A Single-Arm, Phase 2 Study of Neoadjuvant Carboplatin and Mirvetuximab Soravtansine in Subjects with FRa-Expressing Advanced-Stage Serous Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer
Investigational Study for Advanced Ovarian Cancer Treatment
Jessica Parker Metter
Primary Investigator
Brief description of study
Primary: The primary objective of the study is to evaluate the anti-tumor activity of carboplatin + MIRV in newly diagnosed subjects with advanced-stage FRa-expressing (greater than or equal to 75%, greater than or equal to 2+) serous EOC as measured by RECIST v1.1 imaging response. The clinical hypothesis is that the combination of carboplatin and MIRV will be as efficacious as (or more efficacious than) standard of care platinum-based doublet chemotherapy (e.g., carboplatin and paclitaxel) with potentially less toxicity.
Secondary - To further evaluate the anti-tumor activity of carboplatin + MIRV in newly diagnosed subjects with advanced-stage FRa-expressing (greater than or equal to 75%, greater than or equal to 2+) serous EOC as measured by RECIST v1.1 imaging response and CA-125 response. - To assess the proportion of newly diagnosed subjects with advanced-stage FRa-expressing (greater than or equal to 75%, greater than or equal to 2+) serous EOC for whom IDS is feasible after 3-6 cycles of carboplatin + MIRV, and to define the proportion of these subjects with a favorable surgical outcome, as defined by complete (R0) and near-complete (less than or equal to 1 cm residual) resection. - To evaluate the safety and tolerability of neoadjuvant carboplatin + MIRV in newly diagnosed subjects with advanced-stage FRa-expressing (greater than or equal to 75%, greater than or equal to 2+) serous EOC. - To assess PFS in newly diagnosed subjects with advanced-stage FRa-expressing (greater than or equal to 75%, greater than or equal to 2+) serous EOC treated with neoadjuvant carboplatin + MIRV, IDS if feasible, ± postoperative bevacizumab, ± optional standard-of-care maintenance therapy. - To evaluate PROs including time to deterioration in disease-related symptoms in newly diagnosed subjects with advanced-stage FRa-expressing (greater than or equal to 75%, greater than or equal to 2+) serous EOC treated with neoadjuvant carboplatin + MIRV, IDS if feasible, ± postoperative bevacizumab, ± optional standard-of-care maintenance therapy.
Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office
Email: iutrials@iu.edu
Phone: (317) 278-5632
Detailed description of study
Eligible subjects will receive up to 6 cycles of carboplatin (AUC 5 IV) and MIRV (6 mg/kg AIBW IV) Q3W prior to IDS
and a maximum of 9 cycles in total (pre- and post-IDS).
Two weeks after Cycle 3 Day 1 (± 1 week), a radiologic tumor assessment to evaluate response to neoadjuvant
carboplatin/MIRV and suitability for IDS will be performed. IDS will then be performed within 6 weeks after Cycle 3
Day 1 in all subjects deemed appropriate for IDS, including those with PD. Subjects with PD at radiologic tumor
assessment, regardless of if IDS was performed, will not receive additional carboplatin/MIRV. Subjects with CR, PR,
or SD will resume carboplatin/MIRV therapy 3–6 weeks after IDS (6 cycles total intended; maximum 9 cycles total
per investigator's discretion), and after a radiologic tumor assessment against which future imaging will be
compared. Postoperative carboplatin/MIRV therapy must begin within 8 weeks after IDS unless approved by the
sponsor.
If the radiologic tumor assessment after Cycle 3 indicates that IDS is not feasible per investigator, up to 3 additional
cycles of carboplatin/MIRV may be administered (6 total cycles prior to IDS). Imaging will then be repeated to
evaluate suitability for IDS no later than 9 weeks after Cycle 3 scans. IDS may be performed within 6 weeks of
Day 1 of Cycles 3–6, including in those with PD. Subjects with PD at radiologic tumor assessment, regardless of if
IDS was performed, will not receive additional carboplatin/MIRV. Subjects with CR, PR, or SD will resume
carboplatin/MIRV therapy 3-6 weeks after IDS, and after a radiologic tumor assessment against which future
imaging will be compared. Postoperative carboplatin/MIRV therapy must begin within 8 weeks after IDS unless
approved by the sponsor.
If the radiologic tumor assessment after Cycle 6 of study treatment carboplatin/MIRV indicates stable disease and
IDS is not feasible per investigator, then further treatment is per the investigator's discretion in consultation with
the Sponsor.
Imaging assessments will continue every 9 weeks ± 1 week from the date of the post-IDS radiologic tumor
assessment (for those who undergo IDS) or last radiographic assessment (for those who do not undergo IDS) until
1 year from study entry and then every 12 weeks ± 3 weeks until PD, death, or withdrawal of consent (whichever
occurs first).
At the treating physician's discretion, bevacizumab may be given after IDS in combination with carboplatin and
MIRV. As noted in the USPI, bevacizumab should not be administered earlier than 4 weeks after IDS. The treating
physician may also determine whether to administer any type of standard-of-care maintenance therapy which will
begin at least 21 days after completion of carboplatin/MIRV ± bevacizumab. Subjects receiving bevacizumab on
study at the discretion of the investigator should follow local label bevacizumab USPI or the institutional guidelines
regarding inclusion/exclusion criteria, dose modification, and management of toxicities related to bevacizumab.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Advanced-Stage Serous Epithelial Ovarian, Fallopian Tube Cancer, Primary Peritoneal Cancer
-
Age: 18 years - 100 years
-
Gender: All
Key Eligibility Criteria:
• Age ≥ 18 years.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Diagnosis of biopsy-confirmed high-grade, serous epithelial ovarian, fallopian tube or primary peritoneal
cancer with:
• Stage III or IV disease by the FIGO (Fédération Internationale de Gynécologie et d'Obstétrique)
staging system, and
• 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 FOLR1 assay, and
• Measurable disease by RECIST (Response Evaluation Criteria in Solid Tumors) v1.1 criteria.
• Not treated with a prior systemic anti-cancer therapy other than 1 cycle of single-agent carboplatin, which
may be administered at the investigator's discretion while awaiting results of FRα expression testing.
This study investigates an investigational treatment for advanced-stage serous epithelial ovarian, fallopian tube, or primary peritoneal cancer. The purpose is to evaluate the anti-tumor activity of a combination of medications in patients with a specific type of cancer that expresses a protein called FRa. The study aims to see if this combination can be as effective as traditional treatments with potentially less side effects.
Participants will receive a combination of two medications before surgery to shrink the tumor. The study will measure how well the treatment works using imaging and blood tests. Safety and tolerability of the treatment will also be assessed.
- Who can participate: The study is for adults aged 18 and over with newly diagnosed advanced-stage serous epithelial ovarian, fallopian tube, or primary peritoneal cancer that expresses the FRa protein at a high level.
- Study details: Participants will receive a combination of investigational medications before surgery to assess tumor response. If applicable, a placebo may be used, which is an inactive substance that looks like the investigational medicine but does not contain any medicine. The study will monitor treatment effects through imaging and blood tests.
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