Regorafenib and XmAb20717 in Treatment of High-risk Patients With Colorectal Cancer With Radiographic Occult Molecular Residual Disease After End of Established Definitive Therapy (RX-CROME)

Colorectal Cancer Clinical Trial

Official title: Regorafenib and XmAb20717 in Treatment of High-risk Patients With Colorectal Cancer With Radiographic Occult Molecular Residual Disease After End of Established Definitive Therapy (RX-CROME)

Status Withdrawn

Clinical Trial Summary

To measure the level of circulating tumor DNA (ctDNA) in the blood of colorectal cancer patients after 6 months of receiving therapy with regorafenib and XmAb20717 (also known as vudalimab). ctDNA is genetic material from tumor cells that can be found and measured in the blood

Clinical Trial Description

Primary Objective:

1. To determine the 6-month circulating tumor (ctDNA) clearance rate following 6 months of therapy with regorafenib and XmAb20717 (RX regimen) in patients with colorectal cancer (CRC) who present with radiographic occult molecular residual disease (MRD) after completing definitive standard-of-care (SOC) therapy.

Secondary Objectives:

1. To determine the 3-month ctDNA clearance rate following RX treatment.

2. To determine disease-free survival (DFS) following 6 months of RX treatment.

3. To determine overall survival (OS) following 6 months of RX treatment.

4. To determine the safety and tolerability of RX.

Exploratory Objectives:

1. To determine changes in profiles of circulating lymphocytes and ctDNA (including time to ctDNA negative status, duration of ctDNA negative status, overall ctDNA negative rate, lead time from ctDNA detection to radiographic detection) during and following treatment with RX.

2. To determine baseline characteristics in archival tumor and/or plasma that may predict clinical benefit or lack thereof (including but not limited to immune profiles of tumor-infiltrating lymphocytes, expression of immune markers in tumor cells and microenvironment, and tumor molecular profile). ;

Related Conditions & MeSH terms

• Colon Cancer
• Colorectal Cancer
• Colorectal Neoplasms
• Rectal Neoplasms
• Rectum Cancer

• NCT number: NCT05900648
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Withdrawn
• Phase: Phase 2
• Start date: May 17, 2023
• Completion date: February 9, 2024