Spartalizumab for Pancreatic Cancer Metastatic

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Pancreatic Cancer Metastatic+1 MoreSpartalizumab - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a combination of two monoclonal antibodies to treat pancreatic cancer. Monoclonal antibodies are drugs that interfere with the ability of tumors cells to grow and spread.

Eligible Conditions
  • Pancreatic Cancer Metastatic
  • Stage IV Pancreatic Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Up to 2 years from study start

Year 2
Overall survival time
Progression-free survival
Response duration
Year 2
Overall response rate (ORR)
Week 6
Maximal tolerated dose (MTD) of siltuximab that can be combined with spartalizumab

Trial Safety

Safety Progress

1 of 3

Trial Design

4 Treatment Groups

Treatment spartalizumab and siltuximab phase I level 2a
1 of 4
Treatment spartalizumab and siltuximab phase II
1 of 4
Treatment spartalizumab and siltuximab Phase I level 2
1 of 4
Treatment spartalizumab and siltuximab Phase I dose level 1
1 of 4

Experimental Treatment

42 Total Participants · 4 Treatment Groups

Primary Treatment: Spartalizumab · No Placebo Group · Phase 1 & 2

Treatment spartalizumab and siltuximab phase I level 2aExperimental Group · 2 Interventions: Spartalizumab, Siltuximab · Intervention Types: Biological, Biological
Treatment spartalizumab and siltuximab phase IIExperimental Group · 2 Interventions: Spartalizumab, Siltuximab · Intervention Types: Biological, Biological
Treatment spartalizumab and siltuximab Phase I level 2Experimental Group · 2 Interventions: Spartalizumab, Siltuximab · Intervention Types: Biological, Biological
Treatment spartalizumab and siltuximab Phase I dose level 1Experimental Group · 2 Interventions: Spartalizumab, Siltuximab · Intervention Types: Biological, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Spartalizumab
Not yet FDA approved
Siltuximab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years from study start

Who is running the clinical trial?

NovartisIndustry Sponsor
1,585 Previous Clinical Trials
2,702,718 Total Patients Enrolled
EUSA Pharma, Inc.Industry Sponsor
4 Previous Clinical Trials
1,255 Total Patients Enrolled
Emory UniversityLead Sponsor
1,509 Previous Clinical Trials
2,706,127 Total Patients Enrolled
Bassel El-Rayes, MD2.84 ReviewsPrincipal Investigator - Emory University
Emory University
6 Previous Clinical Trials
97 Total Patients Enrolled
1Patient Review
This oncologist is very difficult to get in touch with and follow up with. I would not recommend.

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
A person's platelet level is considered normal if it is ≥ 75 x 109/L.
Aspartate transaminase (AST) ≤ 2.5 times the upper limit of normal, except for patients with liver metastasis, who may only be included if AST ≤ 5.0 times the upper limit of normal.
ALT levels ≤ 2.5 times the upper limit of the normal range (ULN) are acceptable, except for patients with liver metastasis, who may only have ALT levels ≤ 5.0 times the ULN.
The patient has a good prognosis and a relatively low level of disability.
The disease is an advanced form of pancreatic cancer that has failed to respond to at least one prior treatment with a standard regimen, such as gemcitabine and nab-paclitaxel, or folinic acid, fluorouracil, irinotecan, and oxaliplatin (FOLFIRINOX).
, direct bilirubin ≤ 0.3 x ULN, and conjugated bilirubin ≤ 0.1 x ULN
is required The text is saying that in order to be eligible for the study, you must have measurable disease according to the RECIST criteria.
A person's blood has absolute neutrophil count if it contains at least 1.5x 109 white blood cells per liter.
Hemoglobin (Hgb) ≥ 9 g/dL.
If the serum creatinine level is less than 1.5 mg/dL or the creatinine clearance is greater than or equal to 45 mL/min using the Cockcroft-Gault formula, the person has kidney function within the normal range.