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Pancreas CancerPhase 2TESLANCT05638698

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 testing TG01 Vaccine, QS-21 and Balstilimab in people with Pancreas Cancer, run by University of Kansas Medical Center at 5 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreas Cancer
What is being tested?
TG01 Vaccine, QS-21 and Balstilimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
5 sitesUnited States
Study dates
15 Dec 2022to Dec 2025
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Ability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent
  • Males and females age ≥ 18 years
  • ECOG Performance Status 0 - 1 within 28 days prior to registration (Appendix A)
  • Surgically resected stage I/II/III Pancreatic Cancer
  • Life expectancy of at least 6 months
  • Screening tumor tissue positive or known pathogenic or likely pathogenic RAS mutation resulting in amino acid substitution in codon 12A, 12C, 12D, 12R, 12S or 13D . Mutations must be considered pathogenic or likely pathogenic by a reference database such as ClinVar or OncoKb.org.(https://www.ncbi.nlm.nih.gov/clinvar/variation;https://www.oncoKb.org). Local RAS test results are acceptable and central confirmation is not required prior to treatment.
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  • No evidence of recurrent cancer on screening imaging studies
  • 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
  • Prior cancer treatment must be completed at least 14 days prior to registration and the subject must have recovered from all reversible acute toxic effects of the regimen (other than alopecia) to Grade ≤ 1 or baseline.
  • Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to initiating treatment. See also section with title CHILD BEARING POTENTIAL /PREGNANCY
  • Adequate organ function, measured within 28 days prior to enrollment and defined as follows:
  • Hgb ≥ 8g/dL
  • Creatine clearance ≥ 50ml/min (measured or calculated by the Cockroft-Gault method)
  • Leukocytes >1.5K/UL
  • Absolute Neutrophil Count >1.5K/UL NOTE: Patients with established diagnosis of benign neutropenia are eligible to participate with ANC between 1000-1500 if in the opinion of treating physician the trial treatment does not pose excessive risk of infection to the patient.
  • Platelets >100K/UL
  • Total bilirubin ≤ 1.5 x ULN OR direct bilirubin ≤ 1 x ULN
  • Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x ULN unless liver metastases are present, in which case they must be ≤ 5 x ULN
  • Women of child-bearing potential and men with partners of child-bearing potential must agree to practice sexual abstinence or to use the forms of contraception listed in Child-Bearing Potential/Pregnancy section for the duration of study participation and for 30 days after the last dose of TG01/QS-21 immunotherapy and 90 days after the last dose of Balstilimab.

Who cannot join

  • Simultaneously enrolled in any therapeutic clinical trial
  • Current or anticipating use of other anti-neoplastic or investigational agents while participating in this study
  • Diagnosed with a psychiatric illness or is in a social situation that would limit compliance with study requirements
  • Is pregnant, planning pregnancy, or breastfeeding
  • Has a known allergic reaction to any excipient contained in the study drug formulation
  • Has received an investigational drug within 4 weeks prior to study drug administration
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  • Is currently receiving any agent with a known effect on the immune system, unless at dose levels that are not clinically immunosuppressive (e.g. Prednisone at 10 mg/day or less, or as inhaled steroid at doses used for the treatment of asthma
  • Has any other serious illnesses or medical conditions such as, but not limited to:
  • Any uncontrolled infection
  • Uncontrolled cardiac failure classification New York Heart Association (NYHA) III or IV
  • Uncontrolled systemic and gastro-intestinal inflammatory conditions
  • Inadequate bone marrow function with suspected inability to mount an immune response to vaccination
  • Severe intercurrent disease which might affect immunocompetence
  • Unacceptable values of the hematological or chemical tests (in relation to the ability to generate an immune response), as judged by the investigator
  • Active or prior documented autoimmune disease within the past 2 years. Note: subjects with vitiligo, Grave's disease, psoriasis not requiring systemic treatment or hypothyroidism (i.e.
  • following Hashimoto syndrome) stable on hormone replacement are not excluded.
  • Active or prior documented inflammatory bowel disease (i.e. ulcerative colitis)
  • History of adverse reactions to peptide vaccines
  • Positive tests for human immunodeficiency virus (HIV) or hepatitis B or C infection
  • Planning to receive yellow fever or other live (attenuated) vaccines during the course of the study.
  • Have any other active malignancies (except for adequately treated carcinoma of the cervix or basal or squamous cell skin cancer) which in the opinion of the investigator is likely to require treatment within 3 years

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • University of Kansas Cancer Center - Clinical Research Center

    Fairway, Kansas, 66208

  • University of Kansas Cancer Center - North

    Kansas City, Missouri, 64154

  • University of Kansas Cancer Center - Lee's Summit

    Lee's Summit, Missouri, 64064

  • University of Kansas Cancer Center - Overland Park

    Overland Park, Kansas, 66210

  • University of Kansas Cancer Center - Westwood

    Westwood, Kansas, 66205

Other trials in United States

About this study

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)

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.

Read more

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
Pancreas Cancer
Being tested
TG01 Vaccine, QS-21, Balstilimab
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TG01 VaccineBiological

    used to assess molecular disease control rate when combined with other interventional methods.

  • QS-21Drug

    used to assess molecular disease control rate when combined with other interventional methods.

  • BalstilimabDrug

    used to assess molecular disease control rate when combined with other interventional methods.

Study groups in NCT05638698
Study groupRoleWhat they receive
TG01/QS-21 (Vaccine arm)ExperimentalTG01 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.
Receives: Biological: TG01 Vaccine; Drug: QS-21
TG01/QS-21 + Balstilimab (Vaccine + PD-1 arm)ExperimentalTG01 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.
Receives: Biological: TG01 Vaccine; Drug: QS-21; Drug: Balstilimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Molecular disease control rate

    To assess 6-month molecular disease control rate in each cohort as defined by ctDNA stability, decrease or clearance.

    Measured: 6 months

Secondary outcomes (4)

  1. Incidence of Treatment-Emergent Adverse Events

    To assess safety of TG01/QS-21 safety with or without Balstilimab using CTCAE version 5.0

    Measured: 6 months

  2. Disease free survival rate

    To assess 6- month and 12-month Disease free survival rate in each cohort

    Measured: 12 months

  3. Complete molecular response rate

    To assess complete molecular response rate in each cohort as defined by ctDNA clearance

    Measured: 6 months

  4. Correlation between molecular response and disease free survival

    To assess the correlation between the depth of molecular response to disease free survival in each cohort

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Dec 2022
  2. Study start15 Dec 2022
  3. Primary completionDec 2024 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a two arm, open-label, phase II randomized trial of TG01 vaccine and QS- 21 (vaccine arm) or TG01 vaccine and QS-21 plus Balstilimab (Vaccine + PD1i arm) in patients with surgically resected Stage 1-3 RAS mutant pancreatic cancer who have positive circulating tumor DNA (ctDNA+) in the blood despite prior standard therapy including chemotherapy/radiation therapy where applicable; no evidence of disease by imaging.
Masking
None (open label)
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05638698
Sponsor's protocol ID
STUDY00149222
Acronym
TESLA
Status last verified
Sep 2024
First submitted
16 Nov 2022
Last updated
23 Sep 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TG01 Vaccine, QS-21 and Balstilimab in people with Pancreas Cancer, run by University of Kansas Medical Center at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 23 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Molecular disease control rate (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05638698.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2024.

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