An Evaluation of Maintenance Therapy Combination Mirvetuximab Soravtansine and Olaparib

NCT05887609 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 22-0384.cc
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Ovary Cancer; Peritoneal Cancer; Fallopian Tube Cancer

Outcome Measures

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

  Through study completion, average of 12 months

Secondary Outcomes (4)

• To evaluate safety and tolerability of MIRV combined with Olaparib by Adverse Events as measured by CTCAE v 5.0

  Through study completion, average of 12 months

• Determine Overall Response Rate

  Through study completion, average of 12 months

• Determine Duration of Response

  Through study completion, average of 12 months

• Determine Overall Survival

  Up to 5 years

Study Arms (2)

Safety Lead In

EXPERIMENTAL

Drug: Mirvetuximab Soravtansine-gynx; Drug: Olaparib

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.

Drug: Mirvetuximab Soravtansine-gynx; Drug: Olaparib

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).

Also known as: IMGN853, MIRV

Safety Lead In; Treatment

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.

Safety Lead In; Treatment

Eligibility Criteria

• Age: 18 Years - 100 Years
• Gender Eligibility Details: Be a woman aged ≥18 years of age
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 received at least one prior platinum-based chemotherapy regimen for platinum sensitive recurrent disease.
• Most recent prior chemotherapy regimen must have consisted of at least 4 completed cycles and no more than 8 completed cycles
• Most recent prior chemotherapy regimen must have been platinum based
• Patients must have had testing for BRCA mutation (tumor or germline) and, if positive, must have received a prior PARP inhibitor as either treatment or maintenance therapy
• Neoadjuvant +/- adjuvant therapies are considered 1 line of therapy

You may not qualify if:

• 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:
• Uncontrolled major seizure disorder
• Unstable spinal cord compression
• Any psychiatric disorder that prohibits obtaining informed consent.
• Active hepatitis B or C infection (whether or not on active antiviral therapy)
• Immunocompromised patients, e.g., patient who are known to be serologically positive for human immunodeficient virus(HIV)
• Active cytomegalovirus infection
• Any other concurrent infectious disease requiring IV antibiotics within 2 weeks prior to the first dose of MIRV
• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• AbbVie: collaborator

Study Sites (5)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

RECRUITING

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

RECRUITING

University of Pennsylvania Health System, Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

UPMC Magee-Women's Hospital

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

University of Wisconsin - Carbone Cancer Center - University Hospital

Madison, Wisconsin, 53792, United States

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms

Interventions

mirvetuximab soravtansine; olaparib

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases

Study Officials

• Bradley Corr, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Evamaria Kent Bravo, MS

CONTACT

303-724-0131; evamaria.kentbravo@cuanschutz.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 10, 2023
• First Posted: June 5, 2023
• Study Start: October 3, 2023
• Primary Completion (Estimated): January 31, 2029
• Study Completion (Estimated): January 31, 2031
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)