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

NCT04274426 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: AGO-OVAR 2.342018-004207-39
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 19

Brief 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.

Conditions

Recurrent Epithelial Ovarian, Fallopian or Peritoneal Carcinoma

Outcome Measures

Primary Outcomes (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 assess-ment 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.

Secondary Outcomes (11)

• OS

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

• ORR

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

• Efficacy regarding PFS

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

• Efficacy regarding OS

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

• Efficacy regarding ORR

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

Study Arms (2)

Control arm with Platinum-based chemotherapy

ACTIVE COMPARATOR

1. 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

Drug: Carboplatin; Drug: Pegylated liposomal doxorubicin (PLD); Drug: Gemcitabine; Drug: Paclitaxel

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.

Drug: Carboplatin; Drug: Mirvetuximab Soravtansine

Interventions

Carboplatin DRUG

Carboplatin will administered by intravenous route

Carboplatin + Mirvetuximab soravtansine (IMGN853); Control arm with Platinum-based chemotherapy

Pegylated liposomal doxorubicin (PLD) DRUG

PLD will be administered by intravenous route

Control arm with Platinum-based chemotherapy

Gemcitabine DRUG

Gemcitabine will be administered by intravenous route

Control arm with Platinum-based chemotherapy

Paclitaxel DRUG

Paclitaxel will be administered by intravenous route

Control arm with Platinum-based chemotherapy

Mirvetuximab Soravtansine DRUG

Mirvetuximab Soravtansine will be administered by intravenous route

Carboplatin + Mirvetuximab soravtansine (IMGN853)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 should have included platinum 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• AGO Research GmbH: lead

Study Sites (19)

Charite Campus Virchow Klinikum

Berlin, Germany

Location

Städtische Klinikum Dessau

Dessau, Germany

Location

Universitätsklinikum Carl-Gustav-Carus an der Technischen Universität Dresden

Dresden, Germany

Location

Evangelische Kliniken-Essen-Mitte

Essen, Germany

Location

Universitätsklinikum Frankfurt

Frankfurt, Germany

Location

Mammazentrum HH am Krankenhaus Jerusalem

Hamburg, Germany

Location

Universitätsklinikum Hamburg Eppendorf

Hamburg, Germany

Location

Medizinische Hochschule Hannover

Hanover, Germany

Location

ViDia Christliche Kliniken Karlsruhe

Karlsruhe, Germany

Location

St. Elisabeth-Krankenhaus GmbH

Köln-Hohenlind, Germany

Location

HELIOS Klinikum Krefeld

Krefeld, Germany

Location

Klinikum Mannheim

Mannheim, Germany

Location

OnkoNet Marburg

Marburg, Germany

Location

Klinikum der Universität München

München, Germany

Location

Rotkreuzklinikum München

München, Germany

Location

TU München, Klinikum recht der Isar

München, Germany

Location

Universitätsklinik Münster

Münster, Germany

Location

Klinikum Südstadt Rostock

Rostock, Germany

Location

Universitätsfrauenklinik Ulm

Ulm, Germany

Location

Related Links

• Related Info

MeSH Terms

Interventions

Carboplatin; liposomal doxorubicin; Gemcitabine; Paclitaxel; mirvetuximab soravtansine

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Philipp Harter

  Kliniken Essen-Mitte, Germany

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2020
• First Posted: February 18, 2020
• Study Start: October 13, 2021
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 6, 2025

Record last verified: 2025-04

Locations

DE (19)