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NCT04606914 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study of Ovarian Cancer and Primary Peritoneal Cancer, sponsored by University of Alabama at Birmingham.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 70
- Enrollment target
- 9
- Study locations
NCT04606914: Recruiting Phase 2 study of Ovarian Cancer and Primary Peritoneal Cancer, sponsored by University of Alabama at Birmingham.
NCT04606914 is a Phase 2 study of Ovarian Cancer and Primary Peritoneal Cancer that is actively recruiting participants, run by University of Alabama at Birmingham. The registered enrollment target is 70 participants, below the 729-participant average among 322 other Ovarian Cancer trials with a reported enrollment target (90% lower). The trial reports 9 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04606914, a Phase 2 study of Ovarian Cancer and Primary Peritoneal Cancer, is actively recruiting participants, sponsored by University of Alabama at Birmingham.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 70 participants
- Enrollment target
- 9
- Study locations
Study 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.
Primary Outcome
To assess percentage of patients with advanced-stage ovarian, fallopian tube, and peritoneal cancers per Response Evaluation Criteria in Solid Tumors (RECIST)1.1 and Gynecological Cancer Intergroup Cancer antigen 125 (GCIG CA-125) criteria.
Conditions Studied
Interventions
- DRUG mirvetuximab soravtansine (MIRV; IMGN853)
Study Locations (9)
Minnesota
- University of Minnesota - Masonic Cancer Center - Minneapolis
- Mayo Clinic - Rochester
Alabama
- University of Alabama at Birmingham Womens & Infants Center - Birmingham
California
- University of California San Francisco - San Francisco
Mississippi
- University of Mississippi Medical Center - Oxford
Ohio
- Ohio State University - Columbus
Oklahoma
- University of Oklahoma - Oklahoma City
Pennsylvania
- Allegheny Health Network - Pittsburgh
Virginia
- University of Virginia - Richmond
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2021-05-27 |
| Est. Completion | 2028-05-31 |
| Phase | Phase 2 |
What NCT04606914 shows while recruiting
NCT04606914 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 729-participant average among 322 other Ovarian Cancer trials with a reported enrollment target (90% lower).
The record links to 3 conditions, with Ovarian Cancer appearing as the primary indexed condition, and to 1 intervention - of which mirvetuximab soravtansine (MIRV; IMGN853) is the first listed.
NCT04606914 lists 9 locations in 8 states (Minnesota, Alabama, California).
Frequently Asked Questions
What is clinical trial NCT04606914 about?
NCT04606914 is a clinical study titled "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". 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 rece...
What is the current status of trial NCT04606914?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 70 participants. The study started on 2021-05-27. Estimated completion is 2028-05-31.
What conditions does trial NCT04606914 study?
This clinical trial studies the following conditions: Ovarian Cancer, Primary Peritoneal Cancer, Fallopian Tube.
What interventions are being tested in trial NCT04606914?
The interventions under investigation include: mirvetuximab soravtansine (MIRV; IMGN853) (DRUG).
Who is sponsoring clinical trial NCT04606914?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04606914 being conducted?
This trial has 9 study locations across Alabama, California, Minnesota, Mississippi, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04606914's enrollment target sits among peer trials
70 177th of 322 higher than 140 of 322 other Ovarian Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ovarian Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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