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Monoclonal Antibodies

Combination Immunotherapy for Colorectal Cancer (NEST-1 Trial)

Phase 2

Recruiting

Led By Pashtoon Kasi, 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

18 years of age or older

Stage 1-3 adenocarcinoma of the colon with plans to have a surgical resection

Must not have

Previous treatment with immune checkpoint inhibitors targeting CTLA-4, PD-1 or PD-L1

Metastatic cancer (cancer that has spread to other parts of the body)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing two special drugs that help the immune system fight a specific type of cancer. The drugs are given to see if they can shrink the cancer. The study focuses on patients who might not respond well to other treatments. The goal is to see if these drugs are safe and effective.

Who is the study for?

This trial is for adults with early-stage (1-3) colorectal cancer who are planning to have surgery. They must use effective contraception if they can become or get someone pregnant. It's not for those with metastatic cancer, previous immune checkpoint inhibitor treatments, active infections needing treatment, other ongoing clinical trials participation, pregnancy or breastfeeding, on immunosuppressants, or serious heart conditions.

What is being tested?

The study tests a combination of two investigational drugs: balstilimab and botensilimab—both targeting the immune system—to see their effects on colorectal cancer before surgical tumor removal. Participants will receive these drugs intravenously over an 8-week period prior to surgery.

What are the potential side effects?

Potential side effects include reactions related to the immune system such as inflammation in various organs, infusion-related reactions from the IV administration process itself, fatigue, possible digestive issues due to gut inflammation and increased risk of infections.

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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I have stage 1-3 colon cancer and plan to have surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been treated with drugs targeting CTLA-4, PD-1, or PD-L1.

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My cancer has spread to other parts of my body.

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I am currently in another study and taking a study drug.

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I am taking medication that weakens my immune system.

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I do not have recent serious heart problems or uncontrolled heart rhythm issues.

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I am currently being treated for an infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Cohort A and B: Pathological overall response (pOR) rate determined by analysis of tissue resected during surgery reported by cohort

Cohort A: Number of participants who experience potentially treatment-related SAEs according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 at 90 days following the last treatment with balstilimab or botensilimab

Cohort A: Number of participants who experience treatment-related complications leading to delays of 12 weeks or more in surgery after treatment initiation (Day 0)

+1 more

Secondary study objectives

All Cohorts: Changes in Minimal Residual Disease assessed using ctDNA pre- and 30 days post-surgical resection

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: Cohort C:Experimental Treatment2 Interventions

Botensilimab and balstilimab are both monoclonal antibodies that are administered intravenously. Four doses of balstilimab (240 mg IV), will be administered approximately 2 weeks apart. A single dose of botensilimab (75 mg IV) will be administered on the same day as the first dose of balstilimab. Surgical resection will occur 1-6 weeks following the fourth dose of balstilimab. Cohort C only includes patients with dMMR/MSI-High colorectal cancer.

Group II: Cohort B:Experimental Treatment2 Interventions

Group III: Cohort A: Botensilimab and balstilimab (bot/bal)Experimental Treatment2 Interventions

Botensilimab and balstilimab are both monoclonal antibodies that are administered intravenously. Two doses of balstilimab (240 mg IV), will be administered approximately 2 weeks apart. A single dose of botensilimab (75 mg IV) will be administered on the same day as the first dose of balstilimab. Surgical resection will occur 1-6 weeks following the second dose of balstilimab.

0 / 8Eligibility criteria met