Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2026-02-24 @ 11:00 AM
Study NCT ID:
NCT02303951
Status:
TERMINATED
Last Update Posted:
2021-02-03
First Post:
2014-11-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neoadjuvant Vemurafenib + Cobimetinib + Atezolizumab in Melanoma: NEO-VC
Sponsor:
University Hospital Tuebingen
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2020-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The main reason for the early termination is the low recruitment rate.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NEO-VC
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: