A Pilot Study Comparing Neoadjuvant and Adjuvant GVAX vs a Mutated KRAS Peptide Vaccine Given With Anti-PD-1 and Anti-CD137 for the Treatment of Surgically Resectable Pancreatic Adenocarcinoma

Summary

The purpose of this study is to determine the optimal dose of AGEN2373 that is safe when given in combination with balstilimab and Pancreatic GVAX Whole Cell Vaccine and evaluate the safety and clinical activity of balstilimab and AGEN2373 in combination with GVAX (Arm 1) or mKRASvax (Arm 2) in surgically resectable pancreatic adenocarcinoma.

Arms & interventions

• DrugAGEN2373

  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

• DrugBalstilimab

  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

• DrugCyclophosphamide

  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

• DrugGVAX

  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

• DrugAGEN2373 (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

• DrugBalstilimab

  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

• DrugmKRASvax

  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

Outcome measures

Eligibility criteria