C6461003 - An interventional, phase 3, double-blind, randomized study to evaluate the efficacy and safety of PF-08634404 in combination with chemotherapy versus Bevacizumab in combination with chemotherapy in treatment-naïve participants with metastatic colorectal cancer.

Studio Clinico

Patologia: Tumori del colon retto

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: Sì

Fase di studio: III

Linee di trattamento: Prima linea

Criteri di inclusione: 

- Histological or cytological confirmed colorectal adenocarcinoma.
- Evidence of Stage IV metastatic disease.
- Eastern Cooperative Oncology Group performance status (ECOG) 0-1
- At least one measurable lesion according to RECIST 1.1 per Investigator assessment
- Adequate hepatic, liver, and renal function.

Criteri di esclusione: 

- Locally confirmed BRAF V600E mutation
- Locally confirmed microsatellite instability (MSI)-high or DNA mismatch repair deficiency (dMMR) colorectal cancer
- Participants with known active symptomatic CNS lesions, including leptomeningeal metastasis, brainstem, meningeal, or spinal cord metastases or compression
- Clinically significant risk of hemorrhage or fistula
- Major surgery or severe trauma within 4 weeks prior to the first dose, or planned major surgery during the study
- History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation
- Any Grade ≥3 bleeding/hemorrhage events within 28 days of Cycle 1 Day 1, or prior history of clinically significant bleeding events
- Clinically significant cardiovascular disease, or other comorbidities, within 6 months prior to first dose
- Participants with active autoimmune diseases requiring systemic treatment within the past 2 years
- Evidence of non-infectious or drug-induced interstitial lung disease (ILD) pneumonitis. 

Schema di trattamento: 

- Experimental: PF-08634404 + Chemotherapy.
Participants will receive PF-08634404 intravenously (IV) in combination with Chemotherapy.
- Active Comparator: Bevacizumab + Chemotherapy.
Participants will receive bevacizumab IV in combination with Chemotherapy.

Trattamento sperimentale: 

PF-08634404 + Chemotherapy

Trattamento di controllo: 

Bevacizumab + Chemotherapy

Obiettivi primari dello studio: 

- Progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR)
- Overall survival (OS).

Centri partecipanti

Nord Italia

Centro Italia

Sud Italia e isole

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2025-523521-18-00

Data di inserimento: 06.08.2026

Promotore

Pfizer

Principal Investigator ITALIA

Riferimento: Dr. - -

Telefono: 00000

Email: na@na.it

Localita: -