Pancreatic Cancer > Pembrolizumab

SD-101 + Pembrolizumab for Pancreatic Cancer

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: TriSalus Life Sciences, Inc.

Must not be taking: Immunosuppressants, Steroids

Disqualifiers: Chronic pancreatitis, Autoimmune disease, Hepatitis, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial involves injecting a drug called SD-101 directly into the pancreas to treat adults with advanced pancreatic cancer. The drug helps boost the immune system to fight cancer and can be combined with another treatment to make it more effective.

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

The trial requires that you have not received chemotherapy or targeted therapy within 14 days before screening. If you are on chronic anticoagulation therapy, you must be able to be temporarily removed from it. Other medications are not specifically mentioned, so it's best to discuss with the trial team.

What data supports the effectiveness of the drug Pembrolizumab for pancreatic cancer?

Pembrolizumab has shown clinical activity in a variety of solid tumors, including non-small-cell lung cancer and melanoma, and is approved for esophageal cancer, but it provides minimal benefit for most patients with pancreatic cancer.

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Is the combination of SD-101 and Pembrolizumab safe for humans?

Pembrolizumab, also known as Keytruda, has been used in various cancer treatments and is generally considered safe, but it can cause side effects like fatigue, nausea, and immune-related issues such as thyroid problems and type 1 diabetes in rare cases. These side effects have been observed in treatments for other cancers, not specifically pancreatic cancer.

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How is the drug SD-101 + Pembrolizumab unique for treating pancreatic cancer?

The combination of SD-101 and Pembrolizumab is unique because it involves using an immune checkpoint inhibitor (Pembrolizumab) that targets the PD-1 pathway, which is a novel approach for pancreatic cancer, a condition with limited effective treatments. Pembrolizumab has shown activity in other cancers, but its use in pancreatic cancer is still being explored, making this combination a new potential option.

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Eligibility Criteria

Adults with advanced pancreatic cancer who haven't had recent chemotherapy, radiation, or other cancers. They must understand the study, consent to it, have a life expectancy over 3 months, stable organ function and blood counts within certain limits. Women of childbearing age must not be pregnant and agree to contraception.

Inclusion Criteria

Has a QTc interval ≤480 msec

Has a life expectancy of >3 months at screening as estimated by the Investigator

Able to understand the study and provide written informed consent prior to any study procedures

Exclusion Criteria

I have previously been treated with SD-101.

Patients who were enrolled in the Phase 1 portion of the study will not be eligible for enrollment in Phase 1b

My liver disease is moderately to severely advanced.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1 Treatment

Escalating doses of SD-101 administered alone via PRVI into the regional vessels of the pancreas

12 months

Phase 1b Treatment

SD-101 administered with systemic anti-PD-1 checkpoint blockade over 2 cycles, each cycle being about 6 weeks apart

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Participant Groups

The trial is testing SD-101 delivered directly into the pancreas using pressure alongside pebrolizumab given intravenously. It's an early-phase study to see if this combination can help treat locally advanced pancreatic cancer that hasn't spread elsewhere.

Group I: SD-101 Experimental Treatment 2 Interventions

Two doses of SD-101 given over two cycles via pancreatic retrograde venous infusion (PRVI) using the PEDD method of administration.

Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:

🇺🇸 Approved in United States as KEYTRUDA for:

• Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
• Melanoma
• Non-small cell lung cancer (NSCLC)
• Urothelial carcinoma
• Colorectal cancer
• Gastric cancer
• Hepatocellular carcinoma
• Renal cell carcinoma
• Cervical cancer
• Endometrial carcinoma

🇪🇺 Approved in European Union as KEYTRUDA for:

• Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
• Melanoma
• Non-small cell lung cancer (NSCLC)
• Urothelial carcinoma
• Colorectal cancer
• Gastric cancer
• Hepatocellular carcinoma
• Renal cell carcinoma
• Cervical cancer
• Endometrial carcinoma

🇬🇧 Approved in United Kingdom as KEYTRUDA for:

• Untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

MD Anderson Cancer Center Houston, TX

Who Is Running the Clinical Trial?

