Combination Therapy in Patients With Localized Pancreatic Ductal Adenocarcinoma

Part of paid clinical trials in Lake Success, New York.

Sponsor
Gulam Manji
Study ID
NCT06048484
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Stereotactic body radiotherapy (SBRT) — RADIATION
    SBRT 40 gray (Gy) over 5 fractions
  • Zimberelimab — DRUG
    240 mg intravenously (IV)
  • Quemliclustat — DRUG
    100 mg IV
  • Etrumadenant — DRUG
    150 mg orally
  • Modified FOLFIRINOX — DRUG
    * Oxaliplatin 85 mg per square meter IV * Irinotecan 150 mg per square meter IV * Leucovorin 400 mg per square meter IV * Fluorouracil 2400 mg per square meter IV * Pegfilgrastim injector kit (6mg subcutaneous)

Study Details

The purpose of this study is to combine standard radiation therapy with drugs that encourages the body's immune system against cancer cells and simultaneously adding drugs which also target the pathway that the tumor uses to evade the immune system (CD73 and A2a/b). The study hopes that these drugs will work in concert with radiation therapy to kill cancer cells. The specific goal of this study is to ensure that treatment with zimberelimab and stereotactic body radiation therapy (SBRT) alone or in combination with quemliclustat (a drug which blocks CD73), with or without etrumadenant (a drug which blocks the A2a/b) given before surgery is safe and if it can further increase the immune response against the tumor.

Key Dates

Start date
May 10, 2024
Status verified
Feb 2026
Primary completion
Apr 30, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: Safety run-in
    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)
  • Active Comparator: Arm B: SBRT with Zimberelimab (AB122) Alone (Control Arm)
    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)
  • Experimental: Arm C: SBRT, Zimberelimab with quemliclustat (AB680)
    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)
  • Experimental: Arm D: SBRT, Zimberelimab with AB680 and Etrumadenant (AB928)
    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)

Primary Outcome Measure

Change in the number of intratumoral CD8+ T-cells [ Time Frame: Perioperative ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Northwell Health R.J. Zuckerberg Cancer CenterLake SuccessNew York11042
Daniel King, MD., PhD. (PRINCIPAL_INVESTIGATOR)
Columbia University Irving Medical CenterNew YorkNew York10032
Research Nurse Navigator
[email protected]
212-342-5162
Gulam Manji, MD, PhD (PRINCIPAL_INVESTIGATOR)
UNC Hospitals, The University of North Carolina at Chapel HillChapel HillNorth Carolina27514
Ashwin Somasundaram, MD
919-843-7709
University of Pennsylvania, Abramson Cancer CenterPhiladelphiaPennsylvania19104
Mark O'Hara, MD
[email protected]
215-360-0919
Medical College of WisconsinMilwaukeeWisconsin53226
Ben George, MD
[email protected]

Find similar trials in Lake Success, NY

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
Northwell Health R.J. Zuckerberg Cancer Center· Lake Success, NYColumbia University Irving Medical Center· New York, NYUNC Hospitals, The University of North Carolina at Chapel Hill· Chapel Hill, NCUniversity of Pennsylvania, Abramson Cancer Center· Philadelphia, PAMedical College of Wisconsin· Milwaukee, WI

Related Studies