What side effects are associated with this type of intervention?

Common treatments for colorectal cancer, such as those studied in the 3B-FOLFOX trial, include chemotherapy (FOLFOX), antiangiogenesis (bevacizumab), and immune checkpoint inhibitors (botensilimab and balstilimab). FOLFOX chemotherapy is associated with side effects like neuropathy, neutropenia, diarrhea, nausea, and vomiting. Bevacizumab, an antiangiogenic agent, can cause hypertension, proteinuria, and increased risk of bleeding and gastrointestinal perforation. Immune checkpoint inhibitors, such as botensilimab and balstilimab, may lead to immune-related adverse events including colitis, dermatitis, hepatitis, and endocrinopathies.

What prior FDA approvals exist?

For the treatment of colorectal cancer, the FDA has approved several drugs that align with the categories studied in the 3B-FOLFOX trial. Chemotherapy agents like FOLFOX (a combination of folinic acid, fluorouracil, and oxaliplatin) are commonly used. Antiangiogenic agents such as bevacizumab, which inhibits the formation of blood vessels that supply tumors, have also been approved. Additionally, immune checkpoint inhibitors like pembrolizumab, which target PD-1/PD-L1 pathways, have been approved for microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) colorectal cancer. These treatments collectively aim to stop tumor growth, spread, and improve patient outcomes.

What other types of research exist?

Promising alternatives to 3B-FOLFOX for colorectal cancer patients include: 1) FOLFIRI combined with ramucirumab, especially for patients with pre-existing neuropathy. 2) The combination of gemcitabine and oxaliplatin with either cetuximab or panitumumab, although their roles are still being evaluated. 3) Maintenance therapy with FU/LV plus panitumumab following induction with FOLFOX plus panitumumab, as shown in the PANAMA trial. These alternatives offer different mechanisms of action and may be suitable based on individual patient profiles and prior treatment responses.

← Back to Search

Monoclonal Antibodies

3B-FOLFOX for Metastatic Colorectal Cancer

Q: What is the mechanism of action of this treatment?

Common treatments for colorectal cancer include chemotherapy, antiangiogenesis agents, and immune checkpoint inhibitors. Chemotherapy drugs like FOLFOX kill cancer cells or prevent them from dividing and spreading. Antiangiogenesis agents such as bevacizumab inhibit the formation of new blood vessels that supply the tumor, thereby slowing its growth. Immune checkpoint inhibitors like balstilimab and botensilimab enhance the body's immune response against cancer cells by blocking proteins that suppress immune activity. Understanding these mechanisms helps in selecting effective treatment strategies tailored to individual patient needs, improving overall outcomes.

Phase 1 & 2

Recruiting

Led By Marwan G Fakih

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a combination of chemotherapy, a drug that blocks blood vessel growth, and two immune-boosting drugs in patients with advanced colorectal cancer. The goal is to find the best dose and see how well this combination works. The treatment aims to kill cancer cells, cut off their nutrient supply, and help the immune system fight the cancer.

Who is the study for?

Adults with microsatellite stable (MSS) metastatic colorectal cancer who haven't had certain treatments, have a life expectancy of at least 3 months, and are in good physical condition (ECOG <=1). They must not be allergic to oxaliplatin, agree to use contraception if applicable, and have no history of severe organ dysfunction or fistulas. Prior chemotherapy should be completed at least 4 weeks before the trial.

What is being tested?

The trial is testing FOLFOX combined with Bevacizumab plus two monoclonal antibodies: Botensilimab and Balstilimab. It aims to find the safest doses and see how effective this combination is against MSS metastatic colorectal cancer by inhibiting tumor growth through various mechanisms including blocking blood vessel formation and activating immune responses.

What are the potential side effects?

Possible side effects include reactions related to infusion, fatigue, digestive issues like diarrhea or constipation from chemotherapy drugs; high blood pressure or bleeding from Bevacizumab; and immune-related effects such as inflammation in organs due to monoclonal antibodies.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of adverse events (phase I)

Overall response (phase II)

Secondary study objectives

Incidence of adverse events (phase II)

OS (phase II)

Overall response (phase I)

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Phase II, Arm II (3B-FOLFOX)Experimental Treatment11 Interventions

Patients receive FOLFOX, bevacizumab and balstilimab IV with botensilimab IV at a higher dose on study. Patients undergo an x-ray, CT scan, PET scan, and/or MRI throughout the trial. Patients also undergo blood sample collection during screening and on study.

Group II: Phase II, Arm I (3B-FOLFOX)Experimental Treatment11 Interventions

Patients receive FOLFOX, bevacizumab and balstilimab IV with botensilimab IV at a lower dose on study. Patients undergo an x-ray, CT scan, PET scan, and/or MRI throughout the trial. Patients also undergo blood sample collection during screening and on study.

Group III: Phase I (3B-FOLFOX)Experimental Treatment11 Interventions

Patients receive FOLFOX, bevacizumab, balstilimab, and botensilimab IV on study. Patients undergo an x-ray, CT scan, PET scan, and/or MRI throughout the trial. Patients also undergo blood sample collection during screening and on study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fluorouracil

2014

Completed Phase 3

~11700

Computed Tomography

2017

Completed Phase 2

~2740

Leucovorin Calcium

2011

Completed Phase 3

~12500

Oxaliplatin

2011

Completed Phase 4

~2890

Positron Emission Tomography

2011

Completed Phase 2

~2200

Bevacizumab

2013

Completed Phase 4

~5540

Magnetic Resonance Imaging

2017

Completed Phase 3

~1160

Biospecimen Collection

2004

Completed Phase 3

~2020

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for colorectal cancer include chemotherapy, antiangiogenesis agents, and immune checkpoint inhibitors. Chemotherapy drugs like FOLFOX kill cancer cells or prevent them from dividing and spreading. Antiangiogenesis agents such as bevacizumab inhibit the formation of new blood vessels that supply the tumor, thereby slowing its growth. Immune checkpoint inhibitors like balstilimab and botensilimab enhance the body's immune response against cancer cells by blocking proteins that suppress immune activity. Understanding these mechanisms helps in selecting effective treatment strategies tailored to individual patient needs, improving overall outcomes.