Oregovomab + Chemo for Advanced Ovarian Cancer

(FLORA-5 Trial)

Not currently recruiting at 238 trial locations

Overseen By Clinical Operations

Age: 18+

Sex: Female

Trial Phase: Phase 3

Sponsor: OncoQuest Pharmaceuticals Inc.

Must be taking: Paclitaxel, Carboplatin

Must not be taking: PARP inhibitors, Immunosuppressants

Disqualifiers: BRCA mutations, Autoimmune diseases, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: 18 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment approach for advanced ovarian cancer. Researchers aim to determine if adding oregovomab (an experimental treatment) to standard chemotherapy (paclitaxel and carboplatin) is safe and effective compared to chemotherapy alone. The trial includes two groups: one receiving oregovomab with chemotherapy, and the other receiving a placebo with chemotherapy. This trial suits individuals recently diagnosed with advanced ovarian cancer who have already undergone successful surgery to remove as much of the cancer as possible. As a Phase 3 trial, this study represents the final step before potential FDA approval, offering participants a chance to contribute to a treatment that could soon become widely available.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on immunosuppressive drugs or chronic corticosteroids, you may need to stop them, as these are listed in the exclusion criteria.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that oregovomab, when combined with other treatments like niraparib, is well tolerated by patients with ovarian cancer. These studies have identified no new safety issues, suggesting that oregovomab is generally safe for treating ovarian cancer.

Paclitaxel and carboplatin, the chemotherapy drugs used with oregovomab in this trial, are standard treatments for ovarian cancer. Their side effects are well-known, and doctors manage them carefully. This trial is in a later phase, indicating existing evidence supports the safety of these treatments when used together. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for ovarian cancer?

Most treatments for advanced ovarian cancer involve chemotherapy drugs like carboplatin and paclitaxel, which target rapidly dividing cancer cells. But oregovomab works differently, aiming to enhance the body's immune response to fight the cancer. Unlike standard chemotherapy, which directly attacks cancer cells, oregovomab is designed to work alongside these drugs, potentially boosting their effectiveness and helping the immune system recognize and destroy cancer cells more effectively. Researchers are excited about oregovomab because it could offer a new way to improve outcomes for patients by combining the strengths of traditional chemotherapy with innovative immunotherapy.

What evidence suggests that this trial's treatments could be effective for advanced ovarian cancer?

Research has shown that oregovomab, when combined with chemotherapy, might help treat advanced ovarian cancer. In this trial, some participants will receive chemotherapy with oregovomab, while others will receive chemotherapy with a placebo comparator. Some studies have found that this combination could extend the time patients live without the disease worsening. However, results have been mixed, and not all studies showed significant improvement in overall outcomes. On average, patients experienced a small increase in the time their cancer did not progress and in their overall survival. These findings suggest a potential benefit, but results vary, so further research is needed to confirm its effectiveness. ^{2 6 7 8 9}

Who Is on the Research Team?

Sunil Gupta, MD, FRCPC

Principal Investigator

CanariaBio Inc.

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive six 21-day cycles of chemotherapy with either oregovomab or placebo

18 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 6 years

Long-term Follow-up

Participants are monitored for overall survival and progression-free survival

Up to 11 years

What Are the Treatments Tested in This Trial?

Interventions

• Carboplatin
• Oregovomab
• Paclitaxel

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.

How Is the Trial Designed?

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 United States, European Union, Canada for the following indications:

Approved in United States as Paraplatin for:

• Ovarian cancer
• Testicular cancer
• Lung cancer
• Head and neck cancer
• Brain cancer

Approved in European Union as Carboplatin for:

• Ovarian cancer
• Small cell lung cancer

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+

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

Published Research Related to This Trial

A multi-method approach was used to develop a Patient-Reported Outcomes tool tailored for women with endometrial or ovarian cancer undergoing chemotherapy, identifying 21 relevant symptoms from the PRO-CTCAE library.

The final tool includes 44 items that assess the frequency, severity, and impact of these symptoms on daily activities, which can help in monitoring and managing adverse events during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multi-method approach to selecting PRO-CTCAE symptoms for patient-reported outcome in women with endometrial or ovarian cancer undergoing chemotherapy. Christiansen, MG., Pappot, H., Jensen, PT., et al.[2023]

The combination of platinum and paclitaxel has been established as the standard treatment for advanced ovarian cancer since the late 1990s, with further studies suggesting that adding noncross-resistant drugs like epirubicin may enhance treatment efficacy.

