Bemarituzumab plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab Alone

Overview

About this study

The primary objective of this study is to evaluate the safety and tolerability of bemarituzumab plus mFOLFOX6 and nivolumab to treat previously-untreated advanced gastric and gastroesophageal junction cancer.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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) ≥ 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

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 5/2/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Mohamad Bassam Sonbol, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

Jason Starr, D.O.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Rochester, Minn.

Mayo Clinic principal investigator

Harry Yoon, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions