RightFit
RecruitingPhase 3

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Infusions

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants will receive all the study medications through intravenous (IV) infusions, which means the medicine is given directly into a vein."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares PF-08634404 plus chemotherapy with bevacizumab plus chemotherapy for cancer of the colon or rectum. It is for adults whose cancer has spread to other parts of the body and who have not had whole-body drug treatment for the spread cancer.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be at least 18 years old.
  • Have adenocarcinoma of the colon or rectum, a type of cancer confirmed by tissue or cell tests.
  • Have stage IV cancer, meaning it has spread to other parts of the body.
  • Have had no whole-body drug treatment for cancer that has spread.
  • Be fully active or able to do light work despite limits on heavy activity.
  • Have at least one tumor that the study doctor can measure.
  • Have liver and kidneys that work well enough for treatment.
  • Not be pregnant before starting treatment.

Who can't join

  • Have cancer with a BRAF V600E gene change, or cancer called MSI-high or dMMR, which has problems repairing DNA.
  • Have known active cancer spots causing symptoms in the brain, spinal cord, or their coverings, including pressure on the spinal cord.
  • Have a serious risk of bleeding or a fistula (an abnormal opening between body parts), severe bleeding in the 28 days before treatment, or a history of medically serious bleeding.
  • Have had major surgery or a severe injury in the 4 weeks before treatment, or plan major surgery during the study.
  • Have had an organ or blood-forming stem cell transplant from another person.
  • Have had medically serious heart or blood vessel disease, or other medically serious health conditions, in the 6 months before treatment.
  • Have an active autoimmune disease (when the body's defenses attack healthy tissue) that needed whole-body treatment in the past 2 years.
  • Have signs of lung inflammation called interstitial lung disease or pneumonitis that is not caused by an infection or is caused by medicine.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (254)

AR

AZ

CA

CO

CT

FL

GA

ID

IL

IN

KY

MA

MD

ME

MI

MN

NC

NE

NM

NV

NY

OH

OR

SD

TN

TX

VA

WA