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Monoclonal Antibodies
Triple Therapy for 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 2 years
Awards & highlights
Summary
This trial tests a combo of immunotherapy & targeted drugs to treat colorectal cancer that has spread. It may help the body's immune system attack cancer & inhibit tumor growth.
Who is the study for?
This trial is for adults with advanced colorectal cancer that's spread and hasn't responded to previous chemotherapy. Participants must be in good physical condition, able to take oral medication, have a life expectancy of at least 3 months, and use effective birth control if applicable. They can't join if they've had certain recent health issues or treatments, are on high-dose steroids or other immune-suppressing drugs, or have autoimmune diseases.
What is being tested?
The study tests a combination of botensilimab (an immunotherapy drug), balstilimab (another immunotherapy), and regorafenib (a drug that inhibits tumor growth) in patients with metastatic colorectal cancer. The goal is to see if this combo is more effective than the standard treatment alone.
What are the potential side effects?
Possible side effects include reactions related to the immune system attacking normal cells as well as typical chemotherapy effects like fatigue, digestive problems, skin reactions, liver issues, increased risk of infections and potential bleeding complications.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 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 dose limiting toxicities (DLT) (Phase I)
Overall response rate (ORR) (Phase II)
Recommended phase 2 dose of botensilimab, balstilimab, and regorafenib (Phase I)
Secondary study objectives
Incidence of DLTs (Phase I)
Incidence of toxicity (Phase II)
ORR (Phase I)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (botensilimab, balstilimab and regorafenib)Experimental Treatment5 Interventions
Patients receive botensilimab IV, balstilimab IV, and regorafenib PO on study. Patients also undergo CT and collection of blood throughout the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Computed Tomography
2017
Completed Phase 2
~2740
Biospecimen Collection
2004
Completed Phase 3
~2020
Regorafenib
2014
Completed Phase 2
~1600
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
596 Previous Clinical Trials
1,923,474 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,937 Total Patients Enrolled
Marwan G FakihPrincipal InvestigatorCity of Hope Medical Center
4 Previous Clinical Trials
235 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had COVID-19 within the specified timeframes.My cancer returned within 6 months after finishing chemotherapy.My colon or rectum cancer is advanced, spreading, and not responsive to certain DNA repair errors.I am 18 years old or older.I do not have an uncontrolled HIV infection or known hepatitis B or C.I can swallow and digest pills.I rely on IV for nutrition or hydration.I have previously received immunotherapy targeting PD-1, PD-L1, or CTLA-4.I am fully active and can carry on all pre-disease activities without restriction.I am not on steroids or immunosuppressants recently.My colorectal cancer is not MSI-High.I had a severe reaction to previous chemotherapy despite support.I have never had lung inflammation or scarring.I have another cancer besides colorectal that needs treatment or had another metastatic cancer recently.My cancer has worsened after treatment with specific chemotherapy drugs and targeted therapy.I do not have uncontrolled high blood pressure, recent blood clots, serious heart issues, bowel blockages, open wounds, or active bleeding.I have brain metastases but meet the specific exceptions.My condition worsened after my last treatment within the past 6 months.I have no liver metastases or have been free of liver metastases for at least 6 months.I am a woman who cannot become pregnant due to age or surgery.I haven't had surgery in the last 4 weeks, except for minor procedures like port placement.My cancer's RAS and BRAF status are known.I have 5 or fewer liver metastases.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (botensilimab, balstilimab and regorafenib)
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.
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