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Recurrent Epithelial Ovarian, Fallopian or Peritoneal CarcinomaPhase 2MIROVANCT04274426

Mirvetuximab Soravtansine (IMGN853), in Folate Receptor Alpha (FRα) High Recurrent Ovarian Cancer

A Phase 2 study testing Carboplatin, Pegylated liposomal doxorubicin (PLD) and Gemcitabine in people with Recurrent Epithelial Ovarian, Fallopian or Peritoneal Carcinoma, run by AGO Research GmbH at 19 sites in Germany.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This is a multi-center, randomized, two-arm, open-label, comparative phase II trial of Mirvetuximab soravtansine (IMGN853), in folate receptor alpha (FRα) high recurrent ovarian cancer eligible for platinum-based chemotherapy. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Carboplatin, Pegylated liposomal doxorubicin (PLD) and Gemcitabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
136 participants
Where
19 sitesGermany
Study dates
13 Oct 2021to Dec 2026
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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All patients must have a pathologically documented, definite diagnosis of epithelial cancer of the ovary, the fallopian tube or the peritoneum
  • Relapsed disease with a platinum-free interval >3 months
  • All histologic subtypes of ovarian carcinoma including carcinosarcoma (malignant mixed Mullerian tumors, MMMT)
  • Patients with wildtype BRCA1/2 mutation status or with a deleterious BRCA1/2 mutation in germline or somatic testing if they underwent PARP inhibitor therapy in previous treatment line.
  • Patients must be willing to provide archival tumor tissue from current relapse or previous surgeries/biopsies for central confirmation of FRα high status by PS2+ scoring:
  • all tumors must exhibit ≥75% of tumor cells with FRα membrane staining and ≥ 2+ intensity by immunohistochemistry (IHC) using the Ventana FOLR1 (FOLR1 2.1) CDx assay.
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  • Patients must have measurable disease or evaluable disease in combination with GCIG CA-125 criteria.
  • Patients had one or more prior lines of chemotherapy. The last line of chemotherapy must have included platinum (min. 4 cycles) and has resulted in a partial or complete response.
  • Major surgery (not including placement of vascular access device, tumor punch/scrape biopsies or secondary wound closure) must be completed four weeks prior to Day 1.
  • Patients must have adequate hematological, liver, cardiac and kidney function:
  • Hemoglobin ≥ 10.0 g/dL.
  • Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
  • Platelet count ≥ 100 x 109/L.
  • Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN).
  • Aspartate aminotransferase/Serum Glutamic Oxaloacetic Transaminase (ASAT/SGOT)) and Alanine aminotransferase/Serum Glutamic Pyruvate Transaminase (ALAT/SGPT)) ≤ 2.5 x ULN, unless liver metastases are present in which case they must be ≤ 5 x ULN.
  • Serum creatinine ≤ 1.5 x institutional ULN and glomerular filtration rate of at least 40 ml/minute according to Cockroft-Gault formula.
  • Patient is female and ≥18 years of age at the time of the first screening visit.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.
  • Patients must be willing and able to sign the informed consent form, and to adhere to the study visit schedule and other protocol requirements.
  • Women of childbearing potential (a woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently ster-ile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy) must have a negative serum pregnancy test within 3 days from day 1 of cycle 1 and agree to use a highly effective method of contraception while on study treatment and for at least 8 months after end of treatment. Such methods include:
  • Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation:
  • oral
  • intravaginal
  • transdermal
  • Progestogen-only hormonal contraception associated with inhibition of ovulation:
  • oral
  • injectable
  • implantable
  • Intrauterine device (IUD)
  • Intrauterine hormone-releasing system (IUS)
  • Bilateral tubal occlusion
  • Vasectomized partner
  • Sexual abstinence

