Study of Quemliclustat and Chemotherapy Versus Placebo and Chemotherapy in Patients With Metastatic Pancreatic Ductal Adenocarcinoma (PRISM-1)

Arcus Biosciences

Status and phase: Enrolling; Phase 3

Conditions: Metastatic Pancreatic Ductal Adenocarcinoma

Treatments: Drug: Gemcitabine; Drug: Nab-paclitaxel; Drug: Placebo; Drug: Quemliclustat

Study type: Interventional

Funder types: Industry

Identifiers

NCT06608927

2024-513317-12-00 (EU Trial (CTIS) Number)

jRCT2061240084 (Other Identifier)

PRISM-1

Details and patient eligibility

About

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.

Enrollment: 610 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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610 participants in 2 patient groups, including a placebo group

Arm A (Experimental Arm)

Experimental group

Description:

Quemliclustat, nab-paclitaxel and gemcitabine will be administered by IV infusion

Treatment:

Drug: Quemliclustat

Drug: Nab-paclitaxel

Drug: Gemcitabine

Arm B (Comparator Arm)

Placebo Comparator group

Description:

Placebo, nab-paclitaxel and gemcitabine will be administered by IV infusion

Treatment:

Drug: Placebo

Drug: Nab-paclitaxel

Drug: Gemcitabine