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Endometrial CancerPhase 2NCT03836157

Mirvetuximab Soravtansine (IMGN853) and Bevacizumab in Patients With Endometrial Cancer

A Phase 2 study testing Mirvetuximab Soravtansine and Bevacizumab in people with Endometrial Cancer and Endometrial Adenocarcinoma, run by University of Oklahoma at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

IMGN853 is designed to inhibit cell division and cell growth of folate receptor 1 (FRα)-expressing tumor cells. The purpose of this study is to test the safety of IMGN853 and bevacizumab and see what effects (good and bad) that this combination treatment has on subjects with recurrent endometrial cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Mirvetuximab Soravtansine and Bevacizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
31 May 2019to May 2022
Phase
Phase 2
Are there results?
None posted in the registry

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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with histological diagnosis of endometrial carcinoma (including others per protocol).
  • Expression of folate receptor alpha (FRα) on either archival tumor or new biopsy is required.
  • Measurable disease
  • Evidence that the endometrial cancer is advanced, recurrent, or persistent and has relapsed or is refractory to curative therapy or established treatments.
  • At least 1 prior platinum-based chemotherapeutic regimen, but not more than 2 prior chemotherapeutic regimens, for management of endometrial carcinoma. Prior treatment may include chemotherapy, or chemotherapy/radiation therapy . Chemotherapy administered in conjunction with primary radiation as a radio-sensitized therapy will be considered a systemic chemotherapy regimen
  • Female patients 18 years or older
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  • Eastern Cooperative Oncology Group performance status of 0 to 1;
  • Patient must have archival tumor tissue available from the primary or recurrent cancer prior to first dose. If archival tumor sample is not available, tumor sample from new biopsy is acceptable.
  • Patients must have acceptable organ and marrow function as defined per protocol
  • Time from prior therapy:
  • Systemic anti-neoplastic therapy: five half-lives or four weeks, whichever is shorter. Hormonal therapy is not considered anti-neoplastic therapy.
  • Radiotherapy: wide-field radiotherapy (e.g. > 30% of marrow-bearing bones) completed at least four weeks, or focal radiation completed at least two weeks, prior to starting study treatment
  • Patients must have a life expectancy of at least 3 months
  • Patients should have no major existing co-morbidities or medical conditions that will preclude therapy
  • Ability to understand and the willingness to sign a written informed consent document, and to comply with the requirements of the protocol; with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
  • Female patients of reproductive potential and their male partners must agree to practice 1 highly effective method of contraception and 1 additional effective (barrier) method at the same time, from the time of signing the informed consent through at least twelve weeks after the last dose of IMGN853 and/ or bevacizumab.

Who cannot join

  • Previous treatment with mirvetuximab.
  • Invasive cancer within the past 2 years. Noninvasive non-melanoma skin cancers are not exclusions if they have undergone complete resection.
  • Untreated or symptomatic central nervous system (CNS) metastases. Patients with asymptomatic CNS metastases are eligible provided they have been clinically stable for at least 4 weeks prior to first dose of study treatment), have no evidence of new or emerging CNS metastasis, and are not using steroids for at least 7 days prior to first dose of study treatment.
  • Unstable angina or myocardial infarction within the previous 6 months; uncontrolled hypertension (defined as systolic blood pressure > 150 and/or diastolic blood pressure > 100 mmHg on antihypertensive medications); prior history of hypertensive crisis or hypertensive encephalopathy; symptomatic congestive heart failure (NYHA Class III and IV); uncontrolled cardiac arrhythmia; clinically-significant vascular disease (e.g. aortic aneurysm, or dissecting aneurysm), severe aortic stenosis; clinically significant peripheral vascular disease; history of any CNS cerebrovascular ischemia or stroke within the last 6 months.
  • Active pulmonary disease or other coexisting medical condition that would preclude full compliance with the study.
  • Receiving any other investigational agents.
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  • History of prior severe infusion reaction to a monoclonal antibody. Patients with known hypersensitivity of Chinese hamster ovary cell products or other recombinant human antibodies.
  • Persisting ≥Grade 2 toxicity (except alopecia) from previous anti-cancer treatment.
  • Patients with > Grade 1 peripheral neuropathy
  • Active or chronic corneal disorder, including but not limited to the following:
  • Sjogren's syndrome
  • Fuchs corneal dystrophy (requiring treatment)
  • History of corneal transplantation
  • Active herpetic keratitis
  • Active ocular conditions requiring on-going treatment/monitoring such as wet age-related macular degeneration requiring intravitreal injections, active diabetic retinopathy with macular edema, presence of papilledema, and monocular vision.
  • Serious concurrent illness or clinically-relevant active infection, including but not limited to the following:
  • Known active hepatitis B or C
  • Known Human Immunodeficiency Virus (HIV) infection
  • Varicella-zoster virus (shingles)
  • Cytomegalovirus infection
  • Any other known concurrent infectious disease, requiring IV antibiotics within 2 weeks of study enrollment
  • History of cirrhotic liver disease
  • History or evidence of thrombotic or hemorrhagic disorders within 6 months before first study treatment
  • Required used of folate-containing supplements (e.g. for folate deficiency)
  • Pregnancy
  • History of bowel obstruction (including subocclusive disease) related to underlying disease within 6 months of study treatment.
  • Clinically-significant proteinuria defined per protocol

