Arm B: MORAb-202 Dose 2 for Ovarian Neoplasms

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Corewell Health, Grand Rapids, MIOvarian NeoplasmsPaclitaxel - Drug
Eligibility
18+
Female
What conditions do you have?
Select

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.

Eligible Conditions
  • Ovarian Neoplasms

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 11 Secondary · Reporting Duration: Up to 2 years

Up to 2 years
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
Number of participants with AEs leading to discontinuation
Number of participants with AEs of special interest (AESIs)
Number of participants with TRAEs
Number of participants with TRSAEs
Number of participants with adverse events (AEs)
Number of participants with laboratory abnormalities
Number of participants with serious adverse events (SAEs)
Objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per investigator assessment
Progression-free survival (PFS) by RECIST v1.1 per investigator assessment
Therapeutic procedure

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

3 Treatment Groups

Arm B: MORAb-202 Dose 2
1 of 3
Arm A: MORAb-202 Dose 1
1 of 3
Arm C: Investigator's Choice Chemotherapy
1 of 3

Experimental Treatment

150 Total Participants · 3 Treatment Groups

Primary Treatment: Arm B: MORAb-202 Dose 2 · No Placebo Group · Phase 2

Arm B: MORAb-202 Dose 2
Drug
Experimental Group · 1 Intervention: MORAb-202 · Intervention Types: Drug
Arm A: MORAb-202 Dose 1
Drug
Experimental Group · 1 Intervention: MORAb-202 · Intervention Types: Drug
Arm C: Investigator's Choice ChemotherapyExperimental Group · 3 Interventions: Paclitaxel, Pegylated Liposomal Doxorubicin (PLD), Topotecan · Intervention Types: Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
2011
Completed Phase 4
~5660
MORAb-202
2017
Completed Phase 1
~90
Pegylated Liposomal Doxorubicin (PLD)
2016
Completed Phase 2
~90
Topotecan
2017
Completed Phase 3
~1930

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,515 Previous Clinical Trials
3,945,175 Total Patients Enrolled
10 Trials studying Ovarian Neoplasms
2,153 Patients Enrolled for Ovarian Neoplasms

Eligibility Criteria

Age 18+ · Female Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have received 1 to 3 treatments for your condition, and it is recommended that you try a single medication as the next treatment option. You may have had one additional treatment after it was determined that you were resistant to platinum-based treatment.

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.