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

Primary Purpose

Pancreas Cancer

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
TG01 Vaccine
QS-21
Balstilimab
Sponsored by
University of Kansas Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreas Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. 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. Exclusion Criteria: 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 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

Sites / Locations

  • University of Kansas Cancer Center - Clinical Research CenterRecruiting
  • University of Kansas Cancer Center - Overland ParkRecruiting
  • University of Kansas Cancer Center - WestwoodRecruiting
  • University of Kansas Cancer Center - NorthRecruiting
  • University of Kansas Cancer Center - Lee's SummitRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

TG01/QS-21 (Vaccine arm)

TG01/QS-21 + Balstilimab (Vaccine + PD-1 arm)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Incidence of Treatment-Emergent Adverse Events
To assess safety of TG01/QS-21 safety with or without Balstilimab using CTCAE version 5.0
Disease free survival rate
To assess 6- month and 12-month Disease free survival rate in each cohort
Complete molecular response rate
To assess complete molecular response rate in each cohort as defined by ctDNA clearance
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

Full Information

First Posted
November 16, 2022
Last Updated
January 30, 2023
Sponsor
University of Kansas Medical Center
Collaborators
Targovax ASA
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1. Study Identification

Unique Protocol Identification Number
NCT05638698
Brief Title
Tg01 Vaccine / Qs-21 Stimulon™ With Or Without Balstilimab As Maintenance Therapy Following Adjuvant Chemotherapy In Patients With Resected Pancreatic Cancer
Acronym
TESLA
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)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 15, 2022 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Kansas Medical Center
Collaborators
Targovax ASA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreas Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TG01/QS-21 (Vaccine arm)
Arm Type
Experimental
Arm Description
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.
Arm Title
TG01/QS-21 + Balstilimab (Vaccine + PD-1 arm)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
TG01 Vaccine
Intervention Description
used to assess molecular disease control rate when combined with other interventional methods.
Intervention Type
Drug
Intervention Name(s)
QS-21
Intervention Description
used to assess molecular disease control rate when combined with other interventional methods.
Intervention Type
Drug
Intervention Name(s)
Balstilimab
Intervention Description
used to assess molecular disease control rate when combined with other interventional methods.
Primary Outcome Measure Information:
Title
Molecular disease control rate
Description
To assess 6-month molecular disease control rate in each cohort as defined by ctDNA stability, decrease or clearance.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events
Description
To assess safety of TG01/QS-21 safety with or without Balstilimab using CTCAE version 5.0
Time Frame
6 months
Title
Disease free survival rate
Description
To assess 6- month and 12-month Disease free survival rate in each cohort
Time Frame
12 months
Title
Complete molecular response rate
Description
To assess complete molecular response rate in each cohort as defined by ctDNA clearance
Time Frame
6 months
Title
Correlation between molecular response and disease free survival
Description
To assess the correlation between the depth of molecular response to disease free survival in each cohort
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 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. Exclusion Criteria: 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
KUCC Navigation
Phone
913-945-7552
Email
ctnursenav@kumc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anup Kasi
Organizational Affiliation
The University of Kansas Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Cancer Center - Clinical Research Center
City
Fairway
State/Province
Kansas
ZIP/Postal Code
66208
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
KUCC Navigation
Phone
913-588-3671
Email
kucc_navigation@kumc.edu
First Name & Middle Initial & Last Name & Degree
Rahul Parikh, MD
Facility Name
University of Kansas Cancer Center - Overland Park
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trial Nurse Navigator
Email
ctnursenav@kumc.edu
Facility Name
University of Kansas Cancer Center - Westwood
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
KUCC Navigation
Phone
913-588-3671
Email
kucc_navigation@kumc.edu
Facility Name
University of Kansas Cancer Center - North
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64154
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
913-945-7552
Email
ctnursenav@kumc.edu
Facility Name
University of Kansas Cancer Center - Lee's Summit
City
Lee's Summit
State/Province
Missouri
ZIP/Postal Code
64064
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kerry Hepler
Phone
913-945-7552
Email
ctnursenav@kumc.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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