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OpenTrials
Active, Not Recruiting

NCT Number: NCT06532344

An Open-label, Uncontrolled Study of ONO-7913 and ONO-4538 in Combination With Modified FOLFIRINOX Therapy, the Standard of Care, as First-line Treatment in Patients With Metastatic Pancreatic Cancer

To investigate the tolerability and safety of ONO-7913 and ONO-4538 used in combination with modified FOLFIRINOX (mFFX therapy), the standard of care, as first-line treatment in patients with metastatic pancreatic cancer.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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. Untreated metastatic pancreatic cancer
  • 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-7913

Drug

Specified dose on specified days

Other names: Magrolimab

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

Primary outcomes

  1. Dose-limiting toxicities（DLT）

    Time frame: 28 days

  2. Adverse event(AE)

    Time frame: UP to 30 days after the last dose

Secondary outcomes

  1. Pharmacokinetics（serum concentration of ONO-7913）

    Time frame: Through study completion, an average of 6 months

  2. Pharmacokinetics（serum concentration of ONO-4538）

    Time frame: Through study completion, an average of 6 months

  3. Overall response rate (ORR)

    Time frame: Through study completion, an average of 6 months

  4. Disease control rate (DCR)

    Time frame: Through study completion, an average of 6 months

  5. Overall survival (OS)

    Time frame: Through study completion, an average of 6 months

  6. Progression-free survival (PFS)

    Time frame: Through study completion, an average of 6 months

  7. Duration of response (DOR)

    Time frame: Through study completion, an average of 6 months

  8. Time to response (TTR)

    Time frame: Through study completion, an average of 6 months

  9. Best overall response (BOR)

    Time frame: Through study completion, an average of 6 months

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

    Time frame: Through study completion, an average of 6 months

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

    Time frame: Through study completion, an average of 6 months

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

    Time frame: Through study completion, an average of 6 months

Sponsors and collaborators

Lead sponsor

Ono Pharmaceutical Co., Ltd.

Industry

Registry information

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Aug 1, 2024
Registry last updated
Nov 14, 2024

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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