Informations générales (source: ClinicalTrials.gov)
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
Interventional
Phase 3
Amgen (Voir sur ClinicalTrials)
mars 2022
janvier 2027
02 octobre 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Val�rie BOIGE | 10/06/2024 09:29:09 | Contacter | ||
Critères
Tous
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:
- Absolute neutrophil count ≥ 1.5 x 10^9/L
- Platelet count ≥ 100 x 10^9/L
- Hemoglobin ≥ 9 g/dL without red blood cell (RBC) transfusion within 7 days
prior to the first dose of study treatment
- 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 or Gilbert's
disease)
- Part 1 only: Calculated or measured creatinine clearance (CrCl) of ≥ 50
mL/minute calculated using the formula of Cockcroft and Gault ([140 - Age] ×
Mass [kg]/[72 × Creatinine mg/dL]) (x 0.85 if female).
- 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:
- Prior treatment with any selective inhibitor of the fibroblast growth factor
(FGF)-FGFR pathway
- Known positive human epidermal growth factor receptor 2 (HER2) status
- Untreated or symptomatic central nervous system disease metastases and
leptomeningeal disease
- Peripheral sensory neuropathy grade 2 or higher
- Clinically significant cardiac disease
- Other malignancy within the last 2 years (exceptions for definitively treated
disease)
- Chronic or systemic ophthalmologic disorders
- Major surgery or other investigational study within 28 days prior to randomization
- Palliative radiotherapy within 14 days prior to randomization
- Abnormalities of the cornea that may pose an increased risk of developing a corneal
ulcer
- Active autoimmune disease that has required systemic treatment (except replacement
therapy) within the past 2 years or any other diseases requiring immunosuppressive
therapy while on study
- 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:
- Absolute neutrophil count ≥ 1.5 x 10^9/L
- Platelet count ≥ 100 x 10^9/L
- Hemoglobin ≥ 9 g/dL without red blood cell (RBC) transfusion within 7 days
prior to the first dose of study treatment
- 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 or Gilbert's
disease)
- Part 1 only: Calculated or measured creatinine clearance (CrCl) of ≥ 50
mL/minute calculated using the formula of Cockcroft and Gault ([140 - Age] ×
Mass [kg]/[72 × Creatinine mg/dL]) (x 0.85 if female).
- 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:
- Prior treatment with any selective inhibitor of the fibroblast growth factor
(FGF)-FGFR pathway
- Known positive human epidermal growth factor receptor 2 (HER2) status
- Untreated or symptomatic central nervous system disease metastases and
leptomeningeal disease
- Peripheral sensory neuropathy grade 2 or higher
- Clinically significant cardiac disease
- Other malignancy within the last 2 years (exceptions for definitively treated
disease)
- Chronic or systemic ophthalmologic disorders
- Major surgery or other investigational study within 28 days prior to randomization
- Palliative radiotherapy within 14 days prior to randomization
- Abnormalities of the cornea that may pose an increased risk of developing a corneal
ulcer
- Active autoimmune disease that has required systemic treatment (except replacement
therapy) within the past 2 years or any other diseases requiring immunosuppressive
therapy while on study