Neoplasms, OvarianPhase 2NCT05613088
A Study of MORAb-202 Versus Investigator's Choice Chemotherapy in Female Participants With Platinum-resistant High-grade Serous (HGS) Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
A Phase 2 study testing MORAb-202, Paclitaxel and Pegylated Liposomal Doxorubicin (PLD) in people with Neoplasms, Ovarian, run by Bristol-Myers Squibb at 50 sites in 9 countries.
Trial summary
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 (IC) chemotherapy in female participants with platinum-resistant HGS ovarian, primary peritoneal, or fallopian tube cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Neoplasms, Ovarian
- What is being tested?
- MORAb-202, Paclitaxel and Pegylated Liposomal Doxorubicin (PLD)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 50 sitesin 9 countries
- Study dates
- 1 Feb 2023to 10 Sep 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female participants with histologically-confirmed diagnosis of HGS ovarian, primary peritoneal, or fallopian tube cancer.
- Platinum-resistant disease, defined as:
- For participants who had only 1 line of platinum-based therapy: progression between > 1 month and ≤ 6 months after the last dose of platinum-based therapy of at least 4 cycles.
- For participants who had 2 or 3 lines of platinum-based therapy: progression ≤ 6 months after the last dose of platinum-based therapy.
- 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. Participants may have been treated with up to 1 line of therapy subsequent to determination of platinum-resistance.
- Disease progression per RECIST v1.1 (by investigator assessment) of at least 1 measurable lesion on or after the most recent therapy.
- Either formalin-fixed, paraffin-embedded (FFPE) tissue (up to 5 years old) or newly-obtained biopsies must be available for FRα assessment prior to randomization.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
Who cannot join
- Medical Conditions
- Clear cell, mucinous, endometrioid or sarcomatous histology, or mixed tumors containing components of any of these histologies, or low grade or borderline ovarian cancer.
- Primary platinum-refractory ovarian cancer defined as disease progression within 1 month of the last dose of the first line platinum-containing regimen.
- Pulmonary function test (PFT) abnormalities: FEV1 < 70% or FVC < 60%, and DLCO < 80%.
- Investigator-assessed current ILD/pneumonitis, or ILD/pneumonitis suspected at screening or history of ILD/pneumonitis of any severity including ILD/pneumonitis from prior anti-cancer therapy.
- Significant third-space fluid retention (eg, ascites or pleural effusion) that requires repeated drainage.
Show all 12Show fewer
- Physical and Laboratory Test Findings
- Evidence of organ dysfunction or any clinically-significant deviation from normal in physical examination, vital signs, ECG, or clinical laboratory determinations beyond what is consistent with the target population.
- Allergies and Adverse Drug Reactions
- Has any prior severe hypersensitivity (≥ Grade 3) to monoclonal antibodies or eribulin or contraindication to the receipt of corticosteroids or any of the excipients (investigators should refer to the prescribing information for the selected corticosteroid).
- History of allergy or contraindication to IC chemotherapy agent selected if randomized to Arm C.
- Other protocol-defined inclusion/exclusion criteria apply.
Trial locations and contacts
50 sites in 9 countries.
50 sites in 9 countries
United States10 sites
Local Institution - 0023
Canton, Ohio, 44710-1702
Local Institution - 0061
Columbus, Ohio, 43219
Local Institution - 0043
Kansas City, Kansas, 66160
Local Institution - 0044
Nashville, Tennessee, 37203-1625
Local Institution - 0065
Sacramento, California, 95817
Local Institution - 0082
Salt Lake City, Utah, 84124
Local Institution - 0025
San Francisco, California, 94109
Local Institution - 0081
South Bend, Indiana, 46601-1033
Local Institution - 0042
Spokane, Washington, 99204
Local Institution - 0078
Whittier, California, 90602-3171
Spain9 sites
Local Institution - 0039
Barcelona, B, 08035
Local Institution - 0021
Barcelona, 08036
Local Institution - 0020
Girona, 17007
Local Institution - 0005
Madrid, M, 28007
Local Institution - 0001
Madrid, M, 28041
Local Institution - 0038
Madrid, 28033
Local Institution - 0022
Madrid, 28046
Local Institution - 0007
Valencia, V, 46009
Local Institution - 0006
Valencia, V, 46010
Australia6 sites
Local Institution - 0031
Chermside, Queensland, 4032
Local Institution - 0015
Clayton, Victoria, 3168
Local Institution - 0027
Malvern, Victoria, 3144
Local Institution - 0058
Nedlands, Western Australia, 6009
Local Institution - 0016
Sydney, New South Wales, 2065
Local Institution - 0017
Waratah, New South Wales, 2298
Israel5 sites
Local Institution - 0054
Haifa, 31999
Local Institution - 0046
Jerusaelm, JM, 9112001
Local Institution - 0080
Jerusalem, 91031
Local Institution - 0055
Ramat Gan, 5265601
Local Institution - 0048
Tel Aviv, 64239
Italy5 sites
Local Institution - 0003
Bologna, BO, 40138
Local Institution - 0002
Brescia, 25123
Local Institution - 0011
Milan, MI, 20132
Local Institution - 0009
Milan, MI, 20141
Local Institution - 0010
Roma, RM, 00168
Japan5 sites
Local Institution - 0018
Akashi, Hyogo, 673-8558
Local Institution - 0019
Chūōku, 104-0045
Local Institution - 0014
Hidaka-shi, 350-1298
Local Institution - 0004
Kurume-Shi, 830-0011
Local Institution - 0037
Tokyo, 135-8550
Belgium4 sites
Local Institution - 0012
Brussels, 1200
Local Institution - 0032
Leuven, VBR, 3000
Local Institution - 0045
Liège, 4000
Local Institution - 0013
Namur, WNA, 5000
Chile3 sites
Local Institution - 0030
Santiago, RM, 8420323
Local Institution - 0036
Santiago, 7510032
Local Institution - 0029
Temuco, 4800827
South Korea3 sites
Local Institution - 0056
Seoul, 03080
Local Institution - 0049
Seoul, 03722
Local Institution - 0053
Seoul, 5505
About this study
Official title: A Phase 2 Open-label Randomized Study of Farletuzumab Ecteribulin (MORAb-202), a Folate Receptor Alpha-targeting Antibody-drug Conjugate, Versus Investigator's Choice Chemotherapy in Women With Platinum-resistant High-grade Serous (HGS) Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
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 (IC) chemotherapy in female participants with platinum-resistant HGS ovarian, primary peritoneal, or fallopian tube cancer.
- Conditions
- Neoplasms, Ovarian
- Being tested
- MORAb-202, Paclitaxel, Pegylated Liposomal Doxorubicin (PLD), Topotecan
- Keywords
- Platinum-resistant ovarian cancer (PROC), Primary peritoneal cancer, Fallopian tube cancer, MORAb-202, Folate-receptor alpha, ADC, Antibody-drug conjugate, Epithelial ovarian cancer, High grade serous, Farletuzumab ecteribulin
- Medical subject headings
- Ovarian Neoplasms, Fallopian Tube Neoplasms, Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MORAb-202Drug
Also called BMS-986445, Farletuzumab Ecteribulin
Specified dose on specified days
PaclitaxelDrug
Also called Bendalis
Specified dose on specified days
Pegylated Liposomal Doxorubicin (PLD)Drug
Also called Caelyx
Specified dose on specified days
TopotecanDrug
Also called Hycamtin
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| MORAb-202 | Experimental | Not described Receives: Drug: MORAb-202 |
| Investigator's Choice Chemotherapy | Experimental | Not described Receives: Drug: Paclitaxel; Drug: Pegylated Liposomal Doxorubicin (PLD); Drug: Topotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Per Investigator Assessment
Objective Response Rate (ORR) is defined as the number of randomized participants who achieve a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), based on investigator assessments [using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1], divided by the number of all randomized participants.
Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.
Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Measured: From the date of randomization to the date of first objectively-documented progression or the date of subsequent therapy (Up to approximately 70 weeks)
Number of Participants With Treatment-Related Adverse Event (TRAEs) Leading to Discontinuation Within 6 Months From First Dose
An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after starting study treatment, whether or not considered related to the study intervention.
Measured: From first dose of study medication up to 6 months
Secondary outcomes (11)
Number of Participants With Adverse Events (AEs)
An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after starting study treatment, whether or not considered related to the study intervention.
Measured: From first dose of study treatment through 30 days after the last dose of study treatment (up to approximately 25 months)
Number of Participants With Serious Adverse Events (SAEs)
Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, and requires inpatient hospitalization or causes prolongation of existing hospitalization.
Measured: From first dose of study treatment through 30 days after the last dose of study treatment (up to approximately 25 months)
Number of Participants With AEs Leading to Discontinuation
An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after starting study treatment, whether or not considered related to the study intervention.
Measured: From first dose of study treatment through 30 days after the last dose of study treatment (up to approximately 25 months)
Number of Participants With Treatment-Related AEs
An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after starting study treatment, whether or not considered related to the study intervention.
Measured: From first dose of study treatment through 30 days after the last dose of study treatment (up to approximately 25 months)
Number of Participants With Treatment-Related SAEs
Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, and requires inpatient hospitalization or causes prolongation of existing hospitalization.
