Single-Arm Phase II 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 Who Are Folate Receptor α Positive

Who is this study for? Patients with Endometrial Cancer
Status: Recruiting
Location: See all (9) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients must have biopsy-confirmed high grade serous epithelial ovarian cancer.

• Patients must present with stage III or IV disease and be appropriate to receive neoadjuvant chemotherapy

• Patients must be willing to provide an archival tumor tissue block or slides, or undergo procedure to obtain a new biopsy using a low-risk, medically routine procedure for immunohistochemistry (IHC) confirmation of FRα positivity

• Patients must have a performance status of 0 or 1.

• Patient's tumor must be positive for FRα expression as defined by a score of PS2+ intensity in \>75% of cells

• Patients must have adequate hematologic, liver and kidney functions defined as:

• Absolute neutrophil count (ANC) ≥ 1.5 x 109/L (1,500/μL)

• Platelet count ≥ 100 x 109/L (100,000/μL) without platelet transfusion in the prior 10 days

• Hemoglobin ≥ 9.0 g/dL

• Serum creatinine ≤ 1.5 x upper limit of normal (ULN)

• Aspartate aminotransferase (AST) and alanine aminotransferase (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

• Patients must be willing and able to sign the informed consent form (ICF) and to adhere to the protocol requirements

• Women of childbearing potential (WCBP) must agree to use highly effective contraceptive method(s) (as defined in Section 5.8.6 while on MIRV and for at least 4 months after the last dose

• WCBP must have a negative pregnancy test within the 4 days prior to the first dose of MIRV

Locations
United States
Alabama
University of Alabama at Birmingham Womens & Infants Center
RECRUITING
Birmingham
California
University of California San Francisco
RECRUITING
San Francisco
Minnesota
University of Minnesota - Masonic Cancer Center
RECRUITING
Minneapolis
Mayo Clinic
RECRUITING
Rochester
Mississippi
University of Mississippi Medical Center
RECRUITING
Oxford
Ohio
Ohio State University
RECRUITING
Columbus
Oklahoma
University of Oklahoma
RECRUITING
Oklahoma City
Pennsylvania
Allegheny Health Network
RECRUITING
Pittsburgh
Virginia
University of Virginia
RECRUITING
Richmond
Contact Information
Primary
Rebecca Arend, M.D.
rarend@uabmc.edu
205-934-4986
Time Frame
Start Date: 2021-05-27
Estimated Completion Date: 2028-05-31
Participants
Target number of participants: 70
Treatments
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.
Sponsors
Leads: University of Alabama at Birmingham

This content was sourced from clinicaltrials.gov