Oregovomab Plus Chemo in Newly Diagnosed Patients With Advanced Epithelial Ovarian Cancer Following Optimal Debulking Surgery

Active:	No
Cancer Type:	Gynecologic Cancers Ovarian Cancer Primary Peritoneal Cancer	NCT ID:	NCT04498117
Trial Phases:	Phase III	Protocol IDs:	QPT-ORE-005 (primary) NCI-2020-08028 FLORA5 FLORA-5 GOG 3035 GOG-3035
Eligibility:	18 Years and older, Female	Study Type:	Treatment
Study Sponsor:	CanariaBio Inc.
NCI Full Details:	http://clinicaltrials.gov/show/NCT04498117

Summary

Study to compare the safety and efficacy of oregovomab 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 advanced ovarian
cancer who have undergone optimal debulking.

Objectives

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).

For Cohort 1 - Primary Surgery, approximately 372 subjects randomized in a 1:1 ratio
(i.e., chemotherapy with oregovomab or chemotherapy with placebo). For Cohort 2 - NACT +
Interval Surgery, approximately 230 subjects will be randomized in a 1:1 ratio (i.e.,
chemotherapy with oregovomab or chemotherapy and placebo).

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