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4280A-010 - A Multicenter, Randomized, Double-Blind, Phase 2, Basket Study of MK-4280A, a Coformulation of Favezelimab (MK-4280) With Pembrolizumab (MK-3475) in Selected Solid Tumors (KeyForm-010)

Studio Clinico

Patologia: Tumori cutanei non melanoma, Tumori della testa e del collo, Altre neoplasie

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: 

Fase di studio: II Randomizzato

Richiesta mandatoria di tessuto: 

Linee di trattamento: Prima linea

Criteri di inclusione: 

Cohort A only

- Histologically confirmed diagnosis of resectable cutaneous squamous cell carcinoma (cSCC) as the primary site of malignancy (metastatic skin involvement from another primary cancer or from an unknown primary cancer is not permitted)
- Stage II to Stage IV disease without distant metastasis (M1). cSCC tumors arising in the head and neck will be staged according to American Joint Committee on Cancer (AJCC) Edition (Ed.) 8 and cSCC tumors arising in non-head and neck locations will be staged according to Union for International Cancer Control (UICC) Ed. 8
- Is systemic treatment naïve
- Archival tumor tissue sample, or newly obtained surgical resection, or biopsy sample of a tumor lesion not previously irradiated has been provided
- Is an individual of any sex/gender, at least 18 years of age at the time of providing the informed consent

All Cohorts

- Agrees to follow contraception guidelines if a participant of childbearing potential
- Has a life expectancy >3 years per investigator assessment
- Has adequate organ function
- Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- If positive for hepatitis B, has received antiviral therapy for ≥4 weeks and undetectable viral load prior to randomization
- If positive for hepatitis C, has undetectable viral load at screening
- If positive for human immunodeficiency virus (HIV), has well-controlled HIV on a stable highly active antiretroviral therapy.

Criteri di esclusione: 

All Cohorts

- Has known hypersensitivity to active substances or their excipients including previous clinically significant hypersensitivity reaction to treatment with other monoclonal antibody (mAb)
- History of allogeneic tissue/solid organ transplant

Cohort A only

- Received prior radiotherapy to the index lesion (in-field lesion)
- Participants for whom the primary site of cSCC was anogenital area (penis, scrotum, vulva, perianal region) are not eligible.

Trattamento sperimentale: 

Biological: favezelimab/pembrolizumab
Biological: pembrolizumab
Drug: lenvatinib

Trattamento di controllo: 

-

Centri partecipanti

Nord Italia

IRCCS Istituto Nazionale dei Tumori
Via Venezian 1 - 20133 Milano - MI
S.C. Oncologia Medica 3 - Tumori testa-collo

Riferimento: Prof.ssa Lisa Licitra
Telefono: 0223902150
Email: lisa.licitra@istitutotumori.mi.it

 

Sud Italia e isole

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

Riferimento: Dr. Paolo Ascierto
Telefono: 08117770443
Email: p.ascierto@istitutotumori.na.it

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2023-505022-34

Data di inserimento: 09.07.2024

Promotore

Merck Sharp & Dohme LLC

Principal Investigator ITALIA

Riferimento: Dr. Info non applicabile

Telefono: 00000

Email: na@na.it

Localita: na

 

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