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

Bristol-Myers Squibb106 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

106

Conditions

Neoplasms, Ovarian

Interventions

MORAb-202DRUG

Specified dose on specified days

PaclitaxelDRUG

Specified dose on specified days

Pegylated Liposomal Doxorubicin (PLD)DRUG

Specified dose on specified days

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (50)

Outcomes

Primary Outcomes

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.

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)

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.

Time frame: From first dose of study medication up to 6 months

Secondary Outcomes

Number of Participants With Adverse Events (AEs)

Time frame: 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 With Serious Adverse Events (SAEs)

Data from ClinicalTrials.gov

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Specified dose on specified days

Local Institution - 0065

Sacramento, California, United States

Local Institution - 0025

San Francisco, California, United States

Local Institution - 0078

Whittier, California, United States

Local Institution - 0081

South Bend, Indiana, United States

Local Institution - 0043

Kansas City, Kansas, United States

Local Institution - 0023

Canton, Ohio, United States

Local Institution - 0061

Columbus, Ohio, United States

Local Institution - 0044

Nashville, Tennessee, United States

Local Institution - 0082

Salt Lake City, Utah, United States

Local Institution - 0042

Spokane, Washington, United States

...and 40 more locations

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 Leading to Discontinuation

Number of Participants With Treatment-Related AEs

Number of Participants With Treatment-Related SAEs

Number of Participants With AEs of Special Interest (AESIs)

Number of Participants Who Died

Number of participants who died during the study.

Time frame: From first dose of study medication until death due to any cause (up to 70 weeks)

Number of Participants With Grade 3-4 Laboratory Abnormalities

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.

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

Time frame: From the date of randomization to the first date of documented progression, or death whichever occurs first (Up to approximately 70 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

Time frame: 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)

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

Time frame: From the date of randomization to the first date of documented progression, or death whichever occurs first (Up to approximately 70 weeks)