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Monoclonal Antibodies

MORAb-202 for Resistant Ovarian Cancer

Phase 2
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial will compare a new drug to chemo to treat ovarian, peritoneal, and fallopian tube cancer that has not responded to platinum therapy.

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.Check my eligibility
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.See study design
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
Select...
I am a woman diagnosed with high-grade serous ovarian, peritoneal, or fallopian tube cancer.
Select...
I've had 1-3 treatments for my condition and am now considering a single-agent therapy.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My cancer did not respond to platinum-based chemotherapy.
Select...
My cancer has grown or spread after my last treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per investigator assessment
Therapeutic procedure
Secondary outcome measures
Disease control rate (DCR) by RECIST v1.1 per investigator assessment
Duration of Response (DoR) by RECIST v1.1 per investigator assessment
Number of deaths
+8 more

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
~5380
Pegylated Liposomal Doxorubicin (PLD)
2016
Completed Phase 2
~90
Topotecan
2017
Completed Phase 3
~2400

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.

Find a Location

Who is running the clinical trial?

Eisai Inc.Industry Sponsor
516 Previous Clinical Trials
158,802 Total Patients Enrolled
6 Trials studying Ovarian Neoplasms
424 Patients Enrolled for Ovarian Neoplasms
Bristol-Myers SquibbLead Sponsor
2,652 Previous Clinical Trials
4,130,735 Total Patients Enrolled
10 Trials studying Ovarian Neoplasms
2,186 Patients Enrolled for Ovarian Neoplasms

Media Library

MORAb-202 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05613088 — Phase 2
Ovarian Neoplasms Research Study Groups: Investigator's Choice Chemotherapy, MORAb-202
Ovarian Neoplasms Clinical Trial 2023: MORAb-202 Highlights & Side Effects. Trial Name: NCT05613088 — Phase 2
MORAb-202 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05613088 — Phase 2
~39 spots leftby Jun 2025