In a phase III trial involving 1281 patients, 87% completed six cycles of treatment, providing valuable data on treatment response and toxicity, which will help assess the effectiveness of the new combination therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The integration of anthracyclines in the treatment of advanced ovarian cancer. Lück, HJ., Du Bois, A., Weber, B., et al.[2018]

The combination of carboplatin and 3-hour infusional paclitaxel was well-tolerated in a study of 92 women with advanced gynecologic cancers, showing a manageable toxicity profile with neutropenia being the most significant side effect.

In patients with ovarian cancer or primary peritoneal carcinoma, 74% experienced a significant decline in tumor marker levels after treatment, indicating strong antineoplastic activity of this chemotherapy regimen.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Carboplatin plus paclitaxel in the treatment of gynecologic malignancies: the Cleveland Clinic experience. Markman, M., Kennedy, A., Webster, K., et al.[2015]

In a study involving 637 patients with advanced ovarian cancer, the dose-dense regimen of paclitaxel and carboplatin significantly improved median progression-free survival to 28.2 months compared to 17.5 months with the conventional regimen.

The dose-dense treatment also resulted in a longer median overall survival of 100.5 months versus 62.2 months for the conventional treatment, suggesting it could become a new standard of care for first-line chemotherapy in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term results of dose-dense paclitaxel and carboplatin versus conventional paclitaxel and carboplatin for treatment of advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer (JGOG 3016): a randomised, controlled, open-label trial. Katsumata, N., Yasuda, M., Isonishi, S., et al.[2022]

Cytoreductive surgery followed by platinum-based chemotherapy, particularly with carboplatin, remains the standard treatment for advanced epithelial ovarian cancer, but most patients are not cured, highlighting the need for improved therapies.

Paclitaxel, a novel agent effective in platinum-resistant ovarian cancer, is being tested in combination with platinum compounds in clinical trials for previously untreated patients, aiming to enhance treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of ovarian cancer: current status. Ozols, RF.[2015]

In a study involving 247 patients with advanced ovarian cancer, both treatment regimens (standard carboplatin plus paclitaxel and alternating carboplatin/cisplatin plus paclitaxel) showed similar efficacy, with no significant differences in progression-free survival (PFS) or overall survival.

Both regimens were well tolerated, indicating that while the alternating regimen does not provide additional benefits, it is a safe option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Paclitaxel plus carboplatin versus paclitaxel plus alternating carboplatin and cisplatin for initial treatment of advanced ovarian cancer: long-term efficacy results: a Hellenic Cooperative Oncology Group (HeCOG) study. Aravantinos, G., Fountzilas, G., Kosmidis, P., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT01616303

NCT01616303 | A Controlled Study of the Effectiveness of ... This is a Phase 2 randomized study with two treatment arms to compare the effectiveness of oregovomab (a murine monoclonal antibody directed against cancer ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT01616303

A Controlled Study of the Effectiveness of Oregovomab ... This is a Phase 2 randomized study with two treatment arms to compare the effectiveness of oregovomab (a murine monoclonal antibody directed against cancer ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11497973/

OPERA: a phase II trial of oregovomab plus non-platinum ... The efficacy rate in most patients is approximately 10–20%, with a median PFS of 3–4 months and a median overall survival (OS) of 9–12 months [24,25].

4. ascopubs.org ascopubs.org/doi/abs/10.1200/JCO.2025.43.16_suppl.e17592

Long-term survival analysis of a randomized phase II study ... This randomized Phase II study tested the hypothesis that schedule dependent chemotherapy with oregovomab may improve progression free survival (PFS)

5. sciencedirect.com sciencedirect.com/science/article/pii/S1028455923002978

Part II promising results of phase 2 study of paclitaxel- ... Oregovomab maintenance monoimmunotherapy does not improve outcomes in advanced ovarian cancer. J Clin Oncol, 27 (2009), pp. 418-425. View in Scopus Google ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/15337799/

Randomized, placebo-controlled study of oregovomab for ... Abstract. Purpose: To assess oregovomab as consolidation treatment of advanced ovarian cancer and refine the immunotherapeutic strategy for subsequent study.

7. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.5586

Phase 2, single arm clinical trial to evaluate the safety and ... Combination oregovomab and niraparib in patients with platinum sensitive EOC was well tolerated with no new safety signals.

8. sciencedirect.com sciencedirect.com/topics/medicine-and-dentistry/oregovomab

Oregovomab - an overview | ScienceDirect Topics Oregovomab is a murine monoclonal antibody to CA125 that has been studied as a complementary treatment for ovarian cancer. In studies published in 2008–2009, ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT04498117

Study Details | NCT04498117 | Oregovomab Plus Chemo ... Study to compare the safety and efficacy of oregovomab versus placebo, administered in combination with specific cycles of a standard six-cycle chemotherapy ...