NCT06780787View on ClinicalTrials.gov

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

PHASE2RecruitingINTERVENTIONAL
Enrollment

26

Participants

Timeline

Start Date

May 20, 2025

Primary Completion Date

November 5, 2027

Study Completion Date

November 5, 2027

Conditions
Rectal AdenocarcinomaStage IIA Rectal Cancer AJCC v8Stage 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

Trial Locations (1)

91010

RECRUITING

City of Hope Medical Center, Duarte

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

City of Hope Medical Center

OTHER