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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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
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 moreTrial 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
Find a Location
Who is running the clinical trial?
Eisai Inc.Industry Sponsor
515 Previous Clinical Trials
153,892 Total Patients Enrolled
6 Trials studying Ovarian Neoplasms
424 Patients Enrolled for Ovarian Neoplasms
Bristol-Myers SquibbLead Sponsor
2,639 Previous Clinical Trials
4,128,910 Total Patients Enrolled
10 Trials studying Ovarian Neoplasms
2,186 Patients Enrolled for Ovarian Neoplasms
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.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.My ovarian cancer is of a specific type (clear cell, mucinous, endometrioid, sarcomatous, or low grade).I am fully active or restricted in physically strenuous activity but can do light work.My cancer did not respond to platinum-based chemotherapy.I have or might have lung inflammation, including from past cancer treatments.I am allergic or cannot take certain chemotherapy drugs if placed in treatment group C.My health tests show no major issues unrelated to my cancer.My cancer has grown or spread after my last treatment.My ovarian cancer worsened within a month after my first platinum-based treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Investigator's Choice Chemotherapy
- Group 2: MORAb-202
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many locales are managing this trial?
"This trial is enrolling participants from Spectrum Health Hospitals in Grand Rapids, Michigan, UF Health Endoscopy Center in Gainesville, Florida, and Providence Sacred Heart Medical Centre and Children's Hospital in Spokane Washington; additionally there are 12 other medical centres taking part."
Answered by AI
Is the research team actively searching for participants to join this endeavor?
"As reported on clinicaltrials.gov, this research project is not presently accepting new participants; it was originally posted in November 11th 2022 and last revised four days later. Despite this study's current lack of recruitment proceedings, 545 other medical studies are actively enrolling patients at present."
Answered by AI
Has the United States Food and Drug Administration (FDA) approved MORAb-202 Dose 1 in Arm A?
"As this trial is in Phase 2, there are some safety-related data available but no evidence to support efficacy. Thus our team at Power assigned a score of two on the scale from one to three for MORAb-202 Dose 1's safety rating."
Answered by AI
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