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

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT06780787
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Balstilimab — BIOLOGICAL
    Given IV
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Botensilimab — BIOLOGICAL
    Given IV
  • Capecitabine — DRUG
    Given PO
  • Computed Tomography — PROCEDURE
    Undergo CT
  • Digital Rectal Examination — PROCEDURE
    Undergo digital rectal exam
  • Endoscopic Biopsy — PROCEDURE
    Undergo biopsy with endoscopic exam
  • Fluorouracil — DRUG
    Given IV
  • Leucovorin Calcium — DRUG
    Given IV
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Oxaliplatin — DRUG
    Given IV
  • Radiation Therapy — RADIATION
    Undergo radiation therapy
  • Sigmoidoscopy — PROCEDURE
    Undergo sigmoidoscopy

Study Details

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.

Key Dates

Start date
May 20, 2025
Status verified
Jun 2025
Primary completion
Nov 5, 2027
Completion
Nov 5, 2027

Study Design

Enrollment
26 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (FOLFOX, botensilimab, balstilimab)
    Patients receive leucovorin calcium IV over 2 hours, oxaliplatin IV over 2 hours, and fluorouracil IV over 46 hours on day 1 of each cycle. Patients also receive botensilimab IV over 60 minutes on day 1 of cycles 1 and 4 and balstilimab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 14 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Patients with complete clinical response may continue to receive balstilimab alone for an additional 12 cycles. Patients without complete clinical response may receive radiation therapy QD on weekdays and capecitabine PO BID concurrently on days of radiation therapy per standard of care. Additionally, patients undergo blood sample collection, biopsy with endoscopy exam, sigmoidoscopy, digital rectal exam, CT and MRI throughout the study.

Primary Outcome Measure

Complete clinical response (cCR) rate [ Time Frame: At 3 months after treatment ]

Locations (1)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010
Marwan Fakih
[email protected]
626-256-4673
Marwan Fakih (PRINCIPAL_INVESTIGATOR)

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City of Hope Medical Center· Duarte, CA

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