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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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Balstilimab

    Biological/Vaccine

    Given IV

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

  • Botensilimab

    Biological/Vaccine

    Given IV

  • Computed Tomography

    Procedure/Surgery

    Undergo CT scan

  • Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo MRI

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Treatment (botensilimab and balstilimab)Experimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

Two-year disease-free survival rate

Defined as the percentage of patients that remain free from any signs of colon cancer at two years post-enrollment. Will be compared to the historical control rate of 76.8% (from the FoXTROT adjuvant chemotherapy arm) using a one-sided, one-sample log-rank test.

Time frame
At 2 years post enrollment

Secondary outcomes

1

Major pathologic response rate

Defined as the proportion of patients achieving major pathologic responses defined as either a \>= 90% tumor reduction or 100% reduction (near complete response + pathologic complete response). Will be compared with the historical control rate of 10% using a one-sided, continuity corrected Z-test.

Time frame
Up to 3 years
2

Incidence of adverse events

Assessed according to Common Terminology Criteria for Adverse Events version 6.0. Will be summarized using descriptive statistics.

Time frame
Up to 3 years
3

Pathologic response rate

Defined as the proportion of patients achieving a pathologic response, defined as a ≥ 50% tumor reduction.

Time frame
Up to 3 years
4

Three-year disease-free survival rate

Defined as the percentage of patients that remain free from any signs of colon cancer at three years post-enrollment. Will be summarized similar to 2-year survival but at the 3-year mark.

Time frame
At 3 years post-enrollment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

City of Hope Medical Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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