This study is designed to assess the efficacy and safety of ifinatamab deruxtecan (I-DXd) in patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) who have experienced disease progression following treatment with a platinum-based systemic therapy and an immune checkpoint inhibitor (ICI) compared with investigator's choice of chemotherapy (ICC).
Participants aged ≥18 years (follow local regulatory requirements if the legal age of consent for study participation is >18 years old).
Has histologically or cytologically documented unresectable locally advanced or metastatic ESCC according to American Joint Committee on Cancer 8th edition staging system on ESCC.
Has disease progression post a platinum-based chemotherapy and an ICI treatment per global or local guidelines, with a maximum of 1 prior line of systemic therapy for unresectable advanced or metastatic ESCC.
The participant must provide adequate baseline tumor samples with sufficient quantity and quality of tumor tissue content as defined in the Laboratory Manual.
Has received prior treatment with orlotamab, enoblituzumab, or other B7-H3 targeted agents, including I-DXd.
Has received any topoisomerase inhibitor.
Has histologically or cytologically confirmed adenosquamous carcinoma subtype.
Is ineligible to all the chemotherapies in the comparator arm due to prior progression or intolerance.
Daiichi Sankyo
Lead sponsor
Merck Sharp & Dohme LLC
Collaborator