A Study of Novel Anti-cancer Agents in Patients With Metastatic Triple Negative Breast Cancer

Official Title

A Phase IB/II, 2-stage, Open-label, Multicentre Study to Determine the Efficacy and Safety of Durvalumab (MEDI4736) + Paclitaxel and Durvalumab (MEDI4736) in Combination With Novel Oncology Therapies With or Without Paclitaxel for First-line Metastatic Triple Negative Breast Cancer

Summary:

This study is designed to determine the efficacy and safety of durvalumab in combination with novel oncology therapies with or without paclitaxel and durvalumab + paclitaxel for first-line metastatic triple negative breast cancer

Trial Description

Primary Outcome:

• Incidence of adverse events
• Laboratory findings

Secondary Outcome:

• Objective response rate (ORR)
• Progression-free survival (PFS).
• Duration of response (DoR)
• Overall survival (OS)
• Serum concentration of durvalumab and serum or plasma concentration of novel oncology therapies
• Presence of anti-drug antibodies (ADAs) for durvalumab and applicable novel oncology therapies
• Progression-free survival (PFS 6)

This is a Phase IB/II, 2-stage, open-label, multicentre study to determine the efficacy and safety of durvalumab in combination with novel oncology therapies (i.e. therapies designed for immune modulation) with or without paclitaxel and durvalumab+ paclitaxel as first-line treatment in patients with metastatic triple negative breast cancer (TNBC). The study is designed to concurrently evaluate potential novel treatment combinations with clinical promise using a 2-stage approach. The study will use a Simon 2-Stage design to evaluate which cohorts may proceed to expansion. Part 1 is a Phase IB study of safety and initial efficacy, and Part 2 may expand patient enrollment if adequate efficacy signal is observed in Part 1. The treatment regimens evaluated in Part 2 will depend on the evaluation of safety and efficacy outcomes in Part 1.

View this trial on ClinicalTrials.gov