Clinical trial NCT06890338: A Study to Assess Anti-Tumor Activity of Intravenously (IV) Infused Carboplatin With Mirvetuximab Soravtansine in Participants With Newly Diagnosed Folate Receptor Alpha (FRα)Expressing Advanced-Stage Serous Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer.
Official title: A Single-Arm, Phase 2 Study of Neoadjuvant Carboplatin and Mirvetuximab Soravtansine in Subjects With FRα-Expressing Advanced-Stage Serous Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Epithelial Ovarian Cancer
Fallopian Tube Cancer
Primary Peritoneal Cancer
Neoadjuvant
Keywords: Epithelial Ovarian Cancer
Fallopian Tube Cancer
Primary Peritoneal Cancer
Neoadjuvant
Interval Debulking Surgery
Mirvetuximab Soravtansine
MIRV
IMGN853
ELAHERE(R)
Carboplatin
Bevacizumab
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
Collaborators: name: GOG Foundation
First posted: 2025-03-24
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* 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, 27 and
  * Folate Receptor Alpha (FRα) expression positivity as defined by immunohistochemical staining of \>= 75% of viable tumor cells with moderate (2+) and/or strong (3+) membrane staining by the AbbVie specified vendor with the Ventana Folate Receptor Alpha (FOLR1) assay, 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 (exception: Grade 1 noninfectious pneumonitis diagnosed on or within 6 weeks after treatment with an immunotherapeutic agent that has resolved per investigator or resolution of the radiologic findings).
* 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.

Primary outcomes:
measure: Objective Response (OR) by Independent Central Review (ICR)
timeFrame: Up to Approximately 3 years
Secondary outcomes:
measure: Percentage of Participants with Adverse Events (AE)
timeFrame: Up to Approximately 3 years
measure: Percentage of Participants with AEs leading to study drug discontinuation or dose modification
timeFrame: Up to Approximately 3 years
measure: Objective Response (OR) by Investigator
timeFrame: Up to Approximately 3 years
measure: Disease Control by ICR
timeFrame: Up to Approximately 3 years
measure: Disease control by Investigator
timeFrame: Up to Approximately 3 years
measure: Percentage of Participants With CA-125 Confirmed Response Per Gynecologic Cancer Intergroup (GCIG) Criteria
timeFrame: Up to Approximately 3 years
measure: Progression-Free Survival (PFS) as assessed by investigator
timeFrame: Up to Approximately 3 years
measure: Percentage of Participants that Underwent Interval debulking surgery (IDS)
timeFrame: Up to Approximately 3 years
measure: Percentage of participants with Grossly complete tumor cytoreduction at IDS
timeFrame: Up to Approximately 3 years
measure: Percentage of participants with Near-Complete Tumor Cytoreduction at IDS
timeFrame: Up to Approximately 3 years
measure: Time to deterioration in disease-related symptoms as measured by the NCCN-FACT Ovarian Symptom Index (NFOSI-18) disease symptom subscale - physical (DRS-P)
timeFrame: Up to Approximately 3 years
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: