Study on FOLFOX, Botensilimab, and Balstilimab for Treating Localized Rectal Cancer Before Surgery

Sponsor: City of Hope Medical Center

Sponsor score: 40

ClinicalTrials ID:NCT06780787

Provider View

This clinical trial is exploring a new treatment approach using a combination of chemotherapy and immunotherapy drugs before surgery to treat patients with localized rectal cancer. The goal is to see if this combination can improve treatment outcomes and reduce the need for surgery.

Patient Parameters

Program Overview

This study is testing a combination of chemotherapy drugs (fluorouracil, oxaliplatin, and leucovorin calcium) with two immunotherapy drugs (botensilimab and balstilimab) given before surgery to treat rectal cancer that hasn't spread. The aim is to see if this approach can increase the number of patients who have a complete response, meaning no signs of cancer, and potentially reduce the need for surgery and radiation. Chemotherapy works by stopping cancer cells from growing, while immunotherapy helps the immune system attack cancer cells. This combination might improve treatment results for patients with localized rectal cancer.

Description

The main goal of this study is to find out how many patients with localized rectal cancer have a complete response to the treatment combination of FOLFOX (a chemotherapy regimen) with botensilimab and balstilimab (immunotherapy drugs) before surgery.

Secondary goals include evaluating the safety of this treatment, estimating how long patients remain free of cancer, and how long they live after treatment. Researchers will also look at how the treatment affects the cancer environment and track certain blood markers to see if they relate to treatment success.

Participants will receive the chemotherapy drugs intravenously (IV) on the first day of each treatment cycle, which repeats every 14 days for up to 8 cycles. They will also receive botensilimab and balstilimab at specific times during the cycles. If the cancer responds completely, patients may continue with balstilimab alone for additional cycles. If not, they may receive radiation and another chemotherapy drug, capecitabine, as part of standard care. Throughout the study, patients will have regular blood tests, scans, and exams to monitor their progress.

After finishing the treatment, patients will have follow-up visits at 30 and 90 days, then every 3 months for the first year, and every 6 months for up to 2 years.

Eligibility Criteria

Inclusion Criteria

  • Must provide informed consent to participate.
  • Agree to use tissue samples from previous tumor biopsies.
  • Be 18 years or older.
  • Have a confirmed diagnosis of rectal adenocarcinoma.
  • Cancer must be located within 12 cm from the anal verge.
  • Tumor must be at least 3mm away from the mesorectal fascia, with no more than 4 lymph nodes larger than 1 cm.
  • Cancer stage must be T3N0, or TxN1 or TxN2 based on MRI.
  • No signs of cancer spread to distant organs.
  • Have adequate blood cell counts and organ function.
  • Women of childbearing potential must have a negative pregnancy test and agree to use birth control during the study and for a specified time after treatment.
  • Men must agree to use birth control or abstain from sexual activity during the study and for a specified time after treatment.

Exclusion Criteria

  • Any previous treatment for rectal cancer, including chemotherapy, radiation, or immunotherapy.
  • Need for systemic steroids or immunosuppressive medication recently.
  • Previous organ transplant.
  • Recent major surgery, except minor procedures.
  • Other active cancers, except certain skin, cervical, or prostate cancers.
  • Unstable heart disease or recent heart attack.
  • Serious uncontrolled illness.
  • Pregnant or breastfeeding women.
  • Allergic reactions to study drugs.
  • Active autoimmune disease needing treatment recently.
  • Recent blood clots unless on treatment and symptom-free.
  • Lung disease or history of lung inflammation needing treatment.
  • Mental health or substance abuse issues affecting study participation.
  • Recent severe COVID-19 infection.
  • Uncontrolled HIV, hepatitis B, or hepatitis C infections.
  • Severe nerve damage.
  • Dependence on IV nutrition or hydration.
  • Any condition that might make study participation unsafe or difficult.

Locations

FACILITYZIPCITYSTATE
City of Hope Medical Center91010DuarteCalifornia

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.