What side effects are associated with this type of intervention?

Common treatments for pancreatic cancer, such as gemcitabine combined with nab-paclitaxel, often result in side effects including neutropenia, fatigue, neuropathy, and diarrhea. Immunotherapy approaches, like those involving IL-2, can cause severe multiorgan toxicity, including hypotension, cardiac arrhythmias, pulmonary edema, fever, chills, and metabolic acidosis. These treatments aim to stimulate the immune system to target cancer cells but can lead to significant adverse events that require careful management.

What prior FDA approvals exist?

The FDA has approved several treatments for pancreatic cancer, including immunotherapy options. Pembrolizumab, an anti-PD-1 therapy, is approved for tumors with high microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR), which includes some pancreatic cancers. Additionally, the combination of gemcitabine and nab-paclitaxel is a standard chemotherapy regimen for metastatic pancreatic cancer. While Saltikva, an attenuated Salmonella Typhimurium expressing IL-2, is still under investigation, it aims to stimulate the immune system to target cancer cells, similar to how pembrolizumab enhances immune response against cancer cells.

What other types of research exist?

Promising novel alternatives to Saltikva for pancreatic cancer patients include: 1) Pembrolizumab (an anti-PD-1 therapy) combined with chemotherapy, which has shown efficacy in various cancers including pancreatic cancer. 2) Nivolumab (another anti-PD-1 therapy) in combination with ipilimumab (an anti-CTLA-4 therapy), which has demonstrated potential in enhancing immune response against tumors. 3) Lenvatinib combined with transarterial chemoembolization, which has shown promise in hepatocellular carcinoma and may be applicable to pancreatic cancer. 4) Personalized cancer vaccines that target specific tumor antigens to stimulate a robust immune response. These alternatives are based on recent clinical trials and ongoing research in the field of oncology.

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Saltikva for Pancreatic Cancer

Q: What is the mechanism of action of this treatment?

Common treatments for pancreatic cancer include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy, such as FOLFIRINOX or Gemcitabine/Abraxane, works by killing rapidly dividing cancer cells but can also affect normal cells, leading to side effects. Targeted therapies, like PARP inhibitors for BRCA-mutated cancers, specifically target genetic mutations within cancer cells, sparing more normal cells and potentially reducing side effects. Immunotherapy, including immune checkpoint inhibitors like pembrolizumab, enhances the body's immune response against cancer cells, particularly effective in tumors with high mutational burden or specific markers like MSI-H/dMMR. Investigational treatments like Saltikva use attenuated bacteria to deliver immune-stimulating agents (e.g., IL-2) directly to the tumor, aiming to boost the immune system's ability to recognize and destroy cancer cells. These mechanisms are crucial for pancreatic cancer patients as they offer different strategies to combat a highly aggressive and often treatment-resistant cancer, potentially improving outcomes and survival rates.

Phase 2

Waitlist Available

Led By Gerald Batist, MD

Research Sponsored by Salspera LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status =< 1

Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase [SGPT]) =< 2.5 X IULN if no liver metastasis or =< 5 X IULN if liver metastases are present

Must not have

Patients who are on immunosuppressive medications for any reason including for autoimmune diseases, organ transplantation, or hematologic conditions such as myelodysplastic syndrome

Clinically significant ascites

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests Saltikva, a safe, modified Salmonella bacteria that delivers an immune booster directly to tumors, in patients with advanced pancreatic cancer. The goal is to see if adding Saltikva to standard chemotherapy can help patients live longer and slow down the progression of their disease.

Who is the study for?

This trial is for adults over 18 with metastatic pancreatic cancer that can't be surgically removed. Participants need to have a certain level of physical fitness, life expectancy over 16 weeks, and meet specific blood test criteria. They must not be on other experimental drugs or immunosuppressants, have brain metastases, uncontrolled illnesses like heart failure or infections, or significant cardiovascular disease.

What is being tested?

The trial tests Saltikva (a modified Salmonella bacteria expressing IL-2) combined with standard chemotherapy (FOLFIRINOX or Gemcitabine/Abraxane). The goal is to see if adding Saltikva improves survival and slows down the cancer compared to just the standard chemo treatments.

What are the potential side effects?

Possible side effects include reactions related to immune system activation such as fever and chills, digestive issues like nausea and diarrhea from chemotherapy, increased risk of infection due to lowered white blood cell counts, liver function changes, fatigue, and potential allergic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active and can carry on all pre-disease activities without restriction.

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My liver function tests are within the required range.

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My pancreatic cancer cannot be removed with surgery and has spread.

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My kidney function is normal or only slightly above normal.

Exclusion Criteria

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

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I am taking immunosuppressive drugs for a condition like an autoimmune disease.

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I have a noticeable buildup of fluid in my abdomen.

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I do not have brain metastases.

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I do not have HIV, active Hepatitis B or C.

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I do not have severe heart problems or recent heart attacks.

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I do not have any serious illnesses or social situations that would stop me from following the study's requirements.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 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

Overall Survival

Progression Free Survival

Secondary study objectives

Biological response

Radiologic response

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: Saltikva with Gemcitabine/AbraxaneExperimental Treatment2 Interventions

30 patients will be enrolled to receive standard of care Gemcitabine/Abraxane with oral Salmonella-IL2 (Dose: 10-9) every 3 weeks for 2 years

Group II: Saltikva with FOLFIRINOXExperimental Treatment2 Interventions

30 patients will be enrolled to receive standard of care FOLFIRINOX with oral Salmonella-IL2 (Dose 10-9) every 2 weeks for 2 years

0 / 10Eligibility 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 include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy, such as FOLFIRINOX or Gemcitabine/Abraxane, works by killing rapidly dividing cancer cells but can also affect normal cells, leading to side effects. Targeted therapies, like PARP inhibitors for BRCA-mutated cancers, specifically target genetic mutations within cancer cells, sparing more normal cells and potentially reducing side effects. Immunotherapy, including immune checkpoint inhibitors like pembrolizumab, enhances the body's immune response against cancer cells, particularly effective in tumors with high mutational burden or specific markers like MSI-H/dMMR. Investigational treatments like Saltikva use attenuated bacteria to deliver immune-stimulating agents (e.g., IL-2) directly to the tumor, aiming to boost the immune system's ability to recognize and destroy cancer cells. These mechanisms are crucial for pancreatic cancer patients as they offer different strategies to combat a highly aggressive and often treatment-resistant cancer, potentially improving outcomes and survival rates.