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Monoclonal Antibodies
3B-FOLFOX for Metastatic Colorectal Cancer
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
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 moreAwards & 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
~2790
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
~1180
Balstilimab
2023
Completed Phase 1
~20
Biospecimen Collection
2004
Completed Phase 3
~2030
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.
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
605 Previous Clinical Trials
1,923,519 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,958 Previous Clinical Trials
41,112,494 Total Patients Enrolled
Marwan G FakihPrincipal InvestigatorCity of Hope Medical Center
4 Previous Clinical Trials
93 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have moderate to severe nerve damage.I have never had lung inflammation or similar lung issues that needed strong steroids.I rely on IV for nutrition or hydration.I am 18 years old or older.I haven't needed systemic treatment for an autoimmune disease in the last 2 years.I have had hepatitis C but have been virus-free for at least 6 months.I have received immunotherapy before.I have hepatitis B but have been on treatment with undetectable levels for 6 months.I haven't had surgery in the last 4 weeks, except for minor procedures like port placement.My kidneys are working well enough for treatment.I have bowel blockage symptoms due to my untreated cancer.I have had a blood clot in the last month but am on blood thinners without symptoms.I have HIV under control with treatment and normal CD4 counts for 6 months.I do not have active brain or leptomeningeal metastases.I am fully active and can carry on all pre-disease activities without restriction.My liver enzyme levels are within the required range for the study.I have wounds that are not healing.I am currently experiencing active bleeding symptoms.My urine tests show significant protein levels.I had a severe COVID-19 infection more than 20 days ago.I had FOLFOX therapy without needing dose changes or having severe side effects.My colon or rectum cancer is confirmed to be microsatellite stable.I have not had periods for 2 years, haven't had a hysterectomy or oophorectomy, and my hormone levels are in the postmenopausal range.I am over 50 and have not had a period for more than a year.I have no lasting side effects from cancer treatment above mild, except for stable hormone issues, mild nerve pain, or hair loss.I am a woman who can have children and have a recent negative pregnancy test.I have no active cancers besides my current diagnosis or only had early-stage, low-risk, or non-invasive cancers treated any time before.I have had a hysterectomy, both ovaries removed, or my tubes tied.My diagnosis is colorectal adenocarcinoma.I have had 5-FU-based therapy without needing a dose lower than 2400 mg/m^2 every 2 weeks.I have never had a perforation or fistula.It has been at least 4 weeks since my last chemotherapy session.My brain cancer has been treated and I haven't taken steroids for over 10 days.I haven't been treated for metastatic disease, and if I had FOLFOX, I didn't relapse within 12 months.I haven't taken high-dose steroids or immunosuppressants recently.My liver enzyme AST levels are within the required range.I do not have serious heart conditions or recent major heart or stroke events.I have metastatic colorectal cancer, treated 0-2 times, and didn't worsen within 3 months after oxaliplatin.I am using or willing to use birth control during and after my treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Phase II, Arm II (3B-FOLFOX)
- Group 2: Phase II, Arm I (3B-FOLFOX)
- Group 3: Phase I (3B-FOLFOX)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.