A Study of NALIRIFOX in Combination With Radiation Therapy in People With Pancreatic Ductal Adenocarcinoma (PDAC)

PHASE2RecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

May 12, 2023

Primary Completion Date

May 31, 2026

Study Completion Date

May 31, 2026

Conditions
Pancreatic Ductal Adenocarcinoma
Interventions
DRUG

NALIRIFOX

"Patients will receive NALIRIFOX for a total of 4 months. NALIRIFOX will be administered on days 1 and 15 of a 4-week cycle for 4 cycles until completion of therapy, intolerable toxicity, or until the development of criteria for removal from the study.~Liposomal irinotecan: 50 mg/m2 IV over the course of 90 minutes (±10 minutes) on days 1 and 15 of every 4-week cycle.~Oxaliplatin: 60 mg/m2 IV over the course of 120 minutes (±10 minutes) on days 1 and 15 of every 4-week cycle.~Leucovorin: 400 mg/m2 IV over the course of 30 minutes (±5 minutes) on days 1 and 15 of every 4-week cycle.~5-FU: 2400 mg/m2 IV over the course of 48 hours (or until the infusion is complete) on days 1 and 15 of every 4-week cycle"

COMBINATION_PRODUCT

AD-XRT and Capecitabine

The interval between completion of induction chemotherapy and initiation of AD-XRT will be 2-6 weeks. The patient will be concurrently treated with capecitabine (1000-1500 mg flat BID PO Monday to Friday) with radiation, as per standard dosing regimens at MSK.

Trial Locations (7)

10065

RECRUITING

Memorial Sloan Kettering Cancer Center (All Protocol Activities), New York

10604

RECRUITING

Memorial Sloan Kettering Westchester (Limited Protocol Activities), Harrison

11553

RECRUITING

Memorial Sloan Kettering Nassau (Limited Protocol Activities), Uniondale

11725

RECRUITING

Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities), Commack

07920

RECRUITING

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities), Basking Ridge

07748

RECRUITING

Memorial Sloan Kettering Monmouth (Limited Protocol Activities), Middletown

07645

RECRUITING

Memorial Sloan Kettering Bergen (Limited Protocol Activities), Montvale

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Ipsen

INDUSTRY

collaborator

Pancreatic Cancer Research Fund

UNKNOWN

lead

Memorial Sloan Kettering Cancer Center

OTHER