Esophageal Adenocarcinoma, Esophagogastric Junction Cancer, Gastric Cancer
Conditions
Keywords
ONO-4578, Programmed cell death ligand 1 positive, Human epidermal growth factor 2 negative, Nivolumab, HER2-negative, PD-L1-positive, Advanced Gastroesophageal Junction (GEJ), Adenocarcinoma, Advanced Gastric Adenocarcinoma, Advanced Esophageal Adenocarcinoma, Metastatic Gastric Adenocarcinoma, Metastatic Gastroesophageal Junction (GEJ), Metastatic Esophageal Adenocarcinoma
Brief summary
The purpose of this study is to evaluate the efficacy and safety of ONO-4578 in combination nivolumab and chemotherapy in participants with advanced or metastatic gastric cancer, esophagogastric junction cancer, or esophageal adenocarcinoma. Participants will: * Receive either ONO-4578 with nivolumab and chemotherapy or placebo with nivolumab and chemotherapy. * Make visits to the clinic for checkups and tests. * Answer questions about their health throughout the trial.
Interventions
DRUGONO-4578
ONO-4578 will be administered to participants at a specified dose once daily.
OTHERPlacebo
Matching placebo for ONO-4578 will be administered to participants once daily.
DRUGNivolumab
Nivolumab will be administered to participants at a specified dose on specified days.
DRUGOxaliplatin
Oxaliplatin will be administered to participants at a specified dose on specified days.
DRUGCapecitabine
Capecitabine will be administered to participants at a specified dose on specified days.
DRUGTegafur-gimeracil-oteracil potassium (S-1)
S-1 will be administered to participants at a specified dose on specified days.
DRUGFluorouracil
Fluorouracil will be administered to participants at a specified dose on specified days.
DRUGLeucovorin Calcium
Leucovorin Calcium will be administered to participants at a specified dose on specified days.
DRUGLevoleucovorin
Levoleucovorin will be administered to participants at a specified dose on specified days.
Sponsors
Ono Pharmaceutical Co., Ltd.
Deciphera Pharmaceuticals, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Have advanced or metastatic gastric cancer, esophagogastric junction cancer, or esophageal adenocarcinoma that has been histologically confirmed to be predominant adenocarcinoma. * Have not been treated with systemic anticancer agents for advanced or metastatic gastric cancer, esophagogastric junction cancer, or esophageal adenocarcinoma. * Participants who have received neoadjuvant or adjuvant therapy may be included if no residual tumors are found after surgery (R0 resection) and if the therapy was completed at least 180 days before the date of recurrence. * Have measurable or nonmeasurable disease, as defined in Response Evaluation Criteria in Solid Tumors (RECIST) Guideline v1.1, and documented on computed tomography (CT) or magnetic resonance imaging (MRI) images within 42 days before Cycle 1 Day 1 (C1D1). * Tumor programmed cell death ligand 1 (PD-L1) expression must be confirmed as combined positive score (CPS ≥1) prior to randomization. * Participant must be able to provide tissues samples for analyses. Key
Exclusion criteria
* Participants with Human epidermal growth factor 2 (HER2)-positive or indeterminate gastric cancer, esophagogastric junction cancer, or esophageal adenocarcinoma as determined by local testing. Determination for HER2 positivity is made based on the reference in each site. If there is no reference, rough indication for positive is 3+ by immunohistochemistry (IHC), or 2+ by IHC and positive by in situ hybridization. * Participants whose tumors have known microsatellite instability-high or mismatch repair-deficient status. * Marked malnutrition requiring continuous enteral nutrition or intravenous hyperalimentation, or continuous infusion therapy with hospitalization. * Active autoimmune disease, or history of autoimmune disease that might recur, that may affect vital organ function, or that may require immune-suppressive treatment, including systemic corticosteroids. * Participants with vitiligo, type 1 diabetes mellitus, and Hashimoto thyroiditis on appropriate replacement therapy may be enrolled. Other protocol-defined inclusion and
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival (OS) | Up to approximately 4 years |
| Progression-Free Survival (PFS) per Blinded Independent Central Review (BICR) | Up to approximately 4 years |
Secondary
| Measure | Time frame |
|---|---|
| PFS per Investigator Assessment | Up to approximately 4 years |
| Objective Response Rate (ORR) per BICR | Up to approximately 4 years |
| Duration of Response (DOR) per BICR | Up to approximately 4 years |
| Disease Control Rate (DCR) per BICR | Up to approximately 4 years |
| Time to Response (TTR) per BICR | Up to approximately 4 years |
| PFS After the Next-line of Therapy (PFS2) per Investigator Assessment | Up to approximately 4 years |
Contacts
CONTACTClinical Team
STUDY_DIRECTORClinical Team
Ono Pharmaceutical Co., Ltd.
Outcome results
None listed