Recruiting NCT07222800

Symbiotic-GI-03: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Metastatic Colorectal Cancer

Phase III Interventional Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: PF-08634404, Bevacizumab, Chemotherapy.
Who it may be relevant to: Registry conditions: Intestinal Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasms, Neoplasms by Site. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Argentina, Australia, Belgium, Brazil +12
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

The purpose of this study is to learn more about a new medicine called PF-08634404, and how well it works in people with cancer of the colon or rectum (CRC)). The goal is to understand if the new study medicine, combined with chemotherapy that is approved for colorectal cancer, can help people whose cancer has spread or returned after treatments taken before. To join the study, participants must meet the following conditions: * Be 18 years or older. * Have colorectal cancer that has spread to other parts of your body. * Be in good enough health to receive study treatment. * Should not be pregnant before starting treatment. Participants will be randomized (like flipping a coin) to one of 2 different treatment arms. The first arm (Arm A) will include the new medicine PF-08634404 in combination with chemotherapy that is approved for colorectal cancer, and the second arm (Arm B) will include an approved medicine for colorectal cancer, called Bevacizumab, in combination with chemotherapy that is approved for this type of cancer. Participants and their doctors will not know which arm they are being assigned to. Participants will receive all the study medications through intravenous (IV) infusions, which means the medicine is given directly into a vein. The treatment will be given in cycles, and participants may continue receiving it if it is helping and they are not experiencing serious side effects. The medicine will be given at a clinical site, where trained medical staff will check participants during and after each treatment. * The study is expected to last approximately 33 months for each participant. * Participants will have regular visits to the study site for treatment, health checks, and tests. * After stopping treatment, participants will return for a final visit about 30 to37 days later to check their health and review any side effects. * Follow-up will continue every 12 weeks by phone or in person or by reviewing health records to check on health status and any new treatments.

Interventions

Drug PF-08634404
Solution for infusion
Biological Bevacizumab
Injection for intravenous use
Drug Chemotherapy
Injection for intravenous use

Primary outcome measures

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]
Overall survival (OS) [Time frame: Approximately 4 years]

Secondary outcome measures (12)

PFS per RECIST 1.1 by investigator assessment [Time frame: Approximately 4 years]
Objective Response Rate (ORR) by BICR [Time frame: Approximately 4 years]
Objective Response Rate (ORR) by investigator [Time frame: Approximately 4 years]
Duration of Response (DOR) by BICR [Time frame: Approximately 4 years]
DOR by investigator [Time frame: Approximately 4 years]
PFS2 (PFS after next-line therapy) by investigator [Time frame: Approximately 4 years]
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 Abnormalities [Time frame: Through 90 days after the last study intervention; Approximately 4 years]
Pharmacokinetics (PK): Serum concentration of PF-08634404 [Time frame: Approximately 21 months]
Immunogenicity: Incidence of positive Anti-Drug Antibody (ADA) [Time frame: Approximately 21 months]
Mean scores and Change from baseline in the global health status/quality of life (QoL) score on the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) [Time frame: Approximately 4 years]
Mean score change from baseline in participant reported function and symptoms scales per EORTC QLQ-CR29 [Time frame: Approximately 4 years]

Eligibility criteria

Inclusion criteria

Histological or cytological confirmed colorectal adenocarcinoma.
Evidence of Stage IV metastatic disease.
No prior systemic therapy for 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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Double blind
Primary purpose: Treatment