← Back to Search

Other

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.

Must not have

Prior treatment with T-cell co-stimulating or immune checkpoint blockade therapies (including anti-CTLA-4, anti-PD-1, anti-PD-L1, anti-TIGIT, and CD40 agonist therapeutic antibodies)

Known hereditary or acquired coagulopathy (e.g., hemophilia, von Willebrand disease, cancer-associated diffuse intravascular coagulation)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up every 8 weeks up to 38 months

Awards & highlights

No Placebo-Only Group

Approved for 5 Other Conditions

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.

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.

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 below

Select...

I've completed 4-6 months of FOLFIRINOX treatment with no worsening of my condition.

Select...

My pancreatic cancer has spread and treatments aren’t working.

Select...

My blood and organ functions meet the trial's required levels.

Select...

My heart is healthy enough for the trial, classified as class 2B or better.

Select...

I am fully active and can carry on all my pre-disease activities without restriction.

Select...

I have a tumor that can be measured with imaging or physical exam.

Select...

I am 18 years old or older.

Select...

I am willing to have a new biopsy before treatment starts.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have previously received treatments that boost the immune system.

Select...

I have a known blood clotting disorder.

Select...

I have had a bone marrow or organ transplant in the past.

Select...

I have had another type of cancer in the last 2 years.

Select...

I do not have any severe illnesses that are not under control.

Select...

I have a history of certain lung conditions or signs of lung inflammation on a CT scan.

Select...

I haven't had a live vaccine in the last 28 days and won't get one during the study.

Select...

My cancer has worsened despite FOLFIRINOX treatment.

Select...

I have not received any specific treatments listed in this study, except for chemotherapy.

Select...

My cancer is not endocrine or acinar pancreatic carcinoma.

Select...

I have a known deficiency in the enzyme dihydropyrimidine dehydrogenase.

Select...

I have a known BRCA1 or BRCA2 gene mutation.

Select...

I have an autoimmune disease or take medication to suppress my immune system.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and every 8 weeks up to 38 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dose-limiting toxicities-Phase 1

Switch Maintenance-Progression Free Survival

Secondary study objectives

Disease Control Rate

Duration of Response (DoR)

Number of Participants With Treatment-Related Adverse Events

+3 more

Awards & Highlights

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.

Trial 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

0 / 21Eligibility criteria met