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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT05613088
Ethics application status
Date submitted
4/11/2022
Date registered
14/11/2022

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
Active, not 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
Accrual to date
Final
90
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - 0016 - Sydney
Recruitment hospital [2] 0 0
Local Institution - 0017 - Waratah
Recruitment hospital [3] 0 0
Icon Cancer Centre - Chermside - Chermside
Recruitment hospital [4] 0 0
Local Institution - 0015 - 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
Local Institution - 0075 - 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
Indiana
Country [3] 0 0
United States of America
State/province [3] 0 0
Kansas
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
Ohio
Country [7] 0 0
United States of America
State/province [7] 0 0
Tennessee
Country [8] 0 0
United States of America
State/province [8] 0 0
Utah
Country [9] 0 0
United States of America
State/province [9] 0 0
Washington
Country [10] 0 0
Belgium
State/province [10] 0 0
VBR
Country [11] 0 0
Belgium
State/province [11] 0 0
WNA
Country [12] 0 0
Belgium
State/province [12] 0 0
Brussels
Country [13] 0 0
Belgium
State/province [13] 0 0
Liège
Country [14] 0 0
Chile
State/province [14] 0 0
RM
Country [15] 0 0
Chile
State/province [15] 0 0
Santiago
Country [16] 0 0
Chile
State/province [16] 0 0
Temuco
Country [17] 0 0
Israel
State/province [17] 0 0
JM
Country [18] 0 0
Israel
State/province [18] 0 0
Haifa
Country [19] 0 0
Israel
State/province [19] 0 0
Jerusalem
Country [20] 0 0
Israel
State/province [20] 0 0
Ramat Gan
Country [21] 0 0
Israel
State/province [21] 0 0
Tel Aviv-Yafo
Country [22] 0 0
Israel
State/province [22] 0 0
Tel Hashomer
Country [23] 0 0
Italy
State/province [23] 0 0
BO
Country [24] 0 0
Italy
State/province [24] 0 0
MI
Country [25] 0 0
Italy
State/province [25] 0 0
RM
Country [26] 0 0
Italy
State/province [26] 0 0
Brescia
Country [27] 0 0
Japan
State/province [27] 0 0
Akashi, Hyogo
Country [28] 0 0
Japan
State/province [28] 0 0
Akashi
Country [29] 0 0
Japan
State/province [29] 0 0
Chuo-Ku
Country [30] 0 0
Japan
State/province [30] 0 0
Hidaka-shi
Country [31] 0 0
Japan
State/province [31] 0 0
Kurume-Shi
Country [32] 0 0
Japan
State/province [32] 0 0
Tokyo
Country [33] 0 0
Korea, Republic of
State/province [33] 0 0
Goyang-si
Country [34] 0 0
Korea, Republic of
State/province [34] 0 0
Jongno -Gu
Country [35] 0 0
Korea, Republic of
State/province [35] 0 0
Seoul
Country [36] 0 0
Spain
State/province [36] 0 0
B
Country [37] 0 0
Spain
State/province [37] 0 0
M
Country [38] 0 0
Spain
State/province [38] 0 0
V
Country [39] 0 0
Spain
State/province [39] 0 0
Barcelona
Country [40] 0 0
Spain
State/province [40] 0 0
Girona
Country [41] 0 0
Spain
State/province [41] 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
Trial website
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
Clinical.Trials@bms.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
See plan description
Available to whom?
See plan description
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05613088