drugset / Trial / NCT03100006
Phase Ib/IIa Trial to Evaluate Oregovomab and Nivolumab in Epithelial Cancer of Ovarian, Tubal or Peritoneal Origin
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |