FOLFOX, Botensilimab, and Balstilimab for the Treatment of Localized Rectal Cancer Before Surgery

Summary

This phase II trial tests how well fluorouracil, oxaliplatin and leucovorin calcium (folinic acid) (FOLFOX) with botensilimab and balstilimab given before surgery (neoadjuvant) works in treating patients with rectal adenocarcinoma that has not spread to other parts of the body (localized). Currently, neoadjuvant therapy for rectal cancer includes chemotherapy and chemoradiation. Despite these aggressive treatments, only about half of patients achieve a complete clinical response. In fact, over half of rectal cancer patients go on to have surgery and often suffer post-surgery complications involving urine and bowel problems. Thus, there has been an increased focus on non-surgical treatments. Chemotherapy drugs, such as fluorouracil, oxaliplatin and leucovorin calcium, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. 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 neoadjuvant FOLFOX with botensilimab and balstilimab may improve the rate of complete response and decrease the need for surgery and radiation therapy in patients with localized rectal adenocarcinoma.

Conditions

• Rectal Adenocarcinoma
• Stage IIA Rectal Cancer AJCC v8
• Stage III Rectal Cancer AJCC v8

Interventions

BIOLOGICAL

Balstilimab

Given IV

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

BIOLOGICAL

Botensilimab

Given IV

DRUG

Capecitabine

Given PO

PROCEDURE

Computed Tomography

Undergo CT

PROCEDURE

Digital Rectal Examination

Undergo digital rectal exam

PROCEDURE

Endoscopic Biopsy

Undergo biopsy with endoscopic exam

DRUG

Fluorouracil

Given IV

DRUG

Leucovorin Calcium

Given IV

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

DRUG

Oxaliplatin

Given IV

RADIATION

Radiation Therapy

Undergo radiation therapy

PROCEDURE

Sigmoidoscopy

Undergo sigmoidoscopy

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• City of Hope Medical Center

  lead OTHER

Principal Investigators

• Marwan Fakih · City of Hope Medical Center

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-05-20

Primary Completion

2027-11-05

Completion

2027-11-05

FDA Drug

Yes

Countries

• United States

Study Locations