Actively Recruiting
An Evaluation of Maintenance Therapy Combination Mirvetuximab Soravtansine and Olaparib
Led by University of Colorado, Denver · Updated on 2026-04-13
53
Participants Needed
5
Research Sites
382 weeks
Total Duration
On this page
Sponsors
U
University of Colorado, Denver
Lead Sponsor
A
AbbVie
Collaborating Sponsor
AI-Summary
What this Trial Is About
The Principal Investigator hypothesizes the combination of MIRV and Olaparib is an effective, and tolerable, maintenance therapy strategy in platinum sensitive recurrent ovarian cancer.
CONDITIONS
Official Title
An Evaluation of Maintenance Therapy Combination Mirvetuximab Soravtansine and Olaparib
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated consent form
- Willingness to comply with all study procedures and be available for the study duration
- Female aged 18 years or older
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
- Confirmed diagnosis of high-grade serous or endometrioid epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer
- Platinum-sensitive disease with progression more than 6 months after last prior platinum therapy
- Documented complete or partial response, or stable disease, from last line of platinum therapy per RECIST 1.1
- Available archival tissue to confirm folate receptor alpha positivity
- Tumor with medium or high folate receptor alpha expression
- Received at least one prior platinum-based chemotherapy regimen for recurrent disease
- Most recent chemotherapy with 4 to 8 completed platinum-based cycles
- Tested for BRCA mutation; if positive, prior PARP inhibitor treatment or maintenance
- Last chemotherapy dose within 8 weeks before trial therapy start
- Adequate blood counts, liver, and kidney function as specified
You will not qualify if you...
- Clear cell, mucinous, sarcomatous, low grade/borderline, germ cell, or sex-cord stromal ovarian tumors
- Progressed through most recent chemotherapy regimen
- Receiving systemic chemotherapy or radiotherapy within 3 weeks prior to study treatment (except palliative)
- Active or chronic corneal or ocular disorders requiring ongoing treatment or monitoring
- Myelodysplastic syndrome/acute myeloid leukemia or features suggestive of these
- Serious uncontrolled medical disorders or infections including active hepatitis B or C and HIV
- History of multiple sclerosis, demyelinating disease, or Lambert-Eaton syndrome
- Significant cardiac disease or recent myocardial infarction
- History of hemorrhagic or ischemic stroke within 6 months
- Cirrhotic liver disease (Child-Pugh Class B or C)
- Noninfectious interstitial lung disease or extensive bilateral lung disease
- Persistent toxicities greater than grade 2 from prior cancer therapy excluding alopecia
- Need for folate-containing supplements
- Use of strong or moderate CYP3A inhibitors or inducers without proper washout
- Prior hypersensitivity to monoclonal antibodies
- Previous allogenic bone marrow or double umbilical cord blood transplant
- Pregnant or breastfeeding and not agreeing to effective contraception
- Prior treatment with MIRV or other folate receptor alpha-targeting agents
- Gastrointestinal disorders interfering with oral medication absorption
- Untreated or symptomatic CNS metastases
- Other malignancy within 3 years except certain low-risk tumors
- Hypersensitivity to study drugs or excipients
- Recent surgery within 2 weeks or not recovered from major surgery
- Unable to comply with study procedures or clinically unfit per investigator discretion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
University of Colorado Hospital
Aurora, Colorado, United States, 80045
Actively Recruiting
2
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Actively Recruiting
3
University of Pennsylvania Health System, Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
4
UPMC Magee-Women's Hospital
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
5
University of Wisconsin - Carbone Cancer Center - University Hospital
Madison, Wisconsin, United States, 53792
Actively Recruiting
Research Team
E
Evamaria Kent Bravo, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here