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 (Jun 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
Treatments studied
Targeted therapy
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)
Demographics
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 →Frequently asked questions
Is NCT04606914 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require FOLR1?
Yes, FOLR1 overexpression is a required biomarker for enrollment.
What disease stage is eligible?
Stage III or IV is required.
Is this trial open to male patients?
No. This trial enrolls female patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify