Clinical Trials- Front Line Ovarian Cancer
Name of Protocol:
A Phase 3, Double-Blind, Placebo-Controlled, Multicenter Clinical Study comparing Chemo-Immunotherapy (Paclitaxel – Carboplatin – Oregovomab) versus Chemotherapy (Paclitaxel-Carboplatin-Placebo) In Patients with Advanced Epithelial Ovarian, Fallopian Tube or Peritoneal Carcinoma (FLORA-5/GOG-3035)
Purpose
Phase 3 double-blind, placebo-controlled, multi-center study to compare the safety and efficacy of four administrations of oregovomab 2 mg IV versus placebo, administered in combination with specific cycles of a standard six-cycle chemotherapy regimen (paclitaxel and carboplatin), for the treatment of subjects with newly diagnosed ovarian cancer who have undergone optimal debulking surgery and are either pending initiation of chemotherapy (Cohort 1 – Primary Surgery) or resumption of another three cycles of chemotherapy, having already completed three cycles of neoadjuvant chemotherapy (Cohort 2 – NACT + Interval Surgery).
NCT04498117
Status: recruiting
Name of Protocol:
A RANDOMIZED CONTROLLED STUDY ON THE EFFECTIVENESS OF FIRST-LINE CHEMOTHERAPY (CARBOPLATIN AND PACLITAXEL) VERSUS CHEMO-IMMUNOTHERAPY (CARBOPLATIN-PACLITAXEL-OREGOVOMAB) IN PATIENTS WITH ADVANCED EPITHELIAL OVARIAN, ADNEXAL OR PERITONEAL CARCINOMA
Purpose
This is a Phase 2 randomized study with two treatment arms to compare the effectiveness of oregovomab (a murine monoclonal antibody directed against cancer antigen 125 (CA125)) when combined with first-line chemotherapy (carboplatin and paclitaxel) to first-line chemotherapy (carboplatin and paclitaxel alone) in female patients with advanced ovarian cancer.
NCT01616303
Status: completed
Clinical Trials- Recurrent Ovarian Cancer
Name of Protocol:
Prospective Phase Ib clinical trial to evaluate the safety and efficacy of oregovomab and Hiltonol®as a combinatorial immunotherapy strategy in patients with recurrent advanced epithelial cancer of ovarian, tubal, or peritoneal origin)
Purpose
This is a Phase Ib study to look at the combination of an antibody immunization vaccine strategy using oregovomab and an investigational stage immune booster (poly ICLC / Hiltonol), both of which have previously been used in combination with other cancer treatments and demonstrated to be active in advanced cancer, but which have not previously been used together. This study will assess the approach as to whether these two drugs can safely add to the response seen with either drug alone, both of which have doses that are based on prior studies.
NCT03162562
Status: enrollment completed
Name of Protocol:
A Phase Ib/IIa clinical trial to evaluate the safety and activity of oregovomab and nivolumab as a combinatorial immunotherapy strategy in patients with recurrent epithelial cancer of ovarian, tubal or peritoneal origin (ORION-01)
Purpose
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.
NCT03100006 Physician Sponsored Study
Status: completed
Name of Protocol:
Oregovomab in Combination With Bevacizumab Plus Chemo in BRCA Wild Type Platinum Sensitive Recurrent Ovarian Cancer
Purpose
This is a single arm phase 1b/2 evaluation of the combination of oregovomab, and bevacizumab, paclitaxel carboplatin in adult subjects with CA125-associated, advanced recurrent epithelial ovarian, fallopian tube or peritoneal carcinoma (FIGO Stage III/IV) with BRCA-wild type, previously treated with 1 prior lines of therapy, and with platinum free intervals of >6 months since last platinum-based treatment.
NCT04938583 Physician Sponsored Study
Status: recruiting
Name of Protocol:
Clinical Trial of Chemotherapy, Oregovomab and Nivolumab in Patients With Epithelial Cancer of Ovarian, Tubal or Peritoneal Origin (ORION-02)
Purpose
This is an open-label, single-arm, phase I/II, single-center study with dose finding and dose expansion parts.
This study hypothesizes that the combination of platinum-based chemotherapy, Oregovomab and Nivolumab will improve intracellular CA 125 antigen processing and elicit a stronger systemic CA 125-specific T cell response and that it will be in a manner that is synergistic, safe and clinical efficacious in patients with relapsed platinum sensitive epithelial ovarian carcinoma (EOC).
