Comparing Neoadjuvant/Adjuvant GVAX vs a mKRASvax Given With Anti-PD-1 and Anti-CD137 for Surgically Resectable Pancreatic Cancer

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

38

Participants

Timeline

Start Date

May 27, 2025

Primary Completion Date

December 31, 2028

Study Completion Date

December 31, 2028

Conditions
Pancreatic Cancer
Interventions
DRUG

AGEN2373

"1. Up to 3 doses (1 mg/kg, 3 mg/kg, and 10 mg/kg) will be tested in Phase I to determine the dose to be used in Phase II. AGEN2373 will be administered as a 60 minute IV infusion (-5/+15 min) on Day 1 of each cycle for a total of 6 cycles of treatment. Cycle 1 (14 days) is prior to surgical resection, Cycle 2 (14 days) is after surgery and prior to standard of care chemotherapy, and Cycles 3-6 (21 days) are given after completion of chemotherapy.~2. Drug: 1 mg/kg, 3 mg/kg, and 10 mg/kg IV"

DRUG

Balstilimab

"1. 450 mg will be administered as a 30 minute IV Infusion (-5/+15 min) on day 1 of each cycle for a total of 6 cycles of treatment. Cycle 1 (14 days) is prior to surgical resection, Cycle 2 (14 days) is after surgery and prior to standard of care chemotherapy, and Cycles 3-6 (21 days) are given after completion of chemotherapy.~2. Drug: 450 mg IV"

DRUG

Cyclophosphamide

"1. 200 mg/m2 will be administered as a 30 minute IV infusion (-5/+15 min) on day 1 of each cycle for a total of 6 cycles of treatment. Cycle 1 (14 days) is prior to surgical resection, Cycle 2 (14 days) is after surgery and prior to standard of care chemotherapy, and Cycles 3-6 (21 days) are given after completion of chemotherapy.~2. Drug: 200 mg/m2 IV"

DRUG

GVAX

"1. Vaccine (5 × 108 cells) will be administered on Day 2 of each cycle for a total of 6 cycles of treatment. Six intradermal injections will be given in the upper thighs and non-dominant arms. Cycle 1 (14 days) is prior to surgical resection, Cycle 2 (14 days) is after surgery and prior to standard of care chemotherapy, and Cycles 3-6 (21 days) are given after completion of chemotherapy.~2. Drug: GVAX"

DRUG

AGEN2373 (RP2D)

"1. Drug: Up to 3 doses (1 mg/kg, 3 mg/kg, and 10 mg/kg) will be administered as a 60 minute IV. Infusion (-5/+15 min) on Day 1 of each cycle for a total of 6 cycles of treatment. Cycle 1 (14 days) is prior to surgical resection, Cycle 2 (14 days) is after surgery and prior to standard of care chemotherapy, and Cycles 3-6 (21 days) are given after completion of chemotherapy.~2. Drug: 1 mg/kg, 3 mg/kg, and 10 mg/kg IV"

DRUG

Balstilimab

"1. 450 mg will be administered as a 30 minute IV. Infusion (-5/+15 min) on day 1 of each cycle for a total of 6 cycles of treatment. Cycle 1 (14 days) is prior to surgical resection, Cycle 2 (14 days) is after surgery and prior to standard of care chemotherapy, and Cycles 3-6 (21 days) are given after completion of chemotherapy.~2. Drug: 450 mg IV"

DRUG

mKRASvax

"1. mKRASvax will be administered on Day 1 of each cycle and on Day 8 of Cycle 1 only. mKRASvax is given as 5 subcutaneous injections administered in the upper thighs and arms. Cycle 1 (14 days) is prior to surgical resection, Cycle 2 (14 days) is after surgery and prior to standard of care chemotherapy, and Cycles 3-6 (21 days) are given after completion of chemotherapy.~2. 0.3 mg per peptide vaccine + 0.5mg Poly-ICLC"

Trial Locations (1)

21287

RECRUITING

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore

Sponsors

Collaborators (2)

All Listed Sponsors
collaborator

Agenus Inc.

INDUSTRY

collaborator

Lustgarten Foundation

OTHER

collaborator

Oncovir, Inc.

INDUSTRY

lead

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER