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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

NEST-1 Trial Summary

This trial is testing a new combination therapy for colorectal cancer patients before surgery. The two drugs given target the immune system and the study will observe any side effects and the efficacy of the treatment.

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.Check my eligibility
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.See study design
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.

NEST-1 Trial 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.

NEST-1 Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
All Cohorts: Changes in Minimal Residual Disease assessed using ctDNA pre- and 30 days post-surgical resection

NEST-1 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
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 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.

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor
1,057 Previous Clinical Trials
1,317,441 Total Patients Enrolled
Agenus Inc.Industry Sponsor
51 Previous Clinical Trials
4,699 Total Patients Enrolled
Pashtoon Kasi, M.D.Principal InvestigatorWeill Medical College of Cornell University

Media Library

Balstilimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05571293 — Phase 2
Colorectal Cancer Research Study Groups: Cohort A: Botensilimab and balstilimab (bot/bal), Cohort B:, Cohort C:
Colorectal Cancer Clinical Trial 2023: Balstilimab Highlights & Side Effects. Trial Name: NCT05571293 — Phase 2
Balstilimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05571293 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the Food and Drug Administration sanctioned Botensilimab and balstilimab for general use?

"Our team at Power assigned a safety rating of 2 to the combination of Botensilimab and balstilimab (bot/bal), as Phase 2 trials provide evidence regarding safety but not efficacy."

Answered by AI

Are there still openings to join this research endeavor?

"Based on the clinicaltrials.gov page, this trial is no longer recruiting candidates and was last updated on October 4th 2022. However, there are 859 other trials currently seeking volunteers to participate in their research efforts."

Answered by AI

Who else is applying?

What site did they apply to?
Weill Cornell Medicine/NewYork-Presbyterian Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I believe that a clinical trial should be considered as the tumors in my lungs are growing despite every week chemo.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

Is there a Hope Village/Hope Lodge near the Clinical Trials?
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Combination Immunotherapy in Colorectal Cancer
2023. "Combination Immunotherapy in Colorectal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05571293.
All > Colorectal Cancer > Bowel Cancer
~16 spots leftby May 2025
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