Clinical trials

Clinical trials play a major role in advancing cancer treatments. Clinical trials are research studies that investigate new treatments, including combinations of treatments. The Food and Drug Administration (FDA) review data from clinical trials and assess safety, efficacy, and benefit. Based on these factors, the FDA determines whether an experimental treatment should be approved.

Clinical trials provide patients an opportunity to try new treatments when standard treatments fail. This decision is made following extensive conversations between the patient and their doctor.

DISCLAIMER: Our goal here is to be objectively informative. We will NOT publish any opinions regarding which trial is "best". Such decisions are completely dependent on the circumstances of each patient, and should be approached in consultation with an oncologist. Rather, we endeavor to present any associated preclinical or clinical data in a manner that is clear and straightforward.

Currently, there are multiple clinical trials for PDAC ranging from KRAS inhibitors to immunotherapy.

Columbia Pancreas Center Clinical Trials:

A PHASE II, OPEN-LABEL, MULTICENTER, RANDOMIZED STUDY OF THE EFFICACY AND SAFETY OF ADJUVANT AUTOGENE CEVUMERAN PLUS ATEZOLIZUMAB AND mFOLFIRINOX VERSUS mFOLFIRINOX ALONE IN PATIENTS WITH RESECTED PANCREATIC DUCTAL ADENOCARCINOMA
Principal investigator: Gulam A. Manji, MD
This clinical trial compares the effects of autogene cevumeran (mRNA cancer vaccine) plus atezolizumab and mFOLFIRINOX compared with mFOLFIRINOX (standard of care chemotherapy) alone on patients with resected pancreatic ductal adenocarcinoma (PDAC).
In this study, participants get either the combination of autogene cevumeran plus atezolizumab and mFOLFIRINOX or mFOLFIRINOX alone.
Chemo4METPANC - A Phase 2 study with combination Chemotherapy (Gemcitabine and Nab-Paclitaxel), chemokine (C-X-C) motif receptor 4 inhibitor (Motixafortide), and immune checkpoint blockade (Cemiplimab) in METastatic treatment naïve PANCreas
Principal investigator: Gulam A. Manji, MD
This study investigates if combination treatment of immunotherapy and chemotherapy effective in decreasing tumor size and prolonging life in patients with advanced pancreatic cancer.
RASolute 304: A Phase 3 Multicenter, Open-label, Randomized,2-Arm Study of Adjuvant Daraxonrasib versus Standard of CareObservation Following Completion of Neoadjuvant and/orAdjuvant Chemotherapy in Patients with Resected PancreaticDuctal Adenocarcinoma
Principal investigator: Gulam A. Manji, MD
This clinical trial tests daraxonrasib (experimental KRAS inhibitor) compared to the SOC after neoadjuvant and/or adjuvant chemotherapy in patients with resected PDAC.
A Phase I/IIa Randomized Clinical trial to Evaluate the Efficacy of EGFR-targeted, PNU159682-packaged Nanocells and Glycolipid-Packaged Nanocells in combination withGemcitabine and Nab-paclitaxel in Metastatic Pancreatic Ductal Adenocarcinoma
Principal investigator: Linda Y. Wu, MD
The purpose of this study is to test EGFR-targeted EnGeneIC Dream Vector™ (EDV™), carrying a drug called PNU-159682, or E-EDV-D682, as a treatment for metastatic PDAC.
The study drug is a form of chemotherapy packaged inside a delivery vehicle (manufactured from a non–disease- causing salmonella bacteria) called an “EDV,” which transports the drug directly to the tumor.

For more information about clinical trials specific to pancreatic cancer being conducted at Columbia University please visit https://www.cancer.columbia.edu/cancer-types-care/types/pancreatic-cancer

For more information about clinical trials specific to pancreatic cancer visit https://pancan.org/facing-pancreatic-cancer/treatment/treatment-types/clinical-trials/

For more information about clinical trials being conducted around the world please visit https://clinicaltrials.gov

Clinical trials

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