Advanced High-Grade Epithelial Ovarian Cancer, Fallopian Tube Cancers, Primary Peritoneal Cancer
Conditions
Keywords
Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, Fallopian Tube Cancers, High Folate Receptor-Alpha Expression, Platinum Resistant, Mirvetuximab Soravtansine, MIRV, IMGN853
Brief summary
Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess the safety and efficacy of for Mirvetuximab Soravtansine in participants with platinum-resistant advanced high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancer (platinum-resistant ovarian cancer) (PROC) whose tumors express a high level of folate receptor alpha (FRα). Mirvetuximab Soravtansine (MIRV) is an investigational antibody drug conjugate designed to selectively kill cancer cells. The antibody (protein) part of MIRV targets tumors by delivering a cell-killing drug to cancer cells carrying a protein called folate receptor alpha (FRα). There are 2 cohorts in this study, the Randomized Phase 2 Cohort and the Hepatic Impairment Cohort. In the Randomized Phase 2 Cohort, participants are placed in 1 of 2 groups, called treatment arms. Each treatment arm receives MIRV on a different schedule (on day 1 every 21 days or on days 1 and 15 every 28 days). The Hepatic Impairment Cohort is designed to determine the starting dose of MIRV in patients with moderately abnormal liver function. Around 110 participants will be enrolled in the study at approximately 75 sites worldwide. The total study duration will be approximately 24 months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and scans.
Interventions
DRUGMirvetuximab Soravtansine
intravenous (IV) infusion
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Both Cohorts * Participants with a confirmed diagnosis of high-grade serous epithelial ovarian cancer (EOC), primary peritoneal cancer, or fallopian tube cancer. * Participants with platinum-resistant disease: * Participants with 1 prior line of platinum-based therapy who have received ≥ 4 cycles of platinum and had a response (complete response (CR) or partial response (PR)) followed by radiological progressive disease (PD) between \> 3 months and ≤ 6 months after the date of the last dose of platinum. * Participants with 2 or 3 prior lines of platinum-based therapy who had radiological PD ≤ 6 months after the date of the last dose of platinum. * Participants with progression diagnosed radiographically on or after their most recent line of therapy. * Participants with an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1. * Participants with ≥ 1 lesion that meets the definition of measurable disease by RECIST v1.1 (radiologically measured by the investigator). * Participants with a tumor that is positive for folate receptor alpha (FRα) expression as determined by the Ventana folate receptor 1 (FOLR1) assay (≥ 75% of tumor staining at 2+ intensity).
Exclusion criteria
Both Cohorts * Participants with endometrioid, clear cell, mucinous, or sarcomatous histology; mixed tumors containing any of the above histologies; or low-grade or borderline ovarian tumor. * Participants with primary platinum-refractory disease, defined as disease that did not respond (complete response (CR) or partial response (PR)) or that progressed radiographically within 3 months of the last dose of first-line platinum-containing chemotherapy. * Participants with serious concurrent illness or clinically relevant active infection as outlined in the protocol * Participants with a history of hemorrhagic or ischemic stroke within 6 months prior to randomization.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Randomized Phase 2 Cohort: Percentage of Participants with Grade >= 2 Treatment-Emergent Corneal Adverse Events (AEs) | Up to Approximately 24 months | An AE is any noxious, pathologic, or unintended change in anatomical, physiologic, or metabolic function as indicated by physical signs, symptoms, or laboratory changes occurring in any phase of a clinical study, whether or not considered study drug related. |
| Randomized Phase 2 Cohort: Percentage of Participants who Achieved Objective response rate (ORR) | Up to Approximately 24 months | ORR is defined as best response of confirmed complete response (CR) or partial response (PR), as assessed by the Investigator according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). |
| Hepatic Impairment Cohort: Maximal Concentration (Cmax) of Mirvetuximab Soravtansine | Up to Approximately 24 months | Cmax of MIRV |
| Hepatic Impairment Cohort: Area Under the Plasma Concentration (AUC) of Mirvetuximab Soravtansine | Up to Approximately 24 months | AUC of MIRV |
