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NCT Number: NCT06682988

A Study to Assess Adverse Events and Change in Disease Activity in Participants With Platinum-Resistant Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression Treated With Intravenously (IV) Infused Mirvetuximab Soravtansine

Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess the safety and efficacy of for Mirvetuximab Soravtansine in participants with platinum-resistant advanced high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancer (platinum-resistant ovarian cancer) (PROC) whose tumors express a high level of folate receptor alpha (FRα).

Mirvetuximab Soravtansine (MIRV) is an investigational antibody drug conjugate designed to selectively kill cancer cells. The antibody (protein) part of MIRV targets tumors by delivering a cell-killing drug to cancer cells carrying a protein called folate receptor alpha (FRα). There are 2 cohorts in this study, the Randomized Phase 2 Cohort and the Hepatic Impairment Cohort. In the Randomized Phase 2 Cohort, participants are placed in 1 of 2 groups, called treatment arms. Each treatment arm receives MIRV on a different schedule (on day 1 every 21 days or on days 1 and 15 every 28 days). The Hepatic Impairment Cohort is designed to determine the starting dose of MIRV in patients with moderately abnormal liver function. Around 110 participants will be enrolled in the study at approximately 75 sites worldwide.

The total study duration will be approximately 24 months.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and scans.

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Key information

Conditions

Advanced High-Grade Epithelial Ovarian Cancer Adnexal Diseases Fallopian Tube Cancers Fallopian Tube Diseases Fallopian Tube Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Primary Peritoneal Cancer Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Blacktown Hospital /ID# 272182, Blacktown, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Both Cohorts

  • Participants with a confirmed diagnosis of high-grade serous epithelial ovarian cancer (EOC), primary peritoneal cancer, or fallopian tube cancer.
  • Participants with platinum-resistant disease:
  • Participants with 1 prior line of platinum-based therapy who have received ≥ 4 cycles of platinum and had a response (complete response (CR) or partial response (PR)) followed by radiological progressive disease (PD) between > 3 months and ≤ 6 months after the date of the last dose of platinum.
  • Participants 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.
  • Participants with progression diagnosed radiographically on or after their most recent line of therapy.
  • Participants with an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
  • Participants with ≥ 1 lesion that meets the definition of measurable disease by RECIST v1.1 (radiologically measured by the investigator).
  • Participants with a tumor that is positive for folate receptor alpha (FRα) expression as determined by the Ventana folate receptor 1 (FOLR1) assay (≥ 75% of tumor staining at 2+ intensity).

Exclusion criteria

Both Cohorts

  • Participants with endometrioid, clear cell, mucinous, or sarcomatous histology; mixed tumors containing any of the above histologies; or low-grade or borderline ovarian tumor.
  • Participants with primary platinum-refractory disease, defined as disease that did not respond (complete response (CR) or partial response (PR)) or that progressed radiographically within 3 months of the last dose of first-line platinum-containing chemotherapy.
  • Participants with serious concurrent illness or clinically relevant active infection as outlined in the protocol
  • Participants with a history of hemorrhagic or ischemic stroke within 6 months prior to randomization.

Treatment and study plan

Mirvetuximab Soravtansine

Drug

intravenous (IV) infusion

Other names: MIRV, IMGN853

Primary outcomes

  1. Randomized Phase 2 Cohort: Percentage of Participants with Grade >= 2 Treatment-Emergent Corneal Adverse Events (AEs)

    Time frame: Up to Approximately 24 months

    An AE is any noxious, pathologic, or unintended change in anatomical, physiologic, or metabolic function as indicated by physical signs, symptoms, or laboratory changes occurring in any phase of a clinical study, whether or not considered study drug related.

  2. Randomized Phase 2 Cohort: Percentage of Participants who Achieved Objective response rate (ORR)

    Time frame: Up to Approximately 24 months

    ORR is defined as 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).

  3. Hepatic Impairment Cohort: Maximal Concentration (Cmax) of Mirvetuximab Soravtansine

    Time frame: Up to Approximately 24 months

    Cmax of MIRV

  4. Hepatic Impairment Cohort: Area Under the Plasma Concentration (AUC) of Mirvetuximab Soravtansine

    Time frame: Up to Approximately 24 months

    AUC of MIRV

  5. Hepatic Impairment Cohort: Trough Concentration (Ctrough) of Mirvetuximab Soravtansine

    Time frame: Up to Approximately 24 months

    Ctrough of MIRV

  6. Hepatic Impairment Cohort: Volume of Distribution at Steady State (Vss) of Mirvetuximab Soravtansine

    Time frame: Up to Approximately 24 months

    Vss) of MIRV

  7. Hepatic Impairment Cohort: Time to Maximal Concentration (Tmax) of Mirvetuximab Soravtansine

    Time frame: Up to Approximately 24 months

    Tmax of MIRV

  8. Hepatic Impairment Cohort: Terminal Half-Life (t1/2) of Mirvetuximab Soravtansine

    Time frame: Up to Approximately 24 months

    t1/2 of MIRV

Secondary outcomes

  1. Randomized Phase 2 Cohort: Percentage of Participants with Treatment-Emergent All-Grade Ocular AEs, Grade >= 2 Peripheral Neuropathy, All-Grade Infusion Reactions, and All-Grade Pneumonitis

    Time frame: Up to Approximately 24 months

    An AE is any noxious, pathologic, or unintended change in anatomical, physiologic, or metabolic function as indicated by physical signs, symptoms, or laboratory changes occurring in any phase of a clinical study, whether or not considered study drug related.

