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Monoclonal Antibodies

Immunotherapy Combinations for Colorectal Cancer with Liver Metastases

Phase 2

Recruiting

Led By Manish Shah, M.D.

Research Sponsored by Weill Medical College of Cornell University

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 90 days following the last dose of study drug

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to study different combinations of immunotherapy in colorectal cancer patients with liver metastases who are undergoing surgery to remove the tumors. The trial will investigate if these immunotherapy combinations can change the

Who is the study for?

This trial is for adults with colorectal cancer that has spread to the liver and who are set to have surgery to remove these metastases. They must not be pregnant, agree to use contraception, and can't have had certain immune therapies or suffer from uncontrolled conditions like infections or heart disease.

What is being tested?

The study tests different immunotherapy combinations (Botensilimab, Balstilimab, AGEN1423) plus radiation in some groups before and after liver surgery. It aims to see how these treatments affect the tumor environment in the liver and if they're safe and effective.

What are the potential side effects?

Potential side effects may include typical reactions related to immunotherapies such as fatigue, skin reactions, inflammation of organs, flu-like symptoms, allergic reactions, and possibly complications from radiation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90 days following the last dose of study drug

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~90 days following the last dose of study drug

This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days following the last dose of study drug for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Mean CD8:Treg ratio, as determined by flow cytometry of tumor tissue, at time of surgical resection in each treatment arm

Secondary study objectives

Number of Participants Per Arm with ctDNA Clearance

Number of Treatment-Related Adverse Events (TRAEs) as assessed by CTCAE v5.0 per treatment arm

Pathological Response Rate Per Arm

+1 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: Botensilimab, Balstilimab, and RadiationExperimental Treatment3 Interventions

Participants will receive 3 doses of radiation prior to surgery. Additionally, two balstilimab infusions will be given prior to surgery and two infusions will be given after surgery, for a total of four doses. Each infusion will be scheduled approximately 3 weeks apart. On the same day as the first and third balstilimab infusions, botensilimab will also be given, for a total of two doses, one before and one after surgery.

Group II: Botensilimab, Balstilimab, and AGEN1423Experimental Treatment3 Interventions

Two balstilimab infusions will be given prior to surgery and two infusions will be given after surgery, for a total of four doses. On the same day as each balstilimab infusion, participants will also receive AGEN1423 infusions, for a total of four doses. Each infusion will be scheduled approximately 3 weeks apart. On the same day as the first and third balstilimab + AGEN1423 infusions, botensilimab will also be given, for a total of two doses, one before and one after surgery.

Group III: Botensilimab and BalstilimabExperimental Treatment2 Interventions

Two balstilimab infusions will be given prior to surgery and two infusions will be given after surgery, for a total of four doses. Each infusion will be scheduled approximately 3 weeks apart. On the same day as the first and third balstilimab infusions, botensilimab will also be given, for a total of two doses, one before and one after surgery.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Balstilimab

2023

Completed Phase 1

~20

Radiation

2003

Completed Phase 2

~780