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Monoclonal Antibodies
Spartalizumab for Pancreatic Cancer
Phase 1 & 2
Waitlist Available
Led By Bassel El-Rayes, MD
Research Sponsored by Emory University
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 up to 2 years from study start
Awards & highlights
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
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years from study start
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years from study start
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximal tolerated dose (MTD) of siltuximab that can be combined with spartalizumab
Secondary outcome measures
Overall response rate (ORR)
Overall survival time
Progression-free survival
+1 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: Treatment spartalizumab and siltuximab phase IIExperimental Treatment2 Interventions
Arm 4 (Phase II ) Participants receive spartalizumab 300 mg IV over 30 minutes on day 1 and siltuximab at dose determined in Arm 1 to 3 IV over 1 hour on day 1. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Group II: Treatment spartalizumab and siltuximab phase I level 2aExperimental Treatment2 Interventions
Arm 3 (Phase I dose level 2a) Participants receive spartalizumab 300 mg IV over 30 minutes on day 1 and siltuximab 9 mg/Kg IV over 1 hour on day 1. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Group III: Treatment spartalizumab and siltuximab Phase I level 2Experimental Treatment2 Interventions
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.
Group IV: Treatment spartalizumab and siltuximab Phase I dose level 1Experimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Spartalizumab
2020
Completed Phase 2
~280
Siltuximab
2011
Completed Phase 3
~1190
Find a Location
Who is running the clinical trial?
Emory UniversityLead Sponsor
1,642 Previous Clinical Trials
2,563,964 Total Patients Enrolled
NovartisIndustry Sponsor
1,613 Previous Clinical Trials
2,721,226 Total Patients Enrolled
EUSA Pharma, Inc.Industry Sponsor
4 Previous Clinical Trials
1,255 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You cannot have received any live vaccines for diseases in the past 4 weeks before starting the study treatment.You have had severe allergic reactions to other medications similar to the study drug, which could increase the risk of serious side effects during the treatment.You had a heart attack in the last 6 months.You have uncontrolled heart failure.You have experienced unstable chest pain (angina) in the past 6 months.You have serious heart rhythm problems that cause symptoms, like rapid or irregular heartbeat, or blockage in the electrical signals of your heart.You have previously received certain medications that target specific proteins in your body. You can still participate if you had chemotherapy, but you need to wait at least 4 weeks after your last treatment.You have a history of lung disease that is not caused by an infection.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment spartalizumab and siltuximab Phase I dose level 1
- Group 2: Treatment spartalizumab and siltuximab Phase I level 2
- Group 3: Treatment spartalizumab and siltuximab phase I level 2a
- Group 4: Treatment spartalizumab and siltuximab phase II
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment in this experiment currently open?
"According to information available on clinicaltrials.gov, the recruitment for this trial is still ongoing with its inception date being January 17th 2020 and latest update taking place February 1st 2022."
Answered by AI
Is this a pioneering study in its field?
"To date, there are 30 ongoing clinical trials for Spartalizumab occurring in 124 cities and 35 countries. Novartis Pharmaceuticals launched the first trial of this drug back in 2011 with 185 patients; since then, 37 studies have been completed."
Answered by AI
How many individuals are enrolled in this medical experiment?
"Affirmative, the information on clinicaltrials.gov demonstrates that this experiment is currently recruiting participants. Initially posted on January 17th 2020 and amended most recently on February 1st 2022, it seeks 42 patients from 3 separate sites."
Answered by AI
Could you provide a summary of the prior research conducted on Spartalizumab?
"Presently, 30 studies are running on Spartalizumab with a single trial in late-stage development. This medication is being trialed at 511 sites across the country; most of them located in New york City."
Answered by AI
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