Siltuximab and Spartalizumab in Patients With Metastatic Pancreatic Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Metastatic Pancreatic Adenocarcinoma
- Stage IV Pancreatic Cancer AJCC v8
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: Non-RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: Arm 1- (Phase I dose level 1)- Siltuximab 6 mg/Kg every 3 weeks and Spartalizumab 300mg every 3 weeks Arm 2- (Phase I dose level 2)- Siltuximab 11 mg/Kg every 3 weeks and spartalizumab 300 mg every 3weeks Arm 3 - (Phase I doe level 2a)- Siltuximab 9 mg/Kg every 3 weeks and spartalizumab 300 mg every 3weeks Arm 4- (Phase II)- Siltuximab RP2D determined in Arms 1 to 3 and spartalizumab 300 mg every 3weeksMasking: 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 spartalizumab and siltuximab. SECONDARY OBJECTIVES: I. Define the toxicity profile of the combination of the recommended phase II dose of spartalizumab and siltuximab. II. Evaluate the activity of the combination of...
PRIMARY OBJECTIVE: I. Determine the recommended phase II dose for the combination of spartalizumab and siltuximab. SECONDARY OBJECTIVES: I. Define the toxicity profile of the combination of the recommended phase II dose of spartalizumab and siltuximab. II. Evaluate the activity of the combination of spartalizumab and siltuximab in previously treated patients with pancreatic cancer. EXPLORATORY 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 siltuximab. Participants receive spartalizumab intravenously (IV) over 30 minutes on day 1 and siltuximab IV over 1 hour on day 1. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, participants are followed up at 30, 60, 90, 120, and 150 days, then every 12 weeks thereafter.
Tracking Information
- NCT #
- NCT04191421
- Collaborators
- Novartis
- EUSA Pharma, Inc.
- Investigators
- Principal Investigator: Bassel El-Rayes, MD Emory University