Who cannot join

  • Non-epithelial tumor origin of the ovary, the fallopian tube or the peritoneum (i.e. germ cell tumors)
  • Ovarian tumors of low malignant potential (e.g. borderline tumors).
  • Unknown BRCA status.
  • Patients who are planned to receive bevacizumab for the current relapse.
  • Other malignancy within the last 3 years (except cervix or breast in situ carcinoma, type I stage I endometrial cancer)
  • Patients who underwent surgery for the current relapse with macroscopic complete resection
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  • Prior systemic anticancer therapy within 28 days before randomization
  • Prior treatment with folate receptor-targeting investigational agents is not allowed.
  • Patients with > Grade 1 peripheral neuropathy.
  • Serious concurrent illness or clinically-relevant active infection
  • Previous clinical diagnosis of non-infectious interstitial lung disease, including non-infectious pneumonitis.
  • Active or chronic corneal disorders such as Sjogren's syndrome, Fuchs corneal dystrophy (requiring treatment), history of corneal transplantation, active herpetic keratitis, active ocular conditions requiring 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. Active or chronic corneal disorder
  • Required use of folate-containing supplements (e.g. folate deficiency)
  • Women of childbearing potential (WOCBP) not protected by highly effective contraceptive methods.
  • Pregnant and/or breast-feeding women.
  • Known hypersensitivity to one of the chemotherapy re-gimes and/or PARP inhibitors and/or any of their excipients.
  • Patients with prior hypersensitivity to monoclonal antibodies.
  • Patients with potential risks according to contraindication, warnings or interactions of the used chemotherapeutic agents as stated in the SmPCs are not eligible for participation in this trial.
  • Patients with untreated or symptomatic central nervous system (CNS) metastases

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

Germany19 sites

  • Charite - Universitätsmedizin Berlin

    Berlin

  • Städtisches Klinikum Dessau

    Dessau

  • Universitätsklinikum Carl-Gustav-Carus an der Technischen Universität Dresden

    Dresden

  • Evangelische Kliniken-Essen-Mitte

    Essen

  • Universitätsklinikum Frankfurt

    Frankfurt

  • Mammazentrum HH am Krankenhaus Jerusalem

    Hamburg

  • Universitätsklinikum Hamburg Eppendorf

    Hamburg

  • Medizinische Hochschule Hannover

    Hanover

  • ViDia Christliche Kliniken Karlsruhe

    Karlsruhe

  • St. Elisabeth-Krankenhaus GmbH

    Köln-Hohenlind

  • Helios Klinikum Krefeld

    Krefeld

  • Klinikum Mannheim

    Mannheim

  • OnkoNet Marburg GmbH

    Marburg

  • LMU Klinikum

    München

  • Rotkreuzklinikum München

    München

  • TU München, Klinikum recht der Isar

    München

  • Universitätsklinikum Münster

    Münster

  • Klinikum Südstadt Rostock

    Rostock

  • UniversitätsklinikumUlm

    Ulm

Other trials in Germany

About this study

Official title: A Randomized Phase II Trial of Mirvetuximab Soravtansine (IMGN853), in Folate Receptor Alpha (FRα) High Recurrent Ovarian Cancer Eligible for Platinum-based Chemotherapy. Supported by: DIAGNOSTIC PROTOCOL for the VENTANA FOLR1 (FOLR1-2.1) CDx Assay Ventana No. RD004881; Protocol Document No. D152967

This is a multi-center, randomized, two-arm, open-label, comparative phase II trial of Mirvetuximab soravtansine (IMGN853), in folate receptor alpha (FRα) high recurrent ovarian cancer eligible for platinum-based chemotherapy.

Read the detailed description

136 patients will be randomized into the follow-ing two treatment arms as specified below:

Arm A: Control arm Platinum-based chemotherapy Arm B: Carboplatin + Mirvetuximab soravtansine (IMGN853)

Being tested
Carboplatin, Pegylated liposomal doxorubicin (PLD), Gemcitabine, Paclitaxel, Mirvetuximab Soravtansine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CarboplatinDrug

