MORAb-202 for Resistant Ovarian Cancer

Recruiting at 129 trial locations

Overseen By First line of the email MUST contain the NCT# and Site #.

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Bristol-Myers Squibb

Must not be taking: Monoclonal antibodies

Disqualifiers: Clear cell, ILD/pneumonitis, organ dysfunction, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

90 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug that targets and kills cancer cells in women whose ovarian, peritoneal, or fallopian tube cancers do not respond to standard treatments. The drug combines an antibody with chemotherapy to deliver treatment directly to the cancer cells.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug MORAb-202 for resistant ovarian cancer?

Research shows that topotecan, a component of the treatment, has been effective in treating recurrent or persistent ovarian cancer, suggesting potential benefits for MORAb-202 in similar conditions. ^{1 2 3 4 5}

Is MORAb-202 safe for use in humans?

The safety of topotecan (Hycamtin), a drug evaluated for ovarian cancer, shows that it is generally well tolerated with predictable and manageable side effects, primarily affecting blood cell counts (myelosuppression). This suggests that similar treatments like MORAb-202 may also have an acceptable safety profile, but specific data for MORAb-202 would be needed for confirmation. ^{2 3 5 6 7}

How is the drug MORAb-202 different from other treatments for resistant ovarian cancer?

MORAb-202 is unique because it combines an antibody with a chemotherapy drug, which may help target cancer cells more precisely, potentially reducing side effects compared to traditional chemotherapy alone. This approach is different from standard treatments like topotecan, which is a standalone chemotherapy drug used for recurrent ovarian cancer. ^{2 3 5 8 9}

Research Team

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

This trial is for women with high-grade serous ovarian, primary peritoneal, or fallopian tube cancer that's resistant to platinum-based treatments. They should have had 1-3 prior therapies and be in good physical condition (ECOG PS of 0 or 1). Women with certain other cancer types, severe allergies to the study drugs, significant fluid retention issues, poor lung function tests, or organ dysfunction are not eligible.

Inclusion Criteria

I can provide a tissue sample from the last 5 years or a new biopsy for testing.

I am a woman diagnosed with high-grade serous ovarian, peritoneal, or fallopian tube cancer.

I've had 1-3 treatments for my condition and am now considering a single-agent therapy.

Exclusion Criteria

Your lung function test shows that you have trouble breathing out, breathing in, or transferring oxygen.

I need frequent drainage for fluid build-up in my body.

I have had a severe allergic reaction to certain cancer drugs or ingredients.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either farletuzumab ecteribulin (MORAb-202) or Investigator's choice chemotherapy

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• MORAb-202
• Paclitaxel
• Pegylated Liposomal Doxorubicin (PLD)
• Topotecan

Trial Overview The trial is testing MORAb-202 against standard chemotherapy options like Paclitaxel, Pegylated Liposomal Doxorubicin (PLD), or Topotecan. It aims to see which treatment is safer and more effective for patients who haven't responded well to platinum-based chemotherapy.

Participant Groups

Group I: MORAb-202 Experimental Treatment 1 Intervention

Group II: Investigator's Choice Chemotherapy Experimental Treatment 3 Interventions

Who Is Running the Clinical Trial?

Bristol-Myers Squibb

Lead Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania

Eisai Inc.

Industry Sponsor

Trials

524

Recruited

161,000+

Founded

Eisai Inc. was established in 1995 as the U.S. subsidiary of Eisai Co., Ltd.

Headquarters

Woodcliff Lake, NJ, USA

Known For

Neurology and Oncology

Top Products

Aricept (donepezil), Lenvima (lenvatinib), Leqembi (lecanemab), Halaven (eribulin)

Lynn Kramer

Eisai Inc.

Chief Medical Officer since 2019

MD

Tatsuyuki Yasuno

Eisai Inc.

Chief Executive Officer since 2023

MBA from Kellogg School of Management, Northwestern University; Bachelor of Political Science from Waseda University

Findings from Research

In a study of 23 patients with relapsed ovarian and primary peritoneal cancer, weekly administration of topotecan showed a promising overall response rate of 47.8%, with complete responses in 17.4% of patients, indicating its effectiveness even in those with platinum-resistant disease.

The treatment was generally well-tolerated, with manageable side effects such as grade II and III thrombocytopenia in a small number of patients and fatigue in 39.1%, suggesting that topotecan could be a viable option for patients who have already undergone platinum-based chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase II study of weekly topotecan in patients with recurrent or persistent epithelial ovarian cancer. Levy, T., Inbar, M., Menczer, J., et al.[2013]

A retrospective study of 30 patients with recurrent ovarian cancer showed that long-term treatment with topotecan is feasible, with patients receiving an average of 14.4 cycles and a median time to treatment progression of 28 months.

Topotecan demonstrated a response rate of 53%, with manageable non-hematologic toxicity, suggesting it may provide a survival benefit for patients who continue treatment beyond six cycles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term topotecan therapy in recurrent or persistent ovarian cancer. Cormio, G., Loizzi, V., Gissi, F., et al.[2020]

In a study of 63 patients with relapsed or persistent epithelial ovarian cancer and primary peritoneal carcinoma, weekly topotecan treatment resulted in an overall response rate of 23.8%, with a median survival of 22.3 months, indicating its efficacy as a treatment option.

Topotecan was generally well tolerated, with manageable hematologic toxicities such as grade 3 anemia and thrombocytopenia occurring in 4.8% of patients, and the most common nonhematologic side effects being fatigue and nausea.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and toxicity of weekly topotecan in recurrent epithelial ovarian and primary peritoneal cancer. Safra, T., Menczer, J., Bernstein, R., et al.[2013]

Topotecan, a drug that targets topoisomerase I, has shown significant antitumor activity when combined with various chemotherapy agents like cisplatin and doxorubicin in both adult and pediatric patients with solid tumors.

The main side effect of these combination therapies is myelosuppression, particularly neutropenia, which limits the dosage; however, many early studies have reported major responses, indicating the potential effectiveness of these regimens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topotecan in combination chemotherapy. Rowinsky, EK., Kaufmann, SH.[2017]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Salvage therapy with topotecan in heavily pretreated ovarian cancer patients. [2021]

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

Phase II study of weekly topotecan in patients with recurrent or persistent epithelial ovarian cancer. [2013]

3. Singapore pubmed.ncbi.nlm.nih.gov

Long-term topotecan therapy in recurrent or persistent ovarian cancer. [2020]

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

Oral topotecan as single-agent second-line chemotherapy in patients with advanced ovarian cancer. [2017]

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

Efficacy and toxicity of weekly topotecan in recurrent epithelial ovarian and primary peritoneal cancer. [2013]

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

Topotecan in combination chemotherapy. [2017]

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

Efficacy and safety of topotecan in the treatment of advanced ovarian carcinoma. [2015]

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

A phase 1b study of trebananib in combination with pegylated liposomal doxorubicin or topotecan in women with recurrent platinum-resistant or partially platinum-sensitive ovarian cancer. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Topotecan: An Oncologist's View. [2019]