Patologia: Tumori cutanei non melanoma, Tumori della testa e del collo, Altre neoplasie
Osservazionale-Sperimentale: Sperimentale
Monocentrico-Multicentrico: Multicentrico
Randomizzato: Sì
Fase di studio: II Randomizzato
Richiesta mandatoria di tessuto: Sì
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
Cohort B only
Histologically confirmed diagnosis of endometrial cancer (EC) that is not deficient in mismatch repair (dMMR) proficient in mismatch repair (pMMR) as documented by a local test report
Documented evidence of stage IVB (per 2009 International Federation of Gynecology and Obstetrics (FIGO) staging), recurrent, or metastatic EC, and are not candidates for curative surgery or radiation
Has radiographic evidence of disease progression after 1 prior systemic, platinum-based chemotherapy regimen for EC in any setting
Measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST 1.1) by investigator (before first dose of study intervention)
Is assigned female sex at birth, at least 18 years of age at the time of providing the informed consent
Has adequately controlled blood pressure without antihypertensive medication.
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.
Cohort B
Has had major surgery within 3 weeks prior to first dose of study interventions
Has preexisting ≥Grade 3 gastrointestinal or non-gastrointestinal fistula
Has urine protein ≥1 g/24 hours
Has a left ventricle ejection fraction (LVEF) below the institutional (or local laboratory) normal range, as determined by multi-gated acquisition (MUGA) or echocardiogram (ECHO)
Has radiographic evidence of encasement or invasion of a major blood vessel, or of intratumoral cavitation
Has clinically significant cardiovascular disease within 12 months from first dose of study intervention.
Trattamento sperimentale:
Biological: favezelimab/pembrolizumab
Biological: pembrolizumab
Drug: lenvatinib
Trattamento di controllo:
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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
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
Numero di iscrizione a registro: 2023-505022-34
Data di inserimento: 09.07.2024
Data di aggiornamento: 23.09.2024
Merck Sharp & Dohme LLC
Riferimento: Dr. Info non applicabile
Telefono: 00000
Email: na@na.it
Localita: na