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Mirvetuximab Soravtansine (IMGN853) and Bevacizumab in Patients With Endometrial Cancer | Clinical Trials | Clareo Health

WITHDRAWNPHASE2

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

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

NCT03836157•University of Oklahoma

View on ClinicalTrials.gov

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.

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.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

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:
+6 more criteria

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:
+17 more criteria

Locations (1)

Stephenson Cancer Center

Oklahoma City, Oklahoma, United States

Key Dates

Start Date

May 31, 2019

Primary Completion Date

November 30, 2021

Completion Date

May 1, 2022

Last Updated

June 27, 2019

Conditions

Endometrial CancerEndometrial AdenocarcinomaEndometrial Serous AdenocarcinomaEndometrial Clear Cell Adenocarcinoma

Interventions

Mirvetuximab Soravtansine

DRUG

Bevacizumab

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 27, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

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