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ACTIVE NOT RECRUITING Phase 2

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

NCT05638698 · View on ClinicalTrials.gov ↗

Study 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.

Conditions Studied

Interventions

  • DRUG Balstilimab
  • BIOLOGICAL TG01 Vaccine
  • DRUG QS-21

Study Locations (5)

Kansas

  • University of Kansas Cancer Center - Clinical Research Center — Fairway
  • University of Kansas Cancer Center - Overland Park — Overland Park
  • University of Kansas Cancer Center - Westwood — Westwood

Missouri

  • University of Kansas Cancer Center - North — Kansas City
  • University of Kansas Cancer Center - Lee's Summit — Lee's Summit

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2022-12-15
Est. Completion 2025-12
Phase Phase 2

Sponsor

University of Kansas Medical Center

454 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05638698

The ClinicalTrials.gov registry entry for NCT05638698 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Kansas Medical Center, which has 454 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Pancreas Cancer appearing as the primary indexed condition, and to 3 interventions — of which Balstilimab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05638698 reports 5 study locations spanning 2 distinct geographic areas — top geographies include Kansas, Missouri. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05638698 about?

NCT05638698 is a clinical study titled "Tg01 Vaccine / Qs-21 Stimulon™ With Or Without Balstilimab As Maintenance Therapy Following Adjuvant Chemotherapy In Patients With Resected Pancreatic Cancer". 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 othe...

What is the current status of trial NCT05638698?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2022-12-15. Estimated completion is 2025-12.

What conditions does trial NCT05638698 study?

This clinical trial studies the following conditions: Pancreas Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05638698?

The interventions under investigation include: Balstilimab (DRUG), TG01 Vaccine (BIOLOGICAL), QS-21 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05638698?

This trial is sponsored by University of Kansas Medical Center, which has 454 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05638698 being conducted?

This trial has 5 study locations across Kansas, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial