What is the mechanism of action of this treatment?

Common treatments for pancreatic cancer, such as TG01 and Balstilimab, focus on immune system activation and immune checkpoint inhibition. TG01 works by stimulating the immune system to recognize and attack cancer cells, while Balstilimab inhibits immune checkpoints, which are proteins that prevent the immune system from attacking cancer cells. These mechanisms are particularly important for pancreatic cancer patients, as the disease is often diagnosed at an advanced stage, making conventional treatments less effective. By enhancing the body's immune response, these therapies offer a promising approach to target and destroy cancer cells more effectively.

What side effects are associated with this type of intervention?

Common side effects of treatments involving immune system activation and immune checkpoint inhibition, such as TG01 and Balstilimab, include gastrointestinal issues (diarrhea, colitis), skin reactions (rash, pruritus), and endocrine events (thyroid dysfunction, adrenal insufficiency). These treatments can also lead to more severe adverse events like pneumonitis, hepatitis, and nephritis. Patients may experience fatigue, fever, and infusion-related reactions. It is crucial to monitor for these side effects and manage them promptly to ensure patient safety.

What prior FDA approvals exist?

The FDA has approved several treatments for pancreatic cancer, including immune checkpoint inhibitors like pembrolizumab, which targets PD-1. Pembrolizumab is approved for tumors with high microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR). While TG01 and Balstilimab are experimental, they represent a growing interest in immunotherapy for pancreatic cancer, aiming to enhance the immune system's ability to target cancer cells.

What other types of research exist?

Promising alternatives for pancreatic cancer treatment in 2024 include: <ol> <li>CAR-T Cell Therapy: This involves engineering a patient's T cells to better recognize and attack cancer cells.</li> <li>Oncolytic Virotherapy: Uses genetically modified viruses to selectively infect and kill cancer cells while stimulating an immune response.</li> <li>Bispecific T-cell Engagers (BiTEs): These are antibodies that can simultaneously bind to T cells and cancer cells, bringing them into close proximity to enhance the immune response.</li> <li>LAG-3 Inhibitors: These are immune checkpoint inhibitors targeting the LAG-3 protein, which can be used in combination with PD-1 inhibitors to enhance anti-tumor activity.</li> <li>Tumor-Infiltrating Lymphocyte (TIL) Therapy: This involves extracting TILs from a patient's tumor, expanding them in the lab, and reinfusing them to attack the cancer.</li> </ol>

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Cancer Vaccine

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

Phase 2

Waitlist Available

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

Must not have

Active or prior documented inflammatory bowel disease (i.e. ulcerative colitis)

Planning to receive yellow fever or other live (attenuated) vaccines during the course of the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

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.

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.

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.

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.

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.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have or had inflammatory bowel disease like ulcerative colitis.

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I plan to get a live vaccine, like the yellow fever vaccine, during the study.

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I am allergic to an ingredient in the study medication.

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I do not have serious illnesses that could affect my participation.

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I have had an autoimmune disease in the last 2 years.

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I am not using, nor plan to use other cancer treatments while in this study.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Molecular disease control rate

Secondary study objectives

Complete molecular response rate

Correlation between molecular response and disease free survival

Disease free survival rate

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Balstilimab

2023

Completed Phase 1

~20

0 / 13Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for pancreatic cancer, such as TG01 and Balstilimab, focus on immune system activation and immune checkpoint inhibition. TG01 works by stimulating the immune system to recognize and attack cancer cells, while Balstilimab inhibits immune checkpoints, which are proteins that prevent the immune system from attacking cancer cells. These mechanisms are particularly important for pancreatic cancer patients, as the disease is often diagnosed at an advanced stage, making conventional treatments less effective. By enhancing the body's immune response, these therapies offer a promising approach to target and destroy cancer cells more effectively.