TG01 + QS-21 +/- Balstilimab for Pancreatic Cancer

(TESLA Trial)

Not currently recruiting at 4 trial locations

Overseen By KUCC Navigation

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Kansas Medical Center

Must not be taking: Immunosuppressants

Disqualifiers: Pregnancy, Autoimmune disease, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 14

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the experimental TG01 vaccine can help the immune system attack leftover cancer cells after pancreatic cancer surgery. Researchers are also testing whether combining TG01 with Balstilimab, another experimental drug, enhances the treatment's effectiveness. Suitable participants have undergone pancreatic cancer surgery, show signs of minimal residual disease (small traces of cancer) in their blood, and do not have recurrent cancer. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot use other cancer treatments or drugs that affect the immune system unless they are at low doses. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the combination of TG01 and QS-21 is generally safe. In previous studies, half of the participants tolerated the vaccine well, with most experiencing no serious side effects.

The safety of TG01 combined with Balstilimab is also under investigation. Balstilimab has been tested in other cancer types and has shown positive results. However, neither TG01 nor Balstilimab has FDA approval for treating any cancer.

QS-21, which enhances the TG01 vaccine, has FDA approval for use in a shingles vaccine. This approval indicates some level of safety for QS-21, but it is not yet approved for use with TG01.

In summary, early research suggests these treatments are generally well-tolerated, but further testing is needed to confirm their safety when used together. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for pancreatic cancer because they bring unique approaches compared to the standard chemotherapy and radiation therapies. The TG01 vaccine, used alone or combined with the immune checkpoint inhibitor Balstilimab, works by prompting the immune system to target cancer cells, which is a different mechanism than traditional treatments. TG01 is injected subcutaneously, and Balstilimab is administered intravenously, offering a potentially more targeted and sustained immune response. This innovative strategy aims to enhance the body's natural defenses against cancer, potentially leading to better outcomes for patients with pancreatic cancer.

What evidence suggests that this trial's treatments could be effective for pancreatic cancer?

Research has shown that TG01, when combined with QS-21, can help the immune system identify and attack cancer cells in the blood. In earlier studies, TG01 activated certain immune cells to fight cancer. About 50% of patients responded positively to this vaccine combination. In this trial, some participants will receive the TG01/QS-21 combination alone.

Balstilimab, another drug in this trial, has shown potential in treating other types of cancer. It targets PD-1, a protein that helps cancer cells evade the immune system. Other participants in this trial will receive TG01 together with Balstilimab, which might enhance the treatment's effectiveness against pancreatic cancer. ^{1 2 3 5 6}

Who Is on the Research Team?

Anup Kasi, MD

Principal Investigator

The University of Kansas Cancer Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I finished my last cancer treatment at least 14 days ago and have recovered from its side effects.

You are expected to live for at least 6 more months.

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

Exclusion Criteria

You have tested positive for HIV or hepatitis B or C infection.

I do not have any other cancers that need treatment within 3 years, except for treated skin or cervical cancer.

I have or had inflammatory bowel disease like ulcerative colitis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Priming/Booster Treatment

Participants receive TG01 vaccine mixed with QS-21 every two weeks for 12 weeks

12 weeks

6 visits (in-person)

Maintenance Treatment

Participants receive TG01 vaccine mixed with QS-21 every 8 weeks for up to 51 weeks

51 weeks

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

2 visits (in-person) at 30 and 90 days, long-term follow-up

What Are the Treatments Tested in This Trial?

Interventions

• Balstilimab
• TG01 Vaccine

Trial Overview 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.

How Is the Trial Designed?

Group I: TG01/QS-21 + Balstilimab (Vaccine + PD-1 arm) Experimental Treatment 3 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 Treatment 2 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.

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials

527

Recruited

181,000+

Targovax ASA

Industry Sponsor

Trials

6

Recruited

200+

Published Research Related to This Trial

The Rotterdam PancrEAtic Cancer Vaccination-2 trial is investigating the safety and tolerability of a combination treatment using dendritic cell vaccines and an anti-CD40 agonistic antibody in patients with advanced pancreatic cancer, with a focus on those who have not responded to standard chemotherapy.

This phase I trial will include 12 to 18 patients and aims to assess treatment-induced immune responses and tumor-specific effects, potentially offering a new immunotherapy approach for a disease with limited treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and tumour-specific immunological responses of combined dendritic cell vaccination and anti-CD40 agonistic antibody treatment for patients with metastatic pancreatic cancer: protocol for a phase I, open-label, single-arm, dose-escalation study (REACtiVe-2 trial). Lau, SP., van 't Land, FR., van der Burg, SH., et al.[2023]

The dendritic cell (DC) vaccine modified with tumor lysate and Interleukin-18 (IL-18) significantly enhanced immune responses in a mouse model of pancreatic carcinoma, leading to higher levels of IL-18 and IFN-gamma compared to other treatment groups.

Mice treated with the DC-IL18-Lysate vaccine remained tumor-free for at least 50 days and had a median survival of over 62 days, which was significantly longer than other groups, indicating its potential efficacy as a therapeutic vaccine against pancreatic cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The immunotherapeutic effect of dendritic cells vaccine modified with interleukin-18 gene and tumor cell lysate on mice with pancreatic carcinoma. Tang, ZH., Qiu, WH., Wu, GS., et al.[2019]

The combination of GVAX vaccine with nivolumab and urelumab significantly increased the number of activated CD8+ CD137+ T cells in tumors, indicating a robust immune response, and was well-tolerated by patients.

While the median disease-free and overall survival rates were numerically improved with the combination therapy compared to other treatment arms, the results were not statistically significant, suggesting that further studies are needed to confirm these promising findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A platform trial of neoadjuvant and adjuvant antitumor vaccination alone or in combination with PD-1 antagonist and CD137 agonist antibodies in patients with resectable pancreatic adenocarcinoma. Heumann, T., Judkins, C., Li, K., et al.[2023]

In a study involving 93 patients with metastatic pancreatic cancer, combining GVAX vaccine and cyclophosphamide with nivolumab (Arm A) did not significantly improve overall survival compared to the same treatment without nivolumab (Arm B), with median survival times of 5.9 and 6.1 months, respectively.

Despite not meeting the primary endpoint, Arm A showed some objective tumor responses and beneficial immunologic changes in long-term survivors, such as increased CD8+ T cells, suggesting potential for immune modulation even if overall survival was similar to standard therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Cyclophosphamide/GVAX Pancreas Followed by Listeria-Mesothelin (CRS-207) with or without Nivolumab in Patients with Pancreatic Cancer. Tsujikawa, T., Crocenzi, T., Durham, JN., et al.[2023]

Pancreatic cancer is highly lethal due to its immune privilege, characterized by an immunosuppressive environment and poor T cell infiltration, making traditional immunotherapies less effective.

Emerging evidence suggests that combining different immunotherapy strategies, such as checkpoint blockade and engineered T cells, may enhance treatment efficacy for pancreatic cancer, highlighting the need for innovative approaches in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunotherapy and Prevention of Pancreatic Cancer. Morrison, AH., Byrne, KT., Vonderheide, RH.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05638698

Study Details | NCT05638698 | Tg01 Vaccine / Qs-21 ... Researchers want to discover if the new drug "TG01" will work with participants' bodies to help their immune system attack any cancer cells.

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2023.41.16_suppl.TPS4205

Targeting minimal residual disease (MRD) in resected RAS ... TG01 has previously demonstrated ability to activate mutant RAS specific CD4+ and CD8+ T-cell responses in vaccinated patients and repeated TG01 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11988091/

Immune-Based Strategies for Pancreatic Cancer in the ... The preliminary success of this regimen has provided the rationale for the current phase II trial of TG01 RAS vaccine plus QS-21 (Stimulon®, ...

4. kucancercenter.org kucancercenter.org/cancer-clinical-trials/find-trial/clinical-trial-results/study00149222

Phase II Randomized Trial Combining TG01 Vaccine / QS ... Phase II randomized trial combining TG01 vaccine / QS-21 stimulon with or without balstilimab as maintenance therapy following adjuvant chemotherapy.

5. circio.com circio.com/en/tg01-mutant-ras-cancer-vaccine-data-showing-clinical-benefit-in-multiple-myeloma-presented-at-eha-2025/

TG01 mutant RAS cancer vaccine data showing clinical ... Available data demonstrate excellent tolerability and safety of TG01/QS-21 vaccination; 50% (6/12) of vaccinated patients show vaccine ...

6. ashpublications.org ashpublications.org/blood/article/144/Supplement%201/7053/527039/Vaccinating-Against-Mutated-RAS-in-Multiple

The Phase I/II TG01/QS-21 Study | Blood - ASH Publications Conclusion: Preliminary data suggest that TG01/QS-21 has a very tolerable safety profile. No objective responses have so far been observed ...