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

Brief summary public domain (ClinicalTrials.gov)

Researchers want to discover if the new drug "TG01" will work with participants' bodies to help their immune system attack any cancer cells that might still be in the blood stream after surgery for pancreatic cancer. The researchers will also investigate whether or not "TG01" combined with the other study drug, "Balstilimab", will show even greater efficacy. TG01 and Balstilimab are both experimental treatments and are not approved by the US Food and Drug Administration (FDA) as treatment in the United States, or elsewhere, for pancreatic cancer or any other type of cancer. Balstilimab has been studied in other cancers and has shown signs of efficacy. Another drug will be used in this study called "QS-21". It is not intended to treat any disease but is used in this study to improve the action of the study drug TG01. QS-21 has been approved by the US Food and Drug Administration (FDA) to be mixed with a vaccine used to prevent shingles. It has not been approved to be mixed with the study drug, TG01. Participants will undergo eligibility screening, weekly visits during treatment when receiving the study drug or study drug combination, two safety follow-up visits, at about 30 and 90 days after the last dose of study treatment, and long term follow up for about 12 months after the last dose of study treatment.

Intervention public domain (ClinicalTrials.gov)

Biological: TG01 Vaccine. used to assess molecular disease control rate when combined with other interventional methods.

Intervention public domain (ClinicalTrials.gov)

Drug: QS-21. used to assess molecular disease control rate when combined with other interventional methods.

Intervention public domain (ClinicalTrials.gov)

Drug: Balstilimab. used to assess molecular disease control rate when combined with other interventional methods.

Arm public domain (ClinicalTrials.gov)

TG01/QS-21 (Vaccine arm) (experimental): TG01 is mixed with adjuvant QS-21 and given subcutaneously. After six administrations given once every two weeks of TG01 vaccine (+adjuvant QS-21) over 12 weeks during weeks 1,3,5,7,9,11, \[priming/booster phase\]), the treatment will then switch to a maintenance phase of TG01 vaccine (+adjuvant QS-21) once every 8 weeks for up to 51 weeks: The maintenance treatments will occur during weeks 19, 27, 35, 43, and 51. Maintenance treatments will end on week 51 or at the time of disease recurrence; whichever is the earliest.

Arm public domain (ClinicalTrials.gov)

TG01/QS-21 + Balstilimab (Vaccine + PD-1 arm) (experimental): TG01 is mixed with adjuvant QS-21 and given subcutaneously. Balstilimab is given intra-venously as infusion and begins week 3, then given every 2 weeks for up to 51 weeks. After six administrations given once every two weeks of TG01 vaccine (+adjuvant QS-21) over 12 weeks during weeks 1,3,5,7,9,11, \[priming/booster phase\]), the treatment will then switch to a maintenance phase of TG01 vaccine (+adjuvant QS-21) given once every 8 weeks for up to 51 weeks: The maintenance treatments will occur during weeks 19, 27, 35, 43, and 51. Maintenance treatments will end on week 51 or at the time of disease recurrence; whichever is the earliest.

Primary outcome public domain (ClinicalTrials.gov)

Molecular disease control rate. To assess 6-month molecular disease control rate in each cohort as defined by ctDNA stability, decrease or clearance. Time frame: 6 months.

Secondary outcome public domain (ClinicalTrials.gov)

Incidence of Treatment-Emergent Adverse Events. Time frame: 6 months.

Secondary outcome public domain (ClinicalTrials.gov)

Disease free survival rate. Time frame: 12 months.

Secondary outcome public domain (ClinicalTrials.gov)

Complete molecular response rate. Time frame: 6 months.

Secondary outcome public domain (ClinicalTrials.gov)

Correlation between molecular response and disease free survival. Time frame: 6 months.

Eligibility public domain (ClinicalTrials.gov)

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 * 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 …

Enrollment public domain (ClinicalTrials.gov)

Enrollment: 24 participants (estimated).