Combination Immunotherapy for Colorectal Cancer

(NEST-1 Trial)

Recruiting at 2 trial locations

Overseen By Myriam Elizaire-Williams

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Weill Medical College of Cornell University

Must not be taking: Immunosuppressives

Disqualifiers: Metastatic cancer, Active infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 4-8 weeks

36 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Manish Shah, M.D.

Principal Investigator

Weill Medical College of Cornell University

Eligibility Criteria

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.

Inclusion Criteria

If capable of becoming pregnant, or getting someone else pregnant, must be willing to use highly effective contraception from Screening period through 90 days following the last dose of study drug

I am 18 years old or older.

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

Exclusion Criteria

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

Pregnant or breastfeeding

My cancer has spread to other parts of my body.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 2 or 4 doses of balstilimab and a single dose of botensilimab intravenously, approximately 2 weeks apart, before surgical resection

4-8 weeks

Surgical Resection

Surgical resection occurs 1-6 weeks following the last dose of balstilimab

1-6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including post-op follow-up visits

90 days

1-2 visits (in-person)

Treatment Details

Interventions

• Balstilimab
• Botensilimab
• Surgical Removal of Tumor

Trial Overview 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.

Participant Groups

Group I: Cohort C: Experimental Treatment 2 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 Treatment 2 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.

Group III: Cohort A: Botensilimab and balstilimab (bot/bal) Experimental Treatment 2 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.

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

Agenus Inc.

Industry Sponsor

Trials

58

Recruited

4,900+