Bemarituzumab plus Chemotherapy and Nivolumab versus Chemotherapy and Nivolumab Alone
- Conditions
- ntreated Advanced Gastric or Gastroesophageal Junction Cancer with FGFR2b OverexpressionMedDRA version: 21.1Level: PTClassification code 10017758Term: Gastric cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2021-003477-61-PL
- Lead Sponsor
- Amgen Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 528
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)
- 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
Part 2 only: Calculated or measured creatinine clearance (CrCl) of = 30
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.
Subject has no contraindications to nivolumab and either mFOLFOX6 or
CAPOX chemotherapy as per local prescribing information. Subjects in
Part 1 must have no contraindications to mFOLFOX6. Subjects in Part 2
with contraindications to mFOLFOX6 are permitted and may be
administered the CAPOX regimen, if no contraindications for this
regimen exist. Subjects in Part 2 with contraindications to CAPOX are
permitted and may be administered the mFOLFOX6 regimen, if no
contraindications for this regimen exist.
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.
- Confirmed FGFR2b = 10% 2+/3+ TC by centrally performed
immunohistochemistry (IHC) testing based on tumor sample either
archival (obtained within 6 months/180 days prior to signing prescreening
informed consent) or a fresh biopsy.
- For subjects receiving CAPOX only, the ability to take oral medication.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 406
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 122
- 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
-Evidence of, or recent (within 6 months) history of, corneal defects,
corneal ulcerations, keratitis, or keratoconus, history of corneal
transplant, or other known abnormalities of the cornea that may pose an
increased risk of developing a corneal ulcer. Recent (within 6 months)
corneal surgery or ophthalmic laser treatment
- 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
- For subjects receiving CAPOX only, GI tract disease causing the
inability to take oral medication, malabsorption syndrome, or
requirement for IV alimentation, or uncontrolled inflammatory GI
disease (eg, Crohn's disease, ulcerative colitis)
Please refer to protocol for remaining exclusion criteria
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method