MIRVETUXIMAB SORAVTANSINE for Platinum-resistant high-grade epithelial ovarian cancer | Primary peritoneal cancer | Fallopian tube cancer

Inclusion criteria

• {"criterion_text":"- Patients ≥ 18 years of age.\n- Patients with PD diagnosed radiographically on or after their most recent line of therapy.\n- 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.\n- 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.\n- Patients with a tumor that is positive for FRα expression as determined by the Ventana FOLR1 assay (≥ 75% of tumor staining at 2+ intensity).\n- Patients with ≥ 1 lesion that meets the definition of measurable disease by RECIST v1.1 (radiologically measured by the investigator).\n- Patients with an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.\n- 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\n- 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)\n- 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]).\n- 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.\n- Patients with stabilized or recovered (Grade < 1) prior therapy-related toxicities.\n- 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.\n- Patients or their legally authorized representative are willing and able to sign the informed consent form (ICF) and to adhere to the protocol requirements.\n- 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.\n- A negative pregnancy test (serum or urine) for FCBP within 4 days prior to the first dose of study treatment.\n- Patients with a confirmed diagnosis of high-grade serous EOC, primary peritoneal cancer, or fallopian tube cancer.\n- 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)."}

Exclusion criteria

• {"criterion_text":"- Patients with endometrioid, clear cell, mucinous, or sarcomatous histology; mixed tumors containing any of the above histologies; or low-grade or borderline ovarian tumor.\n- Patients with severe hepatic impairment according to NCI-ODWG criteria (Mansfield 2016; see Appendix A).\n- Patients with a previous clinical diagnosis of noninfectious interstitial lung disease, including noninfectious pneumonitis.\n- Patients with required use of folate-containing supplements (eg, folate deficiency).\n- Patients with prior hypersensitivity to monoclonal antibodies.\n- Patients who are pregnant or lactating.\n- Patients with prior treatment with MIRV or other FRα-targeting agents.\n- Patients with untreated or symptomatic central nervous system (CNS) metastases.\n- 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).\n- Prior known hypersensitivity reactions to MIRV and/or any of its excipients.\n- 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.\n- 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.\n- Simultaneous participation in another research study, in countries or localities where this is the health authority guidance.\n- Patients with prior wide-field radiotherapy affecting ≥ 20% of the bone marrow.\n- Patients with Grade > 1 peripheral neuropathy per Common Terminology Criteria for Adverse Events (CTCAE).\n- Patients with the following ocular history and/or concurrent disorders: a. History of corneal transplantation b. Undergoing active postoperative management for refractive surgery, cataract surgery, corneal cross-linking, or corneal complications of surgery c. Confluent superficial punctate keratopathy (SPK) not expected to resolve to non-confluence or better within the screening window with standard of care intervention d. Active or chronic clinically significant (Grade ≥ 3) corneal dystrophy (eg, Fuchs dystrophy) 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 (ie, functional blindness in both eyes)\n- 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.\n- Patients with a history of multiple sclerosis or other demyelinating disease and/or Lambert-Eaton syndrome (paraneoplastic syndrome).\n- 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\n- Patients with a history of hemorrhagic or ischemic stroke within 6 months prior to randomization."}

Primary endpoints

• {"endpoint_text":"- Rates of Grade ≥ 2 treatment-emergent corneal AEs","definition_or_measurement_approach":"Measured as rates of Grade ≥ 2 treatment-emergent corneal adverse events (as reported during treatment)."}
• {"endpoint_text":"- Objective response rate (ORR), which includes a best response of confirmed complete response (CR) or partial response (PR), as assessed by the Investigator according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)","definition_or_measurement_approach":"Assessed by Investigator per RECIST v1.1; ORR = confirmed CR or PR."}
• {"endpoint_text":"- PK parameters in patients with moderate hepatic impairment versus matching patients with normal hepatic function","definition_or_measurement_approach":"Comparison of pharmacokinetic parameters between patients with moderate hepatic impairment and matched patients with normal hepatic function."}

