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Trial Title:
Study of Quemliclustat and Chemotherapy Versus Placebo and Chemotherapy in Patients With Metastatic Pancreatic Ductal Adenocarcinoma
NCT ID:
NCT06608927
Condition:
Metastatic Pancreatic Ductal Adenocarcinoma
Conditions: Official terms:
Adenocarcinoma
Paclitaxel
Gemcitabine
Quemliclustat
Conditions: Keywords:
Quemliclustat
CD73 Inhibitor
Metastatic Pancreatic Ductal Adenocarcinoma
Treatment naive
Pancreatic cancer
PRISM-1
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
Quemliclustat
Description:
Administered as specified in the treatment arm
Arm group label:
Arm A (Experimental Arm)
Intervention type:
Drug
Intervention name:
Placebo
Description:
Administered as specified in the treatment arm
Arm group label:
Arm B (Comparator Arm)
Intervention type:
Drug
Intervention name:
Nab-paclitaxel
Description:
Administered as specified in the treatment arm
Arm group label:
Arm A (Experimental Arm)
Arm group label:
Arm B (Comparator Arm)
Intervention type:
Drug
Intervention name:
Gemcitabine
Description:
Administered as specified in the treatment arm
Arm group label:
Arm A (Experimental Arm)
Arm group label:
Arm B (Comparator Arm)
Summary:
The purpose of this study is to compare overall survival of quemliclustat, nab-paclitaxel
and gemcitabine versus placebo, nab-paclitaxel and gemcitabine in all randomized
patients.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Have histologically or cytologically confirmed PDAC that is metastatic.
- Have not been previously treated for PDAC in the metastatic setting.
1. Prior neoadjuvant and/or adjuvant therapy for PDAC is permitted if completed at
least 12 months before randomization.
2. Prior palliative radiotherapy is allowed if completed at least 2 weeks prior to
randomization and adverse events (AEs) have resolved to Grade 1 or less before
randomization.
3. Prior and/or placement of a biliary stent/tube is permitted if any
treatment-related AEs have improved to Grade ≤ 1 and the patient is not
exhibiting any signs/symptoms of biliary obstruction.
- Eastern Cooperative Oncology Group PS of 0 to 1.
- At least 1 target lesion measurable by computed tomography (CT)/magnetic resonance
imaging (MRI) per RECIST v1.1. not within a field of prior radiation therapy.
Exclusion Criteria:
- Previously treated for locally advanced, unresectable PDAC.
- History of brain metastases or leptomeningeal metastases.
- Prior treatment with a CD73 antagonist or inhibitor.
- Underlying medical or psychiatric conditions that, in the investigator or sponsor's
opinion, will make the administration of study-specified therapy hazardous
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
November 30, 2024
Completion date:
November 30, 2030
Lead sponsor:
Agency:
Arcus Biosciences, Inc.
Agency class:
Industry
Collaborator:
Agency:
Taiho Pharmaceutical Co., Ltd.
Agency class:
Industry
Source:
Arcus Biosciences, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06608927
https://trials.arcusbio.com/study/?id=PRISM1
