A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Pembrolizumab Versus Placebo as Adjuvant Therapy Following Surgery and Radiation in Participants with High-risk Locally Advanced Cutaneous Squamous Cell Carcinoma (LA cSCC)(MK-3475-630/KEYNOTE-630)

Studio Clinico

Patologia: Tumori cutanei non melanoma

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: Sì

Fase di studio: III

Richiesta mandatoria di tessuto: Sì

Linee di trattamento: Adiuvante/neoadiuvante

Criteri di inclusione: 

- Has histologically confirmed 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)
- Has histologically confirmed LA cSCC with ≥1 high-risk feature(s) as the primary site of malignancy
- Has undergone complete macroscopic resection of all known cSCC disease with or without microscopic positive margins. For those participants with residual microscopic positive margin involvement, confirmation that additional re-excision is not possible must be provided
- Has completed adjuvant radiotherapy (RT) for LA cSCC with last dose of RT ≥4 weeks and ≤16 weeks from randomization
- Has completed at least 45 Gray (Gy) of adjuvant RT for LA cSCC prior to study entry
- Is disease free as assessed by the investigator with complete radiographic staging assessment ≤28 days from randomization
- Is not pregnant or breastfeeding
- Is not a woman of childbearing potential (WOCBP)
- Has a negative pregnancy test ≤72 hours before the first dose of study intervention
- Has provided an archival or newly-obtained tumor tissue sample adequate for Programmed Cell Death Ligand 1 (PD-L1) testing as determined by central laboratory testing
- Has a life expectancy of >3 months
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 ≤10 days prior to the first dose of study intervention.

Criteri di esclusione: 

- Has macroscopic residual cSCC after surgery and/or recurrence with active cSCC disease before randomization
- Has any other histologic type of skin cancer other than invasive cSCC (eg, basal cell carcinoma) that has not been definitively treated with surgery or radiation; Bowen's disease; Merkel cell carcinoma; or melanoma
- Has received prior therapy with an anti-programmed cell death receptor 1(PD-1), anti- PD-L1, or anti-programmed cell death receptor ligand 2 (PD-L2) agent or with an agent directed to another co-stimulatory or co-inhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], OX-40, CD137)
- Has received prior systemic anticancer therapy including investigational agents for cSCC ≤4 weeks prior to randomization
- Has not recovered from all radiation-related toxicities and has not had radiation pneumonitis
- Has received a live vaccine ≤30 days prior to the first dose of study intervention
- Is currently participating in or has participated in a study of an investigational agent or has used an investigational device ≤4 weeks prior to the first dose of study intervention
- Has an active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs)
- Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
- Has an active infection requiring systemic therapy
- Has a known history of human immunodeficiency virus (HIV) infection
- Has a known history of hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or known active hepatitis C virus (HCV; defined as HCV RNA [qualitative] is detected) infection
- Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study intervention
- Has had an allogeneic tissue/solid organ transplant. 

Trattamento sperimentale: 

Pembrolizumab

Trattamento di controllo: 

Placebo

Obiettivi primari dello studio: 

- Recurrence-Free Survival (RFS) as Assessed by the Investigator and Confirmed by Biopsy [ Time Frame: Up to approximately 60 months ]
    RFS was defined as the time between the date of randomization to the date of first local or regional recurrence of the index lesion, distant metastasis, or death due to any cause; whichever occurred first.

Centri partecipanti

Nord Italia

Centro Italia

Sud Italia e isole

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2018-001974-76

Data di inserimento: 20.09.2019

Data di aggiornamento: 27.03.2023

Promotore

Merck Sharp & Dohme Corp.

CRO

NA

Principal Investigator ITALIA

Istituto Europeo di Oncologia, Milano

Riferimento: Prof.ssa Emilia Cocorocchio

Telefono: 0257489538

Email: emilia.cocorocchio@ieo.it

Localita: Milano