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OpenTrials
Completed

NCT Number: NCT06538207

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.

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Key information

Conditions

Metastatic Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

National Cancer Center Hospital East, Kashiwa-shi, Chiba, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

ONO-4578

Drug

Specified dose on specified days

ONO-4538

Drug

Specified dose on specified days

Other names: Nivolumab

Oxaliplatin

Drug

Specified dose on specified days

Levofolinate

Drug

Specified dose on specified days

Irinotecan

Drug

Specified dose on specified days

Fluorouracil

Drug

Specified dose on specified days

Gemcitabine

Drug

Specified dose on specified days

Nab-paclitaxel

Drug

Specified dose on specified days

Primary outcomes

  1. Dose-limiting toxicities（DLT）

    Time frame: 28 days

  2. Adverse event(AE)

    Time frame: UP to 28 days after the last dose

Secondary outcomes

  1. Pharmacokinetics (Plasma concentration for ONO-4578)

    Time frame: Up to 28 days after the last dose

  2. Pharmacokinetics (Serum concentration for ONO-4538)

    Time frame: Up to 28 days after the last dose

  3. Overall response rate (ORR)

    Time frame: Up to 2 years

  4. Disease control rate (DCR)

    Time frame: Up to 2 years

  5. Overall survival (OS)

    Time frame: Up to 2 years

  6. Progression-free survival (PFS)

    Time frame: Up to 2 years

  7. Duration of response (DOR)

    Time frame: Up to 2 years

  8. Time to response (TTR)

    Time frame: Up to 2 years

  9. Best overall response (BOR)

    Time frame: Up to 2 years

  10. Percentage of change in the sum of tumor diameters of target lesions

    Time frame: Up to 2 years

  11. Maximum percentage of change in the sum of tumor diameters of target lesions

    Time frame: Up to 2 years

  12. Changes in tumor markers (CEA and CA19-9)

    Time frame: Up to 2 years

Sponsors and collaborators

Lead sponsor

Ono Pharmaceutical Co., Ltd.

Industry

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Aug 5, 2024
Registry last updated
Feb 6, 2025

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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