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

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 years 10 months later Sep 30, 2026 → Aug 28, 2029
See other at-risk trials from National Cancer Institute (NCI)

Record History

  1. Study sites: 1 to 2
  2. Study sites: 2 to 1
  3. Re-verified, no change to tracked fields
  4. Primary and study completion pushed from Sep 30, 2026 to Aug 28, 2029 Recruitment opened · Study sites: 1 to 2 Show 2 more changesShow less
    • Recruitment opened
    • Study sites: 1 to 2
  5. Trial status: Not Yet Recruiting to Recruiting Primary and study completion dates: Sep 30, 2026 to Aug 28, 2029 · Start date: Aug 14, 2026 to May 25, 2027 · Study sites: 0 to 1 · 3 more Show 6 more changesShow less
    • Primary and study completion dates: Sep 30, 2026 to Aug 28, 2029
    • Start date: Aug 14, 2026 to May 25, 2027
    • Study sites: 0 to 1
    • Eligibility criteria expanded, about 148 words
    • Secondary endpoints: details revised at 2 of 5 entries
    • Study description revised
Show 3 earlier versionsHide 3 earlier versions
  1. Start date: May 28, 2026 to Aug 14, 2026v4
  2. 2 versions Re-verified since May 2, 2026, no change to tracked fieldsv2-v3
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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/III colorectal adenocarcinoma. In addition, clearing the ctDNA from the blood may serve as an early indicator of treatment response.
Trial Details
NCT Number NCT07551596
Lead Sponsor National Cancer Institute (NCI)
Conditions Colorectal Adenocarcinoma, Stage II Colorectal Cancer AJCC v8, Stage III Colorectal Cancer AJCC v8
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov