Botensilimab, Balstilimab and Regorafenib or Botensilimab and Balstilimab for the Treatment of Advanced or Metastatic Microsatellite Stable Colorectal Cancer

Sponsor
City of Hope Medical Center
Study ID
NCT06575725
Phase
PHASE2
Status
Withdrawn

Conditions

  • Advanced Colon Adenocarcinoma
  • Advanced Colorectal Adenocarcinoma
  • Advanced Rectal Adenocarcinoma
  • Metastatic Colon Adenocarcinoma
  • Metastatic Colorectal Adenocarcinoma
  • Metastatic Rectal Adenocarcinoma
  • Stage III Colon Cancer AJCC v8
  • Stage III Colorectal Cancer AJCC v8
  • Stage III Rectal Cancer AJCC v8
  • Stage IV Colon Cancer AJCC v8
  • Stage IV Colorectal Cancer AJCC v8
  • Stage IV Rectal Cancer AJCC v8

Eligibility Criteria

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

Interventions

  • Balstilimab — BIOLOGICAL
    Given IV
  • Biopsy — PROCEDURE
    Undergo biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Botensilimab — BIOLOGICAL
    Given IV
  • Computed Tomography — PROCEDURE
    Undergo CT
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Regorafenib — DRUG
    Given PO

Study Details

This phase II trial studies how well the combination of botensilimab, balstilimab and regorafenib works compared to botensilimab and balstilimab in treating patients with microsatellite stable colorectal cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). 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. Regorafenib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals tumor cells to multiply. This helps to slow or stop the spread of tumor cells. The combination of botensilimab, balstilimab and regorafenib or botensilimab and balstilimab may be a safe and effective treatment for advanced or metastatic microsatellite stable colorectal cancer.

Key Dates

Start date
Nov 1, 2024
Status verified
Nov 2024
Primary completion
Jan 28, 2027
Completion
Jan 28, 2027

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm BB (botensilimab, balstilimab)
    Patients receive botensilimab IV over 60 minutes on day 1 of each cycle and balstilimab IV over 30 minutes on days 1, 15, and 29 of each cycle. Cycles repeat every 42 days for up to 2 cycles of botensilimab and up to 2 years of balstilimab in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI and blood sample collection throughout the trial. Patients also undergo tumor biopsy during screening and on study.
  • Experimental: Arm BBR (botensilimab, balstilimab, regorafenib)
    Patients receive botensilimab IV over 60 minutes on day 1 of each cycle, balstilimab IV over 30 minutes on days 1, 15, and 29 of each cycle, and regorafenib PO QD on days 1-7, 15-21, and 29-35 of each cycle or on days 1-5, 15-19, and 29-33 of each cycle. Cycles repeat every 42 days for up to 2 cycles of botensilimab and up to 2 years of balstilimab and regorafenib in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI and blood sample collection throughout the trial. Patients also undergo tumor biopsy during screening and on study.

Primary Outcome Measure

Incidence of dose limiting toxicities (Safety lead in) [ Time Frame: During cycle 1 (42 days) ]

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