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CC-486 + Pembrolizumab in Platinum-Resistant Ovarian Cancer
NCT02900560Phase 2
Key facts
- Status
- Terminated
- Start
- Dec 2016
- Primary completion
- May 2021
- Countries
- 1
- Sponsor
- Translational Research In Oncology
- Modality
- Small Molecules, Drug Delivery Systems
- Drugs
- CC-486
- Conditions
- epithelial ovarian cancer (EOC)fallopian tube cancer (PFTC)primary peritoneal cancer (PPC)
01
Overview
Phase 2, open-label trial of CC-486 in epithelial ovarian cancer (EOC), fallopian tube cancer (PFTC) and primary peritoneal cancer (PPC) (4 cohorts), sponsored by Translational Research In Oncology. Primary endpoints: Number of Subjects With Grade 3, 4, or 5 Adverse Events at 30 weeks, Objective Response Rate (irRECIST) at 30 weeks and 2 more. Started Dec 2016; status: terminated.
02
Design
4 arms- Study design
- Non-randomizedOpen-label
Cohort 1
CC-486 100 mg QD (21/7) + Pembrolizumab
Cohort 2
CC-486 100 mg BID (21/7) + Pembrolizumab
Cohort 3
CC-486 300 mg QD (14/14) + Pembrolizumab
Cohort 4
CC-486 300 mg QD (21/7) + Pembrolizumab
03
Who it enrols
Women >= 18 with platinum-resistant/refractory EOC/FTC/PPC, ECOG 0-1, measurable disease, and amenable to biopsy. Excludes prior PD-1/PD-L1 or hypomethylating agents.
04
Endpoints
Primary
Number of Subjects With Grade 3, 4, or 5 Adverse Events
Objective Response Rate (irRECIST)
Number of Subjects With Treatment Emergent Adverse Events Related to CC-486
Number of Subjects With Treatment Emergent Adverse Events Related to Pembrolizumab
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