Authorised Therapeutic exploratory (Phase II) platinum-resistant advanced high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancers.

A study to evaluate dosing schedules of mirvetuximab soravtansine in patients with epithelial ovarian, primary peritoneal, or fallopian tube cancers

EU CTIS ID: 2024-517184-23-00

What this study is testing

Randomized Phase 2 Cohort To characterize the safety of the alternative dosing schedule (mirvetuximab soravtansine 4mg/kg adjusted ideal body weight [AIBW] once every 2 weeks of a 28-day cycle) and the United States (US) -approved dosing schedule (mirvetuximab 6 mg/kg AIBW administered once every 3 weeks of a 21-day cycle) To evaluate efficacy parameters of the alternative dosing schedule (mirvetuximab soravtansine 4 mg/kg AIBW once every 2 weeks of a 28-day cycle) and the US approved dosing schedule (mirvetuximab 6 mg/kg AIBW administered once every 3 weeks of a 21-day cycle) Hepatic Impairment Cohort To determine the starting dose of MIRV in patients with moderate hepatic impairment

  • Therapeutic exploratory (Phase II)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Patients ≥ 18 years or age of maturity as per local law.
  • Patients with PD diagnosed radiographically on or after their most recent line of therapy.
  • Patients treated with 1, 2, or 3 prior systemic lines of anticancer therapy, with the following clarifications: a. Adjuvant ± neoadjuvant is considered 1 line of therapy. b. Maintenance therapy (eg, bevacizumab, PARP inhibitors) is considered part of the preceding line of therapy (ie, not counted independently). c. Therapy changed due to toxicity in the absence of progression is considered part of the same line (ie, not counted independently). d. Unless given as maintenance therapy, hormonal therapy is counted as a separate line of therapy.
  • Patients are willing to provide an archival tumor tissue block or slides, or undergo procedure to obtain a new biopsy using a low-risk, medically routine procedure for immunohistochemistry (IHC) confirmation of FRα positivity.
  • Patients with a tumor that is positive for FRα expression as determined by the Ventana FOLR1 (FOLR1 2.1) RxDx (commercial) assay the Ventana FOLR1 (FOLR1-2.1) IUO assay, or the Ventana FOLR1 (FOLR-2.1) CDx assay (hereafter referred to collectively as the Ventana FOLR1 assay) (≥ 75% of tumor staining at 2+ intensity).
  • Patients with ≥ 1 lesion that meets the definition of measurable disease by RECIST v1.1 (radiologically measured by the investigator).

You likely can't join if

  • Patients with endometrioid, clear cell, mucinous, or sarcomatous histology; mixed tumors containing any of the above histologies; or low-grade or borderline ovarian tumor.
  • Patients with severe hepatic impairment according to NCI-ODWG criteria (Mansfield 2016; see Appendix A).
  • Patients with a previous clinical diagnosis of noninfectious interstitial lung disease, including noninfectious pneumonitis.
  • Patients with required use of folate-containing supplements (eg, folate deficiency).
  • Patients with prior hypersensitivity to monoclonal antibodies.
  • Patients who are pregnant or lactating.
See the full eligibility criteria
Who can join
  • Patients ≥ 18 years or age of maturity as per local law.
  • Patients with PD diagnosed radiographically on or after their most recent line of therapy.
  • Patients treated with 1, 2, or 3 prior systemic lines of anticancer therapy, with the following clarifications: a. Adjuvant ± neoadjuvant is considered 1 line of therapy. b. Maintenance therapy (eg, bevacizumab, PARP inhibitors) is considered part of the preceding line of therapy (ie, not counted independently). c. Therapy changed due to toxicity in the absence of progression is considered part of the same line (ie, not counted independently). d. Unless given as maintenance therapy, hormonal therapy is counted as a separate line of therapy.
  • Patients are willing to provide an archival tumor tissue block or slides, or undergo procedure to obtain a new biopsy using a low-risk, medically routine procedure for immunohistochemistry (IHC) confirmation of FRα positivity.
  • Patients with a tumor that is positive for FRα expression as determined by the Ventana FOLR1 (FOLR1 2.1) RxDx (commercial) assay the Ventana FOLR1 (FOLR1-2.1) IUO assay, or the Ventana FOLR1 (FOLR-2.1) CDx assay (hereafter referred to collectively as the Ventana FOLR1 assay) (≥ 75% of tumor staining at 2+ intensity).
  • Patients with ≥ 1 lesion that meets the definition of measurable disease by RECIST v1.1 (radiologically measured by the investigator).
  • Patients with an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
  • Patients with adequate hematologic, liver, and kidney function defined as follows: a. Absolute neutrophil count (ANC) ≥ 1.5 × 109/L (1500/μL) without granulocyte colony-stimulating factor (G-CSF) in the prior 10 days or long-acting white blood cell (WBC) growth factors in the prior 20 days b. Platelet count ≥ 100 × 109/L (100,000/μL) without platelet transfusion in the prior 10 days c. Hemoglobin ≥ 9.0 g/dL without packed red blood cell (PRBC) transfusion in the prior 14 days d. Creatinine clearance (CrCl) ≥ 30 mL/min per the Cockcroft-Gault formula (Cockcroft 1976) e. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 × ULN f. Serum bilirubin ≤ 1.5 × ULN (patients with documented diagnosis of Gilbert syndrome are eligible if total bilirubin < 3.0 × ULN) g. Serum albumin ≥ 2 g/dL
  • Patients must have adequate hematologic and kidney function defined as follows: a. ANC ≥ 1.5 × 109/L (1500/μL) without G-CSF in the prior 10 days or long-acting WBC growth factors in the prior 20 days b. Platelet count ≥ 100 × 109/L (100,000/μL) without platelet transfusion in the prior 10 days c. Hemoglobin ≥ 9.0 g/dL without PRBC transfusion in the prior 14 days d. Creatinine clearance (CrCl) ≥ 30 mL/min per the Cockcroft-Gault formula (Cockcroft 1976)
  • Patients must have moderate hepatic impairment according to NCI-ODWG criteria (total bilirubin > 1.5-3 × ULN [Mansfield 2016; see Appendix A for additional details]).
  • Patient’s time from last date of prior therapy: a. Systemic antineoplastic therapy (5 half-lives or 4 weeks, whichever is shorter). b. Focal radiation completed ≥ 2 weeks prior to first dose of study treatment.
  • Patients with stabilized or recovered (Grade < 1) prior therapy-related toxicities.
  • Patients with prior major surgery are ≥ 4 weeks post-surgery prior to first dose of study treatment and have recovered or stabilized from the side effects of prior surgery.
  • Patients or their legally authorized representative are willing and able to sign the informed consent form (ICF) and to adhere to the protocol requirements.
  • Females of childbearing potential (FCBP) agree to use highly effective contraceptive method(s) (as defined in Section 5.8.7) while on study treatment and for ≥ 7 months after the last dose of study treatment.
  • A negative pregnancy test (serum or urine) for FCBP within 4 days prior to the first dose of study treatment.
  • Patients with a confirmed diagnosis of high-grade serous EOC, primary peritoneal cancer, or fallopian tube cancer.
  • Patients with platinum-resistant disease: a. Patients with 1 prior line of platinum-based therapy who have received ≥ 4 cycles of platinum and had a response (CR or PR) followed by radiological PD between > 3 months and ≤ 6 months after the date of the last dose of platinum. b. Patients with 2 or 3 prior lines of platinum-based therapy who had radiological PD ≤ 6 months after the date of the last dose of platinum. Note: PD is calculated from the date of the last administered dose of platinum therapy to the date of the radiographic imaging showing progression. Note: Patients who have platinum-refractory disease following front-line treatment are excluded (see exclusion criteria).
What rules you out
  • Patients with endometrioid, clear cell, mucinous, or sarcomatous histology; mixed tumors containing any of the above histologies; or low-grade or borderline ovarian tumor.
  • Patients with severe hepatic impairment according to NCI-ODWG criteria (Mansfield 2016; see Appendix A).
  • Patients with a previous clinical diagnosis of noninfectious interstitial lung disease, including noninfectious pneumonitis.
  • Patients with required use of folate-containing supplements (eg, folate deficiency).
  • Patients with prior hypersensitivity to monoclonal antibodies.
  • Patients who are pregnant or lactating.
  • Patients with prior treatment with MIRV or other FRα-targeting agents.
  • Patients with untreated or symptomatic central nervous system (CNS) metastases.
  • Patients with a history of other malignancy within 3 years prior to randomization. Note: Does not include tumors with a negligible risk for metastasis or death (eg, adequately controlled basal cell carcinoma or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or breast, or Stage IA Grade 1 endometrioid endometrial cancer).
  • Prior known hypersensitivity reactions to MIRV and/or any of its excipients.
  • People who are detained through a court or administrative decision, receiving psychiatric care against their will, adults who are the subject of a legal protection order (under tutorship/curatorship), people who are unable to express their consent, and people who are subject to a legal guardianship order.
  • Patients with primary platinum-refractory disease, defined as disease that did not respond (CR or PR) or that progressed radiographically within 3 months of the last dose of first-line platinum-containing chemotherapy.
  • Simultaneous participation in another research study, in countries or localities where this is the health authority guidance.
  • Patients with prior wide-field radiotherapy affecting ≥ 20% of the bone marrow.
  • Patients with Grade > 1 peripheral neuropathy per Common Terminology Criteria for Adverse Events (CTCAE).
  • Patients with the following ocular history and/or concurrent disorders: a. Active or chronic corneal epithelial disorders other than non-confluent superficial keratopathy/keratitis, including confluent superficial punctate keratopathy/keratitis (SPK) not expected to resolve to non-confluence or better within the screening window with SOC intervention b. History of corneal transplantation c. Undergoing active postoperative management for refractive surgery, cataract surgery, corneal cross-linking, or corneal complications of surgery d. Active or chronic clinically significant (≥ Grade 3) corneal disorders (e.g., Fuch's dystrophy or neurotrophic keratitis e. Active ocular conditions requiring ongoing treatment/monitoring, such as glaucoma that is not adequately controlled with medication or surgery, wet age-related macular degeneration requiring intravitreal injections, active diabetic retinopathy with macular edema, macular degeneration, presence of papilledema, or an ocular condition with high risk of retinal detachment f. Monocular vision with visual acuity in the better eye worse than 20/200 or visual fields less than 20 degrees (i.e., functional blindness in both eyes)
  • Patients with serious concurrent illness or clinically relevant active infection, including, but not limited to the following: a. Active hepatitis B or C infection (whether or not on active antiviral therapy) b. HIV infection c. Active cytomegalovirus infection d. Any other concurrent infectious disease requiring IV antibiotics within 2 weeks before starting study treatment Note: Testing at Screening is not required for the above infections unless clinically indicated.
  • Patients with a history of multiple sclerosis or other demyelinating disease and/or Lambert-Eaton syndrome (paraneoplastic syndrome).
  • Patients with clinically significant cardiac disease including, but not limited to, any one of the following: a. Myocardial infarction ≤ 6 months prior to first dose b. Unstable angina pectoris c. Uncontrolled congestive heart failure (New York Heart Association > Class II) d. Uncontrolled Grade ≥ 3 hypertension (per CTCAE) e. Uncontrolled cardiac arrhythmias
  • Patients with a history of hemorrhagic or ischemic stroke within 6 months prior to randomization.

The study team makes the final eligibility decision.

Where it's taking place

  • Australia
  • United States
  • United Kingdom
  • Korea, Republic of
  • Turkey
  • Argentina

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling female, 18-64 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Australia; United States; United Kingdom; Korea, Republic of; Turkey; Argentina. Enter your location above to see the nearest site and check your eligibility.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.