48 Participants Needed

Immunotherapy for Pancreatic Cancer

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Overseen ByChris Lefeber
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Vaccinex Inc.
Must be taking: 5FU, Gemcitabine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

Trial Summary

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug Avelumab (Bavencio) for pancreatic cancer?

Research shows that combining immune therapies, like PD-1 inhibitors, can increase the presence of certain immune cells in pancreatic tumors, which might help fight the cancer. Although not directly about Avelumab, these findings suggest that similar immune-based treatments could be promising for pancreatic cancer.12345

Is immunotherapy for pancreatic cancer generally safe in humans?

Immune checkpoint inhibitors, a type of immunotherapy, have been linked to some side effects in the pancreas and other parts of the digestive system. These side effects can include inflammation of the pancreas (pancreatitis) and other gastrointestinal issues, and they may occur more often in women and when combined with other treatments.678910

How does the immunotherapy treatment for pancreatic cancer differ from other treatments?

This immunotherapy treatment is unique because it targets specific immune checkpoints like PD-1 and TIGIT, which are proteins that can inhibit the immune response against cancer cells. By blocking these checkpoints, the treatment aims to enhance the body's immune response to fight pancreatic cancer more effectively, which is different from traditional treatments that may not focus on modulating the immune system.23111213

What is the purpose of this trial?

This trial will assess the safety and tolerability of Pepinemab in combination with Avelumab in patients with metastatic pancreatic adenocarcinoma that has progressed after first line chemotherapy. Phase 2 will assess the efficacy of this combination therapy.

Research Team

DM

Daniel Mulkerin, MD

Principal Investigator

WCICTOResearch@urmc.rochester.edu

Eligibility Criteria

Adults with metastatic pancreatic adenocarcinoma that worsened after first-line chemo can join. They need measurable disease, have had specific prior treatments, and a life expectancy of at least 3 months. Good organ function and performance status are required. Participants must agree to use contraception and consent to biopsies.

Inclusion Criteria

I have a biliary stent for obstruction.
My bone marrow and organs are functioning normally.
- Absolute neutrophil count >1,500/mcl
See 16 more

Exclusion Criteria

I can follow the study's schedule and requirements.
I still have side effects from previous cancer treatments.
I have had an organ or bone marrow transplant.
See 13 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1b Treatment

Participants receive escalating doses of Avelumab and Pepinemab to determine the maximum tolerated dose (MTD)

16-24 weeks

Phase 2 Treatment

Participants receive treatment at the MTD to assess efficacy and objective response rates

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

10 years

Treatment Details

Interventions

  • Avelumab
  • Pepinemab
Trial Overview The trial is testing the safety of Pepinemab combined with Avelumab in patients whose cancer progressed post-chemo. Phase 2 will check how effective this combo is against metastatic pancreatic adenocarcinoma.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: ExperimentalExperimental Treatment1 Intervention
Single arm, all patients serially enrolled to combination doses of Avelumab and Pepinemab

Find a Clinic Near You

Who Is Running the Clinical Trial?

Vaccinex Inc.

Lead Sponsor

Trials
12
Recruited
740+

University of Rochester

Collaborator

Trials
883
Recruited
555,000+

Findings from Research

In a study using mice with pancreatic tumors, the combination of anti-PD-1 and anti-OX40 antibodies significantly improved survival rates, with almost 100% of treated mice surviving for 225 days and showing no detectable tumors, compared to control groups that had poor survival.
The combination therapy not only enhanced survival but also altered the immune cell landscape in tumors, reducing suppressive T cells and increasing memory T cells, suggesting a potential mechanism for overcoming immune resistance in pancreatic ductal adenocarcinoma (PDAC).
Combination of PD-1 Inhibitor and OX40 Agonist Induces Tumor Rejection and Immune Memory in Mouse Models of Pancreatic Cancer.Ma, Y., Li, J., Wang, H., et al.[2022]
The novel immune checkpoint molecule VSIG4 is found to be overexpressed in pancreatic ductal adenocarcinoma (PDAC) and correlates with larger tumor size, liver metastasis, and poorer patient prognosis, suggesting its role as a potential biomarker for disease severity.
Knocking down VSIG4 in pancreatic cancer cells reduced their proliferation and migration, while also enhancing the recruitment of immune cells like CD8+ T cells, indicating that targeting VSIG4 could improve the effectiveness of immunotherapy in PDAC.
Identification of a novel immune checkpoint molecule V-set immunoglobulin domain-containing 4 that leads to impaired immunity infiltration in pancreatic ductal adenocarcinoma.Jiang, Y., Han, L., Yang, J., 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.
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]

References

Combination of PD-1 Inhibitor and OX40 Agonist Induces Tumor Rejection and Immune Memory in Mouse Models of Pancreatic Cancer. [2022]
Identification of a novel immune checkpoint molecule V-set immunoglobulin domain-containing 4 that leads to impaired immunity infiltration in pancreatic ductal adenocarcinoma. [2023]
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]
The pancreatic cancer microenvironment: an immunologic battleground. [2021]
Pancreatic Cancer Immuno-oncology in the Era of Precision Medicine. [2022]
Open-label, Phase I Study of Nivolumab Combined with nab-Paclitaxel Plus Gemcitabine in Advanced Pancreatic Cancer. [2022]
Pancreatic Adverse Events Associated With Immune Checkpoint Inhibitors: A Large-Scale Pharmacovigilance Analysis. [2022]
Safety and activity of the TGFβ receptor I kinase inhibitor galunisertib plus the anti-PD-L1 antibody durvalumab in metastatic pancreatic cancer. [2021]
Pancreatic adverse events of immune checkpoint inhibitors therapy for solid cancer patients: a systematic review and meta-analysis. [2023]
Common Immune-Related Adverse Events of Immune Checkpoint Inhibitors in the Gastrointestinal System: A Study Based on the US Food and Drug Administration Adverse Event Reporting System. [2021]
11.United Statespubmed.ncbi.nlm.nih.gov
Tissue-Resident Memory T Cells in Pancreatic Ductal Adenocarcinoma Coexpress PD-1 and TIGIT and Functional Inhibition Is Reversible by Dual Antibody Blockade. [2023]
VISTA Ligation Reduces Antitumor T-Cell Activity in Pancreatic Cancer. [2023]
Targeting T cell checkpoints 41BB and LAG3 and myeloid cell CXCR1/CXCR2 results in antitumor immunity and durable response in pancreatic cancer. [2023]
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