TriSalus Life Sciences, Inc. Lead Sponsor

References

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

Programmed Cell Death-1 Inhibitor-Induced Type 1 Diabetes Mellitus. [2022] Pembrolizumab (Keytruda; Merck Sharp & Dohme) is a humanized IgG4 monoclonal antibody used in cancer immunotherapy. It targets the programmed cell death-1 (PD-1) receptor, which is important in maintaining self-tolerance. However, immune checkpoint blockade is associated with a risk for immune-related adverse events (irAEs) potentially affecting the endocrine organs. Type 1 diabetes mellitus is a rare irAE of PD-1 inhibitors, occurring in 0.2% of cases.

2. Germany pubmed.ncbi.nlm.nih.gov

Pembrolizumab near the end of life in patients with metastatic pancreatic cancer: a multi-site consecutive series to examine survival and patient treatment burden. [2023] Pembrolizumab confers minimal benefit to most patients with pancreas cancer. We explored survival and patient treatment burden (for example, death within 14 days of therapy) in a subgroup who had early access to pembrolizumab .

3. Ireland pubmed.ncbi.nlm.nih.gov

Neoadjuvant anti-programmed death-1 immunotherapy by pembrolizumab in resectable non-small cell lung cancer: First clinical experience. [2022] A phase II trial investigating the therapeutic effect of neoadjuvant programmed cell death 1 (PD-1) inhibitor pembrolizumab (MK-3475, KEYTRUDA®) administered prior to surgery for the treatment of non-small cell lung cancer (NSCLC) has been conducted (NCT03197467). We report the first clinical results of a planned interim safety analysis after 15 patients were enrolled.

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

Pembrolizumab for the treatment of thoracic malignancies: current landscape and future directions. [2017] New insights into the interaction between the immune system and the tumor microenvironment have led to the development of checkpoint inhibitors that target the PD-1/PD-L1 pathway. Pembrolizumab (MK-3475, lambrolizumab, Keytruda(®)) is a PD-1 inhibitor that has shown clinical activity in a variety of solid tumors and is currently approved for the second-line treatment of PD-L1-positive non-small-cell lung cancer and for unresectable/metastatic melanoma. This article will discuss the results of early-phase trials of pembrolizumab in thoracic malignancies as well as ongoing studies aimed to confirm clinical benefit.

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

Pembrolizumab Approved for Esophageal or Gastroesophageal Cancer. [2023] Pembrolizumab (Keytruda) has been approved to treat metastatic or locally advanced esophageal or gastroesophageal junction cancer. It is used in combination with platinum- and fluoropyrimidine-based chemotherapy.

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

FDA Approval Summary: Accelerated Approval of Pembrolizumab for Second-Line Treatment of Metastatic Melanoma. [2021] On September 4, 2014, the FDA approved pembrolizumab (KEYTRUDA; Merck Sharp & Dohme Corp.) with a recommended dose of 2 mg/kg every 3 weeks by intravenous infusion for the treatment of patients with unresectable or metastatic melanoma who have progressed following treatment with ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. Approval was based on demonstration of objective tumor responses with prolonged response durations in 89 patients enrolled in a randomized, multicenter, open-label, dose-finding, and activity-estimating phase 1 trial. The overall response rate (ORR) by blinded independent central review per RECIST v1.1 was 24% (95% confidence interval, 15-34); with 6 months of follow-up, 86% of responses were ongoing. The most common (≥20%) adverse reactions were fatigue, cough, nausea, pruritus, rash, decreased appetite, constipation, arthralgia, and diarrhea. Immune-mediated adverse reactions included pneumonitis, colitis, hepatitis, hypophysitis, and thyroid disorders. The benefits of the observed ORR with prolonged duration of responses outweighed the risks of immune-mediated adverse reactions in this life-threatening disease and represented an improvement over available therapy. Important regulatory issues in this application were role of durability of response in the evaluation of ORR for accelerated approval, reliance on data from a first-in-human trial, and strategies for dose selection. Clin Cancer Res; 23(19); 5666-70. ©2017 AACR.