OncoMatch/Clinical Trials/NCT04606914
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
Is NCT04606914 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies mirvetuximab soravtansine (MIRV; IMGN853) for ovarian cancer.
Treatment: mirvetuximab soravtansine (MIRV; IMGN853) — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Ovarian Cancer
Biomarker criteria
Required: FOLR1 overexpression (PS2+ intensity in >75% of cells)
tumor must be positive for FRα expression as defined by a score of PS2+ intensity in >75% of cells
Disease stage
Required: Stage III, IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic anti-cancer therapy
Patients who have previously been treated with a systemic anti-cancer therapy
Cannot have received: FRα-targeting agent (mirvetuximab soravtansine)
Patients who received prior treatment with MIRV or other FRα-targeting agents
Lab requirements
Blood counts
ANC ≥ 1.5 x 10^9/L (1,500/μL); platelet count ≥ 100 x 10^9/L (100,000/μL) without platelet transfusion in prior 10 days; hemoglobin ≥ 9.0 g/dL
Kidney function
serum creatinine ≤ 1.5 x ULN
Liver function
AST and ALT ≤ 3.0 x ULN; serum bilirubin ≤ 1.5 x ULN (Gilbert syndrome eligible if total bilirubin < 3.0 x ULN); serum albumin ≥ 2 g/dL
adequate hematologic, liver and kidney functions defined as: ANC ≥ 1.5 x 10^9/L (1,500/μL); Platelet count ≥ 100 x 10^9/L (100,000/μL) without platelet transfusion in the prior 10 days; Hemoglobin ≥ 9.0 g/dL; Serum creatinine ≤ 1.5 x ULN; AST and ALT ≤ 3.0 x ULN; Serum bilirubin ≤ 1.5 x ULN (patients with documented diagnosis of Gilbert syndrome are eligible if total bilirubin < 3.0 x ULN); Serum albumin ≥ 2 g/dL
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Alabama at Birmingham Womens & Infants Center · Birmingham, Alabama
- University of California San Francisco · San Francisco, California
- University of Minnesota - Masonic Cancer Center · Minneapolis, Minnesota
- Mayo Clinic · Rochester, Minnesota
- University of Mississippi Medical Center · Oxford, Mississippi
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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