Trials / Withdrawn
WithdrawnNCT05900648
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- Withdrawn
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- M.D. Anderson Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Detailed 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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Regorafenib | Given by PO |
| DRUG | XmAb20717 | Given by (IV) vein |
Timeline
- Start date
- 2023-05-17
- Primary completion
- 2024-02-09
- Completion
- 2024-02-09
- First posted
- 2023-06-12
- Last updated
- 2024-04-29
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05900648. Inclusion in this directory is not an endorsement.