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NCT05638698 · ClinicalTrials.gov registry record · Phase 2
Tg01 Vaccine / Qs-21 Stimulon™ With Or Without Balstilimab As Maintenance Therapy Following Adjuvant Chemotherapy In Patients With Resected Pancreatic Cancer
A Phase 2 study of Pancreas Cancer, sponsored by University of Kansas Medical Center.
- Active
- Registry status
- Phase 2
- Development phase
- 24
- Enrollment target
- 5
- Study locations
NCT05638698: Active Phase 2 study of Pancreas Cancer, sponsored by University of Kansas Medical Center.
NCT05638698 is a Phase 2 study of Pancreas Cancer that is active but no longer recruiting, run by University of Kansas Medical Center. The registered enrollment target is 24 participants, below the 907-participant average among 54 other Pancreas Cancer trials with a reported enrollment target (97% lower). The trial reports 5 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05638698, a Phase 2 study of Pancreas Cancer, is active but no longer recruiting, sponsored by University of Kansas Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 24 participants
- Enrollment target
- 5
- Study locations
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.
Primary Outcome
To assess 6-month molecular disease control rate in each cohort as defined by ctDNA stability, decrease or clearance.
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
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2022-12-15 |
| Est. Completion | 2025-12 |
| Phase | Phase 2 |
What the registry record for NCT05638698 still lists
NCT05638698 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 907-participant average among 54 other Pancreas Cancer trials with a reported enrollment target (97% lower).
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.
NCT05638698 lists 5 locations in 2 states (Kansas, Missouri).
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.
What interventions are being tested in trial NCT05638698?
The interventions under investigation include: Balstilimab (DRUG), TG01 Vaccine (BIOLOGICAL), QS-21 (DRUG).
Who is sponsoring clinical trial NCT05638698?
This trial is sponsored by University of Kansas Medical Center, which has 408 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT05638698's enrollment target sits among peer trials
24 47th of 54 higher than 7 of 54 other Pancreas Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pancreas Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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