What side effects are associated with this type of intervention?

Common treatments for ovarian neoplasms, particularly antibody-drug conjugates like Farletuzumab Ecteribulin, often result in side effects such as neutropenia, fatigue, peripheral neuropathy, and gastrointestinal issues including nausea and diarrhea. Chemotherapy agents, frequently used in ovarian cancer treatment, can cause myelosuppression, alopecia, mucositis, and increased risk of infections. These side effects are significant but manageable with proper medical supervision.

What prior FDA approvals exist?

The FDA has approved several treatments for ovarian neoplasms, including targeted therapies and antibody-drug conjugates (ADCs). Notably, Bevacizumab, an anti-VEGF antibody, has been approved in combination with chemotherapy for platinum-resistant ovarian cancer. Additionally, Mirvetuximab soravtansine, an ADC targeting folate receptor alpha, has shown efficacy in clinical trials. Other approved treatments include PARP inhibitors like Olaparib, Niraparib, and Rucaparib for BRCA-mutated ovarian cancer. These therapies, similar to Farletuzumab Ecteribulin, aim to target cancer cells more precisely while minimizing damage to normal cells.

What other types of research exist?

Promising novel alternatives to Farletuzumab Ecteribulin for ovarian neoplasms include Sacituzumab Govitecan, a Trop-2-directed ADC, and Tisotumab Vedotin, which has shown efficacy in recurrent or metastatic cervical cancer and may be applicable to ovarian cancer. Both therapies have demonstrated antitumor activity and acceptable safety profiles in clinical trials.

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Monoclonal Antibodies

MORAb-202 for Resistant Ovarian Cancer

Phase 2

Waitlist Available

Research Sponsored by Bristol-Myers Squibb

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Female participants with histologically-confirmed diagnosis of HGS ovarian, primary peritoneal, or fallopian tube cancer

Participants have received at least 1 but no more than 3 prior lines of systemic therapy and for whom single-agent therapy is appropriate as the next line of therapy

Must not have

Significant third-space fluid retention (eg, ascites or pleural effusion) that requires repeated drainage

Has any prior severe hypersensitivity (≥ Grade 3) to monoclonal antibodies or eribulin or contraindication to the receipt of corticosteroids or any of the excipients

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include allergic reactions to the medications used; symptoms related to infusion such as fever and chills; fatigue; hair loss from Paclitaxel; heart-related side effects from Doxorubicin; bone marrow suppression leading to low blood cell counts; nausea and vomiting.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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I am fully active or restricted in physically strenuous activity but can do light work.

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My cancer did not respond to platinum-based chemotherapy.

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My cancer has grown or spread after my last treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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My ovarian cancer is of a specific type (clear cell, mucinous, endometrioid, sarcomatous, or low grade).

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I have or might have lung inflammation, including from past cancer treatments.

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My ovarian cancer worsened within a month after my first platinum-based treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: MORAb-202Experimental Treatment1 Intervention

Group II: Investigator's Choice ChemotherapyExperimental Treatment3 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Paclitaxel

2011

Completed Phase 4

~5450

Pegylated Liposomal Doxorubicin (PLD)

2016

Completed Phase 2

~90

Topotecan

2017

Completed Phase 3

~2890

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for ovarian neoplasms include chemotherapy, immune checkpoint inhibitors, and antibody-drug conjugates (ADCs) like Farletuzumab Ecteribulin. Chemotherapy works by targeting rapidly dividing cells, which include cancer cells, but can also affect healthy cells, leading to significant side effects. Immune checkpoint inhibitors, such as pembrolizumab, enhance the body's immune response against cancer cells by blocking proteins that inhibit immune activity. ADCs, like Farletuzumab Ecteribulin, combine a monoclonal antibody that specifically targets cancer cells with a cytotoxic drug, allowing for precise delivery of the drug to the cancer cells while sparing healthy tissue. This targeted approach is particularly important for ovarian neoplasms, as it can improve treatment efficacy and reduce side effects, offering a more tailored and potentially more effective treatment option for patients.