Ovary CancerPhase 2NCT05887609
An Evaluation of Maintenance Therapy Combination Mirvetuximab Soravtansine and Olaparib
A Phase 2 study testing Mirvetuximab Soravtansine-gynx and Olaparib in people with Ovary Cancer and Peritoneal Cancer, run by University of Colorado, Denver at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years, women only
- Conditions the study is for
- Ovary Cancer, Peritoneal Cancer, Fallopian Tube Cancer
- What is being tested?
- Mirvetuximab Soravtansine-gynx and Olaparib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 6 sitesUnited States
- Study dates
- 3 Oct 2023to 31 Jan 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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:
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- 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
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
University of Colorado Hospital
Aurora, Colorado, 80045
Kailey Palmen, 303-724-2435, kailey.palmen@cuanschutz.edu
Bradley Corr, MD
- Recruiting
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Emma Barber, MD, 312-695-0990, emma.barber@nm.org
Emma Barber, MD
- Recruiting
City of Hope Lennar
Irvine, California, 92618
Joshua Cohen, MD, 714-357-8701, jgcohen@coh.org
- Recruiting
University of Wisconsin - Carbone Cancer Center - University Hospital
Madison, Wisconsin, 53792
Lisa Barroilhet, MD, 608-263-7282, barroilhet@wisc.edu
Lisa Barroilhet, MD
- Recruiting
University of Pennsylvania Health System, Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, 19104
Stefan Gysler, MD, 215-662-4000, stefan.gysler@pennmedicine.upenn.edu
Stefan Gysler, MD
- Recruiting
UPMC Magee-Women's Hospital
Pittsburgh, Pennsylvania, 15213
Sarah Taylor, MD, 412-641-1153, barroilhet@wisc.edu
Lisa Barroilhet, MD
About this study
Official title: A Phase II Evaluation of Maintenance Therapy Combination Mirvetuximab Soravtansine-gynx and Olaparib in Recurrent Platinum Sensitive Ovarian, Peritoneal, and Fallopian Tube Cancer
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
- Being tested
- Mirvetuximab Soravtansine-gynx, Olaparib
- Medical subject headings
- Ovarian Neoplasms, Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mirvetuximab Soravtansine-gynxDrug
Also called IMGN853, MIRV
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).
OlaparibDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Safety Lead In | Experimental | Not described Receives: 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. Receives: Drug: Mirvetuximab Soravtansine-gynx; Drug: Olaparib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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
Measured: Through study completion, average of 12 months
Determine Overall Response Rate
Defined by confirmed best response of CR or PR as assessed by the investigator
Measured: 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
Measured: Through study completion, average of 12 months
Determine Overall Survival
Defined as the time from first dose of MIRV and Olaparib until death
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start3 Oct 2023
- Primary completion31 Jan 2029 (estimated)
- Study completion31 Jan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovary CancerStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 53 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- AbbVie
- Responsible party
- Sponsor
- Investigators
- Bradley Corr, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05887609
- Sponsor's protocol ID
- 22-0384.cc
- Status last verified
- Jul 2026
- First submitted
- 10 May 2023
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Evaluation of Maintenance Therapy Combination Mirvetuximab Soravtansine-gynx and Olaparib in Recurrent Platinum Sensitive Ovarian, Peritoneal, and Fallopian Tube Cancer
- ClinicalTrials.gov ID
- NCT05887609
- Acronym / sponsor ID
- 22-0384.cc
- Conditions
- Ovary Cancer, Peritoneal Cancer, Fallopian Tube Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 53 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- AbbVie
- Study start
- 3 Oct 2023 (actual)
- Primary completion
- 31 Jan 2029 (estimated)
- Study completion
- 31 Jan 2031 (estimated)
- First posted
- 5 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Principal Investigator hypothesizes the combination of MIRV and Olaparib is an effective, and tolerable, maintenance therapy strategy in platinum sensitive recurrent ovarian cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Safety Lead In | Experimental | Drug: Mirvetuximab Soravtansine-gynx, Drug: Olaparib |
| Treatment | Experimental | Drug: Mirvetuximab Soravtansine-gynx, Drug: OlaparibAll 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- 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
Key exclusion criteria (42 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mirvetuximab Soravtansine-gynxAlso: IMGN853, MIRVis 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 | Safety Lead In, Treatment |
| OlaparibOlaparib 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. | Drug | Safety Lead In, Treatment |
Primary outcome
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.
Time frame: Through study completion, average of 12 months
PFS will be defined as the time from first dose of MIRV and Olaparib until investigator-assessed radiologic PD or death, whichever occurs first
4 secondary outcomes
To evaluate safety and tolerability of MIRV combined with Olaparib by Adverse Events as measured by CTCAE v 5.0
Time frame: Through study completion, average of 12 months
Determine Overall Response Rate
Time frame: Through study completion, average of 12 months
Determine Duration of Response
Time frame: Through study completion, average of 12 months
Determine Overall Survival
Time frame: Up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bradley Corr, MD principal investigator
University of Colorado, Denver
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mirvetuximab Soravtansine-gynx and Olaparib in people with Ovary Cancer and Peritoneal Cancer, run by University of Colorado, Denver at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 29 inclusion and 42 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kailey Palmen, BA (303-724-2435, kailey.palmen@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Through study completion, average of 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.