SUSPENDED

Combination Immunotherapy in Colorectal Cancer

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a pilot study to see whether a combination of two investigational drugs that target the immune system can be given to people with colorectal cancer before surgically removing the tumor. This study is also being done to see what side effects this combination of drugs has and what effect they have on colorectal cancer. The two monoclonal antibodies are balstilimab, a programmed cell death protein 1 (PD-1) inhibitor, and botensilimab, a cytotoxic T lymphocyte-associated protein 4 (CTLA-4) inhibitor. This study has 3 cohorts. Participants in Cohort A will receive a total of 2 doses of balstilimab and a single dose of botensilimab, both given intravenously (IV), before surgery. Participants in Cohort B and C will receive a total of 4 doses of balstilimab and a single dose of botensilimab, both given intravenously (IV), before surgery. Participants in Cohort C must have dMMR/MSI-High colorectal cancer.

Official Title

Novel Exploratory Study to Test Combination of Botensilimab and Balstilimab Immunotherapy in Resectable Colorectal Cancer Patients

Quick Facts

Study Start:2023-03-17
Study Completion:2026-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:SUSPENDED

Study ID

NCT05571293

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18 years of age or older
  2. * Histologically, cytologically, or clinically confirmed adenocarcinoma of the colon or rectal cancer as long as there is no plans for neoadjuvant radiation for the patients with rectal cancer. Note: patients can enroll in cohort B while awaiting mismatch repair testing results. If noted to be dMMR/MSI-High, they would be still considered evaluable and moved to cohort C.
  3. * 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
  1. * Metastatic cancer (cancer that has spread to other parts of the body)
  2. * Previous treatment with immune checkpoint inhibitors targeting CTLA-4, PD-1 or PD-L1
  3. * Currently participating in another study and receiving a study drug
  4. * History of severe allergic reactions to immunotherapies
  5. * Pregnant or breastfeeding
  6. * Active infection requiring treatment
  7. * On immunosuppressive medications
  8. * Active cardiovascular disease, such as stroke or myocardial infarction within 6 months of enrollment, unstable angina, congestive heart failure, or serious uncontrolled cardiac arrhythmia requiring medication that may prevent surgery

Contacts and Locations

Principal Investigator

Manish Shah, M.D.
PRINCIPAL_INVESTIGATOR
Weill Medical College of Cornell University

Study Locations (Sites)

Weill Cornell Medicine/New York-Presbyterian Brooklyn Methodist Hospital
Brooklyn, New York, 11215
United States
Weill Cornell Medicine/NewYork Presbyterian - Queens
Flushing, New York, 11355
United States
Weill Cornell Medicine/NewYork-Presbyterian Hospital
New York, New York, 10021
United States

Collaborators and Investigators

Sponsor: Weill Medical College of Cornell University

  • Manish Shah, M.D., PRINCIPAL_INVESTIGATOR, Weill Medical College of Cornell University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-17
Study Completion Date2026-06

Study Record Updates

Study Start Date2023-03-17
Study Completion Date2026-06

Terms related to this study

Keywords Provided by Researchers

  • Immunotherapy
  • Colorectal Cancer
  • PD-1
  • CTLA-4

Additional Relevant MeSH Terms

  • Colorectal Neoplasms