Terminated/Withdrawn
Sponsor ID
20210098

Bemarituzumab plus chemotherapy and Nivolumab versus chemotherapy and Nivolumab for FGFR2b overexpressed untreated advanced gastric and gastroesophageal junction cancer.FORTITUDE-102

Sponsor ID
20210098
Clinicaltrials.gov ID
NCT05111626
EUCTIS ID
2023-505458-16
EudraCT ID
N/A

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.

Additional Study Details

Phase
Phase 3
Product
Bemarituzumab
Type
Interventional
Masking
Double (Participant, Investigator)
Enrollment
515
Additional Study Details

Protocol Summary

Primary Outcome Measures

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

Secondary Outcome Measures

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

Locations

Location
Status
Contact Us
Location
The Oncology Institute Clinical Research
Cerritos, CA, United States, 90703
Status
Recruiting
Location
City of Hope National Medical Center
Duarte, CA, United States, 91010
Status
Recruiting
Location
Sarah Cannon Research Institute
Nashville, TN, United States, 37203
Status
Recruiting
Location
Mayo Clinic
Rochester, MN, United States, 55905
Status
Recruiting
Location
Texas Oncology Central-South
Austin, TX, United States, 78705
Status
Recruiting
Location
Mayo Clinic
Jacksonville, FL, United States, 32224
Status
Recruiting
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