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Neoadjuvant Botensilimab and Balstilimab for the Treatment of Advanced Resectable Colorectal Cancer NEST3

Study acronym: NEST3
StatusRecruiting
PhasePhase 2
Started2026-12-27
View on ClinicalTrials.gov ↗

Amendment history

2026-06-29
minor
Study Status, Contacts/Locations v3
Study sitesdetails revised at 9 of 11 sites
2026-06-16
notable
Study Status, Contacts/Locations v2
Recruitment opened
Study sitesdetails revised at 11 of 11 sites
2026-05-22
minor
Study Identification, Study Status, Contacts/Locations v1
Study title+6 characters
Neoadjuvant Botensilimab and Balstilimab for the Treatment of Advanced Resectable Colorectal Cancer NEST3
2026-05-12
minor
Original filing
This phase II trial tests how well giving botensilimab and balstilimab prior or to surgery (neoadjuvent) works for the treatment of colorectal cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) and that can be removed by surgery (resectable) colorectal cancer. Immunotherapy with monoclonal antibodies, such as botensilimab and balstilimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving botensilimab and balstilimab before surgery may make the tumor smaller. Giving neoadjuvant botensilimab and balstilimab may be effective for the treatment of advanced resectable colorectal cancer.
Trial Details
NCT Number NCT07595874
Lead Sponsor City of Hope Medical Center
Collaborators: National Cancer Institute (NCI)
Conditions Advanced Colon Adenocarcinoma, Advanced Colorectal Adenocarcinoma, Advanced Rectal Adenocarcinoma, Stage IIB Colon Cancer AJCC v8, Stage IIB Rectal Cancer AJCC v8, Stage IIC Colon Cancer AJCC v8, Stage IIC Rectal Cancer AJCC v8, Stage IIIA Colon Cancer AJCC v8 +5 more
Enrollment 100 participants
Start Date 2026-12-27
Primary Completion 2027-05-27 (estimated)
Study Completion 2027-05-27 (estimated)
Updated on ClinicalTrials.gov 2026-07-01