Pembrolizumab and XL888 in Patients With Advanced Gastrointestinal Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Recurrent Colorectal Carcinoma
- Colorectal Adenocarcinoma
- Metastatic Pancreatic Adenocarcinoma
- Unresectable Pancreatic Carcinoma
- Recurrent Pancreatic Carcinoma
- Stage III Colorectal Cancer
- Stage III Pancreatic Cancer
- Stage IIIA Colorectal Cancer
- Stage IIIB Colorectal Cancer
- Stage IVA Pancreatic Cancer
- Stage IVB Colorectal Cancer
- Stage IV Colorectal Cancer
- Stage IVB Pancreatic Cancer
- Stage IV Pancreatic Cancer
- Stage IVA Colorectal Cancer
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-RandomizedIntervention 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 OBJECTIVE: I. Determine the recommended phase II dose for the combination of XL888 and pembrolizumab. SECONDARY OBJECTIVES: I. Define the toxicity profile of the combination of XL888 and pembrolizumab. II. Evaluate the activity of the combination of XL888 and pembrolizumab in previously trea...
PRIMARY OBJECTIVE: I. Determine the recommended phase II dose for the combination of XL888 and pembrolizumab. SECONDARY OBJECTIVES: I. Define the toxicity profile of the combination of XL888 and pembrolizumab. II. Evaluate the activity of the combination of XL888 and pembrolizumab in previously treated patients with gastrointestinal tumors. TERTIARY OBJECTIVE: I. Evaluate the effect of the combination on the immune profile in the serum and in tumor biopsies. OUTLINE: This is a dose-escalation study of Hsp90 inhibitor XL888. Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1 and XL888 orally (PO) on day 1, 4, 8, 11, 15, and 18. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days and periodically thereafter.
Tracking Information
- NCT #
- NCT03095781
- Collaborators
- Merck Sharp & Dohme Corp.
- Exelixis
- Investigators
- Principal Investigator: Bassel El-Rayes, MD Emory University/Winship Cancer Institute
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