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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

Primary Purpose

Neoplasms, Ovarian

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
MORAb-202
Paclitaxel
Pegylated Liposomal Doxorubicin (PLD)
Topotecan
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neoplasms, Ovarian focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • University of California Irvine
  • UC Davis Comprehensive Cancer CenterRecruiting
  • UC Davis Comprehensive Cancer CenterRecruiting
  • California Pacific Medical Center (CPMC) - Research InstituteRecruiting
  • The Oncology Institute of Hope and Innovation - WhittierRecruiting
  • University of Colorado Denver - Anschutz Medical Campus
  • UF Health Endoscopy Center
  • Northwestern University
  • Memorial Hospital of South BendRecruiting
  • University of Kansas Cancer Center - The Richard and Annette Bloch Cancer Care PavilionRecruiting
  • Corewell HealthRecruiting
  • Spectrum Health Hospitals
  • Columbia University Medical Center - Herbert Irving Pavilion LocationRecruiting
  • Memorial Sloan-Kettering Cancer Center
  • University Of North Carolina, Chapel Hill
  • Zangmeister Cancer CenterRecruiting
  • Sarah Cannon Research Institute - Tennessee OncologyRecruiting
  • UT Southwestern-Harold C. Simmons Cancer Center
  • Utah Cancer Specialists
  • Providence Sacred Heart Medical Center & Children's HospitalRecruiting
  • Local Institution - 0031Recruiting
  • Local Institution - 0015Recruiting
  • Local Institution - 0027
  • Local Institution - 0058Recruiting
  • Local Institution - 0075Recruiting
  • Local Institution - 0016Recruiting
  • Local Institution - 0032Recruiting
  • Local Institution - 0033
  • Local Institution - 0013Recruiting
  • Local Institution - 0012Recruiting
  • Local Institution - 0045Recruiting
  • Local Institution - 0030Recruiting
  • Local Institution - 0071
  • Local Institution - 0036Recruiting
  • Local Institution - 0029Recruiting
  • Local Institution - 0046Recruiting
  • Local Institution - 0054Recruiting
  • Local Institution - 0080Recruiting
  • Local Institution - 0048Recruiting
  • Local Institution - 0068Recruiting
  • Local Institution - 0047
  • Local Institution - 0003Recruiting
  • Local Institution - 0011Recruiting
  • Local Institution - 0009Recruiting
  • Local Institution - 0010Recruiting
  • Local Institution - 0002Recruiting
  • Local Institution - 0018Recruiting
  • Local Institution - 0079Recruiting
  • Local Institution - 0019Recruiting
  • Local Institution - 0014Recruiting
  • Local Institution - 0004Recruiting
  • Local Institution - 0037Recruiting
  • Local Institution - 0064
  • Local Institution - 0069Recruiting
  • Local Institution - 0049Recruiting
  • Local Institution - 0053Recruiting
  • Local Institution - 0039Recruiting
  • Local Institution - 0005Recruiting
  • Local Institution - 0001Recruiting
  • Local Institution - 0007Recruiting
  • Local Institution - 0006Recruiting
  • Local Institution - 0021Recruiting
  • Local Institution - 0020Recruiting
  • Local Institution - 0038Recruiting
  • Local Institution - 0022Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

MORAb-202

Investigator's Choice Chemotherapy

Arm Description

Outcomes

Primary Outcome Measures

Objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per investigator assessment
Proportion of participants with treatment related adverse events (TRAEs) leading to study discontinuation

Secondary Outcome Measures

Number of participants with adverse events (AEs)
Number of participants with serious adverse events (SAEs)
Number of participants with AEs leading to discontinuation
Number of participants with TRAEs
Number of participants with TRSAEs
Number of participants with AEs of special interest (AESIs)
Number of deaths
Number of participants with laboratory abnormalities
Disease control rate (DCR) by RECIST v1.1 per investigator assessment
Duration of Response (DoR) by RECIST v1.1 per investigator assessment
Progression-free survival (PFS) by RECIST v1.1 per investigator assessment

Full Information

First Posted
November 4, 2022
Last Updated
October 20, 2023
Sponsor
Bristol-Myers Squibb
Collaborators
Eisai Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05613088
Brief 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
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
June 5, 2024 (Anticipated)
Study Completion Date
October 11, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
Collaborators
Eisai Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MORAb-202
Arm Type
Experimental
Arm Title
Investigator's Choice Chemotherapy
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
MORAb-202
Other Intervention Name(s)
BMS-986445, Farletuzumab Ecteribulin
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
Bendalis
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Pegylated Liposomal Doxorubicin (PLD)
Other Intervention Name(s)
Caelyx
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Topotecan
Other Intervention Name(s)
Hycamtin
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
Objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per investigator assessment
Time Frame
Up to 2 years
Title
Proportion of participants with treatment related adverse events (TRAEs) leading to study discontinuation
Time Frame
Up to 2 years
Secondary Outcome Measure Information:
Title
Number of participants with adverse events (AEs)
Time Frame
Up to 2 years
Title
Number of participants with serious adverse events (SAEs)
Time Frame
Up to 2 years
Title
Number of participants with AEs leading to discontinuation
Time Frame
Up to 2 years
Title
Number of participants with TRAEs
Time Frame
Up to 2 years
Title
Number of participants with TRSAEs
Time Frame
Up to 2 years
Title
Number of participants with AEs of special interest (AESIs)
Time Frame
Up to 2 years
Title
Number of deaths
Time Frame
Up to 2 years
Title
Number of participants with laboratory abnormalities
Time Frame
Up to 2 years
Title
Disease control rate (DCR) by RECIST v1.1 per investigator assessment
Time Frame
Up to 2 years
Title
Duration of Response (DoR) by RECIST v1.1 per investigator assessment
Time Frame
Up to 2 years
Title
Progression-free survival (PFS) by RECIST v1.1 per investigator assessment
Time Frame
Up to 2 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BMS Study Connect Contact Center www.BMSStudyConnect.com
Phone
855-907-3286
Email
Clinical.Trials@bms.com
First Name & Middle Initial & Last Name or Official Title & Degree
First line of the email MUST contain the NCT# and Site #.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
University of California Irvine
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Krishnansu Tewari, Site 0040
Phone
714-509-2430
Facility Name
UC Davis Comprehensive Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817-1514
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hui Amy Chen, Site 0077
Facility Name
UC Davis Comprehensive Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hui Chen, Site 0065
Facility Name
California Pacific Medical Center (CPMC) - Research Institute
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Chan, Site 0025
Facility Name
The Oncology Institute of Hope and Innovation - Whittier
City
Whittier
State/Province
California
ZIP/Postal Code
90602-3171
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul La Porte, Site 0078
Phone
562-693-4777
Facility Name
University of Colorado Denver - Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045-2517
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bradley Corr, Site 0051
Phone
303-724-2053
Facility Name
UF Health Endoscopy Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Merry Markham, Site 0024
Phone
352-262-1072
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60208
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dario Roque, Site 0052
Phone
312-695-0990
Facility Name
Memorial Hospital of South Bend
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Latoya Perry, Site 0081
Phone
574-647-7370
Facility Name
University of Kansas Cancer Center - The Richard and Annette Bloch Cancer Care Pavilion
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Jewell, Site 0043
Phone
000-000-0000
Facility Name
Corewell Health
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503-2560
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gregory Gressel, Site 0070
Phone
616-391-9354
Facility Name
Spectrum Health Hospitals
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gregory Gressel, Site 0041
Phone
616-391-9354
Facility Name
Columbia University Medical Center - Herbert Irving Pavilion Location
City
New York
State/Province
New York
ZIP/Postal Code
10032-3729
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
June Hou, Site 0072
Phone
212-305-3410
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065-6007
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jason Konner, Site 0026
Phone
646-227-2198
Facility Name
University Of North Carolina, Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linda Van Le, Site 0028
Phone
919-784-6875
Facility Name
Zangmeister Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43219
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily Whitman, Site 0061
Facility Name
Sarah Cannon Research Institute - Tennessee Oncology
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203-1625
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erika Hamilton, Site 0044
Phone
615-329-7274
Facility Name
UT Southwestern-Harold C. Simmons Cancer Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235-7320
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Utah Cancer Specialists
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephan Kendall, Site 0082
Phone
801-462-1053
Facility Name
Providence Sacred Heart Medical Center & Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98124-5143
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melanie Bergman, Site 0042
Facility Name
Local Institution - 0031
City
Chermside
State/Province
Queensland
ZIP/Postal Code
4032
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0031
Facility Name
Local Institution - 0015
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0015
Facility Name
Local Institution - 0027
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3144
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0027
Facility Name
Local Institution - 0058
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0058
Facility Name
Local Institution - 0075
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0075
Facility Name
Local Institution - 0016
City
Sydney
ZIP/Postal Code
2065
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0016
Facility Name
Local Institution - 0032
City
Leuven
State/Province
VBR
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0032
Facility Name
Local Institution - 0033
City
Hasselt
State/Province
VLI
ZIP/Postal Code
3500
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0033
Facility Name
Local Institution - 0013
City
Namur
State/Province
WNA
ZIP/Postal Code
5000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0013
Facility Name
Local Institution - 0012
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0012
Facility Name
Local Institution - 0045
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0045
Facility Name
Local Institution - 0030
City
Santiago
State/Province
RM
ZIP/Postal Code
8420323
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0030
Facility Name
Local Institution - 0071
City
Vina Del Mar
State/Province
Valparaiso
ZIP/Postal Code
2540402
Country
Chile
Individual Site Status
Withdrawn
Facility Name
Local Institution - 0036
City
Santiago
ZIP/Postal Code
7510032
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0036
Facility Name
Local Institution - 0029
City
Temuco
ZIP/Postal Code
4781151
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0029
Facility Name
Local Institution - 0046
City
Jerusaelm
State/Province
JM
ZIP/Postal Code
9112001
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0046
Facility Name
Local Institution - 0054
City
Haifa
ZIP/Postal Code
31999
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0054
Facility Name
Local Institution - 0080
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0080
Facility Name
Local Institution - 0048
City
Tel Aviv-Yafo
ZIP/Postal Code
64239
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0048
Facility Name
Local Institution - 0068
City
Tel Hashomer
ZIP/Postal Code
52621
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0068
Facility Name
Local Institution - 0047
City
Tel-Aviv
ZIP/Postal Code
64239
Country
Israel
Individual Site Status
Withdrawn
Facility Name
Local Institution - 0003
City
Bologna
State/Province
BO
ZIP/Postal Code
40138
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0003
Facility Name
Local Institution - 0011
City
Milano
State/Province
MI
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0011
Facility Name
Local Institution - 0009
City
Milano
State/Province
MI
ZIP/Postal Code
20141
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0009
Facility Name
Local Institution - 0010
City
Roma
State/Province
RM
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0010
Facility Name
Local Institution - 0002
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0002
Facility Name
Local Institution - 0018
City
Akashi, Hyogo
ZIP/Postal Code
673-8558
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0018
Facility Name
Local Institution - 0079
City
Akashi
ZIP/Postal Code
673-8558
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0079
Facility Name
Local Institution - 0019
City
Chuo-Ku
ZIP/Postal Code
104-0045
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0019
Facility Name
Local Institution - 0014
City
Hidaka-shi
ZIP/Postal Code
350-1298
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0014
Facility Name
Local Institution - 0004
City
Kurume-Shi
ZIP/Postal Code
830-0011
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0004
Facility Name
Local Institution - 0037
City
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0037
Facility Name
Local Institution - 0064
City
Goyang-si
ZIP/Postal Code
10408
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0064
Facility Name
Local Institution - 0069
City
Jongno -Gu
ZIP/Postal Code
110-744
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0069
Facility Name
Local Institution - 0049
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0049
Facility Name
Local Institution - 0053
City
Seoul
ZIP/Postal Code
5505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0053
Facility Name
Local Institution - 0039
City
Barcelona
State/Province
B
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0039
Facility Name
Local Institution - 0005
City
Madrid
State/Province
M
ZIP/Postal Code
28007
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0005
Facility Name
Local Institution - 0001
City
Madrid
State/Province
M
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0001
Facility Name
Local Institution - 0007
City
Valencia
State/Province
V
ZIP/Postal Code
46009
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0007
Facility Name
Local Institution - 0006
City
Valencia
State/Province
V
ZIP/Postal Code
46010
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0006
Facility Name
Local Institution - 0021
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0021
Facility Name
Local Institution - 0020
City
Girona
ZIP/Postal Code
17007
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0020
Facility Name
Local Institution - 0038
City
Madrid
ZIP/Postal Code
28033
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0038
Facility Name
Local Institution - 0022
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0022

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
IPD Sharing Time Frame
See plan description
IPD Sharing Access Criteria
See plan description
IPD Sharing URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls

Learn more about this trial

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

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