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VECODUE - A Phase II Trial of Vemurafenib Plus Cobimetinib in Patients Treated With Prior First-line Systemic Immunotherapy for Inoperable Locally Advanced or Metastatic Melanoma

Studio Clinico

Patologia: Melanoma

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: No

Fase di studio: II

Linee di trattamento: Non applicabile

Criteri di inclusione: 

1. Patients must have histologically confirmed, unresectable stage IIIc or stage IV metastatic melanoma, as defined by the American Joint Committee on Cancer 7th edition. Unresectability of stage IIIc disease must have confirmation from a surgical oncologist;
2. Patients with advanced melanoma who have received one prior immunotherapy systemic regimen for advanced disease, for whom vemurafenib/cobimetinib treatment has been scheduled by the treating physician.
3. Adjuvant treatment is allowed, except for anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 agents;
4. Patients must be naïve to treatment for locally advanced unresectable or metastatic with BRAF/MEK inhibitors;
5. Documentation of BRAFV600 mutation-positive status in melanoma tumor tissue BRAF V600 mutation test;
6. At least one measurable lesion according to disease per RECIST v1.1 criteria;
7. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0- 2;
8. Male or female patient aged ≥ 18 years;
9. Able to participate and willing to give written informed consent prior to performance of any study-related procedures and to comply with the study protocol;
10. Life expectancy ≥ 12 weeks.

Criteri di esclusione: 

1. History of any prior systemic treatment for unresectable stage IIIc or stage IV melanoma (prior anti RAF or MEK agents) other than one prior first-line immunotherapy;
2. Palliative radiotherapy within 14 days prior to the first dose of study treatment;
3. Major surgery or traumatic injury within 14 days prior to first dose of study treatment;
4. Patients with active malignancy (other than BRAF− mutated melanoma) or a previous malignancy within the past 3 years are excluded; except for patients with resected melanoma, resected BCC,resected cutaneous SCC, resected melanoma in-situ, resected carcinoma in-situ of the cervix, and resected carcinoma in-situ of the breast; Exclusion Criteria Based on Organ Function.

 

Ocular:

 

5. History of, or evidence of retinal pathology on ophthalmologic examination that is considered a risk factor for neurosensory retinal detachment/central serouschorioretinopathy (CSCR), retinal vein occlusion (RVO) or neovascularmacular degeneration;
6. The risk factors for RVO are listed below. Patients will be excluded if they currently have the following conditions:
    a. Uncontrolled glaucoma with intra-ocular pressures ≥21 mmHg;
    b. Serum cholesterol ≥Grade 2;
    c. Hypertriglyceridemia ≥ Grade 2;
    d. Hyperglycemia (fasting) ≥Grade 2;

 

Cardiac:

7. History of clinically significant cardiac dysfunction, including the following:
    a. Current unstable angina;
    b. Symptomatic congestive heart failure of New York Heart Association class 2 or higher;
    c. History of congenital long QT syndrome or mean (average of triplicate measurements) QTcF ≥ 450 msec at baseline or uncorrectable abnormalities inserum electrolytes (sodium, potassium, calcium, magnesium, phosphorus);
    d. Uncontrolled hypertension≥ Grade 2 (patients with a history hypertension controlled with anti-hypertensives to ≤ Grade 1 are eligible);
    e. Left ventricular ejection fraction (LVEF) below institutional lower limit of normal (LLN) or below 50%, whichever is lower.

 

Central Nervous System:

8. Patients with active/symptomatic CNS lesions are excluded.

Trattamento sperimentale: 

Vemurafenib plus Cobimetinib

Trattamento di controllo: 

NA

Obiettivi primari dello studio: 

Overall Survival [ Time Frame: Patients enrolled will receive study medication until disease progression, unaccettable toxicity, withdrawal of consent or death, whichever comes first, assested up to 24 month ]
    OS will be calculated from the first day of treatment until the date of death from any cause.Any patient not know to have died at the time of data analysis will be censored at the time of the last recorded date on which the patient was know to be alive.

Obiettivi secondari dello studio: 

1. PFS [ Time Frame: Patients enrolled will receive study medication until disease progression, unaccettable toxicity, withdrawal of consent or death, whichever comes first, assested up to 24 month ]
    PFS will be defined as the time from initiation of study treatment to the first occurrence of disease progression or death from any cause, whichever occurs first.PFS will be calculated based on disease status evaluated bythe investigator according to RECIST v1.1

2. ORR [ Time Frame: Patients enrolled will receive study medication until disease progression, unaccettable toxicity, withdrawal of consent or death, whichever comes first, assested up to 24 month ]
    ORR, defined as the proportion of patients with a best overall response of either complete response (CR) or partial response (PR), will be calculated based on disease status evaluated by the investigator accordingto RECIST v1.1

Centri partecipanti

Nord Italia

Istituto Europeo di Oncologia
Via Ripamonti 435 - 20141 Milano - MI

 

Centro Italia

Istituto Nazionale Tumori “Regina Elena”
Via Elio Chianesi 53 - 00144 Roma - RM

 

Università La Sapienza Policlinico Umberto I
Viale del Policlinico 155 - 00161 Roma - RM

 

Sud Italia e isole

Istituto Tumori “Giovanni Paolo II” IRCCS
Viale Orazio Flacco 65 - 70124 Bari - BA

 

Istituto Nazionale Tumori IRCCS Fondazione Pascale
Via Mariano Semmola - 80131 Napoli - NA

Riferimento: Paolo Ascierto
Telefono: 0815903236
Email: p.ascierto@istitutotumori.na.it

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2017-000504-20 / NCT03224208

Data di inserimento: 10.10.2019

Promotore

Fondazione Melanoma Onlus

CRO

/

Principal Investigator ITALIA

Istituto Nazionale dei Tumori IRCCS - Fondazione Pascale, Napoli

Riferimento: Dr. Paolo Ascierto

Telefono: 0815903236

Email: p.ascierto@istitutotumori.na.it

Localita: Napoli

 

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