NCT02303951

Neoadjuvant Vemurafenib + Cobimetinib + Atezolizumab in Melanoma: NEO-VC

Neoadjuvant Treatment With the Combination of Vemurafenib, Cobimetinib and Atezolizumab in Limited Metastasis of Malignant Melanoma (AJCC Stage IIIC/IV) and Integrated Biomarker Study: a Single Armed, Two Cohort, Phase II EADO Trial NEO-VC

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: University Hospital Tuebingen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Evaluation of the efficacy, safety and biologic effects of neo-adjuvant treatment with vemurafenib + cobimetinib + atezolizumab in patients with limited metastasis of melanoma in stage IIIC/IV melanoma.

Detailed description

Patients with hardly resectable/unresectable limited metastasis in malignant melanoma stages IIIC/IV (AJCC 2010) carrying the BRAF V600 mutation, in order to achieve operability are enrolled in the NEO-VC-study. The main aim of this study is to achieve operability in a higher percentage of patients by neoadjuvant treatment through shrinkage of the tumors. Patients with operable stage IV disease show an impressive survival benefit with long term (5 y.) survival rates around 30 %. Only a percentage of up to 20 % can presently be treated by complete metastasectomy. This percentage may be enlarged by pre-treatment with an efficacious antitumor drug.

Conditions

• Malignant Melanoma

Interventions

Type	Name	Description
DRUG	Vemurafenib	Run-In: Day 1-21 960 mg bid orally, Day 22-28 720 mg bid orally Triple-Treatment (week 5 ongoing): 720 mg bid orally
DRUG	Cobimetinib	Run-In: Day 1-21 60 mg od orally Triple-Treatment (week 5 ongoing): 60 mg od 21/7 orally (3 weeks on drug, 1 week off)
DRUG	Atezolizumab	Triple-Treatment (week 5 ongoing): 840 mg Q2W i.v

Timeline

• Start date: 2015-01-22
• Primary completion: 2020-05-14
• Completion: 2020-05-14
• First posted: 2014-12-01
• Last updated: 2021-02-03

Locations

7 sites across 2 countries: France, Germany