A Vaccine (TG01 Vaccine) Combined with QS-21 with or without Balstilimab for the Treatment of Stage I-III Resected Pancreatic Cancer, TESLA Trial

Inclusion Criteria

• 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
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0 – 1 within 28 days prior to registration
• Surgically resected stage I/II/III pancreatic ductal adenocarcinoma (PDAC)
• Screening tumor tissue positive or circulating tumor DNA positive for known pathogenic or likely pathogenic RAS mutation resulting in amino acid substitution in codon 12A, 12C, 12D, 12R, 12S, 12V or 13D. Mutations must be considered pathogenic or likely pathogenic. 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 circulating tumor DNA (ctDNA) despite prior standard therapy including surgery and chemotherapy/radiation therapy where applicable. NOTE: Signatera is the preferred test; however, other Clinical Laboratory Improvement Act (CLIA) approved assays will be acceptable
• 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
• Hemoglobin (Hgb) >= 8 g/dL (measured within 28 days prior to enrollment)
• Creatine clearance >= 50 ml/min (measured or calculated by the Cockroft-Gault method) (measured within 28 days prior to enrollment)
• Leukocytes >= 1.5 K/UL (measured within 28 days prior to enrollment)
• Absolute neutrophil count >= 1.0 K/UL (measured within 28 days prior to enrollment)
• Platelets >= 100 K/UL (measured within 28 days prior to enrollment)
• Total bilirubin =< 1.5 x upper limit of normal (ULN) OR direct bilirubin =< 1 x ULN (measured within 28 days prior to enrollment)
• Aspartate aminotransferase and alanine aminotransferase =< 2.5 x ULN (measured within 28 days prior to enrollment)
• Women of child-bearing potential and men with partners of child-bearing potential must agree to practice sexual abstinence or to use contraception 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

Exclusion Criteria

• Simultaneously enrolled in any therapeutic clinical trial
• Current or anticipating use of other anti-neoplastic or investigational agents while participating in this study
• Diagnosed with a psychiatric illness or is in a social situation that would limit compliance with study requirements
• Is pregnant, planning pregnancy, or breastfeeding
• Has a known allergic reaction to any excipient contained in the study drug formulation
• Has received an investigational drug within 4 weeks prior to study drug administration
• Is currently receiving any agent with a known effect on the immune system, unless at dose levels that are not clinically immunosuppressive (e.g. Prednisone at 10 mg/day or less, or as inhaled steroid at doses used for the treatment of asthma
• Has any other serious illnesses or medical conditions such as, but not limited to: * Any uncontrolled infection * Uncontrolled cardiac failure classification New York Heart Association (NYHA) III or IV * Uncontrolled systemic and gastro-intestinal inflammatory conditions
• Severe intercurrent disease which might affect immunocompetence
• Active or prior documented autoimmune disease within the past 2 years * Note: Subjects with vitiligo, Grave’s disease, psoriasis not requiring systemic treatment or hypothyroidism (i.e. following Hashimoto syndrome) stable on hormone replacement are not excluded
• Active or prior documented inflammatory bowel disease (i.e. ulcerative colitis)
• History of adverse reactions to peptide vaccines
• Positive tests for human immunodeficiency virus (HIV) or hepatitis B or C infection
• Planning to receive yellow fever or other live (attenuated) vaccines during the course of the study
• Have any other active malignancies (except for adequately treated carcinoma of the cervix or basal or squamous cell skin cancer) which in the opinion of the investigator is likely to require treatment within 3 years