Testing the Combination of Anti-Cancer Drugs, Botensilimab (AGEN1181) and Balstilimab (AGEN2034), After Standard Treatment for Colorectal Cancer, Combat Trial

This phase II trial tests the effect of the botensilimab in combination with balstilimab in treating patients with stage II/III colorectal adenocarcinoma with detectable circulating tumor (ct) deoxyribonucleic acid (DNA) in the blood. Immunotherapy with monoclonal antibodies, such as botensilimab and balstilimab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Giving botensilimab and balstilimab may be an effective combination to remove any remaining microscopic cancer cells in the bloodstream in patients with stage II/I

Trial Details

NCT ID
NCT07551596
Phase
PHASE2
Sponsor
National Cancer Institute (NCI)
Status
RECRUITING
Cancer Type
Colorectal Cancer
Interventions
  • Balstilimab
  • Biopsy Procedure
  • Biospecimen Collection
  • Botensilimab
  • Radiographic Examination
Locations (sample)
  • New Orleans, Louisiana, United States|29.95465,-90.07507
  • Houston, Texas, United States|29.76328,-95.36327

Key Eligibility Criteria

  • Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of botensilimab (AGEN1181) in combination with balstilim…
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 (or Karnofsky ≥ 60%)
  • Absolute neutrophil count ≥ 1,000/mcL
  • Platelets ≥ 100,000/mcL

For full eligibility, visit ClinicalTrials.gov.

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