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

Neoplasms, Ovarian Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05613088
• Other study ID #: CA116-001
• Secondary ID: 2021-004807-42
• Status: Recruiting
• Phase: Phase 2
• Start date: February 1, 2023
• Est. completion date: October 11, 2026

Study information

• Verified date: May 2024
• Source: Bristol-Myers Squibb
• Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com
• Phone: 855-907-3286
• Email: Clinical.Trials[@]bms.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: October 11, 2026
• Est. primary completion date: June 5, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 FRa 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.

Related Conditions & MeSH terms

• Fallopian Tube Neoplasms
• Neoplasms, Ovarian
• Ovarian Neoplasms

Intervention

Drug:
• MORAb-202
Specified dose on specified days
• Paclitaxel
Specified dose on specified days
• Pegylated Liposomal Doxorubicin (PLD)
Specified dose on specified days
• Topotecan
Specified dose on specified days

Locations

Country	Name	City	State
Australia	Icon Cancer Centre - Chermside	Chermside	Queensland
Australia	Monash Medical Centre Clayton	Clayton	Victoria
Australia	Cabrini Hospital - Malvern	Malvern	Victoria
Australia	Sir Charles Gairdner Hospital	Nedlands	Western Australia
Australia	Sir Charles Gairdner Hospital (SCGH) - WA Cancer Centre	Perth	Western Australia
Australia	GenesisCare - North Shore	Sydney	New South Wales
Australia	Calvary Mater Newcastle	Waratah	New South Wales
Belgium	Local Institution - 0012	Brussels
Belgium	Local Institution - 0033	Hasselt
Belgium	Local Institution - 0032	Leuven	VBR
Belgium	Local Institution - 0045	Liège
Belgium	Local Institution - 0013	Namur	WNA
Chile	Local Institution - 0030	Santiago	RM
Chile	Local Institution - 0059	Santiago	Metropolitana
Chile	Oncovida - Santiago	Santiago
Chile	Local Institution - 0029	Temuco
Chile	Local Institution - 0060	Vina del Mar	Valparaiso
Chile	Local Institution - 0071	Vina Del Mar	Valparaiso
Israel	Local Institution - 0054	Haifa
Israel	Local Institution - 0046	Jerusaelm	JM
Israel	Local Institution - 0080	Jerusalem
Israel	Local Institution - 0055	Ramat Gan
Israel	Local Institution - 0048	Tel Aviv-Yafo
Israel	Local Institution - 0068	Tel Hashomer
Israel	Local Institution - 0047	Tel-Aviv	Tel Aviv
Italy	Local Institution - 0003	Bologna	BO
Italy	Local Institution - 0002	Brescia
Italy	Local Institution - 0009	Milano	MI
Italy	Local Institution - 0011	Milano	MI
Italy	Local Institution - 0010	Roma	RM
Italy	Local Institution - 0008	Torino	TO
Japan	Local Institution - 0079	Akashi
Japan	Hyogo Cancer Center	Akashi, Hyogo
Japan	Local Institution - 0019	Chuo-Ku
Japan	Local Institution - 0014	Hidaka-shi
Japan	Local Institution - 0004	Kurume-Shi
Japan	Local Institution - 0037	Tokyo
Korea, Republic of	Local Institution - 0064	Goyang-si
Korea, Republic of	Local Institution - 0074	Goyang-si
Korea, Republic of	Seoul National University Hospital	Jongno -Gu
Korea, Republic of	Asan Medical Center (AMC)	Seoul
Korea, Republic of	Local Institution - 0056	Seoul
Korea, Republic of	Local Institution - 0057	Seoul
Korea, Republic of	Local Institution - 0066	Seoul
Korea, Republic of	Yonsei University Health System, Severance Hospital	Seoul
Spain	Local Institution - 0021	Barcelona
Spain	Local Institution - 0039	Barcelona	B
Spain	Local Institution - 0020	Girona
Spain	Hospital General Universitario Gregorio Marañón	Madrid	M
Spain	Local Institution - 0001	Madrid	M
Spain	Local Institution - 0022	Madrid
Spain	Local Institution - 0038	Madrid
Spain	Local Institution - 0006	Valencia	V
Spain	Local Institution - 0007	Valencia	V
United States	Local Institution - 0051	Aurora	Colorado
United States	Local Institution - 0035	Bronx	New York
United States	Local Institution - 0067	Bronx	New York
United States	Local Institution - 0023	Canton	Ohio
United States	Local Institution - 0028	Chapel Hill	North Carolina
United States	Local Institution - 0052	Chicago	Illinois
United States	Local Institution - 0076	Columbus	Ohio
United States	Zangmeister Cancer Center	Columbus	Ohio
United States	Local Institution - 0050	Dallas	Texas
United States	Local Institution - 0024	Gainesville	Florida
United States	Corewell Health	Grand Rapids	Michigan
United States	Local Institution - 0041	Grand Rapids	Michigan
United States	Local Institution - 0043	Kansas City	Kansas
United States	Local Institution - 0044	Nashville	Tennessee
United States	Columbia University Medical Center - Herbert Irving Pavilion Location	New York	New York
United States	Local Institution - 0026	New York	New York
United States	Local Institution - 0062	New York	New York
United States	Local Institution - 0063	New York	New York
United States	Local Institution - 0073	New York	New York
United States	Local Institution - 0040	Orange	California
United States	UC Davis Comprehensive Cancer Center	Sacramento	California
United States	UC Davis Comprehensive Cancer Center	Sacramento	California
United States	Local Institution - 0034	Saint Louis	Missouri
United States	Local Institution - 0082	Salt Lake City	Utah
United States	California Pacific Medical Center (CPMC) - Research Institute	San Francisco	California
United States	Local Institution - 0081	South Bend	Indiana
United States	Providence Sacred Heart Medical Center & Children's Hospital	Spokane	Washington
United States	Local Institution - 0078	Whittier	California

Sponsors (2)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	Eisai Inc.

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Chile,  Israel,  Italy,  Japan,  Korea, Republic of,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per investigator assessment		Up to 2 years
Primary	Proportion of participants with treatment related adverse events (TRAEs) leading to study discontinuation		Up to 2 years
Secondary	Number of participants with adverse events (AEs)		Up to 2 years
Secondary	Number of participants with serious adverse events (SAEs)		Up to 2 years
Secondary	Number of participants with AEs leading to discontinuation		Up to 2 years
Secondary	Number of participants with TRAEs		Up to 2 years
Secondary	Number of participants with TRSAEs		Up to 2 years
Secondary	Number of participants with AEs of special interest (AESIs)		Up to 2 years
Secondary	Number of deaths		Up to 2 years
Secondary	Number of participants with laboratory abnormalities		Up to 2 years
Secondary	Disease control rate (DCR) by RECIST v1.1 per investigator assessment		Up to 2 years
Secondary	Duration of Response (DoR) by RECIST v1.1 per investigator assessment		Up to 2 years
Secondary	Progression-free survival (PFS) by RECIST v1.1 per investigator assessment		Up to 2 years

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting