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

Phase 2

Active, not recruiting

Conditions: Neoplasms, Ovarian

Interventions: Drug: MORAb-202
Drug: Paclitaxel
Drug: Pegylated Liposomal Doxorubicin (PLD)
Drug: Topotecan

Registration Number: NCT05613088

Lead Sponsor: Bristol-Myers Squibb

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: ACTIVE_NOT_RECRUITING

Sex: Female

Target Recruitment: 106

Inclusion Criteria

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.

Exclusion Criteria

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.

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MORAb-202	MORAb-202	-
Investigator's Choice Chemotherapy	Paclitaxel	-
Investigator's Choice Chemotherapy	Pegylated Liposomal Doxorubicin (PLD)	-
Investigator's Choice Chemotherapy	Topotecan	-

Primary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Per Investigator Assessment	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	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events (AEs)	From the first dose of study medication until 17Jun2024, which is 30 days after the last dose of study treatment (assessed for an average duration of approximately 5 months, with a maximum of up to 14 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.
Number of Participants With AEs Leading to Discontinuation	From the first dose of study medication until 17Jun2024, which is 30 days after the last dose of study treatment (assessed for an average duration of approximately 5 months, with a maximum of up to 14 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.
Number of Participants With Treatment-Related AEs	From the first dose of study medication until 17Jun2024, which is 30 days after the last dose of study treatment (assessed for an average duration of approximately 5 months, with a maximum of up to 14 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.
Number of Participants Who Died	From first dose of study medication until death due to any cause (up to 70 weeks)	Number of participants who died during the study.
Number of Participants With Serious Adverse Events (SAEs)	From the first dose of study medication until 17Jun2024, which is 30 days after the last dose of study treatment (assessed for an average duration of approximately 5 months, with a maximum of up to 14 months)	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.
Number of Participants With AEs of Special Interest (AESIs)	From the first dose of study medication until 17Jun2024, which is 30 days after the last dose of study treatment (assessed for an average duration of approximately 5 months, with a maximum of up to 14 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. AEs of special interest include: Infusion-related reactions, Interstitial lung disease (ILD) and Pneumonitis
Disease Control Rate (DCR) by RECIST v1.1 Per Investigator Assessment	From the date of randomization to the first date of documented progression, or death whichever occurs first (Up to approximately 70 weeks)	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
Number of Participants With Treatment-Related SAEs	From the first dose of study medication until 17Jun2024, which is 30 days after the last dose of study treatment (assessed for an average duration of approximately 5 months, with a maximum of up to 14 months)	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.
Number of Participants With Grade 3-4 Laboratory Abnormalities	From the first dose of study medication until 17Jun2024, which is 30 days after the last dose of study treatment (assessed for an average duration of approximately 5 months, with a maximum of up to 14 months)	Number of participants experiencing 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.
Duration of Response (DoR) by RECIST v1.1 Per Investigator Assessment	From the date of first dose to the date of the first documented tumor progression, or death, whichever occurs first (Up to approximately 70 weeks)	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
Progression-free Survival (PFS) by RECIST v1.1 Per Investigator Assessment	From the date of randomization to the first date of documented progression, or death whichever occurs first (Up to approximately 70 weeks)	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

Trial Locations

Locations (50): Local Institution - 0065
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Sacramento, California, United States
Local Institution - 0025
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San Francisco, California, United States
Local Institution - 0061
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Columbus, Ohio, United States
Local Institution - 0042
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Spokane, Washington, United States
Local Institution - 0031
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Chermside, Queensland, Australia
Local Institution - 0027
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Malvern, Victoria, Australia
Local Institution - 0058
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Nedlands, Western Australia, Australia
Local Institution - 0036
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Santiago, Chile
Local Institution - 0055
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Ramat Gan, Israel
Local Institution - 0018
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Akashi, Hyogo, Japan
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Local Institution - 0065
🇺🇸Sacramento, California, United States