Azacitidine + Pembrolizumab for Pancreatic Cancer

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Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Susan E. Bates

Must not be taking: Chemotherapy, Radiotherapy, others

Disqualifiers: Investigational agents, Herbal medicine, 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: 3

Duration: 24 months

36 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine the effectiveness of combining immune therapy, pembrolizumab, with a hypomethylating agent, azacitidine, for pancreatic cancer. People who have advanced pancreatic cancer with disease progression on first-line therapy are usually treated with a second chemotherapy regimen. However, there is no single accepted chemotherapy regimen and national guidelines recommend chemotherapy or clinical trial participation. In this study, all study subjects will receive a combination of immune therapy (every 3 weeks) and a hypomethylating agent (every 4 weeks). To date, studies have shown that combining a hypomethylating agent with chemotherapy or immune therapy may benefit patients across different solid tumor types including pancreatic cancer. Preclinical data in a mouse model of pancreatic cancer demonstrates improvement in survival with the combination of a hypomethylating agent and immune therapy. However, the use of single agent hypomethylating agent or immune therapy has not been shown to be effective in patients with pancreatic cancer. The one exception, to date, is the use of immune therapy in those individuals with a particular genetic feature known as mismatch repair deficiency and microsatellite instability. The combination of immune therapy and a hypomethylating agent has not been studied in human subjects and is not approved by the FDA for use in pancreatic cancer. This is a non-randomized, single-center, open-label trial of pembrolizumab and azacitidine in subjects with locally advanced or metastatic pancreatic adenocarcinoma. Approximately 31 individuals will be asked to participate in this study.

Research Team

Susan E Bates, MD

Principal Investigator

Columbia University

Eligibility Criteria

This trial is for adults over 18 with advanced pancreatic cancer who've seen their disease get worse after first-line chemotherapy. They should have a life expectancy of more than 3 months, measurable disease, and be in good enough health to perform daily activities with little or no assistance. Those who've had recent chemo, radiotherapy, or participated in other drug studies can't join.

Inclusion Criteria

Be willing and able to provide written informed consent for the trial

You have been diagnosed with pancreatic ductal adenocarcinoma.

You are expected to live for more than 3 months.

Exclusion Criteria

Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy, or herbal/complementary oral or IV medicine within 2 weeks of the first dose of treatment

Has received chemotherapy or radiotherapy within 14 days of first dose of study medication

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a combination of pembrolizumab (every 3 weeks) and azacitidine (every 4 weeks) for advanced pancreatic cancer

24 months

Visits every 3-4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Azacitidine
• Pembrolizumab

Trial Overview The study tests combining pembrolizumab (an immune therapy given every 3 weeks) with azacitidine (a hypomethylating agent given every 4 weeks) on patients with advanced pancreatic cancer. It's an open-label trial where all participants receive the same treatment without being compared to a control group.

Participant Groups

Group I: Pembrolizumab Experimental Treatment 2 Interventions

Patients with advanced pancreatic cancer will receive pembrolizumab with the hypomethylating agent azacitidine.

Azacitidine is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Vidaza for:

• Acute myeloid leukemia
• Chronic myelomonocytic leukemia
• Myelodysplastic syndromes

Approved in United States as Vidaza for:

• Myelodysplastic syndromes
• Chronic myelomonocytic leukemia

Approved in Canada as Vidaza for:

• Myelodysplastic syndromes
• Acute myeloid leukemia

Approved in Japan as Vidaza for:

• Myelodysplastic syndromes
• Acute myeloid leukemia

Who Is Running the Clinical Trial?

Susan E. Bates

Lead Sponsor

Trials

2

Recruited

70+

Rachael A Safyan, MD

Lead Sponsor

Trials

1

Recruited

40+

Ruth A. White, MD, PhD.

Lead Sponsor

Trials

1

Recruited

40+