Neoadjuvant Vemurafenib + Cobimetinib + Atezolizumab in Melanoma: NEO-VC
NCT02303951 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 47
Last updated 2021-02-03
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.
Conditions
- Malignant Melanoma
Interventions
- 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
-
Triple-Treatment (week 5 ongoing): 840 mg Q2W i.v
Sponsors & Collaborators
-
University Hospital Tuebingen
lead OTHER
Principal Investigators
-
Claus Garbe, Prof. · University Hospital Tübingen
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-01-22
- Primary Completion
- 2020-05-14
- Completion
- 2020-05-14
Countries
- France
- Germany
Study Locations
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