Description:
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.
Title
- Brief Title: Mirvetuximab Soravtansine (IMGN853) and Bevacizumab in Patients With Endometrial Cancer
- Official Title: Phase II Trial of Mirvetuximab Soravtansine (IMGN853) and Bevacizumab in Patients With Endometrial Cancer
Clinical Trial IDs
- ORG STUDY ID:
OUSCC-IMGN-001
- NCT ID:
NCT03836157
Conditions
- Endometrial Cancer
- Endometrial Adenocarcinoma
- Endometrial Serous Adenocarcinoma
- Endometrial Clear Cell Adenocarcinoma
Interventions
Drug | Synonyms | Arms |
---|
Mirvetuximab Soravtansine | IMGN853 | Mirvetuximab and Bevacizumab |
Bevacizumab | | Mirvetuximab and Bevacizumab |
Purpose
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.
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Mirvetuximab and Bevacizumab | Experimental | 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. | - Mirvetuximab Soravtansine
- Bevacizumab
|
Eligibility Criteria
Inclusion Criteria:
1. Patients with histological diagnosis of endometrial carcinoma (including others per
protocol).
2. Expression of folate receptor alpha (FRα) on either archival tumor or new biopsy is
required.
3. Measurable disease
4. Evidence that the endometrial cancer is advanced, recurrent, or persistent and has
relapsed or is refractory to curative therapy or established treatments.
5. 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
6. Female patients 18 years or older
7. Eastern Cooperative Oncology Group performance status of 0 to 1;
8. 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.
9. Patients must have acceptable organ and marrow function as defined per protocol
10. Time from prior therapy:
1. Systemic anti-neoplastic therapy: five half-lives or four weeks, whichever is
shorter. Hormonal therapy is not considered anti-neoplastic therapy.
2. 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
11. Patients must have a life expectancy of at least 3 months
12. Patients should have no major existing co-morbidities or medical conditions that will
preclude therapy
13. 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.
14. 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.
Exclusion Criteria:
1. Previous treatment with mirvetuximab.
2. Invasive cancer within the past 2 years. Noninvasive non-melanoma skin cancers are not
exclusions if they have undergone complete resection.
3. 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.
4. 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.
5. Active pulmonary disease or other coexisting medical condition that would preclude
full compliance with the study.
6. Receiving any other investigational agents.
7. 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.
8. Persisting ≥Grade 2 toxicity (except alopecia) from previous anti-cancer treatment.
9. Patients with > Grade 1 peripheral neuropathy
10. 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.
11. 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
12. History of cirrhotic liver disease
13. History or evidence of thrombotic or hemorrhagic disorders within 6 months before
first study treatment
14. Required used of folate-containing supplements (e.g. for folate deficiency)
15. Pregnancy
16. History of bowel obstruction (including subocclusive disease) related to underlying
disease within 6 months of study treatment.
17. Clinically-significant proteinuria defined per protocol
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | Female |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Response rate of patients who remain progression free |
Time Frame: | 6 months |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Incidence of adverse events |
Time Frame: | up to 3 years |
Safety Issue: | |
Description: | |
Measure: | Progression free survival |
Time Frame: | up to 3 years |
Safety Issue: | |
Description: | |
Measure: | Overall survival |
Time Frame: | up to 3 years |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Withdrawn |
Lead Sponsor: | University of Oklahoma |
Trial Keywords
- Mirvetuximab soravtansine
- gynecologic cancer
Last Updated
June 27, 2019