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
This trial does not accept healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
Mirvetuximab Soravtansine-gynx
Drugis an antibody-drug conjugate (ADC) that consists of a high affinity humanized monoclonal antibody against folate receptor α (FRα, the protein product of the folate receptor 1 \[FOLR1\] gene) that is conjugated to a cytotoxic maytansinoid by the hindered disulfide succinimidyl 4-(pyridine-2-yl)disulfanyl)-2-sulfo-butyrate linker (sulfo-SPDB).
Olaparib
DrugOlaparib is an inhibitor of poly (ADP-ribose) polymerase (PARP) enzymes, including PARP1, PARP2, and PARP3. PARP enzymes are involved in normal cellular functions, such as DNA transcription and DNA repair.
Treatment groups
53 Participants
are divided into 2 treatment groupsGroup A: Safety Lead InExperimental treatment 2 interventions
Group B: TreatmentExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
To measure progression free survival (PFS) with the use of MIRV combined with Olaparib in women with recurrent platinum sensitive ovarian, peritoneal, and fallopian tube cancer.
PFS will be defined as the time from first dose of MIRV and Olaparib until investigator-assessed radiologic PD or death, whichever occurs first
Time frame
Through study completion, average of 12 monthsSecondary outcomes
1
To evaluate safety and tolerability of MIRV combined with Olaparib by Adverse Events as measured by CTCAE v 5.0
The team will use treatment-emergent adverse events (TEAEs) and laboratory test results, physical examination, or vital signs to determine AEs as described by CTCAE v5.0
Time frame
Through study completion, average of 12 months2
Determine Overall Response Rate
Defined by confirmed best response of CR or PR as assessed by the investigator
Time frame
Through study completion, average of 12 months3
Determine Duration of Response
Defined as the time from initial investigator-assessed response (CR or PR) until progressive disease (PD) as assessed by the investigator
Time frame
Through study completion, average of 12 months4
Determine Overall Survival
Defined as the time from first dose of MIRV and Olaparib until death
Time frame
Up to 5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Colorado, Denver
Lead sponsor
AbbVie
Collaborator
Source ClinicalTrials.gov