Bemarituzumab plus chemotherapy and Nivolumab versus chemotherapy and Nivolumab for FGFR2b overexpressed untreated advanced gastric and gastroesophageal junction cancer.FORTITUDE-102
Study Details
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.
Protocol Summary
Part 1: Number of Participants Who Experienced DLTs
Timeframe: 28 days
Part 1: Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAEs)
Timeframe: Up to 4.5 years
Part 1: Number of Participants Who Experienced One or More Related TEAEs
Timeframe: Up to 4.5 years
Part 1: Number of Participants With Clinically Significant Changes in Vital Signs
Timeframe: Up to 4.5 years
Part 1: Number of Participants With Clinically Significant Changes in Visual Acuity
Timeframe: Up to 4.5 years
Part 1: Number of Participants With Clinically Significant Changes in Physical Examinations
Timeframe: Up to 4.5 years
Part 1: Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests
Timeframe: Up to 4.5 years
Part 2: Overall Survival in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants
Timeframe: Up to 4.5 years
Part 1: Objective Response (OR)
Timeframe: Up to 4.5 years
Part 1: Duration of Response (DoR)
Timeframe: Up to 4.5 years
Part 1: Disease Control Rate (DCR)
Timeframe: Up to 4.5 years
Part 1: Progression Free Survival (PFS)
Timeframe: Up to 4.5 years
Part 1: Overall Survival
Timeframe: Up to 4.5 years
Part 1: Maximum Observed Concentration (Cmax) of Bemarituzumab
Timeframe: Day 1 to up to 4.5 years
Part 1: Area Under the Concentration Time Curve (AUC) of Bemarituzumab
Timeframe: Day 1 to up to 4.5 years
Part 1: Observed Concentration at the End of a Dose Interval (Ctrough) of Bemarituzumab
Timeframe: Day 1 to up to 4.5 years
Part 1: Number of Participants With Anti-Bemarituzumab Antibody Formation
Timeframe: Day 1 to up to 4.5 years
Part 2: PFS in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants
Timeframe: Up to 4.5 years
Part 2: Overall Survival in All Randomized Participants
Timeframe: Up to 4.5 years
Part 2: PFS in All Randomized Participants
Timeframe: Up to 4.5 years
Part 2: Number of Participants Who Experienced One or More TEAEs
Timeframe: Up to 4.5 years
Part 2: Number of Participants With Clinically Significant Changes in Vital Signs
Timeframe: Up to 4.5 years
Part 2: Number of Participants With Clinically Significant Changes in Visual Acuity
Timeframe: Up to 4.5 years
Part 2: Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests
Timeframe: Up to 4.5 years
Part 2: OR
Timeframe: Up to 4.5 years
Part 2: DoR
Timeframe: Up to 4.5 years
Part 2: DCR
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: Day 1 to up to 4.5 years
Part 2: AUC of Bemarituzumab
Timeframe: Day 1 to up to 4.5 years
Part 2: Cmax of Bemarituzumab
Timeframe: Day 1 to up to 4.5 years
Part 2: Ctrough of Bemarituzumab
Timeframe: Day 1 to up to 4.5 years
Part 2: Number of Participants With Anti-Bemarituzumab Antibody Formation
Timeframe: Day 1 to up to 4.5 years