未治療進行卵巣がんにおけるアベルマブとタラゾパリブの併用療法（JAVELIN OVARIAN PARP 100）

基本情報

NCT ID: NCT03642132
ステータス: 中止
試験のフェーズ: 第3相
試験タイプ: 介入
目標被験者数: 79
治験依頼者名: Pfizer

概要

JAVELIN Ovarian PARP 100 (B9991030) is an open-label, randomized study designed to evaluate the efficacy and safety of avelumab in combination with chemotherapy followed by maintenance therapy of avelumab in combination with talazoparib versus an active comparator in treatment-naïve patients with locally advanced or metastatic ovarian cancer (Stage III or Stage IV). On March 19, 2019, Sponsors alliance announced the discontinuation of the ongoing Phase III study, and the decision was based on several factors, including previous announced interim results from JAVELIN Ovarian 100 study (B9991010). Patients who remain in B9991030 study will continue receiving their randomized treatment assigned and will be monitored for appropriate safety assessments until treatment discontinuation.

対象疾患

Ovarian Cancer

介入

Chemotherapy + avelumab followed by avelumab + talazoparib(DRUG)

Chemotherapy followed by talazoparib maintenance(DRUG)

Chemotherapy + bevacizumab followed by bevacizumab(DRUG)

依頼者（Sponsor）

ファイザー株式会社(INDUSTRY)

実施施設 (1)

新潟県立がんセンター新潟病院

Niigata, Japan