Trials / Withdrawn

WithdrawnNCT06575725

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

A Phase 2 Study of Botensilimab, Balstilimab and Regorafenib in Patients With Microsatellite Stable Colorectal Cancer

Status: Withdrawn
Phase: Phase 2
Study type: Interventional
Enrollment: 0 (actual)

Sponsor: City of Hope Medical Center · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

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.

Detailed description

COPRIMARY OBJECTIVES: I. Determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of botensilimab, balstilimab and regorafenib (BBR) in microsatellite stable (MSS) metastatic colorectal cancer (mCRC) patients without metastatic liver lesions in the safety run-in. (Safety lead-in) II. Compare the overall response rate in microsatellite stable (MSS) metastatic colorectal cancer (mCRC) patients without metastatic liver lesions receiving botensilimab, balstilimab and regorafenib (BBR) versus botensilimab and balstilimab (BB), by treatment arm. (Phase II) SECONDARY OBJECTIVES: I. Estimate the overall survival in MSS mCRC patients without metastatic liver lesions receiving BBR and BB, by treatment arm. II. Estimate the progression free survival in MSS mCRC patients without metastatic liver lesions receiving BBR and BB, by treatment arm. III. Estimate the duration of response (DOR) in MSS mCRC patients without metastatic liver lesions receiving BBR and BB that experience a response to therapy, by treatment arm. IV. Describe the safety of giving to BBR and BB to patients with MSS mCRC without metastatic liver lesions, by treatment arm. EXPLORATORY OBJECTIVE: I. Through the performance of baseline and on treatment biopsies and serial blood work (cytokines and flow cytometry), explore potential biomarkers of response to BBR and BB therapy given to MSS mCRC patients without metastatic liver lesions, by treatment arm. OUTLINE: Patients are randomized to 1 of 2 arms. ARM BBR: Patients receive botensilimab intravenously (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 orally (PO) once daily (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 computed tomography (CT) or magnetic resonance imaging (MRI) and blood sample collection throughout the trial. Patients also undergo tumor biopsy during screening and on study. ARM BB: 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. After completion of study treatment, patients are followed up at 30 and 90 days and then every 2-3 months for 5 years.

Conditions

Interventions

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

Timeline

Start date: 2024-11-01
Primary completion: 2027-01-28
Completion: 2027-01-28
First posted: 2024-08-28
Last updated: 2024-11-21

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT06575725. Inclusion in this directory is not an endorsement.