Nivolumab in Combination With Chemotherapy for FGFR2-positive Metastatic Gastric Cancer (NCT05859477) | Clinical Trial Compass
UnknownPhase 2
Nivolumab in Combination With Chemotherapy for FGFR2-positive Metastatic Gastric Cancer
United States23 participantsStarted 2022-06-05
Plain-language summary
The goal of this phase 2 clinical trial is to evaluate the efficacy of nivolumab in combination with CAPOX in patients with FGFR2-positive/PD-L1-positive/HER2-negative metastatic gastric cancer.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Previously untreated, unresectable advanced or metastatic gastric adenocarcinoma
* Measurable lesions according to the RECIST 1.1 criteria
* PD-L1 Combined Positive Score (CPS) of five or more assessed by Dako PD-L1 immunohistochemistry 28-8 pharmDx assay
* Positive FGFR2 overexpression status by immunohistochemistry defined as exhibiting any moderate (2+) to strong (3+) membranous staining in more than 1% of tumor cells
* Possibility to assess the amplification of FGFR2
* HER2-negative status
* ECOG PS 0-2
* Age \>= 18 years old
* Adequate function of organs
* Absence of any psychological, family, social or geographical circumstances that could potentially serve as obstacles to the implementation of the study
* Signed Informed Consent
Exclusion Criteria:
* Participation in another clinical study and concomitant treatment with any research drug or any study of antitumor therapy, including radiation, within 28 days before inclusion in this study
* Presence of metastases in the central nervous system and / or carcinoma of the meninges at the time of inclusion in the study
* Presence or history of present signs of any condition, therapy or laboratory abnormalities that could limit the interpretation of the results of this study
* Any malignant tumor within the previous 5 years, with the exception of adequately cured cervical cancer in situ or squamous cell skin cancer, or basal cell skin cancer with limited growth, subject to adequate control over the co…