Metastatic colorectal cancer
Conditions
Interventions
*Drug: PF-08634404
-Solution for infusion
*Biological: Bevacizumab
-Injection for intravenous use
-Other Names: #Avastin
*Drug: Chemotherapy
-Injection for intravenous use
Sponsors
Kawai Norisuke
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria: *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 hematologic, hepatic, and renal function.
Exclusion criteria
Exclusion criteria: Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: *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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| *Progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) [Time Frame: Approximately 4 years] -Progression-free survival is defined as the time from the date of randomization to the date of the first documentation of objective progressive disease (PD) assessed by BICR per RECIST 1.1, or death due to any cause, whichever occurs first. *Overall survival (OS) [Time Frame: Approximately 4 years] -Overall survival defined as the time from the date of randomization to the date of death due to any cause. | — |
Secondary
| Measure | Time frame |
|---|---|
| *PFS per RECIST 1.1 by investigator assessment [Time Frame: Approximately 4 years] -Progression Free Survival (PFS) is defined as the time from the date of randomization to the date of the first documentation of objective PD assessed by investigator per RECIST 1.1, or death due to any cause, whichever occurs first. *Objective Response Rate (ORR) by BICR [Time Frame: Approximately 4 years] -The proportion of participants who have a confirmed CR or PR, as best overall response assessed by BICR as per RECIST 1.1. *Objective Response Rate (ORR) by investigator [Time Frame: Approximately 4 years] -The proportion of participants who have a confirmed CR or PR, as best overall response assessed by investigator as per RECIST 1.1. *Duration of Response (DOR) by BICR [Time Frame: Approximately 4 years] -The time from the first documentation of objective response (CR or PR that is subsequently confirmed) to the date of the first documentation of PD as determined by BICR assessment per RECIST 1.1, or death due to any cause, whichever occurs first. *DOR by investigator [Time Frame: Approximately 4 years] -The time from the first documentation of objective response (CR or PR that is subsequently confirmed) to the date of the first documentation of PD as determined by Investigator per RECIST 1.1, or death due to any cause, whichever occurs first. *PFS2 (PFS after next-line therapy) by investigator [Time Frame: Approximately 4 years] -PFS2 is defined as the time from the date of randomization to the date of second objective disease progression or death due to any cause, whichever occurs first. Second objective disease progression is PD after the start of subsequent anticancer therapy (excluding curative surgery) as assessed by the investigator. *Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time Frame: Through 90 days after the last study intervention; Approximately 4 years] *Number of Participants With Clinical Laboratory Abn | — |
Countries
Japan, Will be updated
Contacts
Public ContactClinical Trials Information Desk
Pfizer R&D Japan G.K.
Outcome results
None listed