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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05613088
Recruitment Status : Recruiting
First Posted : November 14, 2022
Last Update Posted : May 7, 2024
Sponsor:
Collaborator:
Eisai Inc.
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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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.

Condition or disease Intervention/treatment Phase
Neoplasms, Ovarian Drug: MORAb-202 Drug: Paclitaxel Drug: Pegylated Liposomal Doxorubicin (PLD) Drug: Topotecan Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : February 1, 2023
Estimated Primary Completion Date : June 5, 2024
Estimated Study Completion Date : October 11, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: MORAb-202 Drug: MORAb-202
Specified dose on specified days
Other Names:
  • BMS-986445
  • Farletuzumab Ecteribulin
Experimental: Investigator's Choice Chemotherapy Drug: Paclitaxel
Specified dose on specified days
Other Name: Bendalis

Drug: Pegylated Liposomal Doxorubicin (PLD)
Specified dose on specified days
Other Name: Caelyx

Drug: Topotecan
Specified dose on specified days
Other Name: Hycamtin


Outcome Measures
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Primary Outcome Measures :
  1. Objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per investigator assessment [ Time Frame: Up to 2 years ]
  2. Proportion of participants with treatment related adverse events (TRAEs) leading to study discontinuation [ Time Frame: Up to 2 years ]

Secondary Outcome Measures :
  1. Number of participants with adverse events (AEs) [ Time Frame: Up to 2 years ]
  2. Number of participants with serious adverse events (SAEs) [ Time Frame: Up to 2 years ]
  3. Number of participants with AEs leading to discontinuation [ Time Frame: Up to 2 years ]
  4. Number of participants with TRAEs [ Time Frame: Up to 2 years ]
  5. Number of participants with TRSAEs [ Time Frame: Up to 2 years ]
  6. Number of participants with AEs of special interest (AESIs) [ Time Frame: Up to 2 years ]
  7. Number of deaths [ Time Frame: Up to 2 years ]
  8. Number of participants with laboratory abnormalities [ Time Frame: Up to 2 years ]
  9. Disease control rate (DCR) by RECIST v1.1 per investigator assessment [ Time Frame: Up to 2 years ]
  10. Duration of Response (DoR) by RECIST v1.1 per investigator assessment [ Time Frame: Up to 2 years ]
  11. Progression-free survival (PFS) by RECIST v1.1 per investigator assessment [ Time Frame: Up to 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05613088


Contacts
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Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com
Contact: First line of the email MUST contain the NCT# and Site #.

Locations
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Sponsors and Collaborators
Bristol-Myers Squibb
Eisai Inc.
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT05613088    
Other Study ID Numbers: CA116-001
2021-004807-42 ( EudraCT Number )
First Posted: November 14, 2022    Key Record Dates
Last Update Posted: May 7, 2024
Last Verified: May 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: See plan description
Access Criteria: See plan description
URL: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bristol-Myers Squibb:
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
Additional relevant MeSH terms:
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Fallopian Tube Neoplasms
Ovarian Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Fallopian Tube Diseases
Adnexal Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Diseases
Endocrine Gland Neoplasms
Ovarian Diseases
 Endocrine System Diseases
Gonadal Disorders
Paclitaxel
Doxorubicin
Liposomal doxorubicin
Topotecan
Farletuzumab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors