| Title |
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 |
| Protocole ID |
FORTITUDE-102 |
| ClinicalTrials.gov ID |
NCT05111626 |
| Cancer Type(s) |
Oesophagus
Stomach |
| Phase |
Phase I |
| Stage |
|
| Study Type |
Clinical |
| Drug |
Bemarituzumab + chimiothérapie et nivolumab versus placebo + chimiothérapie et nivolumab |
| Institution |
CENTRE HOSPITALIER DE L'UNIVERSITE DE MONTREAL
|
| City |
|
| Principal Investigator |
Dr. Mustapha Tehfé
|
| Coordinator |
Chantal Gosselin
514-890-8000 poste 24892
|
| Status |
Closed |
| Activation Date |
03-03-2023 |
| Eligibility Criteria |
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 mFOLFOX6 chemotherapy or 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 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)
- 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, 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) overexpression positive 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
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Groupe d'étude en oncologie du Québec