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

Study acronym: TESLA
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated September 23, 2024 (before its estimated December 2024 completion). Its status may not reflect the trial's current state.

Record History

  1. Minor Trial status: Recruiting to Active, Not Recruiting Site details revised at 5 of 5 sitesv4 Show 1 more changeShow less
    • Site details revised at 5 of 5 sites
  2. Notable Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Dec 2022 to Dec 15, 2022 · Site details revised at 5 of 5 sitesv3 Show 2 more changesShow less
    • Start date changed from estimate of Dec 2022 to Dec 15, 2022
    • Site details revised at 5 of 5 sites
  3. Minor Secondary endpoints revised (4)v2 See this version in full on ClinicalTrials.gov ↗
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05638698
Lead Sponsor University of Kansas Medical Center
Collaborators: Targovax ASA
Conditions Pancreas Cancer
Enrollment 24 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov