ServiziMenu principale

<< Torna a "Tutti gli studi"

MK-3475-02B - 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 02B (KEYMAKER-U02)

Studio Clinico

Patologia: Melanoma

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: 

Fase di studio: 1, II Randomizzato

Linee di trattamento: Prima linea

Criteri di inclusione: 

- Has histologically or cytologically confirmed melanoma
- Has unresectable Stage III or Stage IV melanoma, not amenable to local therapy Has been untreated for advanced disease.
- Has provided a tumor biopsy
- If capable of producing sperm, male participants agree to the following during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention (7 days):
    - Abstains from penile-vaginal intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agrees to remain abstinent OR
    - Uses contraception unless confirmed to be azoospermic
- A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
    - Is not a WOCBP OR
    - Is a WOCBP and Uses a contraceptive method that is highly effective, with low user dependency, or be abstinent from penile-vaginal intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention. The length of time required to continue contraception for each study intervention is:
      - MK-4280A: 120 days
      - MK-1308A: 120 days
      - MK-7684: 50 days MK-3475: 120 days
      - Lenvatinib: 30 days
      - ATRA: 30 days
- Has adequate organ function
- Has resolution of toxic effect(s) of the most recent prior therapy to Grade 1 or less (except alopecia and Grade 2 neuropathy).

Criteri di esclusione: 

- Has a diagnosis of immunodeficiency or is receiving immunosuppressive therapy within 7 days before the first dose of study intervention
- Has a known additional malignancy that is progressing or requires active treatment within the past 2 years Has known central nervous system (CNS) metastases and/or carcinomatous meningitis
- Has ocular or mucosal melanoma
- Has an active autoimmune disease that has required systemic treatment in the past 2 years
- Has an active infection requiring systemic therapy
- Has known history of human immunodeficiency virus (HIV)
- Has history of Hepatitis B or known Hepatitis C virus infection Has a history of (noninfectious) pneumonitis
- Has a history of active tuberculosis (TB)
- Has received prior systemic anticancer therapy within 4 weeks prior to randomization
- Has received prior radiotherapy within 2 weeks of first dose of study intervention
- Has had major surgery <3 weeks prior to first dose of study intervention
- Has received a live vaccine within 30 days before the first dose of study intervention Has participated in a study of an investigational agent within 4 weeks prior to the first dose of study intervention Has had an allogeneic tissue/solid organ transplant
- Has a known psychiatric or substance abuse disorder that would interfere with requirements of the study
- Participants who receive lenvatinib have the following additional exclusion criteria:
- Has a pre-existing Grade ≥3 gastrointestinal or non-gastrointestinal fistula
- Has radiographic evidence of encasement of invasion of a major blood vessel, or of intratumoral cavitation
- Has clinically significant hemoptysis or tumor bleeding within 2 weeks prior to the first dose of study intervention
- Has clinically significant cardiovascular disease within 12 months from first dose of study intervention
- Has urine protein ≥1 g/24-hour.
- Has presence of gastrointestinal condition including malabsorption, gastrointestinal anastomosis, or any other condition that might affect the absorption of lenvatinib.

Trattamento sperimentale: 

- Pembrolizumab + Vibostolimab
- Coformulation Pembrolizumab/Quavonlimab
- Coformulation Pembrolizumab/Quavonlimab + Lenvatinib
- Coformulation Favezelimab/Pembrolizumab
- Coformulation Favezelimab/Pembrolizumab + All-trans Retinoic Acid (ATRA)
- Coformulation Favezelimab/Pembrolizumab + Vibostolimab.

Trattamento di controllo: 

- Pembrolizumab

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
Email: giuseppe.curigliano@ieo.it

 

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

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

 

Centro Italia

Azienda Ospedaliera Universitaria Senese
Viale Bracci 16 - 53100 Siena - SI
Policlinico Le Scotte - UOC Immunoterapia Oncologica

Email: segr.immunonco@ao-siena.toscana.it

 

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
Email: p.ascierto@istitutotumori.na.it

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2019-003977-24

Data di inserimento: 24.05.2022

Data di aggiornamento: 03.07.2024

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

 

<< Torna a "Tutti gli studi"

Apri