Endometrial CancerPhase 2NCT03832361
Evaluation of Mirvetuximab Soravtansine (IMGN853) in Women With Folate Receptor-α Positive Endometrial Cancer
A Phase 2 study testing IMGN853 in people with Endometrial Cancer, run by Alessandro Santin at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 100 years, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- IMGN853
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2020to Oct 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Smilow Cancer Hospital at Yale New Haven
New Haven, Connecticut, 06510
Alessandro D Santin, M.D., 203-737-4450, alessandro.santin@yale.edu
Lisa Baker, R.N., 203-785-6398, lisa.baker@yale.edu
About this study
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
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).
Read the detailed description
This study will enroll patients with persistent or recurrent FRα-positive uterine serous carcinoma (pure or mixed), Grade 3 endometrial adenocarcinoma, or carcinosarcoma with high grade serous or Grade 3 endometrioid components. All patients must have measurable disease. The primary objective of the study is to assess the activity of IMGN853 as measured by objective response rate (ORR). The secondary objectives are to assess the duration of overall survival (OS), progression-free survival (PFS) and durable disease control rate (DDCR), as well as the safety profile of IMGN853 in endometrial carcinoma patients. Exploratory/correlative objectives are to correlate ORR, PFS, and OS with the level of folate receptor α expression and explore use of circulating tumor (ct) DNA as a biomarker for disease response and compare its performance to cancer antigen 125 (CA-125). All enrolled patients will receive IMGN853 at a dose of 6 mg/kg administered intravenously once every 3 weeks until unacceptable toxicity or progression of disease requiring discontinuation of treatment.
- Conditions
- Endometrial Cancer
- Being tested
- IMGN853
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMGN853Drug
Also called mirvetuximab soravtansine
IMGN853 6 mg/kg intravenously every 3 weeks until disease progression
| Study group | Role | What they receive |
|---|---|---|
| IMGN853 | Experimental | IMGN853 administered 6 mg/kg adjusted ideal body weight (AIBW) once every three weeks (Q3W) Receives: Drug: IMGN853 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 Years
Secondary outcomes (4)
Duration of overall survival (OS)
Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.
Measured: 5 Years
Duration of progression free survival (PFS)
Progression-free survival is defined as the duration of time from study entry to time of progression, death, or the date of last contact, whichever occurs first.
Measured: 5 Years
Durable disease control rate (DDCR)
The percentage of patients who have achieved complete response, partial response, and stable disease.
Measured: 5 Years
Safety profile of mirvetuximab soravtansine (IMGN853) in endometrial cancer patients (adverse events as assessed by CTCAE v5.0)
Incidence of treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Measured: 5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2019
- Study start15 Jul 2020
- Primary completionOct 2026 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alessandro Santin
- Sponsor type
- University, hospital or other
- Collaborators
- ImmunoGen, Inc., AbbVie
- Responsible party
- Sponsor-investigator, Alessandro Santin, Yale University
- Investigators
- Alessandro D. Santin, M.D., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03832361
- Sponsor's protocol ID
- 2000023841
- Status last verified
- Jun 2026
- First submitted
- 4 Feb 2019
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03832361
- Acronym / sponsor ID
- 2000023841
- Conditions
- Endometrial Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Alessandro SantinUniversity, hospital or other
- Collaborators
- ImmunoGen, Inc., AbbVie
- Study start
- 15 Jul 2020 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 6 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
This study will enroll patients with persistent or recurrent FRα-positive uterine serous carcinoma (pure or mixed), Grade 3 endometrial adenocarcinoma, or carcinosarcoma with high grade serous or Grade 3 endometrioid components. All patients must have measurable disease. The primary objective of the study is to assess the activity of IMGN853 as measured by objective response rate (ORR). The secondary objectives are to assess the duration of overall survival (OS), progression-free survival (PFS) and durable disease control rate (DDCR), as well as the safety profile of IMGN853 in endometrial carcinoma patients. Exploratory/correlative objectives are to correlate ORR, PFS, and OS with the level of folate receptor α expression and explore use of circulating tumor (ct) DNA as a biomarker for disease response and compare its performance to cancer antigen 125 (CA-125). All enrolled patients will receive IMGN853 at a dose of 6 mg/kg administered intravenously once every 3 weeks until unacceptable toxicity or progression of disease requiring discontinuation of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IMGN853 | Experimental | Drug: IMGN853IMGN853 administered 6 mg/kg adjusted ideal body weight (AIBW) once every three weeks (Q3W) |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMGN853Also: mirvetuximab soravtansineIMGN853 6 mg/kg intravenously every 3 weeks until disease progression | Drug | IMGN853 |
Primary outcome
Objective response rate (ORR)
Time frame: 5 Years
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
4 secondary outcomes
Duration of overall survival (OS)
Time frame: 5 Years
Duration of progression free survival (PFS)
Time frame: 5 Years
Durable disease control rate (DDCR)
Time frame: 5 Years
Safety profile of mirvetuximab soravtansine (IMGN853) in endometrial cancer patients (adverse events as assessed by CTCAE v5.0)
Time frame: 5 Years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alessandro D. Santin, M.D. principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IMGN853 in people with Endometrial Cancer, run by Alessandro Santin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alessandro D. Santin, M.D. (203-737-4450, alessandro.santin@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: 5 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.