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

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ClinicalTrials.gov Identifier: NCT04274426
Recruitment Status : Not yet recruiting
First Posted : February 18, 2020
Last Update Posted : February 18, 2020
Sponsor:
Information provided by (Responsible Party):
AGO Research GmbH

Tracking Information
First Submitted Date  ICMJE February 10, 2020
First Posted Date  ICMJE February 18, 2020
Last Update Posted Date February 18, 2020
Estimated Study Start Date  ICMJE July 2020
Estimated Primary Completion Date January 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 17, 2020)
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). [ Time Frame: Up to 2.5 years. From date of randomization until date of 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).
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 17, 2020)
  • OS [ Time Frame: Up to 2.5 years. From date of randomization until date of death from any cause. ]
    Overall survival
  • ORR [ Time Frame: Up to 2.5 years. From date of randomization to date of death death from any cause. ]
    Objective response rate
  • Efficacy regarding PFS [ Time Frame: Up to 2.5 years. From date of randomization to date of death from any cause. ]
    Efficacy regarding Progression Free Survival depending on histologic subtype
  • Efficacy regarding OS [ Time Frame: Up to 2.5 years. From date of randomization to date of death from any cause. ]
    Efficacy regarding Overall Survival depending on histologic subtype
  • Efficacy regarding ORR [ Time Frame: Up to 2.5 years. From date of randomization to date of death from any cause. ]
    Efficacy regarding Objective Response Rate depending on histologic subtype
  • Serological progressive disease [ Time Frame: Up to 2.5 years. From date of randomization to date of death death from any cause. ]
    Time to serological progressive disease according to GCIG criteria
  • Time to first subsequent treatment (TFST) [ Time Frame: Up to 2.5 years. From date of randomization to date of death from any cause. ]
    Time to first subsequent treatment (TFST)
  • Time to second subsequent treatment (TSST) [ Time Frame: Up to 2.5 years. From date of randomization until date of death from any cause. ]
    Time to second subsequent treatment (TSST)
  • Patient-reported outcomes [ Time Frame: Up to 2.5 years. From date of randomization until date of death from any cause. ]
    Quality of Life (EORTC C-30)
  • Patient-reported outcomes [ Time Frame: Up to 2.5 years. From date of randomization until date of death from any cause. ]
    Quality of Life (EORTC OV28)
  • Safety and tolerability [ Time Frame: Up to 2.5 years. From date of randomization until date of death from any cause through study completion. ]
    Safety and tolerability of the used drugs evaluated by NCI CTCAE v5.0
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mirvetuximab Soravtansine (IMGN853), in Folate Receptor Alpha (FRα) High Recurrent Ovarian Cancer
Official Title  ICMJE A Randomized Phase II Trial of Mirvetuximab Soravtansine (IMGN853), in Folate Receptor Alpha (FRα) High Recurrent Ovarian Cancer Eligible for Platinum-based Chemotherapy.
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.
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)

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Recurrent Epithelial Ovarian, Fallopian or Peritoneal Carcinoma
Intervention  ICMJE
  • Drug: Carboplatin
    Carboplatin will administered by intravenous route
  • Drug: Pegylated liposomal doxorubicin (PLD)
    PLD will be administered by intravenous route
  • Drug: Gemcitabine
    Gemcitabine will be administered by intravenous route
  • Drug: Paclitaxel
    Paclitaxel will be administered by intravenous route
  • Drug: Mirvetuximab Soravtansine
    Mirvetuximab Soravtansine will be administered by intravenous route
Study Arms  ICMJE
  • Active Comparator: Control arm with Platinum-based chemotherapy
    1. Carboplatin (AUC5, d1) as monotherapy q21d
    2. Carboplatin (AUC5, d1) combined with pegylated liposomal doxorubicin (PLD) (30 mg/m², d1) q28d
    3. Carboplatin (AUC4, d1) combined with gemcitabine (1000 mg/m2, d1 & d8) q21d
    4. Carboplatin (AUC5, d1) combined with paclitaxel (175 mg/m², d1) q21d
    Interventions:
    • Drug: Carboplatin
    • Drug: Pegylated liposomal doxorubicin (PLD)
    • Drug: Gemcitabine
    • Drug: Paclitaxel
  • Experimental: Carboplatin + Mirvetuximab soravtansine (IMGN853)
    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.
    Interventions:
    • Drug: Carboplatin
    • Drug: Mirvetuximab Soravtansine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: February 17, 2020)
136
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2023
Estimated Primary Completion Date January 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. All patients must have a pathologically documented, definite diagnosis of epithelial cancer of the ovary, the fallopian tube or the peritoneum
  2. Relapsed disease with a platinum-free interval >3 months
  3. All histologic subtypes of ovarian carcinoma including carcinosarcoma (malignant mixed Mullerian tumors, MMMT)
  4. 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.
  5. 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.

  6. Patients must have measurable disease or evaluable disease in combination with GCIG CA-125 criteria.
  7. 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.
  8. 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.
  9. Patients must have adequate hematological, liver, cardiac and kidney function:

    1. Hemoglobin ≥ 10.0 g/dL.
    2. Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
    3. Platelet count ≥ 100 x 109/L.
    4. Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN).
    5. 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.
    6. Serum creatinine ≤ 1.5 x institutional ULN and glomerular filtration rate of at least 40 ml/minute according to Cockroft-Gault formula.
  10. Patient is female and ≥18 years of age at the time of the first screening visit.
  11. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.
  12. Patients must be willing and able to sign the informed consent form, and to adhere to the study visit schedule and other protocol requirements.
  13. For women of childbearing potential (a woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy) must use a highly effective method of contraception. Such methods include:

    1. Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation:

      • oral
      • intravaginal
      • transdermal
    2. Progestogen-only hormonal contraception associated with inhibition of ovula-tion:

      • oral
      • injectable
      • implantable
    3. Intrauterine device (IUD)
    4. Intrauterine hormone-releasing system (IUS)
    5. Bilateral tubal occlusion
    6. Vasectomized partner
    7. Sexual abstinence

Exclusion Criteria:

  1. Non-epithelial tumor origin of the ovary, the fallopian tube or the peritoneum (i.e. germ cell tumors)
  2. Ovarian tumors of low malignant potential (e.g. borderline tumors).
  3. Unknown BRCA status.
  4. Patients who are planned to receive bevacizumab for the current relapse.
  5. Other malignancy within the last 3 years (except cervix or breast in situ carcinoma, type I stage I endometrial cancer)
  6. Patients who underwent surgery for the current relapse with macroscopic complete resection
  7. Prior systemic anticancer therapy within 28 days before randomization
  8. Prior treatment with folate receptor-targeting investigational agents is not allowed.
  9. Patients with > Grade 1 peripheral neuropathy.
  10. Serious concurrent illness or clinically-relevant active infection
  11. Previous clinical diagnosis of non-infectious interstitial lung disease, including non-infectious pneumonitis.
  12. 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 on-going 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
  13. Required use of folate-containing supplements (e.g. folate deficiency)
  14. Women of childbearing potential (WOCBP) not protected by highly effective contraceptive methods.
  15. Pregnant and/or breast-feeding women.
  16. Known hypersensitivity to Carboplatin.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Michaela Fredrich +49 611 880467 ext 42 mfredrich@ago-oavr.de
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04274426
Other Study ID Numbers  ICMJE AGO-OVAR 2.34
2018-004207-39 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AGO Research GmbH
Study Sponsor  ICMJE AGO Research GmbH
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account AGO Research GmbH
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP