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

(TESLA Trial)

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

24 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment TG01 + QS-21 +/- Balstilimab for pancreatic cancer?

Research on similar treatments, like the GVAX vaccine combined with other drugs, shows that these combinations can increase immune cell activity in pancreatic cancer, which might help fight the cancer. Although not directly related to TG01 + QS-21 +/- Balstilimab, these findings suggest that combining vaccines with immune-boosting drugs could be promising for pancreatic cancer. ^{1 2 3 4 5}

What makes the TG01 + QS-21 +/- Balstilimab treatment unique for pancreatic cancer?

The TG01 + QS-21 +/- Balstilimab treatment is unique because it combines a vaccine approach with an immune system booster (QS-21) and potentially an immune checkpoint inhibitor (Balstilimab), aiming to enhance the body's immune response against pancreatic cancer, which is known for its challenging immune environment. ^{1 3 4 6 7}

What is the purpose of this trial?

This trial is testing a new drug, TG01, to help the immune system fight leftover cancer cells after pancreatic surgery. It also tests if combining TG01 with another drug, Balstilimab, works better. The study focuses on patients who have had pancreatic cancer surgery.

Research Team

Anup Kasi, MD

Principal Investigator

The University of Kansas Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. United States 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. [2023]

2. England 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. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Immunotherapy and Prevention of Pancreatic Cancer. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Countering tumor-induced immunosuppression during immunotherapy for pancreatic cancer. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Immunologic approaches to the management of pancreatic cancer. [2017]

6. England 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). [2023]

7. United States 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. [2019]