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| Name | Class |
|---|---|
| AbbVie | INDUSTRY |
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The Principal Investigator hypothesizes the combination of MIRV and Olaparib is an effective, and tolerable, maintenance therapy strategy in platinum sensitive recurrent ovarian cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Safety Lead In | Experimental |
| |
| Treatment | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Through study completion, average of 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Through study completion, average of 12 months |
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Inclusion Criteria:
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 adequate hematologic, liver, and kidney function as defined as:
Exclusion Criteria:
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:
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
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
Persistent toxicities (>Common Terminology Criteria for Adverse Event (CTCAE) grade 2) caused by previous cancer therapy, excluding alopecia
Patients requiring use of folate-containing supplements (eg, folate deficiency)
Concomitant use of known strong CYP3A inhibitors (eg. itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (eg. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout period prior to starting study treatment is 2 weeks.
Concomitant use of known strong (eg. phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort ) or moderate CYP3A inducers (eg. bosentan, efavirenz, modafinil). The required washout period prior to starting study treatment is 5 weeks for enzalutamide or phenobarbital and 3 weeks for other agents.
Patients with prior hypersensitivity to monoclonal antibodies (mAb)
Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT).
Women who are pregnant or breastfeeding, and who do not agree to use a highly effective contraceptive method(s) while on study drug and for at least 3 months after the last dose of MIRV and at least 6 months after the last dose of Olaparib. Females of childbearing potential must have a negative serum pregnancy test within 72 hours of study entry.
Patients who received prior treatment with MIRV or other FRα- targeting agents
Patients with duodenal stent or other GI disorder/defect that would interfere with absorption of oral medication
Patients with known untreated or symptomatic central nervous system (CNS) metastases
Patients with a history of other malignancy within 3 years prior to enrollment
Prior known hypersensitivity reaction to study drugs and/or any of their excipients
Minor or major surgical procedure within 2 weeks of starting study treatment and patients must have recovered from any effects of any major surgery.
Inability to comply with study and follow-up procedures
Patients deemed otherwise clinically unfit for clinical trial per investigators discretion
Be a woman aged ≥18 years of age
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kailey Palmen, BA | Contact | 303-724-2435 | kailey.palmen@cuanschutz.edu |
| Name | Affiliation | Role |
|---|---|---|
| Bradley Corr, MD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Hospital | Recruiting | Aurora | Colorado | 80045 | United States |
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Single-arm, study design evaluating the maintenance therapy combination Mirvetuximab soravtansine-gynx and Olaparib in recurrent platinum-sensitive ovarian, peritoneal, and fallopian tube cancers. A six-patient safety lead in will occur, in which relevant the pharmaceutical company will be informed and included in safety evaluation process.
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| 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. |
|
| Determine Overall Response Rate |
Defined by confirmed best response of CR or PR as assessed by the investigator |
| Through study completion, average of 12 months |
| 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 | Through study completion, average of 12 months |
| Determine Overall Survival | Defined as the time from first dose of MIRV and Olaparib until death | Up to 5 years |
| Northwestern Memorial Hospital | Recruiting | Chicago | Illinois | 60611 | United States |
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| University of Pennsylvania Health System, Perelman Center for Advanced Medicine | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| UPMC Magee-Women's Hospital | Recruiting | Pittsburgh | Pennsylvania | 15213 | United States |
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| University of Wisconsin - Carbone Cancer Center - University Hospital | Recruiting | Madison | Wisconsin | 53792 | United States |
|
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D005185 | Fallopian Tube Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D005184 | Fallopian Tube Diseases |
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| ID | Term |
|---|---|
| C000607289 | mirvetuximab soravtansine |
| C531550 | olaparib |
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