Clinical Trials and Innovative Research At the Pancreas Center

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At Columbia's Pancreas Center, our basic and translational science labs are expanding the understanding of the underlying mechanisms of pancreatic cancer. We are home to multiple investigator-initiated clinical trials based on research findings and innovative ideas developed by our outstanding researchers and physician-scientists. Here at Columbia, we're developing tomorrow's treatments, today.

Clinical Trials & Pancreatic Cancer

Clinical trials are carefully controlled research studies of new treatments and technologies that may prove to be more effective than current methods. Because the studies are experimental, the conditions and eligibility requirements are very specific. Though they do not always result in new treatments, clinical trials are essential to developing a better understanding of how to treat diseases safely and effectively as well as identify who will benefit the most.

This is especially true for pancreatic cancer, since no single treatment has proven to work for all types and stages. Trials focus on different strategies to address clinical needs, including:

  • Developing new chemotherapy drugs or immunotherapy treatments
  • Exploring innovative surgical techniques or new radiation therapies
  • Testing combinations of existing medicines and delivery methods to improve their effectiveness
  • Identifying genetic markers to make diagnosis faster, easier, and more reliable
  • Determining which genetic components of specific tumors are likely to make them susceptible to specific medications or treatments

Abstract illustration of researchers in labcoars working in a lab

Our Approach to Clinical Trials at Columbia

“Here at the Pancreas Center, we choose the clinical trials we offer to our patients from promising national studies because they seem likely to change the standard of care.” — Gulam A. Manji, MD

As part of the Herbert Irving Comprehensive Cancer Center (HICCC), the Pancreas Center at Columbia is an important nexus for pancreatic cancer research and innovation. We participate in studies that show promise for moving current treatment strategies forward and addressing important clinical needs for our patients. HICCC has been designated a comprehensive cancer center by the National Cancer Institute (NCI), and our commitment to providing the highest level of care and access to the latest treatments is unmatched.

Connecting Patients With Trials for All Stages of Pancreatic Cancer

Because clinical trials for pancreatic cancer are tackling the challenges of this disease from many different angles, it is critical that eligible patients can find and participate in them.

As an NCI-designated comprehensive cancer center, Columbia has the patient volume to support clinical trials for pancreatic cancer at every stage of the disease. We can connect patients in different phases of their treatment journey with a clinical trial that matches their needs, including for those who:

  • Have metastatic disease
  • Have never been treated with chemotherapy or other treatments before
  • Have progressed on one line of therapy
  • Have locally advanced disease and have received treatment but now are trying to get to surgery
  • Have undergone resection and are now on surveillance

Treatment Designed Around the Genetic Profile of the Tumor

Thanks to our expertise in both genetic profiling and precision medicine, we can identify mutation profiles and match the mutations in a patient's tumor to mutation-specific clinical trials.

Precision Medicine Highlights

Precision medicine tailors treatment to the specific genetic and molecular characteristics of a tumor with the goal of improving outcomes while reducing side effects for the patient. It involves taking samples of a tumor and using genomic sequencing and other molecular profiling techniques to identify relevant genetic mutations. This information can help us develop and apply targeted therapies that are likely to be effective against that specific tumor.

Here are some highlights of our precision medicine work.

KRAS-Targeted Therapy

The KRAS gene produces a protein that helps control cell growth, maturation, and death. A mutation that affects the creation of that protein has been found in approximately 90% of pancreatic cancer cases and is believed to be a major driver of tumor growth. KRAS-targeted therapy inhibits or degrades this mutated protein in an effort to kill the pancreatic cancer cells.

Columbia researchers have pioneered this strategy, taking groundbreaking basic science research and turning it into a large-scale national randomized clinical trial.

3D Organoids

Immunotherapy is a form of treatment that helps the body’s own immune system find and attack cancer cells. But targeting the specific genetic profile of a tumor and designing a treatment for maximum effectiveness requires working with tissue samples from that tumor. These samples can be used to create models called 3D organoids that can then be used to test how the tumor will respond to different treatments.

Columbia researchers are using 3D organoids to help the body find and fight cancer cells. By seeing whether immune cells can recognize these growing tumorous 3D organoids, we hope to find ways to jump-start the immune system’s response to pancreatic cancer.

Genetic Database

Pancreatic cancer is an aggressive disease that often comes back after treatment, sometimes years later. How long each patient lives after recurrence varies widely. For example, patients whose tumors return in the lungs live twice as long as those whose tumors come back in the liver. Understanding how and why some tumors return may hold the key to stopping these recurrences from happening.

Columbia has developed a retrospective database of pancreatic cancer patients who have undergone curative surgeries over the last 10 years. We have tracked the type of treatments they received and if their cancer came back, and if it did return, the location of the tumor.

Our goal is to identify whether there is an embedded signature that makes it more likely a tumor will come back. Using this data, we hope to learn how to manipulate tumors in current patients to make their cancer less likely to return.

What Are the Latest Clinical Trials for Pancreatic Cancer?

The Pancreas Center is at the forefront of research investigating new approaches for treating pancreatic cancer. Some of our current clinical trials include:

  • Chemo4METPANC: Combination Chemokine Inhibitor, Immunotherapy, and Chemotherapy in Pancreatic Adenocarcinoma
    • Patient population: Adult patients with metastatic pancreatic adenocarcinoma and no prior treatment for disease
    • Goal: Evaluate the safety and efficacy of cemiplimab, motixafortide, gemcitabine, and nab-paclitaxel used in combination to treat pancreatic adenocarcinoma
  • Stimulation With Bethanechol in Combination With Gemcitabine and Nab-Paclitaxel in Pancreatic Adenocarcinoma
    • Patient population: Adult patients with pancreatic adenocarcinoma and no evidence of metastatic disease or gastrointestinal obstruction
    • Goal: Evaluate the safety and efficacy of the drug bethanechol in combination with a chemotherapy regimen of gemcitabine and nab-paclitaxel and surgery to reduce cancer recurrence following surgery
  • Precision Oncology in Advanced Pancreatic Cancer
    • Patient population: Adult patients with pancreatic ductal adenocarcinoma who have received one or two chemotherapy treatments
    • Goal: Evaluate the safety and efficacy of matching a tumor to the drug or drug combination that is most likely to destroy it
  • A Study to Evaluate the Safety and Tolerability of AB680 in Participants With Gastrointestinal Malignancies (ARC-8)
    • Patient population: Adult patients with metastatic pancreatic adenocarcinoma and no prior treatment for disease
    • Goal: Evaluate the safety and efficacy of the drug Quemliclustat (AB680) in combination with Zimberelimab (AB122), nab-paclitaxel, and gemcitabine in participants with advanced pancreatic cancer
  • Study of Nab-Paclitaxel and Gemcitabine With or Without SBP-101 in Pancreatic Cancer (ASPIRE)
    • Patient population: Adult patients with metastatic pancreatic adenocarcinoma who are BRCA negative and have had no prior treatment for disease
    • Goal: Evaluate the safety and efficacy of standard treatment with nab-paclitaxel and gemcitabine with or without SBP-101 in participants previously untreated for pancreatic ductal adenocarcinoma

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