What side effects are associated with this type of intervention?

Common treatments for colorectal cancer, such as chemotherapy (e.g., FOLFOX regimen) and targeted therapies (e.g., cetuximab), often result in side effects like diarrhea, mucositis, neutropenia, and infusion-related reactions. Immune checkpoint inhibitors, including anti-CTLA-4 antibodies like Botensilimab, can cause immune-related adverse events such as skin reactions, endocrine disorders, and colitis. These treatments can also lead to severe side effects like pneumonitis, hepatitis, and nephritis, which may require discontinuation of therapy.

What prior FDA approvals exist?

The FDA has approved several immunotherapy drugs for the treatment of colorectal cancer, particularly those targeting immune checkpoints. Notably, pembrolizumab (Keytruda) and nivolumab (Opdivo) are anti-PD-1 antibodies approved for microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer. Additionally, the combination of nivolumab and ipilimumab (Yervoy), an anti-CTLA-4 antibody, has been approved for the same indication. These treatments are similar to botensilimab, which is also an anti-CTLA-4 antibody being studied for its efficacy in colorectal cancer.

What other types of research exist?

Promising novel alternatives to Botensilimab for colorectal cancer patients include the combination of FOLFIRI or FOLFOX with panitumumab or bevacizumab. These combinations have shown improved response rates and survival benefits in clinical trials. Additionally, radiotherapy is becoming an alternative for selected patients where surgery is not an option.

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Monoclonal Antibodies

Botensilimab + Balstilimab for Colorectal Cancer

Phase 2

Waitlist Available

Research Sponsored by Agenus Inc.

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 first dose through up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests botensilimab alone or with balstilimab in adults with advanced colorectal cancer who didn't respond to previous chemotherapy. The new drugs aim to enhance the immune system's ability to fight cancer.

Who is the study for?

This trial is for adults with metastatic colorectal cancer that's unremovable and has worsened after at least one chemotherapy regimen. They must have tried specific standard treatments, be in good physical condition (ECOG 0 or 1), and have a life expectancy of at least 12 weeks. Women should not be pregnant, and men must use contraception if their partners can bear children.

What is being tested?

The study tests botensilimab alone or combined with balstilimab/standard care in patients with refractory metastatic colorectal cancer. It's an open-label Phase 2 trial to see how well these treatments work, how safe they are, what side effects occur, and how the body processes the drugs.

What are the potential side effects?

Potential side effects may include immune-related reactions due to botensilimab/balstilimab stimulating the immune system against cancer cells. This could lead to inflammation in various organs, infusion reactions similar to allergic responses during drug administration, fatigue from treatment burden on the body, digestive issues like nausea or diarrhea.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ first dose through up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~first dose through up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and first dose through up to 3 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Objective Response Rate

Secondary study objectives

Duration of Response

Overall Survival

Progression-free Survival

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups

Experimental Treatment

Active Control

Group I: Monotherapy Botensilimab Dose 2Experimental Treatment1 Intervention

Participants will receive botensilimab dose 2 given IV.

Group II: Monotherapy Botensilimab Dose 1Experimental Treatment1 Intervention

Participants will receive botensilimab dose 1 given IV.

Group III: Combination Botensilimab Dose 2 plus BalstilimabExperimental Treatment2 Interventions

Participants will receive botensilimab at dose 2 given IV and balstilimab given IV.

Group IV: Combination Botensilimab Dose 1 plus BalstilimabExperimental Treatment2 Interventions

Participants will receive botensilimab at dose 1 given IV and balstilimab given IV.

Group V: Standard of CareActive Control1 Intervention

Participants will receive select standard of care as determined by the investigator.

Do I qualify?Apply below to find out

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, targeted therapy, and immunotherapy. Chemotherapy uses drugs to kill rapidly dividing cancer cells, while targeted therapy focuses on specific molecules involved in cancer growth, such as VEGF or EGFR. Immunotherapy, including checkpoint inhibitors like Botensilimab (an anti-CTLA-4 antibody), works by enhancing the immune system's ability to recognize and destroy cancer cells. Botensilimab blocks CTLA-4, a protein that downregulates immune responses, thereby boosting T-cell activity against cancer cells. This is particularly important for colorectal cancer patients as it offers a potential treatment option for those with refractory metastatic disease, where traditional therapies may have failed.

Towards therapeutic vaccines for colorectal carcinoma: a review of clinical trials.