Phase 2 Futibatinib in Combination With PD-1 Antibody Based Standard of Care in Solid Tumors
Locally Advanced Unresectable or Metastatic Esophageal Cancer
About this trial
This is an interventional treatment trial for Locally Advanced Unresectable or Metastatic Esophageal Cancer focused on measuring Futibatinib, Advanced esophageal cancer, Esophageal cancer, TAS-120, Immunotherapy, Esophageal squamous cell cancer (ESCC), GEJ cancer
Eligibility Criteria
Inclusion Criteria: Is ≥18 years of age at the time of informed consent Histologically or cytologically confirmed, locally advanced, unresectable or metastatic adenocarcinoma or squamous cell carcinoma of the esophagus or advanced/metastatic Siewert type 1 adenocarcinoma of the esophagogastric junction (EGJ). No prior systemic treatment for locally advanced, unresectable or metastatic esophageal carcinoma. Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) guidelines. Have documentation of PD-L1 CPS score. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 Adequate organ function Able to take medications orally Exclusion Criteria: Has locally advanced esophageal carcinoma that is resectable or potentially curable with radiation therapy (as determined by local investigator). Has an adenocarcinoma histology and is eligible to receive approved targeted therapy (eg, HER-2 positive patients). Has received prior treatment with an anti-PD-1/PD-L1 or FGF/FGFR targeting drug, or any other agent directed to stimulatory or co-stimulatory T-cell receptor. Has known additional malignancy that is progressing or requires active treatment . History or current evidence of calcium and phosphate homeostasis disorder Current evidence of clinically significant retinal disorder Pregnant or lactating female. Has known hypersensitivity or severe reaction to any of the study drugs or their excipients. Has a diagnosis of immunodeficiency. Has known human immunodeficiency virus (HIV) and/or history of Hepatitis B or C infections, or known to be positive for Hepatitis B antigen (HBsAg)/ Hepatitis B virus (HBV) DNA or Hepatitis C antibody or RNA. Has an active autoimmune disease that has required systemic treatment in the past 2 years Has a history of (noninfectious) pneumonitis that required steroids or has current pneumonitis. Has had an allogenic tissue/organ transplant.
Sites / Locations
- Gabrail Cancer Center Research LLCRecruiting
Arms of the Study
Arm 1
Experimental
futibatinib + pembrolizumab + chemotherapy
Futibatinib will be administered once daily on a continuous dosing regimen in combination with pembrolizumab plus investigator choice of SoC chemotherapy of FP or mFOLFOX6 induction phase followed by a Futibatinib Plus Pembrolizumab consolidation phase.