Health Trials

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

ConditionsAdvanced Colon AdenocarcinomaAdvanced Colorectal AdenocarcinomaAdvanced Rectal AdenocarcinomaStage IIB Colon Cancer AJCC v8Stage IIB Rectal Cancer AJCC v8Stage IIC Colon Cancer AJCC v8Stage IIC Rectal Cancer AJCC v8Stage IIIA Colon Cancer AJCC v8Stage IIIA Rectal Cancer AJCC v8Stage IIIB Colon Cancer AJCC v8Stage IIIB Rectal Cancer AJCC v8Stage IIIC Colon Cancer AJCC v8Stage IIIC Rectal Cancer AJCC v8
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCity of Hope Medical Center

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 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.

Eligibility criteria

Qualifiers

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 future surgery and standard of care biopsies

Age: ≥ 18 years

Disqualifiers

Any treatment for colorectal cancer prior to enrollment that includes (but not limited to) chemotherapy, surgery, radiation, immunotherapy and/or biological therapy.

Note: Surgical intervention e.g. a diverting ostomy to relieve an obstruction from colorectal cancer, those patients will be allowed to enter the study as long as no distant metastatic disease

Patients with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) within 14 days or another immunosuppressive medication within 30 days of the first dose of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease

Prior allogeneic organ transplantation

Trial design

Treatments tested in this trial

  • Balstilimab
  • Biospecimen Collection
  • Botensilimab
  • Computed Tomography
  • Magnetic Resonance Imaging

Treatment groups

100 Participants
are divided into 1 treatment group

Sponsors and collaborators

City of Hope Medical Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov