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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: Altre neoplasie

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: 

Fase di studio: III

Richiesta mandatoria di tessuto: 

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
- Has completed adjuvant radiotherapy (RT) for LA cSCC with last dose of RT ≥4 weeks and ≤16 weeks from randomization
- Has completed at least 50 Gray (Gy) 25 fractions 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: 

Is currently receiving either strong or moderate inhibitors of cytochrome P450 (CYP)3A4 that cannot be discontinued for the duration of the study

Numero di pazienti previsti: 

Italia: 20

Schema di trattamento: 

Pembrolizumab/Placebo IV400mg Q6W up to 9 cycles

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.

Obiettivi secondari dello studio: 

- Overall Survival (OS) [Time Frame: Up to approximately 60 months]
OS is the time from randomization to death due to any cause.

- Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life (QoL) Questionnaire (QLQ)-C30 [Time Frame: Baseline and up to approximately 60 months]
Change from baseline in the score of EORTC QLQ-C30 is reported. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire, which contains 30 items and measures 5 functioning dimensions (physical, role, emotional, cognitive, and social), 3 symptom items (fatigue, nausea/vomiting, and pain), 6 single items (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and financial impact), and a global health and QoL scale. Scores ranged from 0 -100. For functional and global quality of life (QoL) scales, higher scores meant a better level of function. For symptom-oriented scales, a higher score meant more severe symptoms and a decrease in QoL.

- Percentage of Participants Who Experience an Adverse Event (AE) [Time Frame: Up to approximately 63 months]
An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the study treatment or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of study treatment, is also an AE. The percentage of participants who experience at least one AE will be presented.

- Percentage of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE) [Time Frame: Up to approximately 38 months]
An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the study treatment or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of study treatment, is also an AE. The percentage of participants who discontinue study treatment due to an AE will be presented.

Data di inizio dell'arruolamento: 04.04.2019

Periodo previsto di arruolamento: 23

Data di fine dell'arruolamento: 10.03.2021

Centri partecipanti

Nord Italia

IRCCS Istituto Nazionale dei Tumori
Via Venezian 1 - 20133 Milano - MI

 

Istituto Europeo di Oncologia
Via Ripamonti 435 - 20141 Milano - MI

Riferimento: Dr.ssa Emilia Cocorocchio
Telefono: 0257489459
Email: emilia.cocorocchio@ieo.it

 

Centro Italia

AOU Pisana - Santa Chiara
Via Roma 67 - 56126 Pisa - PI

 

Sud Italia e isole

Istituto Nazionale Tumori IRCCS Fondazione Pascale
Via Mariano Semmola - 80131 Napoli - NA

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2018-001974-76

Data di inserimento: 20.09.2019

Promotore

Merck Sharp & Dohme Corp.

CRO

/

Principal Investigator ITALIA

Istituto Europeo di Oncologia - IEO, Milano

Riferimento: Dr.ssa Emilia Cocorocchio

Telefono: 0257489459

Email: emilia.cocorocchio@ieo.it

Localita: Milano

 

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