MORAb-202 for Resistant Ovarian Cancer

No longer recruiting at 136 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the safety and effectiveness of a new treatment, MORAb-202, compared to standard chemotherapy for women with difficult-to-treat ovarian, primary peritoneal, or fallopian tube cancer. It focuses on those whose cancer no longer responds to common platinum-based therapies. Women with long-standing ovarian cancer that has worsened despite treatment might be suitable candidates. The trial compares the new treatment to standard chemotherapy options to determine which is more effective. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group of participants.

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.

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

In earlier studies, MORAb-202 showed promise in treating ovarian cancer. Research on ovarian cancer unresponsive to platinum-based treatments found that different doses of MORAb-202 were generally well-tolerated. Some patients experienced side effects, but these were manageable. The treatment also showed signs of shrinking tumors, which is encouraging.

Topotecan, a chemotherapy drug, is already approved for treating certain cancers. It can cause side effects like a decrease in blood cells, but these are well-known and monitored during treatment.

Researchers are studying both treatments further to ensure safety and effectiveness. For those considering joining a clinical trial, it's important to know that these treatments have been tested before and are generally considered safe, though monitoring for side effects is part of the process. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about MORAb-202 for resistant ovarian cancer because it offers a novel approach compared to standard chemotherapy treatments like paclitaxel and carboplatin. MORAb-202 is unique because it is an antibody-drug conjugate (ADC), which means it combines an antibody with a cytotoxic drug. This allows it to specifically target cancer cells while sparing healthy ones, potentially reducing side effects. By homing in on cancer cells more precisely, MORAb-202 promises to enhance effectiveness where other treatments might falter, especially in resistant cases.

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

Research has shown that MORAb-202, one of the treatments studied in this trial, may help treat ovarian cancer that doesn't respond to standard platinum-based chemotherapy. Early studies found that MORAb-202 had positive effects on many patients with this type of cancer. In one study, 33.3% of patients experienced significant side effects, but the treatment still showed promise in managing the disease. This suggests that MORAb-202 could be a valuable option for those who haven't benefited from traditional treatments. While more research is needed, these findings offer hope for better outcomes in difficult cases. Participants in this trial may receive MORAb-202 or an investigator's choice of chemotherapy, which includes options like Paclitaxel, Pegylated Liposomal Doxorubicin (PLD), or Topotecan. ^{1 2 3 5 6}

Who Is on the Research Team?

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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]

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]

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO.2022.40.16_suppl.5513

Safety and efficacy of MORAb-202 in patients (pts) with ... Safety and efficacy of MORAb-202 in patients (pts) with platinum-resistant ovarian cancer (PROC): Results from the expansion part of a phase 1 ...

2. asco.org asco.org/abstracts-presentations/ABSTRACT364704

Safety and efficacy of MORAb-202 in patients (pts) with ... Safety and efficacy of MORAb-202 in patients (pts) with platinum-resistant ovarian cancer (PROC): Results from the expansion part of a phase 1 trial. download.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05613088

NCT05613088 | A Study of MORAb-202 Versus ... The purpose of the study is to assess the safety, tolerability, and efficacy of farletuzumab ecteribulin (MORAb-202) and compare it to Investigator's choice ...

4. international-journal-of-gynecological-cancer.com international-journal-of-gynecological-cancer.com/article/S1048-891X(24)12359-6/fulltext

2022-RA-680-ESGO Safety and efficacy of MORAb-202 in ... Results. Twenty-four patients were treated in Cohort 1; 21 patients were treated in Cohort 2. Grade ≥3 TEAEs occurred in 33.3% of patients ...

5. eisai.com eisai.com/news/2022/news202245.html

EISAI PRESENTS NEW FINDINGS FOR ANTIBODY DRUG ... Eisai announced today new investigational data from the platinum-resistant ovarian cancer (PROC) cohort expansion of a Phase 1 study (Study 101)

6. sciencedirect.com sciencedirect.com/science/article/pii/S1048891X24123596

2022-RA-680-ESGO Safety and efficacy of MORAb-202 in ... ... MORAb-202 0.9 mg/kg and 1.2 mg/kg Q3W were chosen for the expansion part of this study in patients with platinum-resistant ovarian cancer (PROC).