Oregovomab + Chemo for Advanced Ovarian Cancer

(FLORA-5 Trial)

Recruiting at212 trial locations

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: OncoQuest Pharmaceuticals Inc.

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial tests if oregovomab, an IV medication, can help treat advanced ovarian cancer when used with standard chemotherapy. It targets patients who have had surgery to remove tumors and aims to boost the immune system to fight cancer cells more effectively. Oregovomab has been previously tested in advanced ovarian cancer but did not improve outcomes.

Research Team

Sunil Gupta, MD, FRCPC

Principal Investigator

CanariaBio Inc.

Eligibility Criteria

This trial is for adults over 18 with newly diagnosed advanced ovarian, fallopian tube, or peritoneal cancer who've had successful debulking surgery. They must have certain types of epithelial adenocarcinoma and be willing to avoid pregnancy. Exclusions include those with BRCA mutations intending to use PARP inhibitors, allergies to trial drugs, autoimmune diseases, uncontrolled illnesses, other recent cancers or treatments that might interfere.

Inclusion Criteria

Willingness and ability to complete patient quality of life questionnaires

My cancer is one of the specified types of epithelial cell cancer.

Signed informed consent and authorization permitting release of personal health information

Exclusion Criteria

I cannot take medications that raise blood pressure.

I am not planning to take any other cancer treatments during the study.

I have a history of brain issues, uncontrolled seizures, or brain cancer spread.

Treatment Details

Interventions

• Carboplatin (Alkylating agents)
• Oregovomab (Cancer Vaccine)
• Paclitaxel (Alkylating agents)

Trial Overview The study tests the effectiveness of oregovomab versus a placebo when given alongside standard chemotherapy (paclitaxel and carboplatin) in patients after optimal debulking surgery for advanced ovarian cancer. The goal is to compare safety and efficacy outcomes between the two groups.

Participant Groups

Group I: Cohort 2 - NACT + Interval Surgery Active Experimental Treatment 3 Interventions

In Cohort 2 - NACT + Interval Surgery, subjects must already have received three (3) cycles of paclitaxel and carboplatin neoadjuvant therapy. Subjects in Cohort 2 - NACT + Interval Surgery will receive three (3) cycles of chemotherapy with oregovomab given at four (4) cycles (Cycle 4, Cycle 6, Cycle 6 plus 6 weeks and Cycle 6 plus 18 weeks).

Group II: Cohort 1- Surgery Active Experimental Treatment 3 Interventions

Six (6) 21-day cycles of chemotherapy with oregovomab given at four (4) cycles (Cycle 1, Cycle 3, Cycle 5, and Cycle 5 plus 12 weeks).

Group III: Cohort 2 - NACT + Interval Surgery Control Placebo Group 3 Interventions

In Cohort 2 - NACT + Interval Surgery, subjects must already have received three (3) cycles of paclitaxel and carboplatin neoadjuvant therapy. Subjects in Cohort 2 - NACT + Interval Surgery will receive three (3) cycles of chemotherapy with placebo comparator given at four (4) cycles (Cycle 4, Cycle 6, Cycle 6 plus 6 weeks and Cycle 6 plus 18 weeks).

Group IV: Cohort 1 - Primary Surgery Control Placebo Group 3 Interventions

Six (6) 21-day cycles of chemotherapy with placebo comparator given with chemotherapy at four (4) cycles (Cycle 1, Cycle 3, Cycle 5, and Cycle 5 plus 12 weeks).

Carboplatin is already approved in Canada for the following indications:

Approved in Canada as Carboplatin for:

• Ovarian cancer
• Small cell lung cancer
• Testicular cancer

Who Is Running the Clinical Trial?

OncoQuest Pharmaceuticals Inc.

Lead Sponsor

Trials

4

Recruited

690+

CanariaBio Inc.

Lead Sponsor

Trials

6

Recruited

830+

Gynecologic Oncology Group

Collaborator

Trials

251

Recruited

65,400+

Dr. Larry J. Copeland

Gynecologic Oncology Group

Chief Medical Officer since 2017

MD from The Ohio State University

Dr. Thomas J. Herzog

Gynecologic Oncology Group

Chief Executive Officer since 2023

MD from University of Cincinnati

Iqvia Pty Ltd

Industry Sponsor

Trials

120

Recruited

177,000+

Ari Bousbib

Iqvia Pty Ltd

Chief Executive Officer since 2016

MBA from Columbia University, Master of Science in Mathematics and Mechanical Engineering from Ecole Superieure des Travaux Publics, Paris

Jeffrey Spaeder

Iqvia Pty Ltd

Chief Medical Officer

MD