Regorafenib and Pembrolizumab in Treating Participants With Advanced or Metastatic Colorectal Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Colorectal Cancer
- Colorectal Cancer Metastatic
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVES: I. To assess safety of the combination and identification of the recommended dose (RD) for combination therapy. (Phase I) II. To evaluate preliminary efficacy and tolerability of the combination RD of regorafenib and pembrolizumab. (Phase II) EXPLORATORY OBJECTIVES: I. The associ...
PRIMARY OBJECTIVES: I. To assess safety of the combination and identification of the recommended dose (RD) for combination therapy. (Phase I) II. To evaluate preliminary efficacy and tolerability of the combination RD of regorafenib and pembrolizumab. (Phase II) EXPLORATORY OBJECTIVES: I. The associations between biomarkers and clinical outcome will be investigated. OUTLINE: This is a phase I, dose-escalation study of regorafenib followed by a phase II study. Participants receive pembrolizumab intravenously (IV) over 30 minutes on day 1 and regorafenib orally (PO) once daily (QD) on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, participants are followed up periodically.
Tracking Information
- NCT #
- NCT03657641
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Afsaneh Barzi, MD University of Southern California
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