Has received at least 1 prior systemic therapy regimen for recurrent, persistent, and/or metastatic cervical cancer.
Has recurrent or metastatic cervical cancer (SCC, AC, or ASC histology) and has experienced disease progression during or after treatment with a standard platinum based therapy with or without bevacizumab.Voluntarily agree to participate by giving written informed consent.Eastern Cooperative Oncology Group (ECOG) status 0 vs 1Īpproximately 486 patients will be enrolled and randomized with 2:1 allocation between the BAL and IC chemotherapy arms.Region of the world (United States or Europe Union or Australia vs other countries).Histology (squamous cell carcinoma vs adenocarcinoma or adenosquamous carcinoma ).In this study, > 50% of patients will have received prior treatment with bevacizumab, which will be determined prior to enrollment. Patients with recurrent, unresectable, or metastatic cervical cancer who have progressed after receiving at least 1 prior line of platinum-containing chemotherapy with or without bevacizumab.
Ciaat brava 21 printer maitance trial#
This Phase 3 trial is an open-label, randomized study with single-agent BAL or IC chemotherapy (single-agent gemcitabine, irinotecan, pemetrexed, vinorelbine, or topotecan) in patients with recurrent, persistent, or metastatic cervical cancer who have progressed after receiving platinum based chemotherapy.
The purpose of this Phase 3 trial is to demonstrate prolongation of OS in patients treated with BAL as compared to IC chemotherapy.
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