Circulating Melanoma Cells in Metastatic Patients Treated With Selective BRAF Inhibitors (CMCBRAF)

Istituto Oncologico Veneto IRCCS

Status: Unknown

Conditions: Metastatic Melanoma

Treatments: Drug: Anti-B-RAF

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01878396

IOV2011/35

CE IOV 2011/35 (Other Identifier)

Details and patient eligibility

About

The purpose of this study, is to evaluate Circulating Melanoma Cell (CMC) changes in Metastatic Melanoma (MM) patients, undergoing treatment with selective inhibitors of mutated BRAF.

Full description

This is an observational prospective pilot study aimed to investigate the association between changes of total and apoptotic CMC count and disease progression in MM patients undergoing treatment with selective inhibitors of mutated B-RAF.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Fourth stage Melanoma patients with both measurable and not measurable lesions undergoing treatment with selective B-RAF inhibitors will be included. To determine the prevalence of CMC-positive patients in IV stage Melanoma, patients without mutated B-RAF undergoing chemotherapy and/or vaccines will be also enrolled at baseline, as part of study protocols approved and activated in the participating centers.
• Informed written consent.

Exclusion criteria

• Inadequate compliance to multiple blood draws (baseline, 15 days, 1th month, 4th month, and/or at progression) as scheduled in this adjunctive biologic study for patients carrying B-FAF mutation; inadequate compliance to adjunctive blood draws, as scheduled at baseline for BRAF wild-type
• Previously exposure to immunological treatment.

Trial design

200 participants in 1 patient group

Mutated Anti-B-RAF

Description:

Fourth stage Melanoma patients with both measurable and not measurable lesions undergoing treatment with selective B-RAF inhibitors.

Treatment:

Drug: Anti-B-RAF