A Randomized, Placebo-Controlled, Double-Blind, Multicenter, Phase 3 Trial of Quemliclustat and Chemotherapy Versus Placebo and Chemotherapy in Patients With Treatment-Naive Metastatic Pancreatic Ductal Adenocarcinoma (PRISM-1)
Sponsor: |
Arcus Biosciences |
Enrolling: |
Male and Female Patients |
IRB Number: |
AAAV5505 |
U.S. Govt. ID: |
NCT06608927 |
Contact: |
Research Nurse Navigator: 212-342-5162 / cancerclinicaltrials@cumc.columbia.edu |
The purpose of this research is to determine the safety and efficacy of investigational study drugquemliclustat (also known as AB680) in combination with chemotherapy gemcitabine and nab-paclitaxel (Gem-NP), compared to a placebo (saline solution not containing treatment drug) in combination with chemotherapy gemcitabine and nab-paclitaxel at treating participants with the type of cancer you have. Quemliclustat has not been approved by the Food and Drug Administration (FDA). Gemcitabine and nab-paclitaxel (Gem-NP) is FDA approved but not in combination with quemliclustat. This is a double-blinded study. This means neither you, the study doctor, nor the study team will know whether you are receiving quemliclustat with Gem-NP or placebo with Gem-NP.
Investigator
Gulam Manji, MD, PhD
Are you 18 or older? |
Yes |
No |
Do you have histologically or cytologically confirmed PDAC that is metastatic? |
Yes |
No |