Tg01 Vaccine / Qs-21 Stimulon™ With Or Without Balstilimab As Maintenance Therapy Following Adjuvant Chemotherapy In Patients With Resected Pancreatic Cancer

Ability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent

Males and females age ≥ 18 years

ECOG Performance Status 0 - 1 within 28 days prior to registration (Appendix A)

Surgically resected stage I/II/III Pancreatic Cancer

Life expectancy of at least 6 months

Screening tumor tissue positive or known pathogenic or likely pathogenic RAS mutation resulting in amino acid substitution in codon 12A, 12C, 12D, 12R, 12S or 13D . Mutations must be considered pathogenic or likely pathogenic by a reference database such as ClinVar or OncoKb.org.(https://www.ncbi.nlm.nih.gov/clinvar/variation;https://www.oncoKb.org). Local RAS test results are acceptable and central confirmation is not required prior to treatment.

No evidence of recurrent cancer on screening imaging studies

Positive for Minimal Residual Disease (MRD) as assessed by Signatera circulating tumor DNA (ctDNA) despite prior standard therapy including surgery and chemotherapy/radiation therapy where applicable

Prior cancer treatment must be completed at least 14 days prior to registration and the subject must have recovered from all reversible acute toxic effects of the regimen (other than alopecia) to Grade ≤ 1 or baseline.

Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to initiating treatment. See also section with title CHILD BEARING POTENTIAL /PREGNANCY

Adequate organ function, measured within 28 days prior to enrollment and defined as follows:

* Hgb ≥ 8g/dL

* Creatine clearance ≥ 50ml/min (measured or calculated by the Cockroft-Gault method)

* Leukocytes \>1.5K/UL

* Absolute Neutrophil Count \>1.5K/UL NOTE: Patients with established diagnosis of benign neutropenia are eligible to participate with ANC between 1000-1500 if in the opinion of treating physician the trial treatment does not pose excessive risk of infection to the patient.

* Platelets \>100K/UL

* Total bilirubin ≤ 1.5 x ULN OR direct bilirubin ≤ 1 x ULN

* Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x ULN unless liver metastases are present, in which case they must be ≤ 5 x ULN

* Women of child-bearing potential and men with partners of child-bearing potential must agree to practice sexual abstinence or to use the forms of contraception listed in Child-Bearing Potential/Pregnancy section for the duration of study participation and for 30 days after the last dose of TG01/QS-21 immunotherapy and 90 days after the last dose of Balstilimab.

What this study is about