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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
Age: >= 18 years
Patients should have a pathologically proven diagnosis of colorectal adenocarcinoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial tests a drug combo to treat colorectal cancer that has spread. Chemotherapy drugs, antiangiogenic agents, and monoclonal antibodies may help slow tumor growth and spread.
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.Check my eligibility
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.See study design
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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My diagnosis is colorectal adenocarcinoma.
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I am fully active and can carry on all pre-disease activities without restriction.
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I have never had a perforation or fistula.
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My colon or rectum cancer is confirmed to be microsatellite stable.
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I have not had periods for 2 years, haven't had a hysterectomy or oophorectomy, and my hormone levels are in the postmenopausal range.
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I have had a hysterectomy, both ovaries removed, or my tubes tied.
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I am over 50 and have not had a period for more than a year.
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I have metastatic colorectal cancer, treated 0-2 times, and didn't worsen within 3 months after oxaliplatin.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events (phase I)
Overall response (phase II)
Secondary outcome measures
Duration of response (phase II)
Incidence of adverse events (phase II)
OS (phase II)
+5 moreTrial 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
Positron Emission Tomography
2008
Completed Phase 2
~2260
Bevacizumab
2013
Completed Phase 4
~5280
Fluorouracil
2014
Completed Phase 3
~11540
Magnetic Resonance Imaging
2017
Completed Phase 3
~1180
Oxaliplatin
2011
Completed Phase 4
~2560
Computed Tomography
2017
Completed Phase 2
~2790
Leucovorin Calcium
2011
Completed Phase 3
~12290
Biospecimen Collection
2004
Completed Phase 2
~1920
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
561 Previous Clinical Trials
1,918,166 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,927,261 Total Patients Enrolled
Marwan G FakihPrincipal InvestigatorCity of Hope Medical Center
3 Previous Clinical Trials
128 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this trial actively recruiting participants?
"Clinicaltrials.gov does not indicate that this study is currently recruiting participants, as the posting was first published on April 1st 2023 and revised most recently on November 17th 2022. However, there are 1577 other trials actively seeking patients at present."
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