Oregovomab + Chemo for Advanced Ovarian Cancer
(FLORA-5 Trial)

Recruiting in Palo Alto (17 mi)

+212 other 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.

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

+15 more

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.

+19 more

Participant Groups

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.

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Cohort 2 - NACT + Interval Surgery ActiveExperimental Treatment3 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 ActiveExperimental Treatment3 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 ControlPlacebo Group3 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 ControlPlacebo Group3 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 United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Paraplatin for: