Clinical trialPhase 1 / Phase 2Completed
Siltuximab and Spartalizumab in Patients With Metastatic Pancreatic Cancer
A Phase Ib/II Trial of Siltuximab and Spartalizumab in Metastatic Pancreatic Cancer
- Outcome
- Outcome unknown
- Phase
- Phase 1 / Phase 2
- Status
- Completed
- Study type
- Interventional
- Start
- 17 January 2020
- Expected end
- 5 April 2023
- Enrollment
- 35 participants
- Sites
- 3
- Primary outcomes
- Maximal Tolerated Dose (MTD) of Siltuximab That Can be Combined With Spartalizumab
- Sponsor
- Other
- Results posted
- 2025-08-22
- Last update
- 22 August 2025
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Brief summary public domain (ClinicalTrials.gov)
This phase Ib/II trial studies the best dose and side effects of siltuximab and how well it works in combination with spartalizumab in treating patients with pancreatic cancer that has spread to other places in the body. Monoclonal antibodies, such as siltuximab and spartalizumab, interfere with the ability of tumors cells to grow and spread.
Detailed description public domain (ClinicalTrials.gov)
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.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Maximal Tolerated Dose (MTD) of Siltuximab That Can be Combined With Spartalizumab [Up to 6 weeks from study start]. Number, mg/kg. Treatment Spartalizumab and Siltuximab Phase I Dose Level 1 (n=35): 11.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Overall Response Rate (ORR) [Up to 2 years from study start]. Number, percentage of participants (95% Confidence Interval). Treatment Spartalizumab and Siltuximab Phase I Dose Level 1 (n=4): 0 (0 to 0); Treatment Spartalizumab and Siltuximab RP2D (n=31): 0 (0 to 0).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Response Duration [From treatment start until progression or death, assessed up to 2 years].
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Progression-free Survival [From treatment start until progression or death, assessed up to 2 years]. Median, months (95% Confidence Interval). Treatment Spartalizumab and Siltuximab Phase I Dose Level 1 (n=4): 1.9 (1.6 to NA) [Upper CI was non-evaluable due to insufficient participants with events for DL-1.]; Treatment Spartalizumab and Siltuximab RP2D (n=31): 2.1 (1.5 to 2.2).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Overall Survival Time [From treatment start until progression or death, assessed up to 2 years]. Median, months (95% Confidence Interval). Treatment Spartalizumab and Siltuximab Phase I Dose Level 1 (n=4): 9.3 (5.3 to NA) [Upper CI was non-evaluable due to insufficient participants with events for DL-1.]; Treatment Spartalizumab and Siltuximab RP2D (n=31): 3.1 (1.9 to 5.6).