Recruitment

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