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Trial Title:
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
NCT ID:
NCT06532344
Condition:
Metastatic Pancreatic Cancer
Conditions: Official terms:
Pancreatic Neoplasms
Leucovorin
Nivolumab
Magrolimab
Oxaliplatin
Fluorouracil
Irinotecan
Levoleucovorin
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
ONO-7913
Description:
Specified dose on specified days
Arm group label:
ONO-7913+ONO-4538+mFFX
Other name:
Magrolimab
Intervention type:
Drug
Intervention name:
ONO-4538
Description:
Specified dose on specified days
Arm group label:
ONO-7913+ONO-4538+mFFX
Other name:
Nivolumab
Intervention type:
Drug
Intervention name:
Oxaliplatin
Description:
Specified dose on specified days
Arm group label:
ONO-7913+ONO-4538+mFFX
Intervention type:
Drug
Intervention name:
Levofolinate
Description:
Specified dose on specified days
Arm group label:
ONO-7913+ONO-4538+mFFX
Intervention type:
Drug
Intervention name:
Irinotecan
Description:
Specified dose on specified days
Arm group label:
ONO-7913+ONO-4538+mFFX
Intervention type:
Drug
Intervention name:
Fluorouracil
Description:
Specified dose on specified days
Arm group label:
ONO-7913+ONO-4538+mFFX
Summary:
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
20 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
National Cancer Center Hospital East
Address:
City:
Kashiwa-shi
Country:
Japan
Facility:
Name:
Kanagawa Cancer Center
Address:
City:
Yokohama-shi
Country:
Japan
Facility:
Name:
Seirei Hamamatsu General Hospital
Address:
City:
Hamamatsu-shi
Country:
Japan
Facility:
Name:
Juntendo University Hospital
Address:
City:
Bunkyō-Ku
Country:
Japan
Facility:
Name:
The University of Tokyo Hospital
Address:
City:
Bunkyō-Ku
Country:
Japan
Facility:
Name:
The Cancer Institute Hospital ofJFCR
Address:
City:
Koto-ku
Country:
Japan
Facility:
Name:
Kyorin University Hospital
Address:
City:
Mitaka-shi
Country:
Japan
Facility:
Name:
Keio University Hospital
Address:
City:
Shinjuku-Ku
Country:
Japan
Facility:
Name:
National Cancer Center Hospital
Address:
City:
Chuo Ku
Country:
Japan
Start date:
July 30, 2021
Completion date:
May 31, 2025
Lead sponsor:
Agency:
Ono Pharmaceutical Co. Ltd
Agency class:
Industry
Source:
Ono Pharmaceutical Co. Ltd
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06532344
