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

Phase 2RecruitingNCT06682988

AbbVie110 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

110

Conditions

Advanced High-Grade Epithelial Ovarian

Interventions

Mirvetuximab SoravtansineDRUG

intravenous (IV) infusion

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (37)

First Physicians Group /ID# 272180

Sarasota, Florida, United States

RECRUITING

St. Elizabeth Medical Center - Edgewood /ID# 272113

Edgewood, Kentucky, United States

RECRUITING

Baptist Health Lexington /ID# 272211

Lexington, Kentucky, United States

RECRUITING

UMass Memorial Medical Center /ID# 272122

Worcester, Massachusetts, United States

Outcomes

Primary Outcomes

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

Randomized Phase 2 Cohort: 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

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

Cmax of MIRV

Time frame: Up to Approximately 24 months

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

AUC of MIRV

Time frame: Up to Approximately 24 months

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

Ctrough of MIRV

Time frame: Up to Approximately 24 months

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

Vss) of MIRV

Time frame: Up to Approximately 24 months

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

Tmax of MIRV

Time frame: Up to Approximately 24 months

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

t1/2 of MIRV

Time frame: Up to Approximately 24 months

Secondary Outcomes

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

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

Time frame: Up to Approximately 24 months

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

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

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

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.

Time frame: Up to Approximately 24 months

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

Cmax of MIRV

Time frame: Up to Approximately 24 months

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

Central Contacts

ABBVIE CALL CENTER

CONTACT

844-663-3742 abbvieclinicaltrials@abbvie.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Karmanos Cancer Institute - Detroit /ID# 272112

Detroit, Michigan, United States

RECRUITING

Allegheny Health Network West Penn Hospital /ID# 272267

Pittsburgh, Pennsylvania, United States

RECRUITING

Blacktown Hospital /ID# 272182

Blacktown, New South Wales, Australia

RECRUITING

Newcastle Private Hosptial /ID# 272213

Lambton Heights, New South Wales, Australia

RECRUITING

Royal Brisbane and Women's Hospital /ID# 272123

Brisbane, Queensland, Australia

RECRUITING

Icon Cancer Centre Chermside /ID# 272220

Chermside, Queensland, Australia

RECRUITING

...and 27 more locations

Time frame: Up to Approximately 24 months

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

Ctrough of MIRV

Time frame: Up to Approximately 24 months

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

Vss of MIRV

Time frame: Up to Approximately 24 months

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

Tmax of MIRV

Time frame: Up to Approximately 24 months

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

t1/2 of MIRV

Time frame: Up to Approximately 24 months

Randomized Phase 2 Cohort: Change from baseline in two dosing methods while assessing drug response

Determine the differences in dose amount and exposure between two dosing methods and the effects on exposure-response (ER) relationships

Time frame: Up to Approximately 24 months

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

Time frame: Up to Approximately 24 months

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

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

Time frame: Up to Approximately 24 months

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

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

Time frame: Up to Approximately 24 months

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

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.

Time frame: Up to Approximately 24 months