A Multicenter Study of Vemurafenib plus Cobimetinib (GDC-0973) in Unresectable Stage IIIc or Metastatic Melanoma; Response Monitoring and Resistance Prediction with Positron Emission Tomography and Tumor Characteristics.

Conditions: BRAFV600-mutation positive patients with unresectable stage IIIc or IV melanoma.
MedDRA version: 17.0Level: PTClassification code 10025671Term: Malignant melanoma stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 17.0Level: PTClassification code 10025670Term: Malignant melanoma stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2014-002480-15-NL

Lead Sponsor: The Dutch Working Group on Immunotherapy of Oncology (WIN-O)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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 adjuvant immunotherapy (including ipilimumab) is allowed.
•Documentation of BRAFV600 mutation-positive status in melanoma tumor tissue (archival or newly obtained tumor samples).
•Measurable disease per RECIST v1.1 (50), 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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

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.
•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.