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

NCT05613088 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: CA116-0012021-004807-42
• Study Type: interventional
• Target: 106
• Locations: 9 countries
• Sites: 50

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.

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; High grade serous; Farletuzumab ecteribulin

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  From first dose of study medication up to 6 months

Secondary Outcomes (11)

• 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)

• 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)

• 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)

• 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)

• 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)

Study Arms (2)

MORAb-202

EXPERIMENTAL

Drug: MORAb-202

Investigator's Choice Chemotherapy

EXPERIMENTAL

Drug: Paclitaxel; Drug: Pegylated Liposomal Doxorubicin (PLD); Drug: Topotecan

Interventions

MORAb-202 DRUG

Specified dose on specified days

Also known as: BMS-986445, Farletuzumab Ecteribulin

MORAb-202

Paclitaxel DRUG

Specified dose on specified days

Also known as: Bendalis

Investigator's Choice Chemotherapy

Pegylated Liposomal Doxorubicin (PLD) DRUG

Specified dose on specified days

Also known as: Caelyx

Investigator's Choice Chemotherapy

Topotecan DRUG

Specified dose on specified days

Also known as: Hycamtin

Investigator's Choice Chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead
• Eisai Inc.: collaborator

Study Sites (50)

Local Institution - 0065

Sacramento, California, 95817, United States

Location

Local Institution - 0025

San Francisco, California, 94109, United States

Location

Local Institution - 0078

Whittier, California, 90602-3171, United States

Location

Local Institution - 0081

South Bend, Indiana, 46601-1033, United States

Location

Local Institution - 0043

Kansas City, Kansas, 66160, United States

Location

Local Institution - 0023

Canton, Ohio, 44710-1702, United States

Location

Local Institution - 0061

Columbus, Ohio, 43219, United States

Location

Local Institution - 0044

Nashville, Tennessee, 37203-1625, United States

Location

Local Institution - 0082

Salt Lake City, Utah, 84124, United States

Location

Local Institution - 0042

Spokane, Washington, 99204, United States

Location

Local Institution - 0016

Sydney, New South Wales, 2065, Australia

Location

Local Institution - 0017

Waratah, New South Wales, 2298, Australia

Location

Local Institution - 0031

Chermside, Queensland, 4032, Australia

Location

Local Institution - 0015

Clayton, Victoria, 3168, Australia

Location

Local Institution - 0027

Malvern, Victoria, 3144, Australia

Location

Local Institution - 0058

Nedlands, Western Australia, 6009, Australia

Location

Local Institution - 0032

Leuven, VBR, 3000, Belgium

Location

Local Institution - 0013

Namur, WNA, 5000, Belgium

Location

Local Institution - 0012

Brussels, 1200, Belgium

Location

Local Institution - 0045

Liège, 4000, Belgium

Location

Local Institution - 0030

Santiago, RM, 8420323, Chile

Location

Local Institution - 0036

Santiago, 7510032, Chile

Location

Local Institution - 0029

Temuco, 4800827, Chile

Location

Local Institution - 0046

Jerusaelm, JM, 9112001, Israel

Location

Local Institution - 0054

Haifa, 31999, Israel

Location

Local Institution - 0080

Jerusalem, 91031, Israel

Location

Local Institution - 0055

Ramat Gan, 5265601, Israel

Location

Local Institution - 0048

Tel Aviv, 64239, Israel

Location

Local Institution - 0003

Bologna, BO, 40138, Italy

Location

Local Institution - 0011

Milan, MI, 20132, Italy

Location

Local Institution - 0009

Milan, MI, 20141, Italy

Location

Local Institution - 0010

Roma, RM, 00168, Italy

Location

Local Institution - 0002

Brescia, 25123, Italy

Location

Local Institution - 0018

Akashi, Hyogo, 673-8558, Japan

Location

Local Institution - 0019

Chūōku, 104-0045, Japan

Location

Local Institution - 0014

Hidaka-shi, 350-1298, Japan

Location

Local Institution - 0004

Kurume-Shi, 830-0011, Japan

Location

Local Institution - 0037

Tokyo, 135-8550, Japan

Location

Local Institution - 0056

Seoul, 03080, South Korea

Location

Local Institution - 0049

Seoul, 03722, South Korea

Location

Local Institution - 0053

Seoul, 5505, South Korea

Location

Local Institution - 0039

Barcelona, B, 08035, Spain

Location

Local Institution - 0005

Madrid, M, 28007, Spain

Location

Local Institution - 0001

Madrid, M, 28041, Spain

Location

Local Institution - 0007

Valencia, V, 46009, Spain

Location

Local Institution - 0006

Valencia, V, 46010, Spain

Location

Local Institution - 0021

Barcelona, 08036, Spain

Location

Local Institution - 0020

Girona, 17007, Spain

Location

Local Institution - 0038

Madrid, 28033, Spain

Location

Local Institution - 0022

Madrid, 28046, Spain

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms; Carcinoma, Ovarian Epithelial

Interventions

MORAb-202; Paclitaxel; liposomal doxorubicin; Topotecan

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Camptothecin; Alkaloids; Heterocyclic Compounds

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Please email

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2022
• First Posted: November 14, 2022
• Study Start: February 1, 2023
• Primary Completion: June 17, 2024
• Study Completion: September 10, 2025
• Last Updated: April 30, 2026
• Results First Posted: July 3, 2025

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See plan description
• Access Criteria: See plan description

Locations

CL (3); KR (3); BE (4); ES (9); IT (5); US (10); AU (6); IL (5); JP (5)