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: 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: 

-

Centri partecipanti

Nord Italia

Sud Italia e isole

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2023-505022-34

Data di inserimento: 09.07.2024

Data di aggiornamento: 23.09.2024

Promotore

Merck Sharp & Dohme LLC

Principal Investigator ITALIA

Riferimento: Dr. Info non applicabile

Telefono: 00000

Email: na@na.it

Localita: na