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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

ConditionsAdvanced High-Grade Epithelial Ovarian CancerPrimary Peritoneal CancerFallopian Tube Cancers
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorAbbVie

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants with a confirmed diagnosis of high-grade serous epithelial ovarian cancer (EOC), primary peritoneal cancer, or fallopian tube cancer.

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Mirvetuximab Soravtansine

    Drug

    intravenous (IV) infusion

Treatment groups

110 Participants
are divided into 3 treatment groups
Group A: Randomized Phase 2 Cohort: Arm AExperimental treatment 1 intervention
Group B: Randomized Phase 2 Cohort: Arm BExperimental treatment 1 intervention
Group C: Hepatic Impairment Cohort : Mirvetuximab SoravtansineExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

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.

Time frame
Up to Approximately 24 months
2

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

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).

Time frame
Up to Approximately 24 months
3

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

Cmax of MIRV

Time frame
Up to Approximately 24 months
4

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

AUC of MIRV

Time frame
Up to Approximately 24 months

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

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.

Time frame
Up to Approximately 24 months
2

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

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.

Time frame
Up to Approximately 24 months
3

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

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

Time frame
Up to Approximately 24 months
4

Randomized Phase 2 Cohort: Overall Survival (OS)

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

Time frame
Up to Approximately 24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AbbVie

Lead sponsor

Source ClinicalTrials.gov
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