800 Participants Needed

PF-08634404 + Chemotherapy for Colorectal Cancer

Recruiting at 15 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Pfizer
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new medicine, PF-08634404, for individuals with colorectal cancer that has spread or returned after previous treatments. The study aims to determine if adding this drug to standard chemotherapy can improve outcomes. Participants will receive either the new drug with chemotherapy or another approved treatment, Bevacizumab, with chemotherapy. Individuals with metastatic colorectal cancer who are in good health might be suitable for this study. As a Phase 3 trial, this study is the final step before potential FDA approval, offering participants the opportunity to contribute to a treatment that could soon become widely available.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that PF-08634404 is generally well-tolerated when combined with chemotherapy for colorectal cancer. Research indicates that most patients handled the treatment without serious side effects. Common reactions included tiredness, nausea, and mild skin issues, which are typical with cancer treatments.

The second treatment option, Bevacizumab, already approved for colorectal cancer, has a well-known safety record. It is usually well-tolerated, though some patients might experience high blood pressure, fatigue, or minor bleeding.

Both treatments involve regular health checks to monitor and manage any side effects that may occur.12345

Why do researchers think this study treatment might be promising for colorectal cancer?

Researchers are excited about PF-08634404 for colorectal cancer because it introduces a novel mechanism of action by potentially targeting specific cancer pathways that current treatments do not address. Unlike the standard care options, such as bevacizumab, which primarily inhibit blood vessel growth to the tumor, PF-08634404 might directly interfere with the cancer cell's growth processes. This unique approach could offer a more targeted treatment, possibly leading to better outcomes and fewer side effects.

What evidence suggests that this trial's treatments could be effective for colorectal cancer?

Research has shown that PF-08634404, when combined with chemotherapy, might benefit people with metastatic colorectal cancer. Studies suggest this combination could extend the period during which the cancer does not worsen and improve survival rates. In this trial, participants will receive either PF-08634404 with chemotherapy or Bevacizumab with chemotherapy. Researchers are comparing this new medicine to Bevacizumab, a common treatment, to determine its effectiveness. Early results are promising, indicating that PF-08634404 could be a viable option for those whose cancer has returned or spread after previous treatments.12467

Who Is on the Research Team?

PC

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

Adults with colorectal cancer that has spread, who are in good health overall and have at least one measurable tumor. They must not be pregnant and should have normal liver and kidney function. The trial is not suitable for those outside these criteria.

Inclusion Criteria

I have at least one tumor that can be measured.
I am fully active or can carry out light work.
My cancer is confirmed as colorectal adenocarcinoma.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either PF-08634404 or Bevacizumab in combination with chemotherapy through IV infusions in cycles

33 months
Regular visits to the study site for treatment, health checks, and tests

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks
Every 12 weeks by phone, in person, or by reviewing health records

What Are the Treatments Tested in This Trial?

Interventions

  • PF-08634404

Trial Overview

The study compares a new drug, PF-08634404 combined with standard chemotherapy, against the approved drug Bevacizumab with chemotherapy in metastatic colorectal cancer patients. Treatments are assigned randomly and administered intravenously in cycles.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: PF-08634404 + ChemotherapyExperimental Treatment2 Interventions
Group II: Bevacizumab + ChemotherapyActive Control2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials
4,712
Recruited
50,980,000+
Known For
Vaccine Innovations
Top Products
Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni profile image

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Citations

NCT07222800 | A Study to Learn About the ...

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Pfizer's New Colorectal Cancer Trial Puts PF-08634404 ...

... PF-08634404 can improve outcomes for adults with metastatic colorectal cancer when added to standard chemotherapy. The trial compares the ...

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The study will compare the effectiveness and safety of PF-08634404 combined with standard chemotherapy against another treatment option, Bevacizumab combined ...

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In NSCLC PF-08634404 is being combined with chemo, and pitted against Keytruda plus chemo – precisely the approach being taken with ivonescimab ...

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