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Immunotherapy + Chemotherapy for Pancreatic Cancer
Phase 1 & 2
Recruiting
Research Sponsored by James Cleary, MD, PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants must have received 8-12 cycles (4-6 months) of first-line FOLFIRINOX or modified FOLFIRINOX with stable disease or better.
Participants must have histologically confirmed pancreatic cancer (adenocarcinoma, squamous, or adenosquamous histologies) that is metastatic and for which standard curative or palliative measures do not exist or are no longer effective. Locally advanced patients are not eligible.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 8 weeks up to 38 months
Awards & highlights
Study Summary
This trial is being done to see if it is safe and effective to use these immunotherapy drugs together to treat patients with pancreatic cancer that has spread to other parts of the body.
Who is the study for?
This trial is for adults with metastatic pancreatic cancer who've had stable disease or better after 4-6 months of FOLFIRINOX treatment. They must have measurable disease, be willing to use contraception, and able to provide consent. Excluded are those with recent chemotherapy, certain infections (HIV/HBV/HCV), autoimmune diseases, a history of severe allergies to similar drugs, or major surgery within the last month.Check my eligibility
What is being tested?
The study tests combining domvanalimab (AB154), zimberelimab (AB122), and APX005M as immunotherapy treatments for advanced pancreatic cancer. It aims to see if these drugs can safely enhance the body's immune response against cancer cells.See study design
What are the potential side effects?
Potential side effects may include reactions related to stimulating the immune system such as inflammation in various organs, infusion-related reactions like fever or chills, fatigue, digestive issues like nausea or diarrhea, blood disorders including anemia or clotting problems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I've completed 4-6 months of FOLFIRINOX treatment with no worsening of my condition.
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My pancreatic cancer has spread and treatments aren’t working.
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My blood and organ functions meet the trial's required levels.
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My heart is healthy enough for the trial, classified as class 2B or better.
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I am fully active and can carry on all my pre-disease activities without restriction.
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I have a tumor that can be measured with imaging or physical exam.
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I am 18 years old or older.
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I am willing to have a new biopsy before treatment starts.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ every 8 weeks up to 38 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 8 weeks up to 38 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose-limiting toxicities-Phase 1
Switch Maintenance-Progression Free Survival
Secondary outcome measures
Disease Control Rate
Duration of Response (DoR)
Number of Participants With Treatment-Related Adverse Events
+3 moreTrial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: LEAD-IN: DOSE DE-ESCALATIONExperimental Treatment3 Interventions
The lead-in dose de-escalation cohort (Phase 1b) will enroll 6 patients (up to 12 patients in 2 dose levels if needed; 6 patients per DL) to receive zimberelimab, domvanalimab, and APX005M
Group II: CROSSOVER: ZIMBERELIMAB + DOMVANALIMAB + APX005MExperimental Treatment3 Interventions
Participants in Arm B (control arm) who experience disease progression (as defined by RECIST v1.1) will be given the option to crossover and receive domvanalimab + zimberelimab, + APX005M in the second-line setting, provided they meet eligibility criteria
Group III: ARM A: ZIMBERELIMAB + DOMVANALIMAB + APX005MExperimental Treatment3 Interventions
Participants will be randomly assigned to one of two groups
Arm A will receive domvanalimab, zimberelimab, and APX005M every two weeks through an infusion.
Group IV: ARM B: FOLFIRIActive Control1 Intervention
Arm B will receive leucovorin, fluorouracil, and irinotecan every two weeks through an infusion
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sotigalimab
Not yet FDA approved
Find a Location
Who is running the clinical trial?
James Cleary, MD, PhDLead Sponsor
1 Previous Clinical Trials
Lustgarten FoundationOTHER
23 Previous Clinical Trials
5,327 Total Patients Enrolled
Arcus Biosciences, Inc.Industry Sponsor
41 Previous Clinical Trials
6,020 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My blood and organ functions meet the trial's required levels.I can start Stage 2 treatment within 4 weeks after my disease worsens while on the control treatment.I've completed 4-6 months of FOLFIRINOX treatment with no worsening of my condition.I have previously received treatments that boost the immune system.I have a known blood clotting disorder.I haven't taken any immunosuppressive drugs in the last 14 days.My pancreatic cancer has spread and treatments aren’t working.I had major surgery over 28 days ago and have recovered from it.My heart is healthy enough for the trial, classified as class 2B or better.You have already taken any other experimental drugs for pancreatic cancer.I have had a bone marrow or organ transplant in the past.I have had another type of cancer in the last 2 years.I am fully active and can carry on all my pre-disease activities without restriction.My brain scans show no worsening after treatment for brain metastases.I can provide a tumor sample from my treatment or am willing to undergo a biopsy.I have stored tissue samples available for testing.I do not have any severe illnesses that are not under control.I have a history of certain lung conditions or signs of lung inflammation on a CT scan.I have a tumor that can be measured with imaging or physical exam.I haven't had a live vaccine in the last 28 days and won't get one during the study.I agree to use birth control during and after the study due to unknown effects on fetuses.My cancer has worsened despite FOLFIRINOX treatment.I haven't had chemotherapy or radiotherapy in the last 2 weeks and have recovered from previous treatments, except for hair loss or mild nerve damage.You should not have a history of HIV, hepatitis B, or hepatitis C, unless you have specific test results showing no active virus.You have had serious allergic reactions to certain types of antibodies or similar medications being used in the study.I have not received any specific treatments listed in this study, except for chemotherapy.I am 18 years old or older.My cancer is not endocrine or acinar pancreatic carcinoma.I am willing to have a new biopsy before treatment starts.I have a known deficiency in the enzyme dihydropyrimidine dehydrogenase.I have a known BRCA1 or BRCA2 gene mutation.I have an autoimmune disease or take medication to suppress my immune system.
Research Study Groups:
This trial has the following groups:- Group 1: ARM A: ZIMBERELIMAB + DOMVANALIMAB + APX005M
- Group 2: LEAD-IN: DOSE DE-ESCALATION
- Group 3: ARM B: FOLFIRI
- Group 4: CROSSOVER: ZIMBERELIMAB + DOMVANALIMAB + APX005M
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
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 for this trial open to the public at present?
"Contrary to expectations, this clinical trial is presently not recruiting participants. Initially uploaded on November 1st 2022 and last modified on June 10th 2022, the study has foregone recruitment for now. In contrast, there are currently 3738 other trials actively searching for potential test subjects."
Answered by AI
What is the ultimate goal of this medical research?
"The primary outcome of this research endeavour, which will be examined over an extended period up to 38 months, is the presence of dose-limiting toxicities in Phase 1. Secondary outcomes include objective response rate (ORR) determined by baseline CT scans and restaging images taken every 8 weeks with RECIST v1.1 criteria, progression free survival (PFS), and number of participants that experience treatment-related adverse events as evaluated using CTCAE version 5.0 standards."
Answered by AI
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