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Vemurafenib Plus Cobimetinib in Metastatic Melanoma

NCT02414750 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2022-11-30

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Vemurafenib plus cobimetinib

Molecular targeted therapy for BRAF mutated advanced melanoma patients

DEVICE

Positron Emission Tomography

Patient will need to undergo FDG and FLT PET scanning before and during treatment, and at time of progression

PROCEDURE

Tissue sampling

Before and during treatment and at time of progression patients will undergo tissue sampling of a melanoma lesion

PROCEDURE

Blood sampling

Before and during treatment and at time of progression patients will undergo blood sampling

Sponsors & Collaborators

  • Hoffmann-La Roche

    collaborator INDUSTRY

  • Amsterdam UMC, location VUmc

    collaborator OTHER

  • The Netherlands Cancer Institute

    collaborator OTHER

  • Netherlands Working Group on Immunotherapy of Oncology

    lead OTHER

Principal Investigators

  • Fons JM Van den Eertwegh, MD PhD · Amsterdam UMC, location VUmc

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2020-11-30
Completion
2020-11-30

Countries

  • Netherlands

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02414750 on ClinicalTrials.gov