drugset / Trial / NCT03100006

Phase Ib/IIa Trial to Evaluate Oregovomab and Nivolumab in Epithelial Cancer of Ovarian, Tubal or Peritoneal Origin

NCT03100006

Phase 1/2 Terminated 13 enrolled National Cancer Centre, Singapore
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to characterize the safety and tolerability, identify a recommended dose for expansion (RDE) / recommended phase II dose (RP2D), pharmacodynamics, and antitumor activity of Oregovomab vaccination in combination with Nivolumab as a novel combinatorial immunotherapeutic strategy in in female patients with recurrent epithelial ovarian cancer (EOC) who progressed after two or more prior lines of cytotoxic chemotherapy.

Timeline

Start
2017-02-22
Primary completion
2019-06-07
Completion
2020-04-17

Drugs

EvaluationDrugModalityDoseRoute
Subject Nivolumab Monoclonal antibody 240 mg Intravenous
Subject Oregovomab Monoclonal antibody 0.5 mg Intravenous
Subject Oregovomab Monoclonal antibody 1 mg Intravenous
Subject Oregovomab Monoclonal antibody 2 mg Intravenous