Nataliya Uboha, MD, PhD, University of Wisconsin, Madison, WI, discusses the rationale and study design of a Phase I/II trial (NCT03490292) of the combination therapy of perioperative avelumab and chemoradiotherapy for patients with stage II/III resectable esophageal or gastroesophageal junction (GEJ) cancer. Immunotherapy has recently been approved for patients with early-stage esophageal or GEJ cancer in the adjuvant setting, so this trial aimed to assess the safety and efficacy of immunotherapy in the perioperative setting plus the standard of care neoadjuvant treatment of chemoradiotherapy. Phase I of the trial was a safety run-in and involved 6 patients, with the primary endpoints being safety and tolerability. Phase II was an expansion cohort of 16 patients, with the primary endpoint being pathologic complete response rate. Patients received chemoradiotherapy plus avelumab 8-10 weeks before surgery, after which they received a further treatment of avelumab. This interview took place at the American Society of Clinical Oncology (ASCO) 2022 Annual Meeting in Chicago, IL.
