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New drug combo aims to keep ovarian cancer at bay

NCT ID NCT05887609

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 14, 2026 · Updated 2 times

Summary

This study is testing whether a combination of two drugs, mirvetuximab soravtansine and olaparib, can help keep ovarian, peritoneal, or fallopian tube cancer from coming back after initial treatment. About 53 women with cancer that responded to platinum-based chemotherapy will receive the drug combo as maintenance therapy. The goal is to see if this approach extends the time before the cancer progresses.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 53 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2023

Expected to finish

Jan 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 100 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 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 * Maintenance therapy (eg, Bevacizumab, PARP inhibitors) will be considered part of preceding line of therapy (ie, not counted independently) * Therapy changed due to toxicity in the absence of progression will be considered part of the same line (ie, not counted independently) * Hormonal therapy will be counted as a separate line of therapy unless it was given as maintenance * Prior Bevacizumab use is allowed, but concurrent use with study combination is prohibited. * Cycle 1 Day 1 of trial therapy must be within 8 weeks of last dose of previous chemotherapy. * Patients must have adequate hematologic, liver, and kidney function as defined as: * Absolute neutrophil count (ANC) ≥ 1.5 x 109/L (1500/µL) * Platelet count ≥ 100 x 109/L (100,000 µL) * Hemoglobin ≥ 10.0 g/dL with no blood transfusion in the past 28 days * Serum creatinine ≤ 1.5 x upper limit of normal (ULN) * Patients must have creatinine clearance estimated of ≥51 mL/min using the Cockcroft-Gault equation or based on a 24 hour urine test * Aspartate aminotransferase (AST)(Serum Glutamic Oxaloacetic Transaminase (SGOT)) and alanine aminotransferase (ALT) (Serum Glutamic Pyruvate Transaminase (SGPT)) ≤ 2.5 x ULN unless liver metastases are present in which case they must be ≤ 5x ULN * Serum bilirubin ≤ 1.5 x ULN (patients with documented diagnosis of Gilbert syndrome are eligible if total bilirubin \< 3.0 x ULN) * Serum albumin ≥ 2 g/dL 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: * 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 * Myocardial infarction ≤ 6 months prior to first dose * Uncontrolled ventricular arrhythmia, recent (within 3 months) * Superior vena cava syndrome * Unstable angina pectoris * Uncontrolled congestive heart failure (New York Heart Association \> class II) * Uncontrolled ≥ Grade 3 hypertension (per CTCAE) * Uncontrolled cardiac arrhythmias * 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 * Includes patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study 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 * Note: patients with tumors with a negligible risk for metastasis or death (eg, adequately controlled basal-cell carcinoma or squamous-cell carcinoma of the skin, or carcinoma in situ of the cervix or breast) are eligible * 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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    6 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • City of Hope Lennar

    RECRUITING

    Irvine, California, 92618, United States

  • Northwestern Memorial Hospital

    RECRUITING

    Chicago, Illinois, 60611, United States

  • UPMC Magee-Women's Hospital

    RECRUITING

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Colorado Hospital

    RECRUITING

    Aurora, Colorado, 80045, United States

  • University of Pennsylvania Health System, Perelman Center for Advanced Medicine

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • University of Wisconsin - Carbone Cancer Center - University Hospital

    RECRUITING

    Madison, Wisconsin, 53792, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.