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


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

Treatment Sites in Georgia

Nancy N. and J.C. Lewis Cancer Research Pavilion at St. Joseph Candler
225 Candler Drive
Savannah, GA 31405
912-819-5778
www.sjchs.org

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.