An Evaluation of Maintenance Therapy Combination Mirvetuximab Soravtansine and Olaparib

Recruiting now · Phase 2

Conditions studied: Ovary Cancer, Peritoneal Cancer, Fallopian Tube Cancer

In brief

The Principal Investigator hypothesizes the combination of MIRV and Olaparib is an effective, and tolerable, maintenance therapy strategy in platinum sensitive recurrent ovarian cancer.

Key facts

Study ID: NCT05887609
Run by: University of Colorado, Denver
People needed: 53
Starts: 2023-10-03
Expected to finish: 2031-01-31
Last updated by the study team: 2026-07-13

Who can join

Age: 18 and older, up to 100. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

Provision to sign and date the consent form
Stated willingness to comply with all study procedures and be available for the duration of the study
Be a woman aged ≥18 years of age
Patients must have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
Patients must have a confirmed diagnosis of high-grade serous or endometrioid EOC, primary peritoneal cancer, or fallopian tube cancer
Patients must have platinum-sensitive disease defined as radiographic progression greater than 6 months from last dose of prior platinum therapy (not inclusive of current/most recent platinum therapy)
Patients must have had documented complete or partial response, or stable disease, as defined by RECIST 1.1, from last line of platinum therapy
Patients must have available archival tissue block or slides to confirm FRalpha positivity
Patients' tumor must have FRalpha high or medium expression
Prior anticancer therapy:
Patients must have received at least one prior platinum-based chemotherapy regimen for platinum sensitive recurrent disease.
Most recent prior chemotherapy regimen must have consisted of at least 4 completed cycles and no more than 8 completed cycles
Most recent prior chemotherapy regimen must have been platinum based
Patients must have had testing for BRCA mutation (tumor or germline) and, if positive, must have received a prior PARP inhibitor as either treatment or maintenance therapy
Neoadjuvant +/- adjuvant therapies are considered 1 line of therapy
Maintenance therapy (eg, Bevacizumab, PARP inhibitors) will be considered part of preceding line of therapy (ie, not counted independently)
Therapy changed due to toxicity in the absence of progression will be considered part of the same line (ie, not counted independently)
Hormonal therapy will be counted as a separate line of therapy unless it was given as maintenance
Prior Bevacizumab use is allowed, but concurrent use with study combination is prohibited.
Cycle 1 Day 1 of trial therapy must be within 8 weeks of last dose of previous chemotherapy.
Patients must have adequate hematologic, liver, and kidney function as defined as:
Absolute neutrophil count (ANC) ≥ 1.5 x 109/L (1500/µL)
Platelet count ≥ 100 x 109/L (100,000 µL)
Hemoglobin ≥ 10.0 g/dL with no blood transfusion in the past 28 days
Serum creatinine ≤ 1.5 x upper limit of normal (ULN)

You may not qualify if…

Patients with clear cell, mucinous, sarcomatous, low grade/borderline, germ cell, or sex-cord stromal type ovarian tumor
Patients who have progressed through most recent chemotherapy regimen. Stable disease (SD) is permissible.
Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to study treatment
Patients with active or chronic corneal disorders, history of corneal transplantation, or active ocular conditions require ongoing treatment/monitoring, such as uncontrolled glaucoma, wet age-related macular degeneration requiring intravitreal injections, active diabetic retinopathy with macular edema, macular degeneration, presence of papilledema, and/or monocular vision
Patients with myelodysplastic syndrome/acute myeloid leukemia or with features suggestive of MDS/AML.
Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to:
Uncontrolled major seizure disorder
Unstable spinal cord compression
Any psychiatric disorder that prohibits obtaining informed consent.
Active hepatitis B or C infection (whether or not on active antiviral therapy)
Immunocompromised patients, e.g., patient who are known to be serologically positive for human immunodeficient virus(HIV)
Active cytomegalovirus infection
Any other concurrent infectious disease requiring IV antibiotics within 2 weeks prior to the first dose of MIRV
Patients with a history of multiple sclerosis (MS) or other demyelinating disease and/or Lambert-Eaton syndrome (paraneoplastic syndrome)
Patients with clinically significant cardiac disease including, but not limited to, any of the following
Myocardial infarction ≤ 6 months prior to first dose
Uncontrolled ventricular arrhythmia, recent (within 3 months)
Superior vena cava syndrome
Unstable angina pectoris
Uncontrolled congestive heart failure (New York Heart Association > class II)
Uncontrolled ≥ Grade 3 hypertension (per CTCAE)
Uncontrolled cardiac arrhythmias
Patients with a history of hemorrhagic or ischemic stroke within 6 months prior to enrollment
Patients with a history of cirrhotic liver disease (Child-Pugh Class B or C)
Patients with a previous clinical diagnosis of noninfectious interstitial lung disease (ILD) or Extensive interstitial bilateral lung disease on High Resolution Computed Tomography (HRCT) scan , including noninfectious pneumonitis

Where it is running

City of Hope Lennar — Irvine, California, United States (enrolling)
University of Colorado Hospital — Aurora, Colorado, United States (enrolling)
Northwestern Memorial Hospital — Chicago, Illinois, United States (enrolling)
University of Pennsylvania Health System, Perelman Center for Advanced Medicine — Philadelphia, Pennsylvania, United States (enrolling)
UPMC Magee-Women's Hospital — Pittsburgh, Pennsylvania, United States (enrolling)
University of Wisconsin - Carbone Cancer Center - University Hospital — Madison, Wisconsin, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.