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Monoclonal Antibodies

Canakinumab injection; spartalizumab, nab-paclitaxel, gemcitabine for Pancreatic Cancer (PanCAN-SR1 Trial)

Phase 1
Waitlist Available
Research Sponsored by Pancreatic Cancer Action Network
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up tumor response data from ct/mri scans will be taken at screening visit and every 8 weeks throughout study treatment, an average of 6 months;
Awards & highlights

PanCAN-SR1 Trial Summary

This trial is testing a new four-drug combination to see if it is safe and effective. The combination includes two different kinds of antibodies and two chemotherapy drugs.

Eligible Conditions
  • Pancreatic Cancer

PanCAN-SR1 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~tumor response data from ct/mri scans will be taken at screening visit and every 8 weeks throughout study treatment, an average of 6 months;
This trial's timeline: 3 weeks for screening, Varies for treatment, and tumor response data from ct/mri scans will be taken at screening visit and every 8 weeks throughout study treatment, an average of 6 months; for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Confirm the recommended Phase 2/3 dose of canakinumab, spartalizumab, nab-paclitaxel and gemcitabine in patients with metastatic pancreatic cancer
Secondary outcome measures
Characterize the pharmacokinetics of canakinumab in patients with metastatic pancreatic cancer
Characterize the pharmacokinetics of gemcitabine in patients with metastatic pancreatic cancer
Characterize the pharmacokinetics of nab-paclitaxel in patients with metastatic pancreatic cancer
+8 more
Other outcome measures
Study the immune modulation effect of this 4-drug combination on the tumor micro-environment using CyTOF analysis from tissue biopsies.
Study the immune modulation effect of this 4-drug combination on the tumor micro-environment using flow cytometry from tissue biopsies.
Study the immune modulation effect of this 4-drug combination on the tumor micro-environment using immunostaining from tissue biopsies.
+8 more

PanCAN-SR1 Trial Design

1Treatment groups
Experimental Treatment
Group I: Canakinumab, spartalizumab, nab-paclitaxel and gemcitabineExperimental Treatment1 Intervention
Spartalizumab (PDR001),IV infusion, 400 mg, D1 of each 28-day cycle; Canakinumab (ACZ885), s.c. injection, 250 mg, Day 1 of each 28- day cycle; Gemcitabine, IV Infusion, 1000 mg/m2, Days 1, 8, 15 of each 28-day cycle; Nab-paclitaxel, IV Infusion, 125 mg/m2, Days 1, 8, 15 of each 28-day cycle.

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Who is running the clinical trial?

Novartis PharmaceuticalsIndustry Sponsor
2,866 Previous Clinical Trials
4,199,316 Total Patients Enrolled
Pancreatic Cancer Action NetworkLead Sponsor
5 Previous Clinical Trials
13,452 Total Patients Enrolled
Amy Stoll-D'Astice, MSStudy DirectorPancreatic Cancer Action Network
~2 spots leftby May 2025
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