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Cancer Vaccine

TG01 + QS-21 +/- Balstilimab for Pancreatic Cancer (TESLA Trial)

Q: Is the usage of TG01/QS-21 (Vaccine arm) a risk for human health?

<p>Our team at Power rate the safety of TG01/QS-21 (<a href="https://www.withpower.com/clinical-trials/vaccine">Vaccine</a> arm) as a 2 due to its Phase 2 status. There is evidence that it is safe, however efficacy has yet to be demonstrated through clinical data.</p>

Phase 2

Recruiting

Led By Anup Kasi

Research Sponsored by University of Kansas Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Males and females age ≥ 18 years

Positive for Minimal Residual Disease (MRD) as assessed by Signatera circulating tumor DNA (ctDNA) despite prior standard therapy including surgery and chemotherapy/radiation therapy where applicable

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

TESLA Trial Summary

This trial is testing if a new drug, TG01, and an existing drug, Balstilimab, can help pancreatic cancer patients' immune system fight cancer cells remaining after surgery. QS-21 is also used to improve the effectiveness of TG01.

Who is the study for?

Adults over 18 with resected stage I/II/III Pancreatic Cancer, positive for MRD, and specific RAS mutations. They must have completed prior cancer treatment at least 14 days before and recovered from its effects. Women of childbearing potential need a negative pregnancy test and agree to contraception.Check my eligibility

What is being tested?

The trial is testing the TG01 vaccine combined with QS-21 to boost immune response against pancreatic cancer cells post-surgery. It's also examining if adding Balstilimab increases effectiveness. These drugs are experimental and not FDA-approved for treating any cancers.See study design

What are the potential side effects?

Potential side effects may include typical reactions related to vaccines such as soreness at injection site, fever, fatigue, or allergic responses. Since these treatments aim to stimulate the immune system, there could be risks of autoimmune-like symptoms.

TESLA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I still have cancer signs in my blood after standard treatment, including surgery and chemo or radiation.

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My blood and organ tests show I am healthy enough for treatment.

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I have been mostly active and able to carry on all pre-disease activities without restriction in the last 28 days.

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My pancreatic cancer was surgically removed and was stage I, II, or III.

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My latest scans show no signs of cancer coming back.

Select...

My cancer has a specific RAS mutation identified by a reliable database.

TESLA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Molecular disease control rate

Secondary outcome measures

Complete molecular response rate

Correlation between molecular response and disease free survival

Disease free survival rate

+1 more

TESLA Trial Design

2Treatment groups

Experimental Treatment

Group I: TG01/QS-21 + Balstilimab (Vaccine + PD-1 arm)Experimental Treatment3 Interventions

TG01 is mixed with adjuvant QS-21 and given subcutaneously. Balstilimab is given intra-venously as infusion and begins week 3, then given every 2 weeks for up to 51 weeks. After six administrations given once every two weeks of TG01 vaccine (+adjuvant QS-21) over 12 weeks during weeks 1,3,5,7,9,11, [priming/booster phase]), the treatment will then switch to a maintenance phase of TG01 vaccine (+adjuvant QS-21) given once every 8 weeks for up to 51 weeks: The maintenance treatments will occur during weeks 19, 27, 35, 43, and 51. Maintenance treatments will end on week 51 or at the time of disease recurrence; whichever is the earliest.

Group II: TG01/QS-21 (Vaccine arm)Experimental Treatment2 Interventions

TG01 is mixed with adjuvant QS-21 and given subcutaneously. After six administrations given once every two weeks of TG01 vaccine (+adjuvant QS-21) over 12 weeks during weeks 1,3,5,7,9,11, [priming/booster phase]), the treatment will then switch to a maintenance phase of TG01 vaccine (+adjuvant QS-21) once every 8 weeks for up to 51 weeks: The maintenance treatments will occur during weeks 19, 27, 35, 43, and 51. Maintenance treatments will end on week 51 or at the time of disease recurrence; whichever is the earliest.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

QS-21

2008

Completed Phase 2

~320

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Kansas Medical CenterLead Sponsor

463 Previous Clinical Trials

169,246 Total Patients Enrolled

Targovax ASAIndustry Sponsor

5 Previous Clinical Trials

179 Total Patients Enrolled

Anup KasiPrincipal InvestigatorThe University of Kansas Cancer Center

Media Library

TG01 Vaccine (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT05638698 — Phase 2

Pancreatic Cancer Research Study Groups: TG01/QS-21 (Vaccine arm), TG01/QS-21 + Balstilimab (Vaccine + PD-1 arm)

Pancreatic Cancer Clinical Trial 2023: TG01 Vaccine Highlights & Side Effects. Trial Name: NCT05638698 — Phase 2

TG01 Vaccine (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05638698 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any remaining opportunities for involvement in this research?

"This clinical trial, which was first launched on December 1st 2022 and last edited 5 days later, is no longer recruiting patients. Nevertheless, there are 706 other studies out there that still require participants."

Answered by AI

Are there numerous facilities in Canada executing this medical experiment?

"This trial is being offered at 5 distinct medical centres including University of Kansas Cancer Center - Westwood, University of Kansas Cancer Center - Clinical Research Centre, and University of Kansas Cancer Center - North. Additionally, there are two other locations where this study can be accessed."

Answered by AI

Is the usage of TG01/QS-21 (Vaccine arm) a risk for human health?

"Our team at Power rate the safety of TG01/QS-21 (Vaccine arm) as a 2 due to its Phase 2 status. There is evidence that it is safe, however efficacy has yet to be demonstrated through clinical data."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "Tg01 Vaccine / Qs-21 Stimulon™ With Or Without Balstilimab As Maintenance Therapy Following Adjuvant Chemotherapy In Patients With Resected Pancreatic Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05638698.