Epithelial Ovarian Cancer, Fallopian Tube Cancer, Neoadjuvant, Primary Peritoneal Cancer
Conditions
Keywords
Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer, Neoadjuvant, Interval Debulking Surgery, Mirvetuximab Soravtansine, MIRV, IMGN853, ELAHERE(R), Carboplatin, Bevacizumab
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 neoadjuvant carboplatin and mirvetuximab soravtansine in participants with folate receptor alpha (FRα) -expressing advanced-stage serous epithelial ovarian, fallopian tube or primary peritoneal cancer (EOC). 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). This is a single arm study in adult participants with advanced-stage Fédération Internationale de Gynécologie et d'Obstétrique (FIGO) III-IV FRα-expressing serous EOC. Around 140 participants will be enrolled in the study at approximately 80 sites in the United States. Participants will receive intravenous infusion of MIRV in combination with carboplatin on day 1 of each cycle, every 21 days for up to 6 - 9 Cycles. The total study duration will be approximately 3 years . 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
DRUGCarboplatin
Intravenous (IV) infusion
DRUGMirvetuximab Soravtansine
Intravenous (IV) infusion
DRUGBevacizumab
Intravenous (IV) infusion (per investigator's discretion)
Sponsors
AbbVie
GOG Foundation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2. * Be judged by the investigator and/or treating physician to be an appropriate candidate to receive neoadjuvant chemotherapy. * Diagnosis of biopsy-confirmed high-grade, serous epithelial ovarian, fallopian tube or primary peritoneal cancer. * Participant meets the following disease criteria: * Stage III or IV disease by the Fédération Internationale de Gynécologie et d'Obstétrique (FIGO) staging system, and * Folate Receptor Alpha (FRα) expression positivity as defined by immunohistochemical staining of \>= 75% of viable tumor cells with moderate \>= 2+ membrane staining by the Ventana Folate Receptor Alpha (VENTANA FOLR1) assay, FOLR1 Eligibility Testing - Ventana FOLR1 (FOLR1-2.1) RxDx - Commercial or Central, and * Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria.
Exclusion criteria
* Endometrioid, clear cell, mucinous, or sarcomatous tumor histology; mixed tumors containing any of the above histologies; or low-grade/borderline ovarian tumor. * Previous clinical diagnosis of noninfectious interstitial lung disease, including noninfectious pneumonitis. * Previously treated with anticancer therapy including chemotherapy, radiation therapy, immunotherapy, or biologic agent for current cancer, with the exception of one cycle of single agent carboplatin * Participants with the following ocular history and/or concurrent disorders: * History of corneal transplantation; * Undergoing active postoperative management for refractive surgery, cataract surgery, corneal cross-linking, or corneal complications of surgery; * Confluent superficial punctate keratopathy (SPK) not expected to resolve to non-confluence or better within the screening window with standard of care (SOC) intervention; * Active or chronic clinically significant (\>= Grade 3) corneal dystrophy (e.g., Fuchs dystrophy); * Active ocular conditions requiring ongoing treatment/monitoring, such as glaucoma, which is not adequately controlled with medication or surgery, wet age-related macular degeneration requiring intravitreal injections, active diabetic retinopathy with macular edema, macular degeneration, presence of papilledema or an ocular condition with high risk of retinal detachment; * Monocular vision with visual acuity in the worse eye, worse than 20/200 or visual fields less than 20 degrees (i.e., functional blindness in at least one eye). * History of other malignancy within 3 years prior to signing study consent. -- Note: Participants with tumors with a negligible risk for metastasis or death (e.g., adequately controlled basal-cell carcinoma or squamous-cell carcinoma of the skin, or carcinoma in situ of the cervix or breast) are eligible.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response (OR) by Independent Central Review (ICR) | Up to Approximately 3 years | OR is defined as the best overall response of radiographic complete response (CR) or partial response (PR) as assessed by ICR using RECIST Version 1.1 criteria, prior to any subsequent anticancer therapy, including interval debulking surgery (IDS). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants with Adverse Events (AE) | Up to Approximately 3 years | An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with the treatment. The investigator assesses the relationship of each event to the use of study drug. |
| Percentage of Participants with AEs leading to study drug discontinuation or dose modification | Up to Approximately 3 years | An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with the treatment. The investigator assesses the relationship of each event to the use of study drug. |
| Objective Response (OR) by Investigator | Up to Approximately 3 years | OR is defined as the best overall response of radiographic CR or PR as assessed by investigator using RECIST Version 1.1 criteria, prior to any subsequent anticancer therapy, including IDS. |
| Disease Control by ICR | Up to Approximately 3 years | Disease control defined as CR, PR, or stable disease (SD) as assessed by ICR per RECIST Version 1.1 prior to subsequent anticancer therapy including IDS. |
| Disease control by Investigator | Up to Approximately 3 years | Disease control defined as CR, PR, or stable disease (SD) as assessed by investigator per RECIST Version 1.1 prior to subsequent anticancer therapy including IDS. |
| Percentage of Participants With CA-125 Confirmed Response Per Gynecologic Cancer Intergroup (GCIG) Criteria | Up to Approximately 3 years | The GCIG CA-125 response was defined as at least 50% reduction in CA-125. |
| Progression-Free Survival (PFS) by investigator | Up to Approximately 3 years | PFS by investigator, defined as the time from the date of C1D1 until PD per RECIST v1.1 as assessed by investigator or death from any cause, whichever occurs first. |
| Percentage of Participants that Underwent Interval debulking surgery (IDS) | Up to Approximately 3 years | Percentage of participants that underwent IDS during the course of the study treatment |
| Percentage of participants with complete tumor cytoreduction at IDS | Up to Approximately 3 years | Complete tumor cytoreduction is defined as the absence of macroscopically visible residual disease at the end of the surgery |
| Percentage of participants with Incomplete Tumor Cytoreduction at IDS | Up to Approximately 3 years | Defined as macroscopically visible residual tumor (≤ 1 cm or \> 1cm) at the end of surgery. |
| Change from baseline in disease-related symptoms as measured by the NCCN-FACT Ovarian Symptom Index (NFOSI-18) disease symptom subscale - physical (DRS-P) | Up to Approximately 3 years | The NFOSI-18 provides a total score that sums all 18 items, plus 2 multi-item scales that assess physical disease-related symptoms (DRS-P; 9 items) and general function/well-being (F/WB; 3 items). |
Countries
United States
Contacts
CONTACTABBVIE CALL CENTER
STUDY_DIRECTORABBVIE INC.
AbbVie
Outcome results
None listed