Randomized Phase II Trial of a PD-1 Inhibitor INCMGA00012 as Consolidation Therapy After Definitive Concurrent Chemoradiotherapy(RHAPSODY)

Summary

Participation Requirements

Description

This study is a randomized, multi-center, open-label, phase II study of a PD-1 inhibitor (INCMGA00012) versus observation as consolidation therapy after definitive concurrent chemoradiotherapy in patients with locally advanced ESCC who have not progressed following definitive chemoradiotherapy. Pati...

This study is a randomized, multi-center, open-label, phase II study of a PD-1 inhibitor (INCMGA00012) versus observation as consolidation therapy after definitive concurrent chemoradiotherapy in patients with locally advanced ESCC who have not progressed following definitive chemoradiotherapy. Patients must have received definitive concurrent chemoradiotherapy for locally advanced ESCC (cT1b N1-3 M0 or T2-4b N0-3 M0 according to the 8th American Joint Committee on Cancer [AJCC] staging system) because of unresectable disease status (such as cervical esophageal cancer and cTb), medically inoperable status, or patient's refusal of undergoing surgery. Patients must not have progressed following definitive chemoradiotherapy consisting of fluoropyrimidine or taxane plus platinum chemotherapy (including, but not limited to fluorouracil plus cisplatin, capecitabine plus cisplatin, and paclitaxel plus carboplatin according to the institute standard of care regimens) concurrent with radiation therapy (a total dose of at least 50 Gy). One or two cycles of induction chemotherapy before chemoradiotherapy is allowed, but chemotherapy after concurrent chemoradiotherapy is not allowed. Approximately 110 patients who have not progressed following definitive chemoradiotherapy for locally advanced ESCC will be randomly assigned within 4-8 weeks after completing chemoradiotherapy in a 1:1 ratio to the INCMGA00012 arm or observation arm. INCMGA00012 arm (500 mg iv every 4 weeks for up to 12 months) Observation arm (followed-up every 3 months) Randomization will be stratified by Eastern Cooperative Oncology Group (ECOG) performance status (0-1 vs. 2), clinical response to definitive chemoradiation (complete response [CR] vs. non-CR), and institute.

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