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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
used to assess molecular disease control rate when combined with other interventional methods.
used to assess molecular disease control rate when combined with other interventional methods.
used to assess molecular disease control rate when combined with other interventional methods.
University of Kansas Cancer Center - Clinical Research Center
Fairway, Kansas, United States
University of Kansas Cancer Center - Overland Park
Overland Park, Kansas, United States
University of Kansas Cancer Center - Westwood
Westwood, Kansas, United States
University of Kansas Cancer Center - North
Kansas City, Missouri, United States
University of Kansas Cancer Center - Lee's Summit
Lee's Summit, Missouri, United States
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
Incidence of Treatment-Emergent Adverse Events
To assess safety of TG01/QS-21 safety with or without Balstilimab using CTCAE version 5.0
Time frame: 6 months
Disease free survival rate
To assess 6- month and 12-month Disease free survival rate in each cohort
Time frame: 12 months
Complete molecular response rate
To assess complete molecular response rate in each cohort as defined by ctDNA clearance
Time frame: 6 months
Correlation between molecular response and disease free survival
To assess the correlation between the depth of molecular response to disease free survival in each cohort
Time frame: 6 months
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