Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2018-004207-39 | EudraCT Number | ||
| 2024-516959-40-00 | EU Trial (CTIS) Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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)
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control arm with Platinum-based chemotherapy | Active Comparator |
|
|
| Carboplatin + Mirvetuximab soravtansine (IMGN853) | Experimental | Carboplatin (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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carboplatin | Drug | Carboplatin will administered by intravenous route |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Up to 2.5 years. From date of randomization until date of progressive disease (PD) or death, whichever occurs earlier. |
| Measure | Description | Time Frame |
|---|---|---|
| OS | Overall survival | Up to 2.5 years. From date of randomization until date of death from any cause. |
| ORR | Objective response rate | Up to 2.5 years. From date of randomization to date of death death from any cause. |
Not provided
Inclusion Criteria:
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.
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:
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:
Progestogen-only hormonal contraception associated with inhibition of ovulation:
Intrauterine device (IUD)
Intrauterine hormone-releasing system (IUS)
Bilateral tubal occlusion
Vasectomized partner
Sexual abstinence
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Philipp Harter | Evangelische Kliniken Essen-Mitte, Germany | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charite - Universitätsmedizin Berlin | Berlin | Germany | ||||
| Städtisches Klinikum Dessau |
Not provided
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Pegylated liposomal doxorubicin (PLD) | Drug | PLD will be administered by intravenous route |
|
| Gemcitabine | Drug | Gemcitabine will be administered by intravenous route |
|
| Paclitaxel | Drug | Paclitaxel will be administered by intravenous route |
|
| Mirvetuximab Soravtansine | Drug | Mirvetuximab Soravtansine will be administered by intravenous route |
|
| Efficacy regarding PFS | Efficacy regarding Progression Free Survival depending on histologic subtype | Up to 2.5 years. From date of randomization to date of death from any cause. |
| Efficacy regarding OS | Efficacy regarding Overall Survival depending on histologic subtype | Up to 2.5 years. From date of randomization to date of death from any cause. |
| Efficacy regarding ORR | Efficacy regarding Objective Response Rate depending on histologic subtype | Up to 2.5 years. From date of randomization to date of death from any cause. |
| Serological progressive disease | Time to serological progressive disease according to GCIG criteria | Up to 2.5 years. From date of randomization to date of death death from any cause. |
| Time to first subsequent treatment (TFST) | Time to first subsequent treatment (TFST) | Up to 2.5 years. From date of randomization to date of death from any cause. |
| Time to second subsequent treatment (TSST) | Time to second subsequent treatment (TSST) | Up to 2.5 years. From date of randomization until date of death from any cause. |
| Patient-reported outcomes | Quality of Life (EORTC C-30) | Up to 2.5 years. From date of randomization until date of death from any cause. |
| Patient-reported outcomes | Quality of Life (EORTC OV28) | Up to 2.5 years. From date of randomization until date of death from any cause. |
| Safety and tolerability | Safety and tolerability of the used drugs evaluated by NCI CTCAE v5.0 | Up to 2.5 years. From date of randomization until date of death from any cause through study completion. |
| Dessau |
| Germany |
| Universitätsklinikum Carl-Gustav-Carus an der Technischen Universität Dresden | Dresden | Germany |
| Evangelische Kliniken-Essen-Mitte | Essen | Germany |
| Universitätsklinikum Frankfurt | Frankfurt | Germany |
| Mammazentrum HH am Krankenhaus Jerusalem | Hamburg | Germany |
| Universitätsklinikum Hamburg Eppendorf | Hamburg | Germany |
| Medizinische Hochschule Hannover | Hanover | Germany |
| ViDia Christliche Kliniken Karlsruhe | Karlsruhe | Germany |
| St. Elisabeth-Krankenhaus GmbH | Köln-Hohenlind | Germany |
| Helios Klinikum Krefeld | Krefeld | Germany |
| Klinikum Mannheim | Mannheim | Germany |
| OnkoNet Marburg GmbH | Marburg | Germany |
| LMU Klinikum | München | Germany |
| Rotkreuzklinikum München | München | Germany |
| TU München, Klinikum recht der Isar | München | Germany |
| Universitätsklinikum Münster | Münster | Germany |
| Klinikum Südstadt Rostock | Rostock | Germany |
| UniversitätsklinikumUlm | Ulm | Germany |
| ID | Term |
|---|---|
| D016190 | Carboplatin |
| C506643 | liposomal doxorubicin |
| D000093542 | Gemcitabine |
| D017239 | Paclitaxel |
| C000607289 | mirvetuximab soravtansine |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
Not provided
Not provided