Evaluation of Mirvetuximab Soravtansine (IMGN853) in Women With Folate Receptor-α Positive Endometrial Cancer

NCT03832361 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 2000023841
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the activity and safety profile of mirvetuximab soravtansine (IMGN853) in patients with type II endometrial cancers that overexpress folate receptor alpha (FRα).

Conditions

Endometrial Cancer

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  Objective response rate (complete response and partial response rates) by RECIST 1.1 criteria of mirvetuximab soravtansine in patients with folate receptor α-positive persistent or recurrent endometrial cancer

  5 Years

Secondary Outcomes (4)

• Duration of overall survival (OS)

  5 Years

• Duration of progression free survival (PFS)

  5 Years

• Durable disease control rate (DDCR)

  5 Years

• Safety profile of mirvetuximab soravtansine (IMGN853) in endometrial cancer patients (adverse events as assessed by CTCAE v5.0)

  5 Years

Study Arms (1)

IMGN853

EXPERIMENTAL

IMGN853 administered 6 mg/kg adjusted ideal body weight (AIBW) once every three weeks (Q3W)

Drug: IMGN853

Interventions

IMGN853 DRUG

IMGN853 6 mg/kg intravenously every 3 weeks until disease progression

Also known as: mirvetuximab soravtansine

IMGN853

Eligibility Criteria

• Age: 18 Years - 100 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Radiologically confirmed (ie, CT scan and/or MRI) persistent or recurrent endometrial cancer
• Patients must have one of the following pathologically documented, definitively diagnosed tumor types: Uterine serous carcinoma (Pure or Mixed), Grade 2 or Grade 3 endometrial adenocarcinoma, Carcinosarcoma with high grade serous or Grade 2/3 endometrioid components, or clear cell carcinoma (Pure or Mixed).
• Have measurable disease
• FRα-positive tumor expression as defined in the protocol
• Have at least one "target lesion" to be used to assess response as defined by RECIST v1.1
• Patients must have received prior treatment with ≤ 3 prior lines of therapy for recurrent disease; hormonal agents are not considered a line of therapy; prior treatment with folate receptor-targeting investigational agents is not allowed
• Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Time from prior therapy: Systemic anti-neoplastic therapy: five half-lives or four weeks, whichever is shorter; Radiotherapy: wide-field radiotherapy completed at least four weeks, or focal radiation completed at least two weeks, prior to starting study treatment
• Patients must have resolution of toxic effect(s) of the most recent prior chemotherapy
• Patients must have adequate hematologic, liver and kidney function as defined in the protocol
• Women of child bearing potential (WCBP), must agree to use effective contraceptive methods during study treatment and for at least twelve weeks after the last dose of IMGN853
• WCBP must have a negative pregnancy test within 4 days prior to the first dose of study treatment
• At time of initial surgery, patient may have either been optimally or suboptimally debulked
• Have signed the informed consent form, and willing to adhere to the study visit schedule and other protocol requirements
• ≥ 18 years of age

You may not qualify if:

• Active or chronic corneal disorder
• Serious concurrent illness or clinically-relevant active infection as defined in the protocol
• Clinically-significant cardiac disease such as recent myocardial infarction (≤ 6 months prior to day 1), unstable angina pectoris, uncontrolled congestive heart failure, uncontrolled hypertension, prior history of hypertensive crisis or hypertensive encephalopathy, uncontrolled cardiac arrhythmias, clinically-significant vascular disease, severe aortic stenosis, clinically significant peripheral vascular disease, or cardiac toxicity following prior chemotherapy
• History of neurological conditions
• History of hemorrhagic or ischemic stroke within the last 6 months
• History of cirrhotic liver disease
• Previous clinical diagnosis of non-infectious pneumonitis
• Prior hypersensitivity to monoclonal antibodies
• Women who are pregnant or breast feeding
• Carcinomatous meningitis, untreated central nervous system (CNS) disease or symptomatic CNS metastasis
• History or evidence of thrombotic or hemorrhagic disorders within 6 months before first study treatment
• Required used of folate-containing supplements (e.g. folate deficiency)
• Has a known additional malignancy that is progressing or required active treatment within 3 years of first dose of study treatment

Sponsors & Collaborators

• Alessandro Santin: lead
• ImmunoGen, Inc.: collaborator

Study Sites (1)

Smilow Cancer Hospital at Yale New Haven

New Haven, Connecticut, 06510, United States

RECRUITING

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

mirvetuximab soravtansine

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Alessandro D. Santin, M.D.

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alessandro D. Santin, M.D.

CONTACT

203-737-4450; alessandro.santin@yale.edu

Lisa Baker, R.N.

CONTACT

203-785-6398; lisa.baker@yale.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Obstetrics, Gynecology, and Reproductive Sciences

Study Record Dates

• First Submitted: February 4, 2019
• First Posted: February 6, 2019
• Study Start: July 15, 2020
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2028
• Last Updated: July 18, 2025

Record last verified: 2025-07

Locations

US (1)