Tg01 Vaccine / Qs-21 Stimulon™ With Or Without Balstilimab As Maintenance Therapy Following Adjuvant Chemotherapy In Patients With Resected Pancreatic Cancer
Public ClinicalTrials.gov record NCT05638698. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT05638698
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 24 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 14, 2022
- Primary completion
- Nov 30, 2024
- Completion
- Nov 30, 2025
- Last update posted
- Sep 22, 2024
2022 – 2025
United States locations
- U.S. sites
- 5
- U.S. states
- 2
- U.S. cities
- 5
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Kansas Cancer Center - Clinical Research Center | Fairway | Kansas | 66208 | — |
| University of Kansas Cancer Center - Overland Park | Overland Park | Kansas | 66210 | — |
| University of Kansas Cancer Center - Westwood | Westwood | Kansas | 66205 | — |
| University of Kansas Cancer Center - North | Kansas City | Missouri | 64154 | — |
| University of Kansas Cancer Center - Lee's Summit | Lee's Summit | Missouri | 64064 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05638698, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 22, 2024 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05638698 live on ClinicalTrials.gov.