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MK-7684A-005 - A Multicenter, Open-label, Phase 2 Basket Study of MK-7684A, a Co-formation of Vibostolimab (MK-7684) With Pembrolizumab (MK-3475), With or Without Other Anticancer Therapies in Participants With Selected Solid tumors (KEYVIBE-005)

Studio Clinico

Patologia: Carcinoma della vescica, Epatocarcinoma, Neoplasie della mammella, Neoplasie dello stomaco, Tumori dell’esofago, Tumori delle vie biliari, Tumori dell’utero, Tumori dell’ovaio, Tumori della testa e del collo, Altre neoplasie

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: 

Fase di studio: II Randomizzato

Linee di trattamento: Non applicabile

Criteri di inclusione: 

  • One of the following histologically or cytologically confirmed, advanced (locally recurrent unresectable or metastatic) solid tumors:
    - Squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix
    - Endometrial cancer
    - Head and neck squamous cell carcinoma (HNSCC)
    - Unresectable biliary adenocarcinoma (gallbladder or biliary tree [intrahepatic or extrahepatic] cholangiocarcinoma)
    - Adenocarcinoma or squamous cell carcinoma of the esophagus or advanced/metastatic Siewert type 1 adenocarcinoma of the gastroesophageal junction (GEJ).
    - Triple-negative breast cancer (TNBC)
    - Hepatocellular carcinoma (HCC)
    - Urothelial carcinoma of the renal pelvis, ureter, bladder, or urethra
    - Ovarian cancer
    - Gastric cancer
  • Measurable disease per RECIST v1.1 as assessed by BICR or local site investigator.
  • Adequately controlled blood pressure (BP) with or without antihypertensive medications.
  • Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART).
  • Male participants must agree to follow contraceptive guidance.
  • Female participants are not pregnant or breastfeeding, not a woman of child-bearing potential (WOCBP) or is a WOCBP and agrees to follow contraceptive guidance.
  • Adequate organ function.

Criteri di esclusione: 

  • History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 3 years.
  • Prior therapy with anti-programmed cell-death (PD-1), anti-PD-L1, anti-PD-L2, or anti-T-cell immunoreceptor with Ig and ITIM domains (TIGIT) agent.
  • Prior systemic anticancer therapy including investigational agents within 4 weeks before randomization/allocation.
  • Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.
  • Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days before the first dose of study medication.
  • Active autoimmune disease that has required systemic treatment in past 2 years.
  • Active infection requiring systemic therapy.
  • Concurrent active hepatitis B and hepatitis C virus infection.
  • History of allogenic tissue/solid organ transplant.
  • Previous treatment with lenvatinib (for participants who will receive lenvatinib in their assigned treatment arm).
  • Has clinically significant cardiovascular disease within 12 months from first dose of study intervention.

Trattamento sperimentale: 

BIOLOGICAL: Pembrolizumab/Vibostolimab Co-Formulation
BIOLOGICAL: Pembrolizumab
DRUG: Lenvatinib
DRUG: 5-Fluorouracil
DRUG: Cisplatin
DRUG: Paclitaxel
DRUG: Gemcitabine
DRUG: Carboplatin
DRUG: Docetaxel
DRUG: Bevacizumab
DRUG: Capecitabine
DRUG: Oxaliplatin

Trattamento di controllo: 

NA

Centri partecipanti

Nord Italia

Ospedale San Raffaele di Milano
Via Olgettina 60 - 20132 Milano - MI
Oncologia Medica

Riferimento: Dr. Giancluca Del Conte
Email: oncologia.medica@hsr.it

 

Centro Italia

Fondazione Policlinico A. Gemelli
Largo Agostino Gemelli 8 - 00168 Roma - RM
Ginecologia Oncologica

 

Sud Italia e isole

Istituto Nazionale Tumori IRCCS Fondazione Pascale
Via Mariano Semmola - 80131 Napoli - NA
S.C. Sperimentazioni Cliniche

Riferimento: Dr. Adriano Gravina
Email: a.gravina@istitutotumori.na.it

Informazioni Generali

Protocollo

Numero di iscrizione a registro: NCT05007106

Data di inserimento: 11.05.2022

Data di aggiornamento: 23.11.2023

Promotore

Merck Sharp & Dohme LLC

CRO

/

Principal Investigator ITALIA

Istituto Nazionale Tumori IRCCS Fondazione Pascale

Riferimento: Dr. Adriano Gravina

Telefono: 0815903448

Email: a.gravina@istitutotumori.na.it

Localita: Napoli

 

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