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Research & Innovation

Gastric / Esophageal Clinical Trials

Clinical Trials

Roche-Genentech YO42137

Physician & Study Coordinator

Physician

Asim Ali, MD

Asim Ali, MD

Study Coordinator

Janine Schippang
484-658-1790

JanineL.Schippang@sluhn.org

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Synopsis

Synopsis: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Of Atezolizumab With Or Without Tiragolumab (Anti-Tigit Antibody) In Patients With Unresectable Esophageal Squamous Cell Carcinoma Whose Cancers Have Not Progressed Following Definitive Concurrent Chemoradiotherapy

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Eligibility Criteria
  • Is ≥18 years of age, at the time of signing the informed consent
  • Histologically or cytologically confirmed diagnosis of stage II-IVA squamous cell carcinoma of the esophagus
  • Unresectable locally advanced disease (medically or surgery is declined)
  • Received definitive concurrent chemoradiation treatment according to regional oncology guidelines for esophageal cancer
  • Patients with inoperable cancer must have received at least 2 cycles of platinum-based chemotherapy and radiation therapy consistent with definitive treatment (50-64 Gy) without evidence of radiographic disease progression per RECIST v1.1
  • prior therapy with CD137 agonists or immune checkpoint inhibitors

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Protocol# Amgen 20210098

Physician & Study Coordinator

Physician

Asim Ali, MD

Asim Ali, MD

Study Coordinator

Vivian Colon
484-658-1793

Vivian.colon@sluhn.org

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Synopsis

Synopsis: A Phase 1b/3 Study of Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab Alone in Subjects With Previously Untreated Advanced Gastric and Gastroesophageal Junction Cancer With FGFR2b Overexpression (NCT 05111626)

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Eligibility Criteria
  • Histologically documented gastric or GEJ adenocarcinoma that is unresectable, locally advanced or metastatic (not amenable to curative therapy)
  • ECOG PS 0 or 1
  • Measurable disease or non-measurable, but evaluable disease, according to RECIST v1.1
  • No known contraindications to mFOLFOX6 chemotherapy or nivolumab
  • 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 was completed more than 6 months prior to first dose of study treatment
  • For Part 2: FGFR2b overexpression positive as determined by central IHC testing
  • Patients may not have untreated or symptomatic CNS metastases or leptomeningeal disease
  • Patients with tumors with known positive HER2 status are excluded
  • No evidence of any ongoing ophthalmologic abnormalities or symptoms that are acute or actively progressing; must be willing to avoid use of contact lenses while on study treatment
  • Patients with sensory neuropathy grade 2 or higher are excluded

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