RecruitingPhase 2NCT05887609

An Evaluation of Maintenance Therapy Combination Mirvetuximab Soravtansine and Olaparib

A Phase II Evaluation of Maintenance Therapy Combination Mirvetuximab Soravtansine-gynx and Olaparib in Recurrent Platinum Sensitive Ovarian, Peritoneal, and Fallopian Tube Cancer


Sponsor

University of Colorado, Denver

Enrollment

53 participants

Start Date

Oct 3, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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

Sex: FEMALEMin Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two maintenance therapy drugs — mirvetuximab soravtansine (a targeted antibody-drug) and olaparib (a PARP inhibitor) — for women with platinum-sensitive ovarian, primary peritoneal, or fallopian tube cancer after completing platinum chemotherapy. **You may be eligible if...** - You are a woman 18 years old or older - You have been diagnosed with high-grade serous or endometrioid ovarian, primary peritoneal, or fallopian tube cancer - Your cancer responded to (or stabilized on) your most recent platinum-based chemotherapy - Your cancer is platinum-sensitive (progressed more than 6 months after your last platinum treatment) - Your general health is good (ECOG 0 or 1) **You may NOT be eligible if...** - You have platinum-resistant cancer (progressed within 6 months of platinum therapy) - You have severe bone marrow problems or low blood counts - You have serious heart or lung conditions - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMirvetuximab Soravtansine-gynx

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).

DRUGOlaparib

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.


Locations(5)

University of Colorado Hospital

Aurora, Colorado, United States

Northwestern Memorial Hospital

Chicago, Illinois, United States

University of Pennsylvania Health System, Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, United States

UPMC Magee-Women's Hospital

Pittsburgh, Pennsylvania, United States

University of Wisconsin - Carbone Cancer Center - University Hospital

Madison, Wisconsin, United States

View Full Details on ClinicalTrials.gov

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NCT05887609


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