An Open-label, Uncontrolled Study of ONO-4578 and ONO-4538 in Combination With Standard-of-care Modified FOLFIRINOX (mFFX) or Gemcitabine Plus Nab-paclitaxel (GnP) Therapy as First-line Treatment in Patients With Metastatic Pancreatic Cancer

This study is a multicenter, open-label, uncontrolled study to investigate the tolerability and safety of ONO-4578, ONO-4538, and standard of care in combination as first-line treatment in patients with metastatic pancreatic cancer.

Study Overview

• Status: Completed
• Conditions: Metastatic Pancreatic Cancer
• Intervention / Treatment: Drug: Fluorouracil; Drug: Gemcitabine; Drug: Oxaliplatin; Drug: Irinotecan; Drug: ONO-4538; Drug: Levofolinate; Drug: ONO-4578; Drug: Nab-Paclitaxel

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Chiba
    • Kashiwa-shi, Chiba, Japan
      • National Cancer Center Hospital East
  • Kanagawa
    • Yokohama-shi, Kanagawa, Japan
      • Kanagawa Cancer Center
  • Shizuoka
    • Hamamatsu-shi, Shizuoka, Japan
      • Seirei Hamamatsu General Hospital
  • Tokyo
    • Bunkyō-Ku, Tokyo, Japan
      • The University of Tokyo Hospital
    • Bunkyō-Ku, Tokyo, Japan
      • Juntendo University Hospital
    • Chuo Ku, Tokyo, Japan
      • National Cancer Center Hospital
    • Koto-Ku, Tokyo, Japan
      • The Cancer Institute Hospital of JFCR
    • Mitaka-shi, Tokyo, Japan
      • Kyorin University Hospital
    • Shinjuku-Ku, Tokyo, Japan
      • Keio University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 1. Pancreatic invasive ducatal adenocarcinoma
• 2. Life expectancy of at least 3 months
• 3. Patients with ECOG performance status 0 or 1

Exclusion Criteria:

• 1. Patients with severe complication
• 2. Patients with multiple primary cancers

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ONO-4578+ONO-4538+mFFX	Drug: Fluorouracil; Specified dose on specified days; Drug: Oxaliplatin; Specified dose on specified days; Drug: Irinotecan; Specified dose on specified days; Drug: ONO-4538; Specified dose on specified days; Other Names: Nivolumab; Drug: Levofolinate; Specified dose on specified days; Drug: ONO-4578; Specified dose on specified days
Experimental: ONO-4578+ONO-4538+GnP	Drug: Gemcitabine; Specified dose on specified days; Drug: ONO-4538; Specified dose on specified days; Other Names: Nivolumab; Drug: ONO-4578; Specified dose on specified days; Drug: Nab-Paclitaxel; Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Dose-limiting toxicities（DLT）	28 days
Adverse event(AE)	UP to 28 days after the last dose

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall survival (OS)	Up to 2 years
Progression-free survival (PFS)	Up to 2 years
Overall response rate (ORR)	Up to 2 years
Duration of response (DOR)	Up to 2 years
Time to response (TTR)	Up to 2 years
Disease control rate (DCR)	Up to 2 years
Pharmacokinetics (Plasma concentration for ONO-4578)	Up to 28 days after the last dose
Pharmacokinetics (Serum concentration for ONO-4538)	Up to 28 days after the last dose
Best overall response (BOR)	Up to 2 years
Percentage of change in the sum of tumor diameters of target lesions	Up to 2 years
Maximum percentage of change in the sum of tumor diameters of target lesions	Up to 2 years
Changes in tumor markers (CEA and CA19-9)	Up to 2 years

Collaborators and Investigators

• Sponsor: Ono Pharmaceutical Co. Ltd
• Investigators: Study Director: Project Leader, Ono Pharmaceutical Co. Ltd

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2021
• Primary Completion (Actual): October 1, 2024
• Study Completion (Actual): January 30, 2025

Study Registration Dates

• First Submitted: July 29, 2024
• First Submitted That Met QC Criteria: August 1, 2024
• First Posted (Actual): August 5, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 4, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Micronutrients; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Topoisomerase I Inhibitors; Topoisomerase Inhibitors; Antineoplastic Agents, Phytogenic; Protective Agents; Antidotes; Vitamin B Complex; Vitamins; Oxaliplatin; Nivolumab; Irinotecan; Gemcitabine; Fluorouracil; Leucovorin; Levoleucovorin; Paclitaxel
• Other Study ID Numbers: ONO-4578-04; jRCT2031200286 (Registry Identifier: Japan Registry of Clinical Trials)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No