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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 below
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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 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

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 more

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
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

Balstilimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05627635 — Phase 1 & 2
Colorectal Cancer Research Study Groups: Phase II, Arm II (3B-FOLFOX), Phase II, Arm I (3B-FOLFOX), Phase I (3B-FOLFOX)
Colorectal Cancer Clinical Trial 2023: Balstilimab Highlights & Side Effects. Trial Name: NCT05627635 — Phase 1 & 2
Balstilimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05627635 — Phase 1 & 2

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."

Answered by AI
~47 spots leftby Apr 2025