Netherlands
Leiden, Netherlands
Maastricht, Netherlands
Nijmegen, Netherlands
Rotterdam, Netherlands
Utrecht, Netherlands
Zwolle, Netherlands