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Novel Exploratory Study to Test combination of Botensilimab and Balstilimab Immunotherapy in Patients with Resectable Colorectal Cancer (NEST-1)

Clinical Trial Details

This clinical trial is for men and women with colorectal cancer who are going to undergo surgery to remove the cancer.
   
The purpose of this study is to evaluate the safety and effectiveness of a combination of the drugs botensilimab and balstilimab given before a participant’s standard of care surgery to remove their tumor.

Botensilimab and balstilimab are experimental, which means that they are being tested and are not yet approved by the United States Food and Drug Administration (FDA).
   
Some cancer cells may still remain in the body despite surgery and these cells could begin to grow again. New drugs like botensilimab and balstilimab work to block signals that stop the body’s immune system from killing cancer. This study aims to determine whether giving these drugs before surgery may help the participant’s immune system kill any remaining cancer cells.
   
In this study, botensilimab and balstilimab will be given intravenously (meaning through a needle in the vein directly into the blood). Botensilimab and balstilimab will be given separately, one after another, during the first study drug visit. Each infusion will take approximately 30 minutes. About two weeks after the first study drug visit, participants will receive a second dose of balstilimab.

Participants will schedule their surgery to remove their tumor 1 to 6 weeks after their second dose of balstilimab. Every 2 weeks after the second dose of balstilimab until the surgery, participants will come into the clinic for blood draws.
   
Participation is expected to last up to 6 months. During that time, participants will have about 5-6 study visits, in addition to their surgery to remove their tumor.

Key Eligibility: 
  1. Men and women with a confirmed adenocarcinoma of the colon
  2. Plans for surgical resection of their cancer

Detailed eligibility reviewed when participant contacts the study team

Study contact by location

Upper East Side - Manhattan

Contact(s)

Carina Puello, RN
(646) 962-3541
cap4008@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2209025238

ClinicalTrials.gov:

NCT05571293

Sponsor:

NEST-1

Status

Open to Enrollment

Age Group

Adult

Sponsor