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73104

Other trials in United States

About this study

Official title: Phase II Trial of Mirvetuximab Soravtansine (IMGN853) and Bevacizumab in Patients With Endometrial Cancer

IMGN853 is designed to inhibit cell division and cell growth of folate receptor 1 (FRα)-expressing tumor cells. The purpose of this study is to test the safety of IMGN853 and bevacizumab and see what effects (good and bad) that this combination treatment has on subjects with recurrent endometrial cancer.

Read the detailed description

SCREENING: During the screening portion of the study, the subject will need to have tumor tissue tested and other exams to determine if s/he may proceed to the treatment part of the study. The subject's tumor tissue will be tested from either a previous or recent surgery or biopsy to see if it contains the FRα protein. If the tumor is positive and the patient meets all other eligibility, then the subject may proceed to treatment.

TREATMENT: Study drugs (IMGN853 and bevacizumab) will be given by vein (IV) once each cycle on day 1 of 21 day cycle.

Regular cancer care exams, tests, and procedures will occur. Additionally, an eye doctor visit with complete eye examination every other treatment cycle. Subjects will also self-administer eye drops as prescribed by the eye doctor.

Study participation is up to three years.

Being tested
Mirvetuximab Soravtansine, Bevacizumab
Keywords
Mirvetuximab soravtansine, gynecologic cancer
Medical subject headings
Endometrial Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mirvetuximab SoravtansineDrug

    Also called IMGN853

    The dose will not be recalculated unless the patient has ±10% weight change.

  • BevacizumabDrug

    Subject will receive IMGN853 first followed by bevacizumab. There is no planned delay between the IMGN853 and bevacizumab administration.

Study groups in NCT03836157
Study groupRoleWhat they receive
Mirvetuximab and BevacizumabExperimental* Mirvetuximab Soravtansine 6mg/kg IV (adjusted ideal body weight), on day 1 of each 21 day cycle. * Bevacizumab 15 mg/kg, IV, on day 1 of each 21-day cycle.
Receives: Drug: Mirvetuximab Soravtansine; Drug: Bevacizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response rate of patients who remain progression free

    Measured: 6 months

  2. Percentage of patients who remain progression free

    Measured: 6 months

Secondary outcomes (3)

  1. Incidence of adverse events

    Measured: up to 3 years

  2. Progression free survival

    Measured: up to 3 years

  3. Overall survival

    Measured: up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2019
  2. Study start31 May 2019 (estimated)
  3. Primary completion30 Nov 2021 (estimated)
  4. Study completionMay 2022 (estimated)

Why it stopped: Study was not initiated.

Resources

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03836157
Sponsor's protocol ID
OUSCC-IMGN-001
Status last verified
Jun 2019
First submitted
7 Feb 2019
Last updated
27 Jun 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Mirvetuximab Soravtansine and Bevacizumab in people with Endometrial Cancer and Endometrial Adenocarcinoma, run by University of Oklahoma 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 16 inclusion and 27 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: withdrawn, as of the sponsor's last update on 27 Jun 2019. 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?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response rate of patients who remain progression free (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03836157.

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 27 Jun 2019.

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