Trial Search Results

Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab for FGFR2b Overexpressed Untreated Advanced Gastric and Gastroesophageal Junction Cancer

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Amgen

Stanford Investigator(s):

Intervention(s):

  • Drug: Bemarituzumab
  • Drug: Nivolumab
  • Drug: mFOLFOX6
  • Other: Placebo

Phase:

Phase 1

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 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

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

Ages Eligible for Study

18 Years - 100 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Flordeliza Mendoza
650-724-2056
Not Recruiting