  2. Randomized Phase 2 Cohort: Duration of Response (DOR) as Assessed by the Investigator Using RECIST v1.1

    Time frame: Up to Approximately 24 months

    Defined as the time from initial investigator-assessed response (complete response (CR) or partial response (PR)) until progressive disease (PD) as assessed by the investigator or death, whichever occurs first.

  3. Randomized Phase 2 Cohort: Progression-Free Survival (PFS)

    Time frame: Up to Approximately 24 months

    PFS is defined as the time from date of randomization until disease progression or death whichever occurs first.

  4. Randomized Phase 2 Cohort: Overall Survival (OS)

    Time frame: Up to Approximately 24 months

    Overall survival is defined as the time from the date of first dose until the date of death from any cause.

  5. Randomized Phase 2 Cohort: Percentage of Participants With CA-125 Confirmed Clinical Response Per Gynecologic Cancer Intergroup (GCIG) Criteria

    Time frame: Up to Approximately 24 months

    The GCIG CA-125 response is defined as at least 50% reduction in CA-125 levels from baseline. The response must be confirmed and maintained for at least 28 days.

  6. Randomized Phase 2 Cohort: Maximal Concentration (Cmax) of Mirvetuximab Soravtansine

    Time frame: Up to Approximately 24 months

    Cmax of MIRV

  7. Randomized Phase 2 Cohort: Area Under the Plasma Concentration (AUC) of Mirvetuximab Soravtansine

    Time frame: Up to Approximately 24 months

    (AUC) of MIRV

  8. Randomized Phase 2 Cohort: Trough Concentration (Ctrough) of Mirvetuximab Soravtansine

    Time frame: Up to Approximately 24 months

    Ctrough of MIRV

  9. Randomized Phase 2 Cohort: Volume of Distribution at Steady State (Vss) of Mirvetuximab Soravtansine

    Time frame: Up to Approximately 24 months

    Vss of MIRV

  10. Randomized Phase 2 Cohort: Time to Maximal Observed Concentration (Tmax) of Mirvetuximab Soravtansine

    Time frame: Up to Approximately 24 months

    Tmax of MIRV

  11. Randomized Phase 2 Cohort: Terminal Half-Life (t1/2) of Mirvetuximab Soravtansine

    Time frame: Up to Approximately 24 months

    t1/2 of MIRV

  12. Both Cohorts: Number of Participants With Treatment-emergent Adverse Events (TEAEs)

    Time frame: Up to Approximately 24 months

    An AE is any noxious, pathologic, or unintended change in anatomical, physiologic, or metabolic function as indicated by physical signs, symptoms, or laboratory changes occurring in any phase of a clinical study, whether or not considered study drug related.

  13. Both Cohorts: Percentage of Participants with Clinically Significant Vital Sign Measurements as Assessed by the Investigator

    Time frame: Up to Approximately 24 months

    Vital signs include blood pressure, heart rate, respiratory rate, and body temperature.

  14. Both Cohorts: Percentage of Participants with Clinically Significant Laboratory Values (test) as Assessed by the Investigator

    Time frame: Up to Approximately 24 months

    Percentage of participants with clinically significant laboratory values (hematology, chemistry, and coagulation) as assessed by the investigator.

  15. Both Cohorts: Number of Participants With Clinically Significant Abnormalities in Physical Examination Findings

    Time frame: Up to Approximately 24 months

    Physical examination included assessments of general appearance, skin, head (eyes, ears, nose, and throat), neck, lungs, heart, abdomen, back, lymph nodes, extremities, and neurological system.

Study contacts

Contact information is provided by the study sponsor or research team.

ABBVIE CALL CENTER

CONTACT

[email protected]

844-663-3742

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

A Randomized Phase 2, Open-label Study of Mirvetuximab Soravtansine in Patients With Platinum-resistant Advanced High-grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-alpha Expression Testing 2 Schedules of Administration for Dose Optimization, With a Separate Cohort to Determine Starting Dose in Patients With Moderate Hepatic Impairment

Important dates

Study start
2025
Primary completion
2026
Study completion
2028
First posted
Nov 12, 2024
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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