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Neoadjuvant Vemurafenib + Cobimetinib + Atezolizumab in Melanoma: NEO-VC | Clinical Trials | Clareo Health

TERMINATEDPHASE2

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

NCT02303951•University Hospital Tuebingen

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Signed ICF
•2. Age ≥ 18 years
•3. Histologically confirmed Stage IV (metastatic) or unresectable Stage IIIC (locally advanced) melanoma, as defined by the AJCC, 7th revised edition
•1. Naïve to prior systemic anti-cancer therapy for melanoma, with the following exceptions: Adjuvant treatment with IFN, IL-2, or vaccine therapies, if discontinued at least 28 days prior to initiation of study treatment
•2. Adjuvant treatment with herbal therapies, if discontinued at least 7 days prior to initiation of study treatment
•4. Documentation of BRAFV600 mutation-positive status in melanoma tumor tissue (archival or newly obtained) through use of a clinical mutation test approved by the local health authority
•5. ECOG of 0 or 1
•6. Decision of eligibility for neoadjuvant combined vem+cobi+atezo treatment by in-terdisciplinary tumor board. Patient with limited numbers of metastases and few organ systems involved should be selected, making surgical resection after neo-adjuvant treatment probable.
•7. Measurable disease by RECIST V1.1 criteria (must be outside the CNS)
•8. Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 14 days prior to initiation of study treatment, with the exception of amylase, lipase, and LDH where up to 28 days is acceptable
+23 more criteria

Exclusion Criteria

•1. Candidates for direct surgery: patients with single site easily resectable metasta-sis
•2. Major surgical procedure or significant traumatic injury within 2 weeks prior to first dose of study drug treatment
•3. Palliative radiotherapy within 14 days prior to initiation of study treatment
•4. Active malignancy (other than BRAFV600 mutation-positive melanoma) or malig-nancy within 3 years prior to screening are excluded, with the exception of resected melanoma, resected BCC, resected cuSCC, resected carcinoma in situ of the cervix, resected carcinoma in situ of the breast, in situ prostate cancer, limited-stage bladder cancer, or any other curatively treated malignancies from which the patient has been disease-free for at least 3 years
•a. Patients with a history of isolated elevation in prostate-specific antigen in the absence of radiographic evidence of metastatic prostate cancer are eligible for the study.
•5. A history of or evidence of retinal pathology on ophthalmologic examination that is considered a risk factor for neurosensory retinal detachment, CSCR, RVO, or ne-ovascular macular degeneration
•a. Patients will be excluded from study participation if they currently are known to have any of the following risk factors for RVO: i. History of serous retinopathy ii. History of RVO iii. Evidence of ongoing serous retinopathy or RVO at baseline
•6. History of clinically significant cardiac dysfunction, including the following:
•1. Poorly controlled hypertension, defined as sustained, uncontrolled, non-episodic baseline hypertension consistently above 159/99mmHg despite opti-mal medical management
•2. Unstable angina, or new-onset angina within 3 months prior to initiation of study treatment
+50 more criteria

Locations (7)

Department of Dermatology & Skin Cancer University Hospital La Timone, Aix-Marseille University

Marseille, France

Department of Dermatology, University Hospital of Nantes

Nantes, France

Hopital Saint-Louis Hopitaux Universitaires Saint-Louis Laboisiere Fernand-Widal

Paris, France

Department of Dermatology, Elbe Hospital

Buxtehude, Germany

Universitätsklinikum Carl Gustav Carus

Dresden, Germany

Department of Dermatology, University Hospital

Kiel, Germany

University hospital Tübingen

Tübingen, Germany

Key Dates

Start Date

January 22, 2015

Primary Completion Date

May 14, 2020

Completion Date

May 14, 2020

Last Updated

February 3, 2021

Enrollment

ACTUAL participants

Conditions

Malignant Melanoma

Interventions

Vemurafenib

DRUG

Cobimetinib

DRUG

Atezolizumab

DRUG

An Phase Ib/II Clinical Trial of TCC1727 Combination Therapy in Advanced Solid Tumors

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Solid CancersNSCLC (Advanced Non-small Cell Lung Cancer)+3 more

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RECRUITINGPHASE1/PHASE2

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Malignant Melanoma

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 3, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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