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NCT Number: NCT06608927

Study of Quemliclustat and Chemotherapy Versus Placebo and Chemotherapy in Patients With Metastatic Pancreatic Ductal Adenocarcinoma

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Camperdown, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Have histologically or cytologically confirmed PDAC that is metastatic.
  • Have not been previously treated for PDAC in the metastatic setting.
  • Prior neoadjuvant and/or adjuvant therapy for PDAC is permitted if completed at least 12 months before randomization.
  • Prior palliative radiotherapy is allowed if completed at least 2 weeks prior to randomization and AEs have resolved to Grade 1 or less before randomization.
  • 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 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.

Treatment and study plan

Quemliclustat

Drug

Administered as specified in the treatment arm

Placebo

Drug

Administered as specified in the treatment arm

Nab-paclitaxel

Drug

Administered as specified in the treatment arm

Gemcitabine

Drug

Administered as specified in the treatment arm

Primary outcomes

  1. Overall Survival (OS)

    Time frame: Up to 72 months

Secondary outcomes

  1. Progression-free Survival (PFS) as determined by the Investigator according to RECIST v1.1

    Time frame: Up to 72 months

  2. Objective response rate (ORR) as determined by the Investigator according to RECIST v1.1

    Time frame: Up to 72 months

  3. Duration of response (DoR) as determined by the Investigator according to RECIST v1.1

    Time frame: Up to 72 months

  4. Disease Control Rate (DCR) as determined by the Investigator according to RECIST v1.1

    Time frame: Up to 72 months

  5. The incidence and severity of adverse events (AEs) and serious adverse events (SAEs)

    Time frame: Up to 72 months

Sponsors and collaborators

Lead sponsor

Arcus Biosciences, Inc.

Industry

Collaborators

  • Taiho Pharmaceutical Co., Ltd.

Registry information

Official study title

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

Acronym: PRISM-1

Important dates

Study start
2024
Primary completion
2030
Study completion
2030
First posted
Sep 23, 2024
Registry last updated
Jul 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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