Clinical trial NCT05613088: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: 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
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Eisai Inc.
First posted: 2022-11-14
Enrollment: 106
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per investigator assessment
timeFrame: Up to 2 years
measure: Proportion of participants with treatment related adverse events (TRAEs) leading to study discontinuation
timeFrame: Up to 2 years
Secondary outcomes:
measure: Number of participants with adverse events (AEs)
timeFrame: Up to 2 years
measure: Number of participants with serious adverse events (SAEs)
timeFrame: Up to 2 years
measure: Number of participants with AEs leading to discontinuation
timeFrame: Up to 2 years
measure: Number of participants with TRAEs
timeFrame: Up to 2 years
measure: Number of participants with TRSAEs
timeFrame: Up to 2 years
measure: Number of participants with AEs of special interest (AESIs)
timeFrame: Up to 2 years
measure: Number of deaths
timeFrame: Up to 2 years
measure: Number of participants with laboratory abnormalities
timeFrame: Up to 2 years
measure: Disease control rate (DCR) by RECIST v1.1 per investigator assessment
timeFrame: Up to 2 years
measure: Duration of Response (DoR) by RECIST v1.1 per investigator assessment
timeFrame: Up to 2 years
measure: Progression-free survival (PFS) by RECIST v1.1 per investigator assessment
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Local Institution - 0065
state: California
city: San Francisco
country: United States
facility: Local Institution - 0025
state: California
city: Whittier
country: United States
facility: Local Institution - 0078
state: California
city: South Bend
country: United States
facility: Local Institution - 0081
state: Indiana
city: Kansas City
country: United States
facility: Local Institution - 0043
state: Kansas
city: Canton
country: United States
facility: Local Institution - 0023
state: Ohio
city: Columbus
country: United States
facility: Local Institution - 0061
state: Ohio
city: Nashville
country: United States
facility: Local Institution - 0044
state: Tennessee
city: Salt Lake City
country: United States
facility: Local Institution - 0082
state: Utah
city: Spokane
country: United States
facility: Local Institution - 0042
state: Washington
city: Sydney
country: Australia
facility: Local Institution - 0016
state: New South Wales
city: Waratah
country: Australia
facility: Local Institution - 0017
state: New South Wales
city: Chermside
country: Australia
facility: Local Institution - 0031
state: Queensland
city: Clayton
country: Australia
facility: Local Institution - 0015
state: Victoria
city: Malvern
country: Australia
facility: Local Institution - 0027
state: Victoria
city: Nedlands
country: Australia
facility: Local Institution - 0058
state: Western Australia
city: Leuven
country: Belgium
facility: Local Institution - 0032
state: VBR
city: Namur
country: Belgium
facility: Local Institution - 0013
state: WNA
city: Brussels
country: Belgium
facility: Local Institution - 0012
city: Liège
country: Belgium
facility: Local Institution - 0045
city: Santiago
country: Chile
facility: Local Institution - 0030
state: RM
city: Santiago
country: Chile
facility: Local Institution - 0036
city: Temuco
country: Chile
facility: Local Institution - 0029
city: Jerusaelm
country: Israel
facility: Local Institution - 0046
state: JM
city: Haifa
country: Israel
facility: Local Institution - 0054
city: Jerusalem
country: Israel
facility: Local Institution - 0080
city: Ramat Gan
country: Israel
facility: Local Institution - 0055
city: Tel Aviv-Yafo
country: Israel
facility: Local Institution - 0048
city: Bologna
country: Italy
facility: Local Institution - 0003
state: BO
city: Milano
country: Italy
facility: Local Institution - 0011
state: MI
city: Milano
country: Italy
facility: Local Institution - 0009
state: MI
city: Roma
country: Italy
facility: Local Institution - 0010
state: RM
city: Brescia
country: Italy
facility: Local Institution - 0002
city: Akashi, Hyogo
country: Japan
facility: Local Institution - 0018
city: Chuo-Ku
country: Japan
facility: Local Institution - 0019
city: Hidaka-shi
country: Japan
facility: Local Institution - 0014
city: Kurume-Shi
country: Japan
facility: Local Institution - 0004
city: Tokyo
country: Japan
facility: Local Institution - 0037
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0056
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0049
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0053
city: Barcelona
country: Spain
facility: Local Institution - 0039
state: B
city: Madrid
country: Spain
facility: Local Institution - 0005
state: M
city: Madrid
country: Spain
facility: Local Institution - 0001
state: M
city: Valencia
country: Spain
facility: Local Institution - 0007
state: V
city: Valencia
country: Spain
facility: Local Institution - 0006
state: V
city: Barcelona
country: Spain
facility: Local Institution - 0021
city: Girona
country: Spain
facility: Local Institution - 0020
city: Madrid
country: Spain
facility: Local Institution - 0038
city: Madrid
country: Spain
facility: Local Institution - 0022
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: