Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab for FGFR2b Overexpressed Untreated Advanced Gastric and Gastroesophageal Junction Cancer (FORTITUDE-102)
A Phase 1b/3 Study of Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab Alone in Subjects With Previously Untreated Advanced Gastric and Gastroesophageal Junction Cancer With FGFR2b Overexpression (FORTITUDE-102)
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Clinical Trial Information
Trial Contact: Bobe Cortes, Estefania
Trial Phone: 321.841.6626
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IRB No: 20214559
Protocol Abbrev: TRIO-AMGEN-20210098
Principal Investigator: Omar R. Kayaleh, MD
Phase: Drug: Phase III
Age Group: Adult
Secondary Protocol No: FORTITUDE-102
Treatment: Drug: Bemarituzumab Drug: Nivolumab Drug: mFOLFOX6 Other: Placebo
Therapies Involved: Oncology: 1st line
ClinicalTrials.gov ID: NCT05111626
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Objective
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 mFOLFOX6 and nivolumab to placebo plus mFOLFOX6 and nivolumab as assessed by overall survival. -
Key Eligibility
Inclusion Criteria Part 1:
Adult with unresectable, locally advanced or metastatic (not amenable to curative therapy) histologically documented gastric or gastroesophageal junction adenocarcinoma
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
Measurable disease or non-measurable, but evaluable disease, according to Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST v1.1)
Participant must be a candidate to receive mFOLFOX6 and nivolumab
Adequate organ function as follows:
Absolute neutrophil count ≥ 1.5 x 10^9/L
Platelet count ≥ 100 x 10^9/L
Hemoglobin ≥ 9 g/dl
Aspartate aminotransaminase (AST) and Alanine aminotransaminase (ALT) <3 x upper limit of normal (ULN) (or < 5 x ULN if liver involvement). Total bilirubin <1.5 x ULN (or < 2 x ULN if liver involvement); with the exception of participants with Gilbert's disease)
Calculated or measured creatinine clearance (CrCl) of ≥ 50 mL/minute calculated using the formula of Cockcroft and Gault
International Normalized Ratio (INR) or prothrombin time (PT) < 1.5 × ULN except for participants receiving anticoagulation, who must be on a stable dose of anticoagulant therapy for 6 weeks prior to enrollment.
Additional Inclusion Criteria Part 2:
No prior treatment for metastatic or unresectable disease except for a maximum of 1 dose of mFOLFOX6 with or without nivolumab. Prior adjuvant or neo-adjuvant therapy for localized disease is allowed, provided it has been completed more than 6 months prior to the first dose of study treatment.
Fibroblast growth factor receptor 2b (FGFR2b) overexpression as determined by centrally performed immunohistochemistry (IHC) testing