    Carboplatin will administered by intravenous route

  • Pegylated liposomal doxorubicin (PLD)Drug

    PLD will be administered by intravenous route

  • GemcitabineDrug

    Gemcitabine will be administered by intravenous route

  • PaclitaxelDrug

    Paclitaxel will be administered by intravenous route

  • Mirvetuximab SoravtansineDrug

    Mirvetuximab Soravtansine will be administered by intravenous route

Study groups in NCT04274426
Study groupRoleWhat they receive
Control arm with Platinum-based chemotherapyActive comparator1. Carboplatin (AUC5, d1) combined with pegylated liposomal doxorubicin (PLD) (30 mg/m², d1) q28d 2. Carboplatin (AUC4, d1) combined with gemcitabine (1000 mg/m2, d1 \& d8) q21d 3. Carboplatin (AUC5, d1) combined with paclitaxel (175 mg/m², d1) q21d
Receives: Drug: Carboplatin; Drug: Pegylated liposomal doxorubicin (PLD); Drug: Gemcitabine; Drug: Paclitaxel
Carboplatin + Mirvetuximab soravtansine (IMGN853)ExperimentalCarboplatin (AUC5, d1) + Mirvetuximab soravtansine (IMGN853) 6 mg/kg IV d1 x 6 cycles q21d, followed by subsequent monotherapy of Mirvetuximab soravtansine (IMGN853) 6 mg/kg IV q3w until disease progression.
Receives: Drug: Carboplatin; Drug: Mirvetuximab Soravtansine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression free survival (PFS) defined as the time from randomization to progressive disease (PD) or death, whichever occurs earlier. PD is based on investigator assessment using the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).

    PD is based on investigator assessment using the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).

    Measured: Up to 2.5 years. From date of randomization until date of progressive disease (PD) or death, whichever occurs earlier.

Secondary outcomes (11)

  1. OS

    Overall survival

    Measured: Up to 2.5 years. From date of randomization until date of death from any cause.

  2. ORR

    Objective response rate

    Measured: Up to 2.5 years. From date of randomization to date of death death from any cause.

  3. Efficacy regarding PFS

    Efficacy regarding Progression Free Survival depending on histologic subtype

    Measured: Up to 2.5 years. From date of randomization to date of death from any cause.

  4. Efficacy regarding OS

    Efficacy regarding Overall Survival depending on histologic subtype

    Measured: Up to 2.5 years. From date of randomization to date of death from any cause.

  5. Efficacy regarding ORR

    Efficacy regarding Objective Response Rate depending on histologic subtype

    Measured: Up to 2.5 years. From date of randomization to date of death from any cause.

  6. Serological progressive disease

    Time to serological progressive disease according to GCIG criteria

    Measured: Up to 2.5 years. From date of randomization to date of death death from any cause.

  7. Time to first subsequent treatment (TFST)

    Time to first subsequent treatment (TFST)

    Measured: Up to 2.5 years. From date of randomization to date of death from any cause.

  8. Time to second subsequent treatment (TSST)

    Time to second subsequent treatment (TSST)

    Measured: Up to 2.5 years. From date of randomization until date of death from any cause.

  9. Patient-reported outcomes

    Quality of Life (EORTC C-30)

    Measured: Up to 2.5 years. From date of randomization until date of death from any cause.

  10. Patient-reported outcomes

    Quality of Life (EORTC OV28)

    Measured: Up to 2.5 years. From date of randomization until date of death from any cause.

  11. Safety and tolerability

    Safety and tolerability of the used drugs evaluated by NCI CTCAE v5.0

    Measured: Up to 2.5 years. From date of randomization until date of death from any cause through study completion.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Feb 2020
  2. Study start13 Oct 2021
  3. Primary completion3 Dec 2025
  4. Study completionDec 2026 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
136 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04274426
Sponsor's protocol ID
AGO-OVAR 2.34
Other IDs
2018-004207-39, 2024-516959-40-00, 2018
Acronym
MIROVA
Status last verified
May 2026
First submitted
10 Feb 2020
Last updated
13 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Carboplatin, Pegylated liposomal doxorubicin (PLD) and Gemcitabine in people with Recurrent Epithelial Ovarian, Fallopian or Peritoneal Carcinoma, run by AGO Research GmbH at 19 sites in Germany.

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 33 inclusion and 19 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: under way, not looking for participants, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in Germany. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival (PFS) defined as the time from randomization to progressive disease (PD) or death, whichever occurs earlier. PD is based on investigator assessment using the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). (time frame: Up to 2.5 years. From date of randomization until date of progressive disease (PD) or death, whichever occurs earlier.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04274426.

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 May 2026.

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