Skip to main content
TTrialFinderData
TrialFinderData is for informational purposes only and does not provide medical advice. Always talk to your doctor.

Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

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

An Evaluation of Maintenance Therapy Combination Mirvetuximab Soravtansine and Olaparib (NCT05887609) is a Phase 2 interventional studying Ovary Cancer and Peritoneal Cancer, sponsored by University of Colorado, Denver. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

The Principal Investigator hypothesizes the combination of MIRV and Olaparib is an effective, and tolerable, maintenance therapy strategy in platinum sensitive recurrent ovarian cancer.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Ovary Cancer and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 53 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Ovary Cancer subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

Mirvetuximab 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).

DRUG

Olaparib

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)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

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

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05887609), the sponsor (University of Colorado, Denver), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05887609 clinical trial studying?

The Principal Investigator hypothesizes the combination of MIRV and Olaparib is an effective, and tolerable, maintenance therapy strategy in platinum sensitive recurrent ovarian cancer. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT05887609?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05887609?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05887609. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05887609. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.