Oregovomab + Chemo for Advanced Ovarian Cancer

(FLORA-5 Trial)

Recruiting at 212 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

615 Participants Needed

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.

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.

What data supports the effectiveness of the drug combination Oregovomab, Carboplatin, and Paclitaxel for advanced ovarian cancer?

Research shows that combining Paclitaxel and Carboplatin is a common and effective treatment for advanced ovarian cancer, and adding Oregovomab, which helps the immune system recognize cancer cells, may enhance this effect. Studies suggest that this combination can improve immune responses and potentially increase progression-free survival. ^{1 2 3 4 5}

Is the combination of Oregovomab, Carboplatin, and Paclitaxel safe for treating advanced ovarian cancer?

The combination of Carboplatin and Paclitaxel, which are part of the treatment, has been shown to be generally safe in humans, with common side effects including low white blood cell counts (neutropenia), nerve damage (peripheral neuropathy), and allergic reactions. These side effects are manageable, and the treatment is often given in an outpatient setting. ^{1 6 7 8 9}

What makes the drug combination of Oregovomab, Carboplatin, and Paclitaxel unique for advanced ovarian cancer?

This drug combination is unique because it includes Oregovomab, an antibody that targets a specific protein on cancer cells, alongside the standard chemotherapy drugs Carboplatin and Paclitaxel. This approach aims to enhance the immune system's ability to fight cancer, potentially offering a novel mechanism compared to traditional chemotherapy alone. ^{1 2 4 10 11}

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.

Timeline

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

Treatment Details

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.

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 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

Findings from Research

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]

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]

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Treatment of ovarian cancer: current status. [2015]

2. England 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. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

The Immune adjuvant properties of front-line carboplatin-paclitaxel: a randomized phase 2 study of alternative schedules of intravenous oregovomab chemoimmunotherapy in advanced ovarian cancer. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Taxane/platinum/anthracycline combination therapy in advanced epithelial ovarian cancer. [2015]

5. England 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. [2022]

6. Japan pubmed.ncbi.nlm.nih.gov

[Docetaxel and carboplatin for epithelial ovarian cancer]. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Taxol in epithelial ovarian cancer. [2015]

8. Germany 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. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Carboplatin plus paclitaxel in the treatment of gynecologic malignancies: the Cleveland Clinic experience. [2015]

10. United States pubmed.ncbi.nlm.nih.gov

Paclitaxel (Taxol)/carboplatin combination chemotherapy in the treatment of advanced ovarian cancer. [2015]

11. England pubmed.ncbi.nlm.nih.gov

The integration of anthracyclines in the treatment of advanced ovarian cancer. [2018]