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A Phase 1/2 Open-Label Rolling-Arm Umbrella Platform Design of Investigational Agents With or Without Pembrolizumab or Pembrolizumab Alone in Participants With Melanoma: Substudy 02D - MK-3475-02D (KEYMAKER-U02)

Studio Clinico

Patologia: Melanoma

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: 

Fase di studio: 1, II Randomizzato

Richiesta mandatoria di tessuto: 

Linee di trattamento: Terza/N linea

Criteri di inclusione: 

  • AJCC Stage IV (any T, any N, M1D) melanoma
  • At least 1 and no more than 5 measurable brain metastasis disease
  • ≥10 mm and ≤30 mm, prior SRT in ≤3 MBM, history of excision ≤2 MBM
  • Submission of tumor tissue at enrollment.
    Note: Adequacy confirmation from Central Laboratory Vendor is not required for randomization
  • Neurologically asymptomatic from brain metastases
  • Not have required or received systemic corticosteroid therapy in the 10 days prior to beginning study intervention
  • Able to undergo MRI with Gadolinium contrast agent.

Criteri di esclusione: 

  • No more than 3 lines of therapy for their metastatic melanoma, inclusive of an adjuvant therapy regimen
  • Previous treatment for unresectable or metastatic disease allowed
  • Approved adjuvant regimens, IFN-α, anti-PD-1/PD-L1, anti-CTLA-4, and approved molecularly target agents.
  • Steroids for physiological replacement are allowed
  • Participants who have received anti-PD-1/PD-L1 therapy must have received at least 2 prior doses of an anti-PD-1/L1 mAb
  • Participants with prior BRAF inhibitor treatment
  • Intracranial disease progression must be demonstrated compared with the nadir of intracranial response during BRAF inhibitor treatment and confirmed with a second MRI brain scan after the drug washout period ±3 days.
  • Pre-study images that are of diagnostic quality from at least 3 dates
  • Confirmation of progression by repeat MRI may not be necessary for new lesions on BRAF inhibitor

Trattamento sperimentale: 

  • Coformulation Pembrolizumab/Quavonlimab + Lenvatinib
  • Pembrolizumab + Lenvatinib

Trattamento di controllo: 

NA

Obiettivi primari dello studio: 

The goal of substudy 02D is to evaluate the safety and efficacy of investigational treatment arms in programmed cell-death 1 (PD-1) naïve or PD-1 exposed participants with melanoma brain metastasis (MBM) and to identify the investigational agent(s) that, when used in combination, are superior to the current treatment options/historical control available.

Centri partecipanti

Nord Italia

IRCCS Istituto Nazionale dei Tumori
Via Venezian 1 - 20133 Milano - MI

 

Istituto Europeo di Oncologia
Via Ripamonti 435 - 20141 Milano - MI
Divisione Sviluppo di Nuovi Farmaci per Terapie Innovative

Riferimento: Prof. Giuseppe Curigliano
Telefono: 0257489599
Email: giuseppe.curigliano@ieo.it

 

Istituto Oncologico Veneto IRCCS
Via Gattamelata 64 - 35128 Padova - PD

Riferimento: Dr. Jacopo Pigozzo
Telefono: 0498215931
Email: oncologia.melanoma@iov.veneto.it

 

Centro Italia

Azienda Ospedaliera Universitaria Senese
Viale Bracci 16 - 53100 Siena - SI

 

Sud Italia e isole

Istituto Nazionale Tumori IRCCS Fondazione Pascale
Via Mariano Semmola - 80131 Napoli - NA
S.C. Oncologia Clinica Sperimentale Melanoma Immunoterapia e Terapie Innovative

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

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2020-003742-36

Data di inserimento: 24.05.2022

Promotore

Merck Sharp & Dohme LLC

Principal Investigator ITALIA

Istituto Europeo di Oncologia, Milano - Divisione Sviluppo di Nuovi Farmaci per Terapie Innovative

Riferimento: Prof. Giuseppe Curigliano

Telefono: 0257489599

Email: giuseppe.curigliano@ieo.it

Localita: Milano

 

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