Ovarian Cancer, Peritoneal Cancer and Fallopian Tube Cancer
Conditions
Interventions
Arm 1: Mirvetuximab Soravtansine (MIRV) plus Bevacizumab
Participants will receive MIRV 6.0 mg/kg adjusted ideal body weight (AIBW) plus Bevacizumab 15mg/kg every 3 weeks
Arm 2: Bevacizumab monothera
Sponsors
Fukunaga Shinichi
AbbVie
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1.Adult women >=18 years old 2.Confirmed diagnosis of high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer 3.Confirmed high FRalfa expression by regulatory-agency approved Ventana FOLR1 (FOLR1-2.1) 4.Relapsed disease after frontline (first-line) platinum-based chemotherapy and must be plantinum-sensitive 5.Willing and able to sign the informed consent form (ICF) and adhere to protocol requirements 6.Negative pregnancy test and willing to use highly effective contraceptive method(s) while on study medication and for at least 7 months after the last dose of MIRV and 6 months after the last dose of bevacizumab
Exclusion criteria
Exclusion criteria: 1.Endometrioid, clear cell, mucinous, or sarconmatous histology; mixed tumors containing any of the above or low grade/borderline ovarian tumor 2.More than one line of prior chemotherapy before current/planned triplet therapy 3.PD (progressive disease) while on or following platinum-based therapy 4.Prior or whole-pelvis or wide-field radiotherapy 5.> Grade 1 peripheral neuropathy 6.History of or concurrent ocular disorders 7.Grade 4 thromboembolic events 8.Not appropriate for bevacizumab treatment 9.Requiring use of folate-containing supplements 10.Prior hypersensitivity to monoclonal antibodies 11.Pregnant or breatfeeding women 12.Received prior MIRV or other FRalfa-targeting agents 13.Untreated or symptomatic central nervous system metastases 14.History of other malignancy within 3 years prior to signing study consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Assess Progression-free survival (PFS) Time Frame: Up to 4 years Progression-free survival defined as assessed by BICR per RECIST v1.1, defined as the time from date of randomization until BICR -assessed PD or death due to any cause, whichever occurs first. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Assess Overall survival (OS) Time Frame: Up to 10 years Overall survival (OS), defined as the time from randomization to death 2.Assess Safety and tolerability Time Frame: Up to 10 years Adverse events (AEs) will be evaluated according to the NCI CTCAE v5 3.Assess time to second disease progression (PFS2) Time Frame: Up to 10 years Second disease progression (PFS2) defined as the time from date of randomization until second disease progression or death, whichever occurs first 4.Assess Objective Response Rate (ORR) Time Frame: Up to 10 years Objective response includes best response of complete response (CR) or partial response (PR). 5.Assess Duration of response (DOR) Time Frame: Up to 10 years DOR as assessed by the investigator and by BICR in patients who have measurable disease per RECIST v1.1 at randomization and achieved a confirmed response of CR or PR after maintenance therapy 6.Assess Disease-free survival (DFS) Time Frame: Up to 10 years DOR as assessed by the investigator and by BICR in patients who have no measurable disease per RECIST v1.1 at randomization 7.CA-125 response Time Frame: Up to 10 years Serum CA-125 response determined using the GCIG criteria 8.Patient-reported outcome health-related quality of life (HRQoL) of disease-related symptoms using the NCCN-FACT Ovarian Symptom Index (NFOSI-18) DRS-P (disease-related symptom subscale - physical). Time Frame: Up to 10 years A questionnaire assessing the health of patients with ovarian cancer. | — |
Countries
Argentina, Australia, Belgium, Bulgaria, Canada, China, Czechia, France, Germany, Greece, Ireland, Israel, Italy, Japan, Korea, Philippines, Poland, Spain, Sweden, Turkey, United Kingdom, United States
Contacts
Public ContactContact for Clinical Trial Information
Takeda Pharmaceutical Company Limited
Outcome results
None listed