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New treatment option for Endometrial Cancer
Official title Evaluation of Mirvetuximab Soravtansine (IMGN853) in Women With Folate Receptor-α Positive Endometrial Cancer
ClinicalTrials.gov ID: NCT03832361
What this study is testing
What is IMGN853?
IMGN853 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for endometrial cancer.
Also referred to as mirvetuximab soravtansine.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100, women only
You may be able to join 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)...
- 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
You likely can't join 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...
- History of neurological conditions
- History of hemorrhagic or ischemic stroke within the last 6 months
- History of cirrhotic liver disease
See the full eligibility 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...
- 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- New Haven, Connecticut, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Haven, Connecticut, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.