Measured: From first dose of study treatment through 30 days after the last dose of study treatment (up to approximately 25 months)
Number of Participants With AEs of Special Interest (AESIs)
An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after starting study treatment, whether or not considered related to the study intervention.
An adverse event of special interest (AESI) is an AE (serious or nonserious) of scientific and medical concern specific to the sponsor's product/program that may require further investigation. AESIs for MORAb-202 include infusion-related reactions and interstitial lung disease (ILD)/pneumonitis. The number of participants experiencing at least one AESI was assessed during the study.
Measured: From first dose of study treatment through 30 days after the last dose of study treatment (up to approximately 25 months)
Number of Participants Who Died
Number of participants who died during the study.
Measured: From first dose of study medication until death due to any cause (up to 136 weeks)
Number of Participants With Grade 3-4 Laboratory Abnormalities
Number of participants experiencing most frequently reported clinical abnormalities in laboratory testing including hematology, chemistry, liver function, and renal function.
Laboratory findings are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal.
Measured: From first dose of study treatment through 30 days after the last dose of study treatment (up to approximately 25 months)
Disease Control Rate (DCR) by RECIST v1.1 Per Investigator Assessment
Disease Control Rate (DCR) is defined as the number of randomized participants who achieve a BOR of confirmed CR, confirmed PR, or stable disease (SD), based on investigator assessments (using RECIST v1.1) divided by the number of all randomized participants.
Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.
Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition, the sum must also demonstrate an absolute increase of at least 5mm (Note: The appearance of 1or more new lesions is also considered progression).
Based on Clopper and Pearson estimates of duration of response
Measured: From randomization until disease progression, withdrawal from study treatment, initiation of new therapy, or study completion, whichever occurred first (up to approximately 136 weeks)
Duration of Response (DoR) by RECIST v1.1 Per Investigator Assessment
Duration of Response (DoR) is defined as the time between the date of first documented response (CR or PR) confirmed, to the date of the first objectively documented tumor progression by investigator (per RECIST v1.1) or death, whichever occurs first.
Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.
Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition, the sum must also demonstrate an absolute increase of at least 5mm (Note: The appearance of 1or more new lesions is also considered progression).
Based on Kaplan-Meier estimates of duration of response
Measured: From first documented response (complete response or partial response) until first documented disease progression or death, whichever occurred first (up to approximately 136 weeks)
Progression-free Survival (PFS) by RECIST v1.1 Per Investigator Assessment
Progression-free Survival (PFS) is defined as the time between the date of randomization and the first date of documented progression, per investigator assessments (using RECIST v1.1), or death due to any cause, whichever occurs first.
Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition, the sum must also demonstrate an absolute increase of at least 5mm (Note: The appearance of 1or more new lesions is also considered progression).
Based on Kaplan-Meier estimates of progression-free survival
Measured: From the date of randomization to the first date of documented progression, or death whichever occurs first (Up to approximately 136 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start1 Feb 2023
- Primary completion17 Jun 2024
- Study completion10 Sep 2025
Why it stopped: Business objectives have changed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Neoplasms, OvarianStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eisai Inc.
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05613088
- Sponsor's protocol ID
- CA116-001
- Other IDs
- 2021-004807-42
- Status last verified
- Oct 2026
- First submitted
- 4 Nov 2022
- Last updated
- 28 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Open-label Randomized Study of Farletuzumab Ecteribulin (MORAb-202), a Folate Receptor Alpha-targeting Antibody-drug Conjugate, Versus Investigator's Choice Chemotherapy in Women With Platinum-resistant High-grade Serous (HGS) Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
- ClinicalTrials.gov ID
- NCT05613088
- Acronym / sponsor ID
- CA116-001
- Conditions
- Neoplasms, Ovarian
- Keywords
- Platinum-resistant ovarian cancer (PROC), Primary peritoneal cancer, Fallopian tube cancer, MORAb-202, Folate-receptor alpha, ADC, Antibody-drug conjugate, Epithelial ovarian cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business objectives have changed.
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Collaborators
- Eisai Inc.
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 17 Jun 2024 (actual)
- Study completion
- 10 Sep 2025 (actual)
- First posted
- 14 Nov 2022 (actual)
- Results
- Posted 3 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 (IC) chemotherapy in female participants with platinum-resistant HGS ovarian, primary peritoneal, or fallopian tube cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MORAb-202 | Experimental | Drug: MORAb-202 |
| Investigator's Choice Chemotherapy | Experimental | Drug: Paclitaxel, Drug: Pegylated Liposomal Doxorubicin (PLD), Drug: Topotecan |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Female participants with histologically-confirmed diagnosis of HGS ovarian, primary peritoneal, or fallopian tube cancer.
- Platinum-resistant disease, defined as:
- For participants who had only 1 line of platinum-based therapy: progression between > 1 month and ≤ 6 months after the last dose of platinum-based therapy of at least 4 cycles.
- For participants who had 2 or 3 lines of platinum-based therapy: progression ≤ 6 months after the last dose of platinum-based therapy.
- 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. Participants may have been treated with up to 1 line of therapy subsequent to determination of platinum-resistance.
Key exclusion criteria (12 listed)
- Medical Conditions
- Clear cell, mucinous, endometrioid or sarcomatous histology, or mixed tumors containing components of any of these histologies, or low grade or borderline ovarian cancer.
- Primary platinum-refractory ovarian cancer defined as disease progression within 1 month of the last dose of the first line platinum-containing regimen.
- Pulmonary function test (PFT) abnormalities: FEV1 < 70% or FVC < 60%, and DLCO < 80%.
- Investigator-assessed current ILD/pneumonitis, or ILD/pneumonitis suspected at screening or history of ILD/pneumonitis of any severity including ILD/pneumonitis from prior anti-cancer therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MORAb-202Also: BMS-986445, Farletuzumab EcteribulinSpecified dose on specified days | Drug | MORAb-202 |
| PaclitaxelAlso: BendalisSpecified dose on specified days | Drug | Investigator's Choice Chemotherapy |
| Pegylated Liposomal Doxorubicin (PLD)Also: CaelyxSpecified dose on specified days | Drug | Investigator's Choice Chemotherapy |
| TopotecanAlso: HycamtinSpecified dose on specified days | Drug | Investigator's Choice Chemotherapy |
Primary outcome
Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Per Investigator Assessment
Time frame: From the date of randomization to the date of first objectively-documented progression or the date of subsequent therapy (Up to approximately 70 weeks)
Objective Response Rate (ORR) is defined as the number of randomized participants who achieve a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), based on investigator assessments [using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1], divided by the number of all randomized participants. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Number of Participants With Treatment-Related Adverse Event (TRAEs) Leading to Discontinuation Within 6 Months From First Dose
Time frame: From first dose of study medication up to 6 months
An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after starting study treatment, whether or not considered related to the study intervention.
11 secondary outcomes
Number of Participants With Adverse Events (AEs)
Time frame: From first dose of study treatment through 30 days after the last dose of study treatment (up to approximately 25 months)
Number of Participants With Serious Adverse Events (SAEs)
Time frame: From first dose of study treatment through 30 days after the last dose of study treatment (up to approximately 25 months)
Number of Participants With AEs Leading to Discontinuation
Time frame: From first dose of study treatment through 30 days after the last dose of study treatment (up to approximately 25 months)
Number of Participants With Treatment-Related AEs
Time frame: From first dose of study treatment through 30 days after the last dose of study treatment (up to approximately 25 months)
Number of Participants With Treatment-Related SAEs
Time frame: From first dose of study treatment through 30 days after the last dose of study treatment (up to approximately 25 months)
Number of Participants With AEs of Special Interest (AESIs)
Time frame: From first dose of study treatment through 30 days after the last dose of study treatment (up to approximately 25 months)
Number of Participants Who Died
Time frame: From first dose of study medication until death due to any cause (up to 136 weeks)
Number of Participants With Grade 3-4 Laboratory Abnormalities
Time frame: From first dose of study treatment through 30 days after the last dose of study treatment (up to approximately 25 months)
Disease Control Rate (DCR) by RECIST v1.1 Per Investigator Assessment
Time frame: From randomization until disease progression, withdrawal from study treatment, initiation of new therapy, or study completion, whichever occurred first (up to approximately 136 weeks)
Duration of Response (DoR) by RECIST v1.1 Per Investigator Assessment
Time frame: From first documented response (complete response or partial response) until first documented disease progression or death, whichever occurred first (up to approximately 136 weeks)
Progression-free Survival (PFS) by RECIST v1.1 Per Investigator Assessment
Time frame: From the date of randomization to the first date of documented progression, or death whichever occurs first (Up to approximately 136 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
50 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MORAb-202, Paclitaxel and Pegylated Liposomal Doxorubicin (PLD) in people with Neoplasms, Ovarian, run by Bristol-Myers Squibb at 50 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in United States, Spain, Australia, Israel, Italy and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Per Investigator Assessment (time frame: From the date of randomization to the date of first objectively-documented progression or the date of subsequent therapy (Up to approximately 70 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.