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
- Conditions
- Neoplasms, Ovarian
- Interventions
- Registration Number
- NCT05613088
- Lead Sponsor
- Bristol-Myers Squibb
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 90
- 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.
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MORAb-202 MORAb-202 - Investigator's Choice Chemotherapy Paclitaxel - Investigator's Choice Chemotherapy Pegylated Liposomal Doxorubicin (PLD) - Investigator's Choice Chemotherapy Topotecan -
- Primary Outcome Measures
Name Time Method Objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per investigator assessment Up to 2 years Proportion of participants with treatment related adverse events (TRAEs) leading to study discontinuation Up to 2 years
- Secondary Outcome Measures
Name Time Method Number of participants with adverse events (AEs) Up to 2 years Number of participants with serious adverse events (SAEs) Up to 2 years Number of participants with AEs leading to discontinuation Up to 2 years Number of deaths Up to 2 years Number of participants with laboratory abnormalities Up to 2 years Number of participants with TRAEs Up to 2 years Duration of Response (DoR) by RECIST v1.1 per investigator assessment Up to 2 years Number of participants with TRSAEs Up to 2 years Number of participants with AEs of special interest (AESIs) Up to 2 years Disease control rate (DCR) by RECIST v1.1 per investigator assessment Up to 2 years Progression-free survival (PFS) by RECIST v1.1 per investigator assessment Up to 2 years
Trial Locations
- Locations (50)
Local Institution - 0065
🇺🇸Sacramento, California, United States
Local Institution - 0025
🇺🇸San Francisco, California, United States
Local Institution - 0061
🇺🇸Columbus, Ohio, United States
Local Institution - 0042
🇺🇸Spokane, Washington, United States
Local Institution - 0031
🇦🇺Chermside, Queensland, Australia
Local Institution - 0027
🇦🇺Malvern, Victoria, Australia
Local Institution - 0058
🇦🇺Nedlands, Western Australia, Australia
Local Institution - 0036
🇨🇱Santiago, Chile
Local Institution - 0055
🇮🇱Ramat Gan, Israel
Local Institution - 0018
🇯🇵Akashi, Hyogo, Japan
Local Institution - 0056
🇰🇷Seoul, Korea, Republic of
Local Institution - 0005
🇪🇸Madrid, M, Spain
Local Institution - 0078
🇺🇸Whittier, California, United States
Local Institution - 0081
🇺🇸South Bend, Indiana, United States
Local Institution - 0043
🇺🇸Kansas City, Kansas, United States
Local Institution - 0023
🇺🇸Canton, Ohio, United States
Local Institution - 0044
🇺🇸Nashville, Tennessee, United States
Local Institution - 0082
🇺🇸Salt Lake City, Utah, United States
Local Institution - 0016
🇦🇺Sydney, New South Wales, Australia
Local Institution - 0017
🇦🇺Waratah, New South Wales, Australia
Local Institution - 0015
🇦🇺Clayton, Victoria, Australia
Local Institution - 0032
🇧🇪Leuven, VBR, Belgium
Local Institution - 0013
🇧🇪Namur, WNA, Belgium
Local Institution - 0012
🇧🇪Brussels, Belgium
Local Institution - 0045
🇧🇪Liège, Belgium
Local Institution - 0030
🇨🇱Santiago, RM, Chile
Local Institution - 0029
🇨🇱Temuco, Chile
Local Institution - 0046
🇮🇱Jerusaelm, JM, Israel
Local Institution - 0054
🇮🇱Haifa, Israel
Local Institution - 0080
🇮🇱Jerusalem, Israel
Local Institution - 0048
🇮🇱Tel Aviv-Yafo, Israel
Local Institution - 0003
🇮🇹Bologna, BO, Italy
Local Institution - 0011
🇮🇹Milano, MI, Italy
Local Institution - 0009
🇮🇹Milano, MI, Italy
Local Institution - 0010
🇮🇹Roma, RM, Italy
Local Institution - 0002
🇮🇹Brescia, Italy
Local Institution - 0019
🇯🇵Chuo-Ku, Japan
Local Institution - 0014
🇯🇵Hidaka-shi, Japan
Local Institution - 0004
🇯🇵Kurume-Shi, Japan
Local Institution - 0037
🇯🇵Tokyo, Japan
Local Institution - 0049
🇰🇷Seoul, Korea, Republic of
Local Institution - 0053
🇰🇷Seoul, Korea, Republic of
Local Institution - 0039
🇪🇸Barcelona, B, Spain
Local Institution - 0001
🇪🇸Madrid, M, Spain
Local Institution - 0007
🇪🇸Valencia, V, Spain
Local Institution - 0006
🇪🇸Valencia, V, Spain
Local Institution - 0021
🇪🇸Barcelona, Spain
Local Institution - 0020
🇪🇸Girona, Spain
Local Institution - 0038
🇪🇸Madrid, Spain
Local Institution - 0022
🇪🇸Madrid, Spain