RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

A Phase II Evaluation of the Safety and Efficacy of Mirvetuximab Soravtansine (IMGN853) in Women With Folate Receptor-α Positive Persistent or Recurrent Endometrial Cancer

Quick Facts

Study Start:2020-07-15

Study Completion:2028-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03832361

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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	* 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

Inclusion Criteria

Exclusion Criteria

* 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

* 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

Contacts and Locations

Study Contact

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

Principal Investigator

Alessandro D. Santin, M.D.

PRINCIPAL_INVESTIGATOR

Yale University

Study Locations (Sites)

Smilow Cancer Hospital at Yale New Haven

New Haven, Connecticut, 06510

United States

Collaborators and Investigators

Sponsor: Alessandro Santin

Alessandro D. Santin, M.D., PRINCIPAL_INVESTIGATOR, Yale University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-07-15

Study Completion Date2028-10

Study Record Updates

Study Start Date2020-07-15

Study Completion Date2028-10

Terms related to this study

Additional Relevant MeSH Terms

Endometrial Cancer