Bemarituzumab or Placebo plus Chemotherapy in Gastric Cancers with Fibroblast Growth Factor Receptor 2b (FGFR2b) OverexpressionFORTITUDE-101
Study Details
The main objective of this study is to compare efficacy of bemarituzumab combined with oxaliplatin, leucovorin, and 5-fluorouracil (5-FU) (mFOLFOX6) to placebo plus mFOLFOX6 as assessed by overall survival (OS) in participants with FGFR2b ≥10% 2+/3+ tumor cell staining (FGFR2b ≥10% 2+/3+TC)
Protocol Summary
Overall Survival
Timeframe: Up to approximately 3.5 years
Progression-free Survival (PFS)
Timeframe: Up to approximately 3.5 years
Objective Response Rate (ORR)
Timeframe: Up to approximately 3.5 years
Number of Participants who Experience a Treatment-emergent Adverse Event (TEAE)
Timeframe: Up to approximately 3.5 years
Overall Survival
Timeframe: Up to approximately 3.5 years
Progression-free Survival (PFS)
Timeframe: Up to approximately 3.5 years
Objective Response Rate (ORR)
Timeframe: Up to approximately 3.5 years
Duration of Response (DOR)
Timeframe: Up to approximately 3.5 years
Disease Control Rate
Timeframe: Up to approximately 3.5 years
Mean Subjective Score in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30)
Timeframe: Up to approximately 3.5 years
Change from Baseline Score in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30)
Timeframe: Baseline up to approximately 3.5 years
Stomach Cancer Related Symptom Mean Subjective Score as Measured by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire – Stomach (EORTC-QLQ-STO22)
Timeframe: Up to approximately 3.5 years
Change from Baseline in Stomach Cancer Related Symptom Score as Measured by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire – Stomach (EORTC-QLQ-STO22)
Timeframe: Baseline up to approximately 3.5 years
Mean Subjective Score in Visual Analogue Scale (VAS) as Measured by the EuroQol 5-dimensional 5-levels (EQ-5D-5L)
Timeframe: Up to approximately 3.5 years
Change from Baseline of Visual Analogue Scale (VAS) as Measured by the EuroQol 5-dimensional 5-levels (EQ-5D-5L)
Timeframe: Baseline up to approximately 3.5 years
Time to Deterioration in Stomach Cancer Related Symptom Score as Measured by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire – Stomach (EORTC-QLQ-STO22)
Timeframe: Up to approximately 3.5 years
Time to Deterioration in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30) Score
Timeframe: Up to approximately 3.5 years
Time to Deterioration in Visual Analogue Scale (VAS) as Measured by the EuroQol 5-dimensional 5-levels (EQ-5D-5L) Score
Timeframe: Up to approximately 3.5 years
Time to Deterioration in Physical Function Score as Measured by a Subscale of European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30)
Timeframe: Day 1 up to approximately 3.5 years
Maximum Observed Concentration (Cmax) of Bemarituzumab in Combination with mFOLFOX6 in Plasma
Timeframe: Day 1 up to approximately 3.5 years
Observed Concentration at the End of a Dose Interval (Ctrough) of Bemarituzumab in Combination with mFOLFOX6 in Plasma
Timeframe: Day 1 up to approximately 3.5 years
Number of Participants with an Anti-bemarituzumab Antibody Formation
Timeframe: Day 1 up to approximately 3.5 years