Neoadjuvant Botensilimab and Balstilimab for the Treatment of Advanced Resectable Colorectal Cancer NEST3
Recruiting
Phase 2
Interventional Study
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
Stage IIIA Rectal Cancer AJCC v8
Stage IIIB Colon Cancer AJCC v8
Stage IIIB Rectal Cancer AJCC v8
Stage IIIC Colon Cancer AJCC v8
Stage IIIC Rectal Cancer AJCC v8
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 100 (estimated)
- Sponsor
- City of Hope Medical Center · Other
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About This Trial
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 …
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Documented informed consent of the participant and Legally Authorized Representative (when applicable)
* Assent, when appropriate, will be obtained and documented for adults lacking capacity per institutional guidelines
* Agreement to allow the use of tissue from past and f…
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