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: No
Fase di studio: II
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:
pembrolizumab/vibostolimab co-formulation (MK-7684A) with or without other anticancer therapies
Trattamento di controllo:
NA
Centri partecipanti
Nord Italia
Istituto Europeo di Oncologia
Via Ripamonti 435 - 20141 Milano - MI
Sviluppo di Nuovi Farmaci per Terapie Innovative
Riferimento: Prof. Giuseppe Curigliano
Telefono: 0257489599
Email: giuseppe.curigliano@ieo.it
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
Telefono: 0815903448
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