An Evaluation of Maintenance Therapy Combination Mirvetuximab Soravtansine and Olaparib

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT05887609
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Fallopian Tube Cancer
  • Ovary Cancer
  • Peritoneal Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Mirvetuximab Soravtansine-gynx — DRUG
    is 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 — DRUG
    Olaparib 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.

Study Details

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 Dates

Start date
Oct 3, 2023
Status verified
Jun 2026
Primary completion
Jan 31, 2029
Completion
Jan 31, 2031

Study Design

Enrollment
53 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Safety Lead In
  • Experimental: Treatment
    All patients will receive MIRV at 5mg/kg AIBW administered through IV infusion on Day 1 of every 3-week cycle (Q3W). All patients will receive Olaparib at 300mg taken orally twice daily with or without food. Dosage and administration will follow current single-agent Olaparib package insert dosage and administration guidelines. Patients will continue to receive MIRV and Olaparib until PD, unacceptable toxicity, withdrawal of consent, or death, whichever comes first. If toxicity deems the patient to discontinue one drug, the patient may continue the other drug until PD, unacceptable toxicity, withdrawal of consent, or death, whichever comes first.

Primary Outcome Measure

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. [ Time Frame: Through study completion, average of 12 months ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
University of Colorado HospitalAuroraColorado80045
Samantha Hopp
[email protected]
303-724-0131
Bradley Corr, MD (PRINCIPAL_INVESTIGATOR)
Northwestern Memorial HospitalChicagoIllinois60611
Emma Barber, MD
[email protected]
312-695-0990
Emma Barber, MD (PRINCIPAL_INVESTIGATOR)
University of Pennsylvania Health System, Perelman Center for Advanced MedicinePhiladelphiaPennsylvania19104
Stefan Gysler, MD
[email protected]
215-662-4000
Stefan Gysler, MD (PRINCIPAL_INVESTIGATOR)
UPMC Magee-Women's HospitalPittsburghPennsylvania15213
Sarah Taylor, MD
[email protected]
412-641-1153
Lisa Barroilhet, MD (PRINCIPAL_INVESTIGATOR)
University of Wisconsin - Carbone Cancer Center - University HospitalMadisonWisconsin53792
Lisa Barroilhet, MD
[email protected]
608-263-7282
Lisa Barroilhet, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Aurora, CO

By research site
University of Colorado Hospital· Aurora, CONorthwestern Memorial Hospital· Chicago, ILUniversity of Pennsylvania Health System, Perelman Center for Advanced Medicine· Philadelphia, PAUPMC Magee-Women's Hospital· Pittsburgh, PAUniversity of Wisconsin - Carbone Cancer Center - University Hospital· Madison, WI

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