The main objective of Part 1 is to evaluate the safety and tolerability of bemarituzumab plus 5-fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) and nivolumab. The main objective Part 2 is to compare efficacy of bemarituzumab plus chemotherapy (mFOLFOX6 or capecitabine combined with oxaliplatin (CAPOX)) and nivolumab to placebo plus chemotherapy (mFOLFOX6 or CAPOX) and nivolumab as assessed by overall survival.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
515
Bemarituzumab will be administered as intravenous (IV) infusion.
Nivolumab will be administered as IV infusion.
mFOLFOX6: 5-fluorouracil, leucovorin, and oxaliplatin will be administered as IV infusion. OR CAPOX: oxaliplatin will be administered as IV infusion and capecitabine will be administered orally.
Placebo will be administered as IV infusion.
Mayo Clinic - Arizona
Phoenix, Arizona, United States
The Oncology Institute Clinical Research
Cerritos, California, United States
Cancer and Blood Specialty Clinic
Downey, California, United States
City of Hope National Medical Center
Duarte, California, United States
University of California Los Angeles
Los Angeles, California, United States
Part 1: Number of Participants Who Experienced DLTs
Time frame: 28 days
Part 1: Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to 4.5 years
Part 1: Number of Participants Who Experienced One or More Related TEAEs
Time frame: Up to 4.5 years
Part 1: Number of Participants With Clinically Significant Changes in Vital Signs
Time frame: Up to 4.5 years
Part 1: Number of Participants With Clinically Significant Changes in Visual Acuity
Time frame: Up to 4.5 years
Part 1: Number of Participants With Clinically Significant Changes in Physical Examinations
Time frame: Up to 4.5 years
Part 1: Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests
Time frame: Up to 4.5 years
Part 2: Overall Survival in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants
Time frame: Up to 4.5 years
Part 1: Objective Response (OR)
Time frame: Up to 4.5 years
Part 1: Duration of Response (DoR)
Time frame: Up to 4.5 years
Part 1: Disease Control Rate (DCR)
Time frame: Up to 4.5 years
Part 1: Progression Free Survival (PFS)
Time frame: Up to 4.5 years
Part 1: Overall Survival
Time frame: Up to 4.5 years
Part 1: Maximum Observed Concentration (Cmax) of Bemarituzumab
Time frame: Day 1 to up to 4.5 years
Part 1: Area Under the Concentration Time Curve (AUC) of Bemarituzumab
Time frame: Day 1 to up to 4.5 years
Part 1: Observed Concentration at the End of a Dose Interval (Ctrough) of Bemarituzumab
Time frame: Day 1 to up to 4.5 years
Part 1: Number of Participants With Anti-Bemarituzumab Antibody Formation
Time frame: Day 1 to up to 4.5 years
Part 2: PFS in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants
Time frame: Up to 4.5 years
Part 2: Overall Survival in All Randomized Participants
Time frame: Up to 4.5 years
Part 2: PFS in All Randomized Participants
Time frame: Up to 4.5 years
Part 2: Number of Participants Who Experienced One or More TEAEs
Time frame: Up to 4.5 years
Part 2: Number of Participants With Clinically Significant Changes in Vital Signs
Time frame: Up to 4.5 years
Part 2: Number of Participants With Clinically Significant Changes in Visual Acuity
Time frame: Up to 4.5 years
Part 2: Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests
Time frame: Up to 4.5 years
Part 2: OR
Time frame: Up to 4.5 years
Part 2: DoR
Time frame: Up to 4.5 years
Part 2: DCR
Time frame: Up to 4.5 years
Part 2: Mean Score in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Version 3.0 (QLQ-C30) Individual Scores in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants
Time frame: Up to 4.5 years
Part 2: Change From Baseline in EORTC QLQ-C30 Individual Scores in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants
Time frame: Baseline to up to 4.5 years
Part 2: Mean Score in Stomach Cancer Related Symptoms Measured by EORTC Quality of Life Questionnaire-Stomach 22 (QLQ-STO22) in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants
Time frame: Up to 4.5 years
Part 2: Change From Baseline in Stomach Cancer Related Symptoms Measured by EORTC QLQ-STO22 in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants
Time frame: Baseline to up to 4.5 years
Part 2: Mean Score of Visual Analogue Scale (VAS) Scores as Measured by EuroQol 5-dimensional (EQ-5D-5L) in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants
Time frame: Up to 4.5 years
Part 2: Change From Baseline of VAS Scores as Measured by EQ-5D-5L in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants
Time frame: Baseline to up to 4.5 years
Part 2: Time to Deterioration in Stomach Cancer Related Symptoms Measured by EORTC QLQ-STO22 in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants
Time frame: Day 1 to up to 4.5 years
Part 2: Time to Deterioration in Health-Related Quality of Life (HRQoL) Scores in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants
Time frame: Day 1 to up to 4.5 years
Part 2: Time to Deterioration in Physical Function Scores in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants
Time frame: Day 1 to up to 4.5 years
Part 2: AUC of Bemarituzumab
Time frame: Day 1 to up to 4.5 years
Part 2: Cmax of Bemarituzumab
Time frame: Day 1 to up to 4.5 years
Part 2: Ctrough of Bemarituzumab
Time frame: Day 1 to up to 4.5 years
Part 2: Number of Participants With Anti-Bemarituzumab Antibody Formation
Time frame: Day 1 to up to 4.5 years
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University of California Irvine
Orange, California, United States
Torrance Memorial Physician Network
Redondo Beach, California, United States
Translational Research in Oncology - US Inc
Santa Monica, California, United States
Translational Research in Oncology US Inc, Trio Central Pharmacy
Santa Monica, California, United States
Olive View-University of California in Los Angeles Medical Center
Sylmar, California, United States
...and 338 more locations