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ACTIVE NOT RECRUITING
NCT05638698
PHASE2

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

Sponsor: University of Kansas Medical Center

View on ClinicalTrials.gov

Summary

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2022-12-15

Completion Date

2025-12

Last Updated

2024-09-23

Healthy Volunteers

No

Conditions

Interventions

BIOLOGICAL

TG01 Vaccine

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

DRUG

QS-21

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

DRUG

Balstilimab

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

Locations (5)

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