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Vaccines

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.

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.

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

TG01 Vaccine

QS-21

Balstilimab

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Rahul Parikh, MD

Clinical Trial Nurse Navigator

Kerry Hepler

Anup Kasi

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.

This is a two arm, open-label, phase II randomized trial of TG01 vaccine and QS- 21 (vaccine arm) or TG01 vaccine and QS-21 plus Balstilimab (Vaccine + PD1i arm) in patients with surgically resected Stage 1-3 RAS mutant pancreatic cancer who have positive circulating tumor DNA (ctDNA+) in the blood despite prior standard therapy including chemotherapy/radiation therapy where applicable; no evidence of disease by imaging.

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

Phase II Randomized Trial Combining Tg01 Vaccine / Qs-21 Stimulon™ With Or Without Balstilimab As Maintenance Therapy Following Adjuvant Chemotherapy In Patients With Resected Pancreatic Cancer(TESLA)

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

To assess safety of TG01/QS-21 safety with or without Balstilimab using CTCAE version 5.0

To assess 6- month and 12-month Disease free survival rate in each cohort

To assess complete molecular response rate in each cohort as defined by ctDNA clearance

To assess the correlation between the depth of molecular response to disease free survival in each cohort

Spots Global Cancer Trial Database for tg01 vaccine

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