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 3RecruitingNCT07222800

Pfizer800 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (228)

Ironwood Cancer & Research Centers

Chandler, Arizona, United States

RECRUITING

Ironwood Cancer & Research Centers

Gilbert, Arizona, United States

RECRUITING

Ironwood Cancer & Research Centers

Glendale, Arizona, United States

RECRUITING

Ironwood Cancer & Research Centers

Goodyear, Arizona, United States

Outcomes

Primary Outcomes

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

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.

Time frame: Approximately 4 years

Overall survival (OS)

Overall survival defined as the time from the date of randomization to the date of death due to any cause.

Time frame: Approximately 4 years

Secondary Outcomes

PFS per RECIST 1.1 by investigator assessment

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.

Time frame: Approximately 4 years

Objective Response Rate (ORR) by BICR

The proportion of participants who have a confirmed CR or PR, as best overall response assessed by BICR as per RECIST 1.1.

Time frame: Approximately 4 years

Objective Response Rate (ORR) by investigator

The proportion of participants who have a confirmed CR or PR, as best overall response assessed by investigator as per RECIST 1.1.

Time frame: Approximately 4 years

Duration of Response (DOR) by BICR

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.

Time frame: Approximately 4 years

DOR by investigator

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.

Time frame: Approximately 4 years

PFS2 (PFS after next-line therapy) by investigator

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.

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)

To characterize the immunogenicity of PF-08634404

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)

The EORTC QLQ-C30 is a questionnaire for quantitative measure of health-related quality of life pertinent to participants with a broad range of cancers who are participating in international clinical trials.

Time frame: Approximately 4 years

Mean score change from baseline in participant reported function and symptoms scales per EORTC QLQ-CR29

The EORTC QLQ-CR29 is a supplemental colorectal cancer-specific module with measures of symptoms associated with colorectal cancer.

Time frame: Approximately 4 years

Time to definitive deterioration (TTdD) in the global health status/QoL score on the EORTC QLQ-C30

TTdD is defined as the time from date of randomization to first onset of Patient Reported Outcome (PRO) deterioration without subsequent recovery.

Time frame: Approximately 4 years

Time to definitive deterioration (TTdD) in participant reported function and symptoms per EORTC QLQ-CR29

TTdD is defined as the time from date of randomization to first onset of Patient Reported Outcome (PRO) deterioration without subsequent recovery.

Time frame: Approximately 4 years

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

Overview

Conditions

Interventions

Eligibility

Locations (228)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts