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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05613088




Registration number
NCT05613088
Ethics application status
Date submitted
4/11/2022
Date registered
14/11/2022
Date last updated
31/05/2024

Titles & IDs
Public 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
Scientific 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
Secondary ID [1] 0 0
2021-004807-42
Secondary ID [2] 0 0
CA116-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neoplasms, Ovarian 0 0
Condition category
Condition code
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)
Cancer 0 0 0 0
Ovarian and primary peritoneal

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - MORAb-202
Treatment: Drugs - Paclitaxel
Treatment: Drugs - Pegylated Liposomal Doxorubicin (PLD)
Treatment: Drugs - Topotecan

Experimental: MORAb-202 -

Experimental: Investigator's Choice Chemotherapy -


Treatment: Drugs: MORAb-202
Specified dose on specified days

Treatment: Drugs: Paclitaxel
Specified dose on specified days

Treatment: Drugs: Pegylated Liposomal Doxorubicin (PLD)
Specified dose on specified days

Treatment: Drugs: Topotecan
Specified dose on specified days
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per investigator assessment
Timepoint [1] 0 0
Up to 2 years
Primary outcome [2] 0 0
Proportion of participants with treatment related adverse events (TRAEs) leading to study discontinuation
Timepoint [2] 0 0
Up to 2 years
Secondary outcome [1] 0 0
Number of participants with adverse events (AEs)
Timepoint [1] 0 0
Up to 2 years
Secondary outcome [2] 0 0
Number of participants with serious adverse events (SAEs)
Timepoint [2] 0 0
Up to 2 years
Secondary outcome [3] 0 0
Number of participants with AEs leading to discontinuation
Timepoint [3] 0 0
Up to 2 years
Secondary outcome [4] 0 0
Number of participants with TRAEs
Timepoint [4] 0 0
Up to 2 years
Secondary outcome [5] 0 0
Number of participants with TRSAEs
Timepoint [5] 0 0
Up to 2 years
Secondary outcome [6] 0 0
Number of participants with AEs of special interest (AESIs)
Timepoint [6] 0 0
Up to 2 years
Secondary outcome [7] 0 0
Number of deaths
Timepoint [7] 0 0
Up to 2 years
Secondary outcome [8] 0 0
Number of participants with laboratory abnormalities
Timepoint [8] 0 0
Up to 2 years
Secondary outcome [9] 0 0
Disease control rate (DCR) by RECIST v1.1 per investigator assessment
Timepoint [9] 0 0
Up to 2 years
Secondary outcome [10] 0 0
Duration of Response (DoR) by RECIST v1.1 per investigator assessment
Timepoint [10] 0 0
Up to 2 years
Secondary outcome [11] 0 0
Progression-free survival (PFS) by RECIST v1.1 per investigator assessment
Timepoint [11] 0 0
Up to 2 years

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
11/10/2026
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
GenesisCare - North Shore - Sydney
Recruitment hospital [2] 0 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [3] 0 0
Icon Cancer Centre - Chermside - Chermside
Recruitment hospital [4] 0 0
Monash Medical Centre Clayton - Clayton
Recruitment hospital [5] 0 0
Cabrini Hospital - Malvern - Malvern
Recruitment hospital [6] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [7] 0 0
Sir Charles Gairdner Hospital (SCGH) - WA Cancer Centre - Perth
Recruitment postcode(s) [1] 0 0
2065 - Sydney
Recruitment postcode(s) [2] 0 0
2298 - Waratah
Recruitment postcode(s) [3] 0 0
4032 - Chermside
Recruitment postcode(s) [4] 0 0
3168 - Clayton
Recruitment postcode(s) [5] 0 0
3144 - Malvern
Recruitment postcode(s) [6] 0 0
6009 - Nedlands
Recruitment postcode(s) [7] 0 0
6009 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Kansas
Country [7] 0 0
United States of America
State/province [7] 0 0
Michigan
Country [8] 0 0
United States of America
State/province [8] 0 0
Missouri
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
North Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Ohio
Country [12] 0 0
United States of America
State/province [12] 0 0
Tennessee
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
United States of America
State/province [14] 0 0
Utah
Country [15] 0 0
United States of America
State/province [15] 0 0
Washington
Country [16] 0 0
Belgium
State/province [16] 0 0
VBR
Country [17] 0 0
Belgium
State/province [17] 0 0
WNA
Country [18] 0 0
Belgium
State/province [18] 0 0
Brussels
Country [19] 0 0
Belgium
State/province [19] 0 0
Hasselt
Country [20] 0 0
Belgium
State/province [20] 0 0
Liège
Country [21] 0 0
Chile
State/province [21] 0 0
Metropolitana
Country [22] 0 0
Chile
State/province [22] 0 0
RM
Country [23] 0 0
Chile
State/province [23] 0 0
Valparaiso
Country [24] 0 0
Chile
State/province [24] 0 0
Santiago
Country [25] 0 0
Chile
State/province [25] 0 0
Temuco
Country [26] 0 0
Israel
State/province [26] 0 0
JM
Country [27] 0 0
Israel
State/province [27] 0 0
Tel Aviv
Country [28] 0 0
Israel
State/province [28] 0 0
Haifa
Country [29] 0 0
Israel
State/province [29] 0 0
Jerusalem
Country [30] 0 0
Israel
State/province [30] 0 0
Ramat Gan
Country [31] 0 0
Israel
State/province [31] 0 0
Tel Aviv-Yafo
Country [32] 0 0
Israel
State/province [32] 0 0
Tel Hashomer
Country [33] 0 0
Italy
State/province [33] 0 0
BO
Country [34] 0 0
Italy
State/province [34] 0 0
MI
Country [35] 0 0
Italy
State/province [35] 0 0
RM
Country [36] 0 0
Italy
State/province [36] 0 0
TO
Country [37] 0 0
Italy
State/province [37] 0 0
Brescia
Country [38] 0 0
Japan
State/province [38] 0 0
Akashi, Hyogo
Country [39] 0 0
Japan
State/province [39] 0 0
Akashi
Country [40] 0 0
Japan
State/province [40] 0 0
Chuo-Ku
Country [41] 0 0
Japan
State/province [41] 0 0
Hidaka-shi
Country [42] 0 0
Japan
State/province [42] 0 0
Kurume-Shi
Country [43] 0 0
Japan
State/province [43] 0 0
Tokyo
Country [44] 0 0
Korea, Republic of
State/province [44] 0 0
Goyang-si
Country [45] 0 0
Korea, Republic of
State/province [45] 0 0
Jongno -Gu
Country [46] 0 0
Korea, Republic of
State/province [46] 0 0
Seoul
Country [47] 0 0
Spain
State/province [47] 0 0
B
Country [48] 0 0
Spain
State/province [48] 0 0
M
Country [49] 0 0
Spain
State/province [49] 0 0
V
Country [50] 0 0
Spain
State/province [50] 0 0
Barcelona
Country [51] 0 0
Spain
State/province [51] 0 0
Girona
Country [52] 0 0
Spain
State/province [52] 0 0
Madrid

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Eisai Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05613088
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
BMS Study Connect Contact Center www.BMSStudyConnect.com
Address 0 0
Country 0 0
Phone 0 0
855-907-3286
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05613088