Study of Carboplatin and Mirvetuximab Soravtansine in First-Line Treatment of Patients Receiving Neoadjuvant Chemotherapy With Advanced-Stage Ovarian, Fallopian Tube or Primary Peritoneal Cancer

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT04606914
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • mirvetuximab soravtansine (MIRV; IMGN853) — DRUG
    Mirvetuximab soravtansine (also known as IMGN853 and MIRV) is an antibody-drug conjugate (ADC) that consists of a high affinity humanized monoclonal antibody against folate receptor α (FRα, the protein product of the folate receptor 1 \[FOLR1\] gene) that is conjugated to a cytotoxic maytansinoid by the hindered disulfide succinimidyl 4-(pyridin-2-yl)disulfanyl)-2-sulfo-butyrate linker (sulfo-SPDB) linker. FRα is a glycosyl-phosphatidylinositol (GPI)-linked protein, which shows limited normal tissue expression and high expression on the surface of solid tumors, particularly epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer (referenced herein collectively as EOC), endometrial cancer, non-small cell lung cancer (NSCLC), and renal cell cancer.

Study Details

The proposed study design is a single arm Phase II trial to document the feasibility of carboplatin-mirvetuximab - in patients with advanced-stage EOC. Patients with biopsy confirmed, newly diagnosed, advanced-stage serous EOC deemed appropriate for NACT will have their tumors evaluated for FRα receptor over-expression via a centralized immunohistochemical assay (IHC) and identified as appropriate for study participation if IHC staining is PS2+ in \>75% of cells (40% of all serous patients). Eligible patients will receive NACT with one cycle of carboplatin, followed by mirvetuximab + carboplatin (if FRα +) every 21 days for three cycles prior to interval cytoreductive surgery (iCRS). A total of 70 will be included in the study. Following completion of 4 cycles total of NACT and after allowing for appropriate recovery of cycle # 4, patients eligible for surgery, will undergo an iCRS. Patients will then complete 3 more cycles of mirvetuximab + carboplatin for a total of 7 intended cycles of treatment. It is up to the treating physician if they want to add bevacizumab to the last 2 cycles or use any type of maintenance therapy. The decision to add bevacizumab or use maintenance therapy does not need to be made upfront. Patients will sign a screening consent form prior to tissue biopsy. If a patient is found to be FRα negative, their treating physician can select the treatment they deem appropriate and the patient will be declared a screen failure. Patients with BRCA mutations are not excluded from this trial and are allowed to receive standard of care maintenance therapy including bevacizumab and/or PARP inhibitors.

Key Dates

Start date
May 27, 2021
Status verified
Sep 2025
Primary completion
May 31, 2026
Completion
May 31, 2028

Study Design

Enrollment
70 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: alpha receptor positive_neoadjuvant chemotherapy regimen
    * IV Carboplatin AUC 5 (Q21 days) 7 cycles (first cycle is Carbo alone, dosing for C1D1 will be provider's choice) * IV Mirvetuximab 6 mg/kg (adjusted ideal body weight) day 1 (Q21 days) 6 cycles (starting with cycle #2)
  • No Intervention: Arm B: alpha receptor negative
    If a patient is found to be negative for FRα expression, they will be ineligible to receive the study treatment under the main study (Arm A). FRα negative patients will be enrolled under the biomarker-only arm (Arm B), and their treating physician can select the treatment they deem appropriate.

Primary Outcome Measure

progression free survival (PFS) [ Time Frame: Baseline through 2 years ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
University of Alabama at Birmingham Womens & Infants CenterBirminghamAlabama35233
Rebecca Arend
University of California San FranciscoSan FranciscoCalifornia94158
Jocelyn Chapman, MD
[email protected]
415-353-9600
University of Minnesota - Masonic Cancer CenterMinneapolisMinnesota55455
Britt Erickson, MD
[email protected]
612-676-4200
Mayo ClinicRochesterMinnesota55905
Andrea Hendrickson, MD
[email protected]
507-284-2511
University of Mississippi Medical CenterOxfordMississippi36607
Rodney Rocconi, MD
[email protected]
251-435-2273
Ohio State UniversityColumbusOhio43026
David O'Malley, MD
[email protected]
614-688-9220
University of OklahomaOklahoma CityOklahoma73104
Debra Richardson, MD
[email protected]
405-271-8707
Allegheny Health NetworkPittsburghPennsylvania15224
Thomas Krivack, MD
[email protected]
412-578-1116
University of VirginiaRichmondVirginia23219
Marilyn Huang, MD
[email protected]
434-924-5100

Find similar trials in Birmingham, AL

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
University of Alabama at Birmingham Womens & Infants Center· Birmingham, ALUniversity of California San Francisco· San Francisco, CAUniversity of Minnesota - Masonic Cancer Center· Minneapolis, MNMayo Clinic· Rochester, MNUniversity of Mississippi Medical Center· Oxford, MSOhio State University· Columbus, OH

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