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Checkpoint Inhibitor

Combination Therapy for Pancreatic Cancer (AIRPanc Trial)

Phase 2

Recruiting

Led By Gulam Manji, MD, PhD

Research Sponsored by Gulam Manji

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Eligible to undergo SBRT

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 years

Awards & highlights

AIRPanc Trial Summary

This trial seeks to combine radiation and drugs to boost the body's immune system to fight cancer cells.

Who is the study for?

This trial is for adults with localized pancreatic ductal adenocarcinoma who've completed 8 cycles of mFOLFIRINOX treatment, can undergo surgery and SBRT, have an ECOG status of 0 or 1, and proper organ function. Excluded are those with autoimmune diseases, uncontrolled hypercalcemia, active infections (HIV/HBV/HCV), significant liver disease, psychiatric/substance abuse issues that affect compliance, prior immune therapy use, or certain allergies.Check my eligibility

What is being tested?

The study tests if combining standard radiation (SBRT) with zimberelimab (an immunotherapy drug) alone or alongside quemliclustat and/or etrumadenant (drugs targeting tumor evasion pathways) before surgery is safe and boosts the immune response against tumors in patients with pancreatic cancer.See study design

What are the potential side effects?

Potential side effects include typical reactions to immunotherapies such as fatigue, skin reactions at injection sites; inflammation-related symptoms affecting lungs or other organs; possible digestive disturbances; allergic responses to medication components; and increased risk of infection.

AIRPanc Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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I am cleared to receive focused radiation therapy.

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My pancreatic cancer diagnosis has been confirmed by a pathologist.

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My cancer is confirmed as pancreatic adenocarcinoma.

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I am 18 years old or older.

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I have only received mFOLFIRINOX for my pancreatic cancer.

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My pancreatic cancer can be removed with surgery, and I am fit for the operation.

AIRPanc Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in the number of intratumoral CD8+ T-cells

Secondary outcome measures

Count of Grade 3 or Higher Adverse Events

Microscopically Negative Margins (R0) resection rate

Overall Survival

+3 more

AIRPanc Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Arm D: SBRT, Zimberelimab with AB680 and Etrumadenant (AB928)Experimental Treatment5 Interventions

Prior to resection: SBRT 40 Gy over 5 fractions, 240 mg IV zimberelimab (AB122) every 2 weeks for 7 weeks (4 doses) prior to surgery in combination with quemliclustat IV at the RTD every 2 weeks for 7 weeks (4 doses) and etrumadenant (AB928) PO at the RTD daily for 7 weeks prior to surgery. After resection: mFOLFIRINOX (4 cycles)

Group II: Arm C: SBRT, Zimberelimab with quemliclustat (AB680)Experimental Treatment4 Interventions

Prior to resection: SBRT 40 Gy over 5 fractions, 240 mg IV zimberelimab (AB122) every 2 weeks for 7 weeks (4 doses) prior to surgery in combination with quemliclustat IV at the recommended therapeutic dose (RTD)every 2 weeks for 7 weeks (4 doses) prior to surgery. After resection: mFOLFIRINOX (4 cycles)

Group III: Arm A: Safety run-inExperimental Treatment5 Interventions

Prior to resection: SBRT 40 Gy over 5 fractions, zimberelimab (AB122) 240 mg intravenously (IV) every 2 weeks for 7 weeks (4 doses), quemliclustat (AB680) 100 mg IV every 2 weeks for 7 weeks (4 doses) and etrumadenant (AB928) 150 mg PO daily for 7 weeks. After resection: mFOLFIRINOX (4 cycles)

Group IV: Arm B: SBRT with Zimberelimab (AB122) Alone (Control Arm)Active Control3 Interventions

Prior to resection: SBRT 40 Gy over 5 fractions, 240 mg IV zimberelimab (AB122) every 2 weeks for 7 weeks (4 doses) prior to surgery. After resection: mFOLFIRINOX (4 cycles)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Zimberelimab

2018

Completed Phase 1

~50

Stereotactic body radiotherapy (SBRT)

2015

Completed Phase 1

~50

Modified FOLFIRINOX

2011

Completed Phase 1

~20

Etrumadenant

2018

Completed Phase 1

~130

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Gulam ManjiLead Sponsor

4 Previous Clinical Trials

103 Total Patients Enrolled

Arcus Biosciences, Inc.Industry Sponsor

41 Previous Clinical Trials

6,006 Total Patients Enrolled

Gulam Manji, MD, PhDPrincipal InvestigatorColumbia University

2 Previous Clinical Trials

50 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the experimental protocol for Arm A: Safety run-in been approved by the FDA?

"As a Phase 2 trial, the safety of Arm A: Safety run-in was given a rating of two due to existing data that supports its protection but none indicating it is efficacious."

Answered by AI

How many participants are anticipated to join this research program?

"Affirmative. According to information posted on clinicaltrials.gov, this research endeavor is presently recruiting subjects. It was first listed on October 1st 2023 and most recently updated on September 15th 2023; the study requires 60 participants at a single site of recruitment."

Answered by AI

Is participation in this experiment still available for volunteers?

"Affirmative. According to clinicaltrials.gov, this research endeavour was launched on October 1st 2023 and is currently in search of 60 participants at just one location. The trial has been regularly updated as recently as September 15th 2023."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Combination Therapy in Patients With Localized Pancreatic Ductal Adenocarcinoma

Gulam Manji 2024. "Combination Therapy in Patients With Localized Pancreatic Ductal Adenocarcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06048484.