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
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
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.
Inclusion Criteria Part 1 and Part 2:
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 has no contraindications to nivolumab and either mFOLFOX6 or CAPOX chemotherapy as per local prescribing information. Participants in Part 1 must have no contraindications to mFOLFOX6. Participants in Part 2 with contraindications to mFOLFOX6 are permitted and may be administered the CAPOX regimen, if no contraindications for this regimen exist. Participants in Part 2 with contraindications to CAPOX are permitted and may be administered the mFOLFOX6 regimen, if no contraindications for this regimen exist
Adequate organ function as follows:
Part 2 only: Calculated or measured creatinine clearance (CrCl) of ≥ 30 mL/minute calculated using the formula of Cockcroft and Gault ([140 - Age] × Mass [kg]/[72 × Creatinine mg/dL]) (x 0.85 if female).
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 chemotherapy with or without nivolumab; prior adjuvant, neo-adjuvant, and peri-operative therapy 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) ≥ 10% 2+/3+ tumor cells (TC) as determined by centrally performed immunohistochemistry (IHC) testing, based on tumor sample either archival (obtained within 6 months/180 days prior to signing pre-screening informed consent) or a fresh biopsy.
Exclusion Criteria:
Santa Monica, California 90404, United States
Sylmar, California 91342, United States
Whittier, California 90602, United States
Orlando, Florida 32804, United States
Ciudad Autonoma de Buenos Aires, Buenos Aires C1431FWO, Argentina
Capital Federal, C1199ABB, Argentina
Cachoeiro de Itapemirim, Espírito Santo 29308-014, Brazil
Porto Alegre, Rio Grande do Sul 90110-270, Brazil
São José do Rio Preto, São Paulo 15090-000, Brazil
São Paulo, 04501-000, Brazil
Beijing, Beijing Municipality 100032, China
Chongqing, Chongqing Municipality 400042, China
Luoyang, Henan 471000, China
Wuhan, Hubei 430000, China
Shanghai, Shanghai Municipality 200025, China
Hangzhou, Zhejiang 310009, China
Hangzhou, Zhejiang 310009, China
Rionegro, Antioquia 054040, Colombia
Clermont-Ferrand, 63003, France
Saint-Priest-en-Jarez, 42270, France
Shatin, New Territories, Hong Kong
Nyíregyháza, 4400, Hungary
Kashiwa-shi, Chiba 277-8577, Japan
Akashi-shi, Hyōgo 673-8558, Japan
Hirakata-shi, Osaka 573-1191, Japan
Osakasayama-shi, Osaka 589-8511, Japan
Suita-shi, Osaka 565-0871, Japan
Kitaadachi-gun, Saitama 362-0806, Japan
Sunto-gun, Shizuoka 411-8777, Japan
Chuo-ku, Tokyo 104-0045, Japan
Koto-ku, Tokyo 135-8550, Japan
Bielsko-Biala, 43-300, Poland
Gliwice, 44-102, Poland
Szczecin, 71-252, Poland
Warsaw, 02-034, Poland
Matosinhos Municipality, 4464-513, Portugal
Cluj-Napoca, 400000, Romania
Goyang-si Gyeonggi-do, 10408, South Korea
Seongnam-si, Gyeonggi-do, 13620, South Korea
L'Hospitalet de Llobregat, Catalonia 08908, Spain