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MK4280A-007 - A Phase 3 Study of MK-4280A (Coformulated Favezelimab [MK-4280] Plus Pembrolizumab [MK-3475]) Versus Standard of Care in Previously Treated Metastatic PD-L1 Positive Colorectal Cancer

Studio Clinico

Patologia: Tumori del colon retto

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: 

Fase di studio: III

Richiesta mandatoria di tessuto: 

Linee di trattamento: Seconda linea, Terza/N linea

Criteri di inclusione: 

- Has a histologically confirmed colorectal adenocarcinoma that is metastatic and unresectable.
- Has measurable disease per RECIST 1.1 as assessed by the local site investigator.
- Has been previously treated for the disease and radiographically progressed on or after or could not tolerate standard treatment.
- Submits an archival (≤ 5 years) or newly obtained tumor tissue sample or newly obtained tumor tissue sample that has not been previously irradiated.
- Has an Eastern Cooperative Oncology Group Performance Score (ECOG PS) of 0 to 1 within 10 days prior to first dose of study intervention.
- Has a life expectancy of at least 3 months, based on the investigator assessment.
- Has the ability to swallow and retain oral medication and not have any clinically significant gastrointestinal abnormalities that might alter absorption.
- Has adequate organ function.

Criteri di esclusione: 

- Has previously been found to have deficient mismatch repair/microsatellite instability-high (dMMR/MSI-H) tumor status.
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis or leptomeningeal disease.
- Has a history of acute or chronic pancreatitis.
- Has neuromuscular disorders associated with an elevated creatine kinase (eg, inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy).
- Has clinically significant cardiovascular disease within 12 months from first dose of study intervention, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability.
- Has urine protein greater than or equal to 1g/24h.
- A woman of childbearing potential who has a positive urine/serum pregnancy test within 24/72 hours prior to the first dose of study intervention.
- Has received prior therapy with an anti-programmed cell death 1 (PD-1), anti-programmed death ligand 1 (PD-L1), or anti-programmed cell death ligand 2 (PD-L2), anti-lymphocyte activation gene 3 (LAG-3) antibody, with a tyrosine kinase inhibitor (TKI; eg, lenvatinib) other than rapidly accelerated fibrosarcoma (RAF) inhibitors (binimetinib is permitted if combined with a RAF inhibitor), or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein 4, OX-40, cluster of differentiation [CD] 137).
- Has previously received regorafenib or TAS-102.
- Has received prior systemic anticancer therapy including investigational agents within 28 days before randomization.
- Has received prior radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.
- Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.
- Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
- Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
- Has an active autoimmune disease that has required systemic treatment in past 2 years.
- Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
- Has an active infection requiring systemic therapy (eg, tuberculosis, known viral or bacterial infections, etc.).
- Has a known history of human immunodeficiency virus (HIV) infection.
- Has known history of Hepatitis B or known active Hepatitis C virus infection.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.
- Has had an allogenic tissue/solid organ transplant.

Numero di pazienti previsti: 

432

Schema di trattamento: 

Experimental: Favezelimab/Pembrolizumab(800 mg/200 mg) intravenously (IV) on Day 1, then every 3 weeks (Q3W), for up to 35 infusions.
Active Comparator: Standard of Care (Regorafenib or TAS-102). Participants will receive 160 mg regorafenib orally daily on Days 1-21 of each 28-day cycle. Participants will also receive 35 mg/m^2 TAS-102 orally twice daily on Days 1-5 and Days 8-12 of each 28-day treatment cycle

Trattamento sperimentale: 

Favezelimab/Pembrolizumab

Trattamento di controllo: 

Regorafenib /TAS 102

Obiettivi primari dello studio: 

Overall Survival (OS)

Data di fine dell'arruolamento: 30.11.2022

Centri partecipanti

Nord Italia

Ospedale Niguarda Ca' Granda
Piazza dell'Ospedale Maggiore 3 - 20162 Milano - MI

Riferimento: Prof. Salvatore Siena
Email: oncologia@ospedaleniguarda.it

 

Istituto Clinico Humanitas Rozzano
Via Manzoni 56 - 20089 Rozzano - MI

Riferimento: Prof. Armando Santoro
Telefono: 0282244080
Email: armando.santoro@humanitas.it

 

Centro Italia

Fondazione Policlinico A. Gemelli
Largo Agostino Gemelli 8 - 00168 Roma - RM

Telefono: 0630155202
Email: oncomedsperimentali@policlinicogemelli.it

 

Sud Italia e isole

IRCCS Ospedale Casa Sollievo della Sofferenza
Viale Cappuccini 1 - 71013 San Giovanni Rotondo - FG

Riferimento: Dr. Evaristo Maiello
Telefono: 0882410640
Email: e.maiello@operapadrepio.it

 

AOU degli studi della Campania Luigi Vanvitelli
Piazza Luigi Miraglia 2 - 80138 Napoli - NA

Riferimento: Prof. Fortunato Ciardiello
Telefono: 081566688
Email: daniela.renato.trials@outlook.it

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2021-001309-60

Data di inserimento: 10.05.2022

Promotore

Merck Sharp & Dohme LLC

CRO

/

Principal Investigator ITALIA

Policlinico Universitario Fondazione Agostino Gemelli

Riferimento: Dr. Informazione non disponibile

Telefono: 0630155202

Email: oncomedsperimentali@policlinicogemelli.it

Localita: Roma

 

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