| Hepatic Impairment Cohort: Trough Concentration (Ctrough) of Mirvetuximab Soravtansine | Up to Approximately 24 months | Ctrough of MIRV |
| Hepatic Impairment Cohort: Volume of Distribution at Steady State (Vss) of Mirvetuximab Soravtansine | Up to Approximately 24 months | Vss) of MIRV |
| Hepatic Impairment Cohort: Time to Maximal Concentration (Tmax) of Mirvetuximab Soravtansine | Up to Approximately 24 months | Tmax of MIRV |
| Hepatic Impairment Cohort: Terminal Half-Life (t1/2) of Mirvetuximab Soravtansine | Up to Approximately 24 months | t1/2 of MIRV |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Randomized Phase 2 Cohort: Percentage of Participants with Treatment-Emergent All-Grade Ocular AEs, Grade >= 2 Peripheral Neuropathy, All-Grade Infusion Reactions, and All-Grade Pneumonitis | Up to Approximately 24 months | An AE is any noxious, pathologic, or unintended change in anatomical, physiologic, or metabolic function as indicated by physical signs, symptoms, or laboratory changes occurring in any phase of a clinical study, whether or not considered study drug related. |
| Randomized Phase 2 Cohort: Duration of Response (DOR) as Assessed by the Investigator Using RECIST v1.1 | Up to Approximately 24 months | Defined as the time from initial investigator-assessed response (complete response (CR) or partial response (PR)) until progressive disease (PD) as assessed by the investigator or death, whichever occurs first. |
| Randomized Phase 2 Cohort: Progression-Free Survival (PFS) | Up to Approximately 24 months | PFS is defined as the time from date of randomization until disease progression or death whichever occurs first. |
| Randomized Phase 2 Cohort: Overall Survival (OS) | Up to Approximately 24 months | Overall survival is defined as the time from the date of first dose until the date of death from any cause. |
| Randomized Phase 2 Cohort: Percentage of Participants With CA-125 Confirmed Clinical Response Per Gynecologic Cancer Intergroup (GCIG) Criteria | Up to Approximately 24 months | The GCIG CA-125 response is defined as at least 50% reduction in CA-125 levels from baseline. The response must be confirmed and maintained for at least 28 days. |
| Randomized Phase 2 Cohort: Maximal Concentration (Cmax) of Mirvetuximab Soravtansine | Up to Approximately 24 months | Cmax of MIRV |
| Randomized Phase 2 Cohort: Area Under the Plasma Concentration (AUC) of Mirvetuximab Soravtansine | Up to Approximately 24 months | (AUC) of MIRV |
| Randomized Phase 2 Cohort: Trough Concentration (Ctrough) of Mirvetuximab Soravtansine | Up to Approximately 24 months | Ctrough of MIRV |
| Randomized Phase 2 Cohort: Volume of Distribution at Steady State (Vss) of Mirvetuximab Soravtansine | Up to Approximately 24 months | Vss of MIRV |
| Randomized Phase 2 Cohort: Time to Maximal Observed Concentration (Tmax) of Mirvetuximab Soravtansine | Up to Approximately 24 months | Tmax of MIRV |
| Randomized Phase 2 Cohort: Terminal Half-Life (t1/2) of Mirvetuximab Soravtansine | Up to Approximately 24 months | t1/2 of MIRV |
| Both Cohorts: Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Up to Approximately 24 months | An AE is any noxious, pathologic, or unintended change in anatomical, physiologic, or metabolic function as indicated by physical signs, symptoms, or laboratory changes occurring in any phase of a clinical study, whether or not considered study drug related. |
| Both Cohorts: Percentage of Participants with Clinically Significant Vital Sign Measurements as Assessed by the Investigator | Up to Approximately 24 months | Vital signs include blood pressure, heart rate, respiratory rate, and body temperature. |
| Both Cohorts: Percentage of Participants with Clinically Significant Laboratory Values (test) as Assessed by the Investigator | Up to Approximately 24 months | Percentage of participants with clinically significant laboratory values (hematology, chemistry, and coagulation) as assessed by the investigator. |
| Both Cohorts: Number of Participants With Clinically Significant Abnormalities in Physical Examination Findings | Up to Approximately 24 months | Physical examination included assessments of general appearance, skin, head (eyes, ears, nose, and throat), neck, lungs, heart, abdomen, back, lymph nodes, extremities, and neurological system. |
Countries
Australia, Belgium, France, Poland, South Korea, Spain, United Kingdom, United States
Contacts
CONTACTABBVIE CALL CENTER
STUDY_DIRECTORABBVIE INC.
AbbVie
Outcome results
None listed