Trial Title:
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
NCT ID:
NCT05613088
Condition:
Neoplasms, Ovarian
Conditions: Official terms:
Fallopian Tube Neoplasms
Ovarian Neoplasms
Paclitaxel
Doxorubicin
Liposomal doxorubicin
Topotecan
Farletuzumab
Conditions: 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
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
MORAb-202
Description:
Specified dose on specified days
Arm group label:
MORAb-202
Other name:
BMS-986445
Other name:
Farletuzumab Ecteribulin
Intervention type:
Drug
Intervention name:
Paclitaxel
Description:
Specified dose on specified days
Arm group label:
Investigator's Choice Chemotherapy
Other name:
Bendalis
Intervention type:
Drug
Intervention name:
Pegylated Liposomal Doxorubicin (PLD)
Description:
Specified dose on specified days
Arm group label:
Investigator's Choice Chemotherapy
Other name:
Caelyx
Intervention type:
Drug
Intervention name:
Topotecan
Description:
Specified dose on specified days
Arm group label:
Investigator's Choice Chemotherapy
Other name:
Hycamtin
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.
Criteria for eligibility:
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Local Institution - 0040
Address:
City:
Orange
Zip:
92868
Country:
United States
Status:
Withdrawn
Facility:
Name:
UC Davis Comprehensive Cancer Center
Address:
City:
Sacramento
Zip:
95817-1514
Country:
United States
Status:
Recruiting
Contact:
Last name:
Hui Amy Chen, Site 0077
Facility:
Name:
UC Davis Comprehensive Cancer Center
Address:
City:
Sacramento
Zip:
95817
Country:
United States
Status:
Recruiting
Contact:
Last name:
Hui Chen, Site 0065
Facility:
Name:
California Pacific Medical Center (CPMC) - Research Institute
Address:
City:
San Francisco
Zip:
94109
Country:
United States
Status:
Recruiting
Contact:
Last name:
John Chan, Site 0025
Facility:
Name:
Local Institution - 0078
Address:
City:
Whittier
Zip:
90602-3171
Country:
United States
Status:
Completed
Facility:
Name:
Local Institution - 0051
Address:
City:
Aurora
Zip:
80045-2517
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Site 0051
Facility:
Name:
Local Institution - 0024
Address:
City:
Gainesville
Zip:
32611
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Site 0024
Facility:
Name:
Local Institution - 0052
Address:
City:
Chicago
Zip:
60611
Country:
United States
Status:
Withdrawn
Facility:
Name:
Local Institution - 0081
Address:
City:
South Bend
Zip:
46601-1033
Country:
United States
Status:
Active, not recruiting
Facility:
Name:
Local Institution - 0043
Address:
City:
Kansas City
Zip:
66160
Country:
United States
Status:
Completed
Facility:
Name:
Corewell Health
Address:
City:
Grand Rapids
Zip:
49503-2560
Country:
United States
Status:
Recruiting
Contact:
Last name:
Gregory Gressel, Site 0070
Phone:
616-391-9354
Facility:
Name:
Local Institution - 0041
Address:
City:
Grand Rapids
Zip:
49503
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Site 0041
Facility:
Name:
Local Institution - 0034
Address:
City:
Saint Louis
Zip:
63110-1010
Country:
United States
Status:
Withdrawn
Facility:
Name:
Local Institution - 0035
Address:
City:
Bronx
Zip:
10467-2836
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Site 0035
Facility:
Name:
Local Institution - 0067
Address:
City:
Bronx
Zip:
10467
Country:
United States
Status:
Withdrawn
Facility:
Name:
Local Institution - 0073
Address:
City:
New York
Zip:
10016-6402
Country:
United States
Status:
Withdrawn
Facility:
Name:
Local Institution - 0063
Address:
City:
New York
Zip:
10016
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Site 0063
Facility:
Name:
Columbia University Medical Center - Herbert Irving Pavilion Location
Address:
City:
New York
Zip:
10032-3729
Country:
United States
Status:
Recruiting
Contact:
Last name:
June Hou, Site 0072
Phone:
212-305-3410
Facility:
Name:
Local Institution - 0062
Address:
City:
New York
Zip:
10032
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Site 0062
Facility:
Name:
Local Institution - 0026
Address:
City:
New York
Zip:
10065-6007
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Site 0026
Facility:
Name:
Local Institution - 0028
Address:
City:
Chapel Hill
Zip:
27599
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Site 0028
Facility:
Name:
Local Institution - 0023
Address:
City:
Canton
Zip:
44710-1702
Country:
United States
Status:
Completed
Facility:
Name:
Local Institution - 0076
Address:
City:
Columbus
Zip:
43219
Country:
United States
Status:
Active, not recruiting
Facility:
Name:
Zangmeister Cancer Center
Address:
City:
Columbus
Zip:
43219
Country:
United States
Status:
Recruiting
Contact:
Last name:
Emily Whitman, Site 0061
Facility:
Name:
Local Institution - 0044
Address:
City:
Nashville
Zip:
37203-1625
Country:
United States
Status:
Active, not recruiting
Facility:
Name:
Local Institution - 0050
Address:
City:
Dallas
Zip:
75235-7320
Country:
United States
Status:
Active, not recruiting
Facility:
Name:
Local Institution - 0082
Address:
City:
Salt Lake City
Zip:
84124
Country:
United States
Status:
Completed
Facility:
Name:
Providence Sacred Heart Medical Center & Children's Hospital
Address:
City:
Spokane
Zip:
99204
Country:
United States
Status:
Recruiting
Contact:
Last name:
Melanie Bergman, Site 0042
Facility:
Name:
GenesisCare - North Shore
Address:
City:
Sydney
Zip:
2065
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Sally Baron Hay, Site 0016
Facility:
Name:
Calvary Mater Newcastle
Address:
City:
Waratah
Zip:
2298
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Janine Lombard, Site 0017
Facility:
Name:
Icon Cancer Centre - Chermside
Address:
City:
Chermside
Zip:
4032
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Jeffrey Goh, Site 0031
Phone:
61402240196
Facility:
Name:
Monash Medical Centre Clayton
Address:
City:
Clayton
Zip:
3168
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Sophia Frentzas, Site 0015
Phone:
+61 426 2788 74
Facility:
Name:
Cabrini Hospital - Malvern
Address:
City:
Malvern
Zip:
3144
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Gary Richardson, Site 0027
Facility:
Name:
Sir Charles Gairdner Hospital
Address:
City:
Nedlands
Zip:
6009
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Tarek Meniawy, Site 0058
Phone:
61893463841
Facility:
Name:
Sir Charles Gairdner Hospital (SCGH) - WA Cancer Centre
Address:
City:
Perth
Zip:
6009
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Tarek Meniawy, Site 0075
Phone:
61893463841
Facility:
Name:
Local Institution - 0032
Address:
City:
Leuven
Zip:
3000
Country:
Belgium
Status:
Active, not recruiting
Facility:
Name:
Local Institution - 0013
Address:
City:
Namur
Zip:
5000
Country:
Belgium
Status:
Completed
Facility:
Name:
Local Institution - 0012
Address:
City:
Brussels
Zip:
1200
Country:
Belgium
Status:
Active, not recruiting
Facility:
Name:
Local Institution - 0033
Address:
City:
Hasselt
Zip:
3500
Country:
Belgium
Status:
Withdrawn
Facility:
Name:
Local Institution - 0045
Address:
City:
Liège
Zip:
4000
Country:
Belgium
Status:
Completed
Facility:
Name:
Local Institution - 0059
Address:
City:
Santiago
Zip:
8420383
Country:
Chile
Status:
Withdrawn
Facility:
Name:
Local Institution - 0030
Address:
City:
Santiago
Zip:
8420323
Country:
Chile
Status:
Active, not recruiting
Facility:
Name:
Local Institution - 0060
Address:
City:
Vina del Mar
Zip:
2540402
Country:
Chile
Status:
Not yet recruiting
Contact:
Last name:
Site 0060
Facility:
Name:
Local Institution - 0071
Address:
City:
Vina Del Mar
Zip:
2540402
Country:
Chile
Status:
Withdrawn
Facility:
Name:
Oncovida - Santiago
Address:
City:
Santiago
Zip:
7510032
Country:
Chile
Status:
Recruiting
Contact:
Last name:
Pamela Salman Boghikian, Site 0036
Phone:
5697215168156
Facility:
Name:
Local Institution - 0029
Address:
City:
Temuco
Zip:
4800827
Country:
Chile
Status:
Active, not recruiting
Facility:
Name:
Local Institution - 0046
Address:
City:
Jerusaelm
Zip:
9112001
Country:
Israel
Status:
Completed
Facility:
Name:
Local Institution - 0047
Address:
City:
Tel-Aviv
Zip:
64239
Country:
Israel
Status:
Withdrawn
Facility:
Name:
Local Institution - 0054
Address:
City:
Haifa
Zip:
31999
Country:
Israel
Status:
Completed
Facility:
Name:
Local Institution - 0080
Address:
City:
Jerusalem
Zip:
91031
Country:
Israel
Status:
Active, not recruiting
Facility:
Name:
Local Institution - 0055
Address:
City:
Ramat Gan
Zip:
5265601
Country:
Israel
Status:
Not yet recruiting
Contact:
Last name:
Site 0055
Facility:
Name:
Local Institution - 0048
Address:
City:
Tel Aviv-Yafo
Zip:
64239
Country:
Israel
Status:
Completed
Facility:
Name:
Local Institution - 0068
Address:
City:
Tel Hashomer
Zip:
52621
Country:
Israel
Status:
Active, not recruiting
Facility:
Name:
Local Institution - 0003
Address:
City:
Bologna
Zip:
40138
Country:
Italy
Status:
Active, not recruiting
Facility:
Name:
Local Institution - 0011
Address:
City:
Milano
Zip:
20132
Country:
Italy
Status:
Completed
Facility:
Name:
Local Institution - 0009
Address:
City:
Milano
Zip:
20141
Country:
Italy
Status:
Active, not recruiting
Facility:
Name:
Local Institution - 0010
Address:
City:
Roma
Zip:
00168
Country:
Italy
Status:
Active, not recruiting
Facility:
Name:
Local Institution - 0008
Address:
City:
Torino
Zip:
10126
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Site 0008
Facility:
Name:
Local Institution - 0002
Address:
City:
Brescia
Zip:
25123
Country:
Italy
Status:
Active, not recruiting
Facility:
Name:
Hyogo Cancer Center
Address:
City:
Akashi, Hyogo
Zip:
673-8558
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Koji Matsumoto, Site 0018
Phone:
+81789291151
Facility:
Name:
Local Institution - 0079
Address:
City:
Akashi
Zip:
673-8558
Country:
Japan
Status:
Active, not recruiting
Facility:
Name:
Local Institution - 0019
Address:
City:
Chuo-Ku
Zip:
104-0045
Country:
Japan
Status:
Completed
Facility:
Name:
Local Institution - 0014
Address:
City:
Hidaka-shi
Zip:
350-1298
Country:
Japan
Status:
Active, not recruiting
Facility:
Name:
Local Institution - 0004
Address:
City:
Kurume-Shi
Zip:
830-0011
Country:
Japan
Status:
Active, not recruiting
Facility:
Name:
Local Institution - 0037
Address:
City:
Tokyo
Zip:
135-8550
Country:
Japan
Status:
Active, not recruiting
Facility:
Name:
Local Institution - 0064
Address:
City:
Goyang-si
Zip:
10408
Country:
Korea, Republic of
Status:
Not yet recruiting
Contact:
Last name:
Site 0064
Facility:
Name:
Local Institution - 0074
Address:
City:
Goyang-si
Zip:
10408
Country:
Korea, Republic of
Status:
Not yet recruiting
Contact:
Last name:
Site 0074
Facility:
Name:
Seoul National University Hospital
Address:
City:
Jongno -Gu
Zip:
110-744
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Jae-Weon Kim, Site 0069
Facility:
Name:
Local Institution - 0056
Address:
City:
Seoul
Zip:
03080
Country:
Korea, Republic of
Status:
Not yet recruiting
Contact:
Last name:
Site 0056
Facility:
Name:
Yonsei University Health System, Severance Hospital
Address:
City:
Seoul
Zip:
03722
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Jung-Yun Lee, Site 0049
Phone:
+82222282246
Facility:
Name:
Local Institution - 0057
Address:
City:
Seoul
Zip:
06351
Country:
Korea, Republic of
Status:
Not yet recruiting
Contact:
Last name:
Site 0057
Facility:
Name:
Local Institution - 0066
Address:
City:
Seoul
Zip:
135-710
Country:
Korea, Republic of
Status:
Not yet recruiting
Contact:
Last name:
Site 0066
Facility:
Name:
Asan Medical Center (AMC)
Address:
City:
Seoul
Zip:
5505
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Jeong Yeol Park, Site 0053
Facility:
Name:
Local Institution - 0039
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Status:
Active, not recruiting
Facility:
Name:
Hospital General Universitario Gregorio Marañón
Address:
City:
Madrid
Zip:
28007
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Sara Perez Ramirez, Site 0005
Phone:
34914269393
Facility:
Name:
Local Institution - 0001
Address:
City:
Madrid
Zip:
28041
Country:
Spain
Status:
Active, not recruiting
Facility:
Name:
Local Institution - 0007
Address:
City:
Valencia
Zip:
46009
Country:
Spain
Status:
Active, not recruiting
Facility:
Name:
Local Institution - 0006
Address:
City:
Valencia
Zip:
46010
Country:
Spain
Status:
Completed
Facility:
Name:
Local Institution - 0021
Address:
City:
Barcelona
Zip:
08036
Country:
Spain
Status:
Active, not recruiting
Facility:
Name:
Local Institution - 0020
Address:
City:
Girona
Zip:
17007
Country:
Spain
Status:
Completed
Facility:
Name:
Local Institution - 0038
Address:
City:
Madrid
Zip:
28033
Country:
Spain
Status:
Active, not recruiting
Facility:
Name:
Local Institution - 0022
Address:
City:
Madrid
Zip:
28046
Country:
Spain
Status:
Active, not recruiting
Start date:
February 1, 2023
Completion date:
October 11, 2026
Lead sponsor:
Agency:
Bristol-Myers Squibb
Agency class:
Industry
Collaborator:
Agency:
Eisai Inc.
Agency class:
Industry
Source:
Bristol-Myers Squibb
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05613088
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
https://www.bmsstudyconnect.com/content/studyconnect/us/en/clinical-trials/NCT05613088.html
