Neoplasms, Ovarian Clinical Trial
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
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.
| Status | Recruiting |
| Enrollment | 90 |
| Est. completion date | October 11, 2026 |
| Est. primary completion date | June 5, 2024 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility | 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. 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. |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Icon Cancer Centre - Chermside | Chermside | Queensland |
| Australia | Monash Medical Centre Clayton | Clayton | Victoria |
| Australia | Cabrini Hospital - Malvern | Malvern | Victoria |
| Australia | Sir Charles Gairdner Hospital | Nedlands | Western Australia |
| Australia | Sir Charles Gairdner Hospital (SCGH) - WA Cancer Centre | Perth | Western Australia |
| Australia | GenesisCare - North Shore | Sydney | New South Wales |
| Australia | Calvary Mater Newcastle | Waratah | New South Wales |
| Belgium | Local Institution - 0012 | Brussels | |
| Belgium | Local Institution - 0033 | Hasselt | |
| Belgium | Local Institution - 0032 | Leuven | VBR |
| Belgium | Local Institution - 0045 | Liège | |
| Belgium | Local Institution - 0013 | Namur | WNA |
| Chile | Local Institution - 0030 | Santiago | RM |
| Chile | Local Institution - 0059 | Santiago | Metropolitana |
| Chile | Oncovida - Santiago | Santiago | |
| Chile | Local Institution - 0029 | Temuco | |
| Chile | Local Institution - 0060 | Vina del Mar | Valparaiso |
| Chile | Local Institution - 0071 | Vina Del Mar | Valparaiso |
| Israel | Local Institution - 0054 | Haifa | |
| Israel | Local Institution - 0046 | Jerusaelm | JM |
| Israel | Local Institution - 0080 | Jerusalem | |
| Israel | Local Institution - 0055 | Ramat Gan | |
| Israel | Local Institution - 0048 | Tel Aviv-Yafo | |
| Israel | Local Institution - 0068 | Tel Hashomer | |
| Israel | Local Institution - 0047 | Tel-Aviv | Tel Aviv |
| Italy | Local Institution - 0003 | Bologna | BO |
| Italy | Local Institution - 0002 | Brescia | |
| Italy | Local Institution - 0009 | Milano | MI |
| Italy | Local Institution - 0011 | Milano | MI |
| Italy | Local Institution - 0010 | Roma | RM |
| Italy | Local Institution - 0008 | Torino | TO |
| Japan | Local Institution - 0079 | Akashi | |
| Japan | Hyogo Cancer Center | Akashi, Hyogo | |
| Japan | Local Institution - 0019 | Chuo-Ku | |
| Japan | Local Institution - 0014 | Hidaka-shi | |
| Japan | Local Institution - 0004 | Kurume-Shi | |
| Japan | Local Institution - 0037 | Tokyo | |
| Korea, Republic of | Local Institution - 0064 | Goyang-si | |
| Korea, Republic of | Local Institution - 0074 | Goyang-si | |
| Korea, Republic of | Seoul National University Hospital | Jongno -Gu | |
| Korea, Republic of | Asan Medical Center (AMC) | Seoul | |
| Korea, Republic of | Local Institution - 0056 | Seoul | |
| Korea, Republic of | Local Institution - 0057 | Seoul | |
| Korea, Republic of | Local Institution - 0066 | Seoul | |
| Korea, Republic of | Yonsei University Health System, Severance Hospital | Seoul | |
| Spain | Local Institution - 0021 | Barcelona | |
| Spain | Local Institution - 0039 | Barcelona | B |
| Spain | Local Institution - 0020 | Girona | |
| Spain | Hospital General Universitario Gregorio Marañón | Madrid | M |
| Spain | Local Institution - 0001 | Madrid | M |
| Spain | Local Institution - 0022 | Madrid | |
| Spain | Local Institution - 0038 | Madrid | |
| Spain | Local Institution - 0006 | Valencia | V |
| Spain | Local Institution - 0007 | Valencia | V |
| United States | Local Institution - 0051 | Aurora | Colorado |
| United States | Local Institution - 0035 | Bronx | New York |
| United States | Local Institution - 0067 | Bronx | New York |
| United States | Local Institution - 0023 | Canton | Ohio |
| United States | Local Institution - 0028 | Chapel Hill | North Carolina |
| United States | Local Institution - 0052 | Chicago | Illinois |
| United States | Local Institution - 0076 | Columbus | Ohio |
| United States | Zangmeister Cancer Center | Columbus | Ohio |
| United States | Local Institution - 0050 | Dallas | Texas |
| United States | Local Institution - 0024 | Gainesville | Florida |
| United States | Corewell Health | Grand Rapids | Michigan |
| United States | Local Institution - 0041 | Grand Rapids | Michigan |
| United States | Local Institution - 0043 | Kansas City | Kansas |
| United States | Local Institution - 0044 | Nashville | Tennessee |
| United States | Columbia University Medical Center - Herbert Irving Pavilion Location | New York | New York |
| United States | Local Institution - 0026 | New York | New York |
| United States | Local Institution - 0062 | New York | New York |
| United States | Local Institution - 0063 | New York | New York |
| United States | Local Institution - 0073 | New York | New York |
| United States | Local Institution - 0040 | Orange | California |
| United States | UC Davis Comprehensive Cancer Center | Sacramento | California |
| United States | UC Davis Comprehensive Cancer Center | Sacramento | California |
| United States | Local Institution - 0034 | Saint Louis | Missouri |
| United States | Local Institution - 0082 | Salt Lake City | Utah |
| United States | California Pacific Medical Center (CPMC) - Research Institute | San Francisco | California |
| United States | Local Institution - 0081 | South Bend | Indiana |
| United States | Providence Sacred Heart Medical Center & Children's Hospital | Spokane | Washington |
| United States | Local Institution - 0078 | Whittier | California |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb | Eisai Inc. |
United States, Australia, Belgium, Chile, Israel, Italy, Japan, Korea, Republic of, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per investigator assessment | Up to 2 years | ||
| Primary | Proportion of participants with treatment related adverse events (TRAEs) leading to study discontinuation | Up to 2 years | ||
| Secondary | Number of participants with adverse events (AEs) | Up to 2 years | ||
| Secondary | Number of participants with serious adverse events (SAEs) | Up to 2 years | ||
| Secondary | Number of participants with AEs leading to discontinuation | Up to 2 years | ||
| Secondary | Number of participants with TRAEs | Up to 2 years | ||
| Secondary | Number of participants with TRSAEs | Up to 2 years | ||
| Secondary | Number of participants with AEs of special interest (AESIs) | Up to 2 years | ||
| Secondary | Number of deaths | Up to 2 years | ||
| Secondary | Number of participants with laboratory abnormalities | Up to 2 years | ||
| Secondary | Disease control rate (DCR) by RECIST v1.1 per investigator assessment | Up to 2 years | ||
| Secondary | Duration of Response (DoR) by RECIST v1.1 per investigator assessment | Up to 2 years | ||
| Secondary | Progression-free survival (PFS) by RECIST v1.1 per investigator assessment | Up to 2 years |
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