Secondary endpoints

• {"endpoint_text":"- Rates of treatment-emergent all-grade ocular AEs, Grade ≥ 2 peripheral neuropathy, all-grade infusion reactions, and all-grade pneumonitis","definition_or_measurement_approach":"Measured as rates of specified adverse events occurring during treatment."}
• {"endpoint_text":"- Treatment-emergent adverse events (TEAEs) and changes in laboratory test results, physical examination (PE) results, and vital signs","definition_or_measurement_approach":"Evaluation and reporting of TEAEs and changes from baseline in labs, physical exams, and vital signs."}
• {"endpoint_text":"- Duration of response (DOR), defined as the time from initial investigator-assessed response (CR or PR) until progressive disease (PD) as assessed by the investigator","definition_or_measurement_approach":"Time (interval) from initial investigator-assessed confirmed CR/PR to investigator-assessed radiologic PD."}
• {"endpoint_text":"- Progression-free survival (PFS), defined as the time from first dose of MIRV until investigator-assessed radiological PD or death, whichever occurs first","definition_or_measurement_approach":"Time from first dose to radiologic PD or death, per investigator assessment."}
• {"endpoint_text":"- Overall survival (OS), defined as the time from first dose of MIRV until death","definition_or_measurement_approach":"Time from first dose to death from any cause."}
• {"endpoint_text":"- Cancer antigen 125 (CA-125) response rate per Gynecologic Cancer Intergroup (GCIG) criteria","definition_or_measurement_approach":"CA-125 response evaluated according to GCIG criteria."}
• {"endpoint_text":"- PK parameters in both schedules, such as maximal concentration (Cmax), area under the concentration-time curve (AUC), trough concentration (Ctrough), volume of distribution at steady state (Vss), time to maximal concentration (Tmax), and terminal half-life (t½); relationships between efficacy/safety endpoints and exposure metrics; covariates on the ER relationships","definition_or_measurement_approach":"Measurement of standard PK parameters (Cmax, AUC, Ctrough, Vss, Tmax, t½) and assessment of exposure-response relationships and covariates."}
• {"endpoint_text":"- Determine the differences in dose amount and exposure between the 2 schedules (BSA vs AIBW) and the effects on ER relationships","definition_or_measurement_approach":"Comparison of dose/exposure differences between BSA-based and AIBW-based schedules and evaluation of effects on exposure-response relationships."}
• {"endpoint_text":"- TEAEs and changes in laboratory test results, PE results, and vital signs","definition_or_measurement_approach":"Assessment of treatment-emergent adverse events and clinical/laboratory parameter changes."}

Spain

Earliest CTIS Part Ii Submission Date

21-07-2025

Latest Decision Or Authorization Date

07-11-2025

Processing Time Days

109

Number Of Sites

12

Number Of Participants

11

Poland

Earliest CTIS Part Ii Submission Date

10-07-2025

Latest Decision Or Authorization Date

11-08-2025

Processing Time Days

32

Number Of Sites

11

Number Of Participants

13

Belgium

Earliest CTIS Part Ii Submission Date

08-07-2025

Latest Decision Or Authorization Date

31-07-2025

Processing Time Days

23

Number Of Sites

5

Number Of Participants

5

France

Earliest CTIS Part Ii Submission Date

08-07-2025

Latest Decision Or Authorization Date

31-07-2025

Processing Time Days

23

Number Of Sites

9

Number Of Participants

8

Primary sponsor

Full Name

AbbVie Deutschland GmbH & Co. KG

Organisation Type

Pharmaceutical company

Country Of Registered Address

Germany

Contract research organisations

Name

Ppd Laboratories (Suzhou) Co. Ltd.

Responsibilities

code 4

Name

PPD Development LP

Responsibilities

code 4

Name

Icon Laboratory Services Inc.

Responsibilities

code 4

Name

Iqvia Biotech LLC

Responsibilities

codes 1,12,13,5,6,8 (various operational responsibilities as listed)

Name

Almac Clinical Services (Ireland) Limited

Responsibilities

code 14 | code 15: labelling

Name

Labcorp Central Laboratory Services LP

Responsibilities

code 15: Samples Collection Services, Samples Transportation Services, Specimen Management, Investigator Training

Name

4g Clinical LLC

Responsibilities

code 15: Trial Supply Management | code 3

Third parties

• {"country":"China","full_name":"Ppd Laboratories (Suzhou) Co. Ltd.","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Icon Laboratory Services Inc.","duties_or_roles":"code 4","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Ireland","full_name":"Almac Clinical Services (Ireland) Limited","duties_or_roles":"code 14 | code 15: labelling","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"code 15: Tumor sample long term storage","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"4g Clinical LLC","duties_or_roles":"code 15: Trial Supply Management | code 3","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"code 15: Samples Collection Services,Samples Transportation Services, Specimen Management, Investigator Training","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Iqvia Biotech LLC","duties_or_roles":"code 1 | code 12 | code 13 | code 5 | code 6 | code 8","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Vivos Technology Limited","duties_or_roles":"code 15: Biometrics services provision","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Roche Tissue Diagnostics","duties_or_roles":"code 4","organisation_type":"Industry"}