Clinical trial for Epithelial Ovarian Cancer
Official title A Study to Assess Anti-Tumor Activity of Intravenously (IV) Infused Carboplatin With Mirvetuximab Soravtansine in Participants With Newly Diagnosed Folate Receptor Alpha (FRα)Expressing Advanced-Stage Serous Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer.
ClinicalTrials.gov ID: NCT06890338
What this study is testing
What is Carboplatin?
An investigational chemotherapy drug being studied for advanced-stage epithelial ovarian cancer. It is designed to damage DNA in cancer cells, preventing them from dividing.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to see how safe and effective this drug combination is before surgery in people with advanced‑stage serous epithelial ovarian, fallopian tube, or primary peritoneal cancer that shows the folate receptor alpha protein.
- Who it's for
- Adults with advanced (stage III or IV) serous epithelial ovarian, fallopian tube, or primary peritoneal cancer that tests positive for folate receptor alpha.
- What's involved
- Participants receive an IV infusion of mirvetuximab soravtansine together with carboplatin on day 1 of each 21‑day cycle, up to 6–9 cycles. They will have regular hospital or clinic visits, blood tests, and scans to monitor treatment.
- Time commitment
- The study lasts about 3 years, with visits every 3 weeks for treatment and additional routine check‑ups during the study period.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
- Be judged by the investigator and/or treating physician to be an appropriate candidate to receive neoadjuvant chemotherapy.
- Diagnosis of biopsy-confirmed high-grade, serous epithelial ovarian, fallopian tube or primary peritoneal cancer.
- Stage III or IV disease by the Fédération Internationale de Gynécologie et d'Obstétrique (FIGO) staging system, and
- Folate Receptor Alpha (FRα) expression positivity as defined by immunohistochemical staining of \>= 75% of viable tumor cells with moderate \>= 2+...
You likely can't join if
- Endometrioid, clear cell, mucinous, or sarcomatous tumor histology; mixed tumors containing any of the above histologies
- Previous clinical diagnosis of noninfectious interstitial lung disease, including noninfectious pneumonitis.
- Previously treated with anticancer therapy including chemotherapy, radiation therapy, immunotherapy, or biologic agent for current cancer, with the...
- History of corneal transplantation;
- Undergoing active postoperative management for refractive surgery, cataract surgery, corneal cross-linking, or corneal complications of surgery;
- Confluent superficial punctate keratopathy (SPK) not expected to resolve to non-confluence or better within the screening window with standard of...
See the full eligibility criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
- Be judged by the investigator and/or treating physician to be an appropriate candidate to receive neoadjuvant chemotherapy.
- Diagnosis of biopsy-confirmed high-grade, serous epithelial ovarian, fallopian tube or primary peritoneal cancer.
- Stage III or IV disease by the Fédération Internationale de Gynécologie et d'Obstétrique (FIGO) staging system, and
- Folate Receptor Alpha (FRα) expression positivity as defined by immunohistochemical staining of \>= 75% of viable tumor cells with moderate \>= 2+ membrane staining by the Ventana Folate Receptor Alpha (VENTANA FOLR1)...
- Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria.
- Endometrioid, clear cell, mucinous, or sarcomatous tumor histology; mixed tumors containing any of the above histologies; or low-grade/borderline ovarian tumor.
- Previous clinical diagnosis of noninfectious interstitial lung disease, including noninfectious pneumonitis.
- Previously treated with anticancer therapy including chemotherapy, radiation therapy, immunotherapy, or biologic agent for current cancer, with the exception of one cycle of single agent carboplatin
- History of corneal transplantation;
- Undergoing active postoperative management for refractive surgery, cataract surgery, corneal cross-linking, or corneal complications of surgery;
- Confluent superficial punctate keratopathy (SPK) not expected to resolve to non-confluence or better within the screening window with standard of care (SOC) intervention;
- Active or chronic clinically significant (\>= Grade 3) corneal dystrophy (e.g., Fuchs dystrophy);
- Active ocular conditions requiring ongoing treatment/monitoring, such as glaucoma, which is not adequately controlled with medication or surgery, wet age-related macular degeneration requiring intravitreal injections...
- Monocular vision with visual acuity in the worse eye, worse than 20/200 or visual fields less than 20 degrees (i.e., functional blindness in at least one eye).
- History of other malignancy within 3 years prior to signing study consent. -- Note: Participants with tumors with a negligible risk for metastasis or death (e.g., adequately controlled basal-cell carcinoma or...
The study team makes the final eligibility decision.
Where it is enrolling
- Birmingham, Alabama, United States
- Mobile, Alabama, United States
- Irvine, California, United States
- Los Angeles, California, United States
- San Diego, California, United States
- San Francisco, California, United States
- Danbury, Connecticut, United States
- New Haven, Connecticut, United States
- Norwalk, Connecticut, United States
- Jupiter, Florida, United States
- Chicago, Illinois, United States
- Peoria, Illinois, United States
- Urbana, Illinois, United States
- Fort Wayne, Indiana, United States
- Indianapolis, Indiana, United States
- Lexington, Kentucky, United States
- Louisville, Kentucky, United States
- Covington, Louisiana, United States
- New Orleans, Louisiana, United States
- Shreveport, Louisiana, United States
+ 46 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Birmingham, Alabama, United States; Mobile, Alabama, United States; Irvine, California, United States; Los Angeles, California, United States; San Diego, California, United States; San Francisco, California, United States and 60 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.