Trial Outcomes & Findings for Siltuximab and Spartalizumab in Patients With Metastatic Pancreatic Cancer (NCT NCT04191421)
NCT ID: NCT04191421
Last Updated: 2025-08-22
Results Overview
Maximal tolerated dose (MTD )is defined as the dose at which less than one-third of the subjects experience a dose-limiting toxicity (DLT) in the first 6 weeks of treatment. A DLT is defined as an adverse event or abnormal laboratory value assessed as definitely at least possibly related to study treatment treatment related that occurs within the first 6 weeks. National Cancer Institute Common Terminology Criteria for Adverse events (NCI CTCAE) version 4.03 will be used for all grading.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
35 participants
Primary outcome timeframe
Up to 6 weeks from study start
Results posted on
2025-08-22
Participant Flow
Participant milestones
| Measure |
Treatment Spartalizumab and Siltuximab Phase I Dose Level 1
Arm 1 (Phase I dose level 1) Participants receive spartalizumab 300 mg IV over 30 minutes on day 1 and siltuximab 6 mg/Kg IV over 1 hour on day 1. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Siltuximab: Given IV
Spartalizumab: Given IV
|
Experimental: Treatment Spartalizumab and Siltuximab Phase I Level 2
Arm 2 (Phase I dose level 2) Participants receive spartalizumab 300 mg IV over 30 minutes on day 1 and siltuximab 11 mg/Kg IV over 1 hour on day 1. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Siltuximab: Given IV
Spartalizumab: Given IV
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
31
|
|
Overall Study
COMPLETED
|
4
|
31
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Siltuximab and Spartalizumab in Patients With Metastatic Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
Treatment Spartalizumab and Siltuximab Phase I Dose Level 1
n=4 Participants
Arm 1 (Phase I dose level 1) Participants receive spartalizumab 300 mg IV over 30 minutes on day 1 and siltuximab 6 mg/Kg IV over 1 hour on day 1. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Siltuximab: Given IV
Spartalizumab: Given IV
|
Treatment Spartalizumab and Siltuximab RP2D
n=31 Participants
Arm 2 (Phase I dose level 2) Participants receive spartalizumab 300 mg IV over 30 minutes on day 1 and siltuximab 11 mg/Kg IV over 1 hour on day 1. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Siltuximab: Given IV
Spartalizumab: Given IV
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
31 participants
n=7 Participants
|
35 participants
n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 6 weeks from study startMaximal tolerated dose (MTD )is defined as the dose at which less than one-third of the subjects experience a dose-limiting toxicity (DLT) in the first 6 weeks of treatment. A DLT is defined as an adverse event or abnormal laboratory value assessed as definitely at least possibly related to study treatment treatment related that occurs within the first 6 weeks. National Cancer Institute Common Terminology Criteria for Adverse events (NCI CTCAE) version 4.03 will be used for all grading.
Outcome measures
| Measure |
Treatment Spartalizumab and Siltuximab Phase I Dose Level 1
n=35 Participants
Arm 1 (Phase I dose level 1) Participants receive spartalizumab 300 mg IV over 30 minutes on day 1 and siltuximab 6 mg/Kg IV over 1 hour on day 1. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Siltuximab: Given IV
Spartalizumab: Given IV
|
Treatment Spartalizumab and Siltuximab RP2D
Arm 2 (Phase I dose level 2) Participants receive spartalizumab 300 mg IV over 30 minutes on day 1 and siltuximab 11 mg/Kg IV over 1 hour on day 1. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Siltuximab: Given IV
Spartalizumab: Given IV
|
|---|---|---|
|
Maximal Tolerated Dose (MTD) of Siltuximab That Can be Combined With Spartalizumab
|
11 mg/kg
|
—
|
SECONDARY outcome
Timeframe: Up to 2 years from study startOverall response rate is defined as complete response (CR) + partial response (PR) in participants treated with siltuximab and spartalizumab and will be assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
Outcome measures
| Measure |
Treatment Spartalizumab and Siltuximab Phase I Dose Level 1
n=4 Participants
Arm 1 (Phase I dose level 1) Participants receive spartalizumab 300 mg IV over 30 minutes on day 1 and siltuximab 6 mg/Kg IV over 1 hour on day 1. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Siltuximab: Given IV
Spartalizumab: Given IV
|
Treatment Spartalizumab and Siltuximab RP2D
n=31 Participants
Arm 2 (Phase I dose level 2) Participants receive spartalizumab 300 mg IV over 30 minutes on day 1 and siltuximab 11 mg/Kg IV over 1 hour on day 1. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Siltuximab: Given IV
Spartalizumab: Given IV
|
|---|---|---|
|
Overall Response Rate (ORR)
|
0 percentage of participants
Interval 0.0 to 0.0
|
0 percentage of participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: From treatment start until progression or death, assessed up to 2 yearsPopulation: No patients achieved CR/PR. The response duration cannot be evaluated.
Will be assessed by RECIST 1.1.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From treatment start until progression or death, assessed up to 2 yearsWill be assessed by RECIST 1.1.
Outcome measures
| Measure |
Treatment Spartalizumab and Siltuximab Phase I Dose Level 1
n=4 Participants
Arm 1 (Phase I dose level 1) Participants receive spartalizumab 300 mg IV over 30 minutes on day 1 and siltuximab 6 mg/Kg IV over 1 hour on day 1. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Siltuximab: Given IV
Spartalizumab: Given IV
|
Treatment Spartalizumab and Siltuximab RP2D
n=31 Participants
Arm 2 (Phase I dose level 2) Participants receive spartalizumab 300 mg IV over 30 minutes on day 1 and siltuximab 11 mg/Kg IV over 1 hour on day 1. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Siltuximab: Given IV
Spartalizumab: Given IV
|
|---|---|---|
|
Progression-free Survival
|
1.9 months
Interval 1.6 to
Upper CI was non-evaluable due to insufficient participants with events for DL-1.
|
2.1 months
Interval 1.5 to 2.2
|
SECONDARY outcome
Timeframe: From treatment start until progression or death, assessed up to 2 yearsWill be assessed by RECIST 1.1.
Outcome measures
| Measure |
Treatment Spartalizumab and Siltuximab Phase I Dose Level 1
n=4 Participants
Arm 1 (Phase I dose level 1) Participants receive spartalizumab 300 mg IV over 30 minutes on day 1 and siltuximab 6 mg/Kg IV over 1 hour on day 1. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Siltuximab: Given IV
Spartalizumab: Given IV
|
Treatment Spartalizumab and Siltuximab RP2D
n=31 Participants
Arm 2 (Phase I dose level 2) Participants receive spartalizumab 300 mg IV over 30 minutes on day 1 and siltuximab 11 mg/Kg IV over 1 hour on day 1. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Siltuximab: Given IV
Spartalizumab: Given IV
|
|---|---|---|
|
Overall Survival Time
|
9.3 months
Interval 5.3 to
Upper CI was non-evaluable due to insufficient participants with events for DL-1.
|
3.1 months
Interval 1.9 to 5.6
|
Adverse Events
Treatment Spartalizumab and Siltuximab Phase I Dose Level 1
Serious events: 0 serious events
Other events: 2 other events
Deaths: 4 deaths
Experimental: Treatment Spartalizumab and Siltuximab Phase I Level 2
Serious events: 0 serious events
Other events: 15 other events
Deaths: 26 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment Spartalizumab and Siltuximab Phase I Dose Level 1
n=4 participants at risk
Arm 1 (Phase I dose level 1) Participants receive spartalizumab 300 mg IV over 30 minutes on day 1 and siltuximab 6 mg/Kg IV over 1 hour on day 1. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Siltuximab: Given IV Spartalizumab: Given IV
|
Experimental: Treatment Spartalizumab and Siltuximab Phase I Level 2
n=31 participants at risk
Arm 2 (Phase I dose level 2) Participants receive spartalizumab 300 mg IV over 30 minutes on day 1 and siltuximab 11 mg/Kg IV over 1 hour on day 1. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Siltuximab: Given IV
Spartalizumab: Given IV
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
25.0%
1/4 • Number of events 1 • 24 months
|
6.5%
2/31 • Number of events 2 • 24 months
|
|
Gastrointestinal disorders
Abdominal Distension
|
0.00%
0/4 • 24 months
|
3.2%
1/31 • Number of events 1 • 24 months
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • 24 months
|
6.5%
2/31 • Number of events 2 • 24 months
|
|
Investigations
Diarrhea
|
0.00%
0/4 • 24 months
|
3.2%
1/31 • Number of events 1 • 24 months
|
|
Nervous system disorders
Flatulence
|
0.00%
0/4 • 24 months
|
3.2%
1/31 • Number of events 1 • 24 months
|
|
Blood and lymphatic system disorders
Vomiting
|
0.00%
0/4 • 24 months
|
3.2%
1/31 • Number of events 1 • 24 months
|
|
Metabolism and nutrition disorders
Fatigue
|
25.0%
1/4 • Number of events 1 • 24 months
|
9.7%
3/31 • Number of events 3 • 24 months
|
|
General disorders
General Disorders-other
|
0.00%
0/4 • 24 months
|
6.5%
2/31 • Number of events 2 • 24 months
|
|
General disorders
Hepatic Failure
|
0.00%
0/4 • 24 months
|
3.2%
1/31 • Number of events 1 • 24 months
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.00%
0/4 • 24 months
|
9.7%
3/31 • Number of events 3 • 24 months
|
|
General disorders
Alanine aminotransferase increased
|
0.00%
0/4 • 24 months
|
9.7%
3/31 • Number of events 3 • 24 months
|
|
General disorders
Alkaline phosphatase increased
|
0.00%
0/4 • 24 months
|
9.7%
3/31 • Number of events 3 • 24 months
|
|
Investigations
Blood Bilirubin Increased
|
0.00%
0/4 • 24 months
|
3.2%
1/31 • Number of events 1 • 24 months
|
|
General disorders
Blood bilirubin increased
|
0.00%
0/4 • 24 months
|
3.2%
1/31 • Number of events 1 • 24 months
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders
|
0.00%
0/4 • 24 months
|
3.2%
1/31 • Number of events 1 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4 • 24 months
|
3.2%
1/31 • Number of events 1 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/4 • 24 months
|
3.2%
1/31 • Number of events 1 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
|
0.00%
0/4 • 24 months
|
3.2%
1/31 • Number of events 1 • 24 months
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/4 • 24 months
|
3.2%
1/31 • Number of events 1 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/4 • 24 months
|
3.2%
1/31 • Number of events 1 • 24 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place