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AGEN1423 + Balstilimab With/Without Chemo for Pancreatic Cancer
Phase 2
Waitlist Available
Research Sponsored by Bruno Bockorny
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Complete resolution of toxic effect(s) of the most recent prior chemotherapy to Grade 1 or less (except alopecia and peripheral neuropathy)
ECOG status ≤1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 8 weeks until eot, for up to 2 years.
Awards & highlights
Study Summary
This trial will assess the safety and effectiveness of a combination of AGEN1423 and Balstilimab in advanced pancreatic cancer which has progressed after one or more treatments.
Who is the study for?
This trial is for adults with advanced pancreatic ductal adenocarcinoma that's worsened after treatment. They must understand the study, sign consent, have good organ function, use contraception, and not be eligible for curative therapy. Exclusions include other active cancers or treatments, certain medical conditions like heart disease or lung issues, recent vaccines, pregnancy/breastfeeding intentions during the trial period.Check my eligibility
What is being tested?
The study tests AGEN1423 and Balstilimab combined with or without chemotherapy drugs gemcitabine and nab-paclitaxel in treating advanced pancreatic cancer. Participants will receive this treatment over two years and then be monitored for an additional year to assess safety and effectiveness.See study design
What are the potential side effects?
Potential side effects may include typical reactions to immunotherapy such as fatigue, nausea, skin reactions; chemo-related hair loss (alopecia), nerve damage (neuropathy); plus risks of infection due to lowered immune response from both drug types.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My side effects from the last chemotherapy are mostly gone, except for hair loss and nerve issues.
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I am fully active and can carry on all pre-disease activities without restriction.
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My cancer can be measured by scans.
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I am 18 years old or older.
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My pancreatic cancer is advanced and cannot be removed by surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ every 8 weeks until eot, for up to 2 years.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 8 weeks until eot, for up to 2 years.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective Response Rate
Secondary outcome measures
Disease Control Rate
Grade 3-5 Treatment-related Toxicity Rate
Median Duration of Overall Response (DOR)
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: COHORT 2: AGEN1423 Plus Balstilimab and ChemotherapyExperimental Treatment4 Interventions
Treatment is AGEN1423 plus balstilimab in combination with gemcitabine and nab-paclitaxel for 2 cycles (8 weeks) followed by balstilimab in combination with gemcitabine and nab-paclitaxel for up to 2 years. AGEN1423 will be administered in a total of 4 doses. Balstilimab will be administered once every 2 weeks.
Group II: COHORT 1: AGEN1423 Plus BalstilimabExperimental Treatment2 Interventions
Treatment is AGEN1423 plus balstilimab for 4 cycles (8 weeks) followed by balstilimab alone for up to 2 years. AGEN1423 will be administered in a total of 4 doses. Balstilimab will be administered every 2 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gemcitabine
2017
Completed Phase 3
~2070
Nab-paclitaxel
2014
Completed Phase 3
~2030
Find a Location
Who is running the clinical trial?
Dana-Farber Cancer InstituteOTHER
1,079 Previous Clinical Trials
340,924 Total Patients Enrolled
Bruno BockornyLead Sponsor
Bruno Bockorny, MDLead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My side effects from the last chemotherapy are mostly gone, except for hair loss and nerve issues.I have not received a live vaccine in the last 30 days.You are expected to live for at least 3 more months.I have an immune system disorder or have taken steroids in the past week.I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.My pancreatic tumor is not adenocarcinoma.You have had allergic reactions to similar medicines or substances in the past.I am fully active and can carry on all pre-disease activities without restriction.I have a blockage in my intestines.I have not needed treatment for an autoimmune disease in the last 2 years.I haven't had cancer treatment with monoclonal antibodies in the last 4 weeks or still have side effects from them.I have another cancer that is getting worse or needs treatment.I do not have an active or uncontrolled infection requiring treatment.I have a heart condition.I am HIV positive but my viral load is undetectable due to effective treatment.My cancer can be measured by scans.I am 18 years old or older.I have a history of Chronic Hepatitis B or C.I have had fluid drained from my abdomen or chest 2+ times in the last month or have a permanent drain.I have had pneumonitis treated with steroids or have it now.Your oxygen level is below 92% when breathing normally.You have a history of mental health or drug problems.I have cancer that has spread to my brain or spinal cord.My condition can be treated with the goal of curing it.I do not have any health issues that could affect the trial's results or my participation.My organs and bone marrow are working well.I haven't had cancer treatment or recovered from its side effects in the last 2 weeks.I have a history of lung scarring or fibrosis.My pancreatic cancer is advanced and cannot be removed by surgery.
Research Study Groups:
This trial has the following groups:- Group 1: COHORT 1: AGEN1423 Plus Balstilimab
- Group 2: COHORT 2: AGEN1423 Plus Balstilimab and Chemotherapy
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.
Has the combination of AGEN1423 and Balstilimab been given regulatory clearance?
"Our analysis assigns a safety score of 2 to COHORT 1: AGEN1423 Plus Balstilimab given the Phase 2 trial status and evidence supporting general safety, yet not efficacy."
Answered by AI
Is this research endeavor currently accessible to participants?
"Clinicaltrials.gov reports that this particular trial has not been actively recruiting since November 18th 2022, the date of its last update. Despite this, there are presently 1381 other trials in search for new patients."
Answered by AI
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