Clinical Trials Search
Clinical Trial 19184
Cancer Type: Gynecological Tumor
Interventions:Avelumab; Entinostat; MSB00100718C (Avelumab); Not Applicable; Placebo
Study Type: Treatment
Phase of Study: Phase I/II
- Robert Wenham
A Randomized, Placebo-controlled, Double-blind, Multicenter Phase 1b/2 Study of Avelumab With or Without Entinostat in Patients with Advanced Epithelial Ovarian Cancer Which Has Progressed or Recurred After First-line Platinum-based Chemotherapy and at Least Two Subsequent Lines of Treatment with a Safety Lead-in [SNDX-275-0603]
The purpose of this study is to determine the biologically active dose of entinostat, when given in combination with avelumab, that is safe and warrants further investigation. Additionally, this study will evaluate the effectiveness of entinostat in combination with avelumab at the determined dose in terms of progression free survival compared to avelumab plus placebo in patients with refractory or recurrent epithelial ovarian cancer.
Primary Objective: Phase 1b: (Safety lead-in): To determine the dose-limiting toxicities (DLTs) and maximum-tolerated dose (MTD) or recommended Phase 2 dose (RP2D) of entinostat (SNDX-275) given in combination with avelumab. Phase 2 (Expansion Phase): To perform an evaluation of the efficacy of entinostat in combination with avelumab at the RP2D versus avelumab plus placebo in patients with refractory or recurrent epithelial ovarian cancer, as determined by the duration of progression-free survival (PFS) based on the local investigator's assessment of progressive disease according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). Secondary Objectives: Efficacy: To evaluate the efficacy of entinostat in combination with avelumab in patients with advanced epithelial ovarian cancer, as determined by: PFS based on immune response RECIST (irRECIST); Overall response rate (ORR) (i.e., complete response [CR] or partial response [PR]) based on RECIST 1.1 and irRECIST; Clinical benefit rate (CBR) (i.e., CR or PR or stable disease [SD] for at least 24 weeks) based on RECIST 1.1 and irRECIST; Overall survival (OS).