An Evaluation of Maintenance Therapy Combination Mirvetuximab Soravtansine and Olaparib
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-100
SponsorUniversity of Colorado, Denver
About this trial
The Principal Investigator hypothesizes the combination of MIRV and Olaparib is an effective, and tolerable, maintenance therapy strategy in platinum sensitive recurrent ovarian cancer.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Mirvetuximab Soravtansine-gynx
- Olaparib
Treatment groups
53 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Colorado, Denver
Lead sponsor
AbbVie
Collaborator
Source ClinicalTrials.gov