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

NCT03836157 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: OUSCC-IMGN-001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Endometrial Cancer; Endometrial Adenocarcinoma; Endometrial Serous Adenocarcinoma; Endometrial Clear Cell Adenocarcinoma

Keywords

Mirvetuximab soravtansine; gynecologic cancer

Outcome Measures

Primary Outcomes (2)

• Response rate of patients who remain progression free

  6 months

• Percentage of patients who remain progression free

  6 months

Secondary Outcomes (3)

• Incidence of adverse events

  up to 3 years

• Progression free survival

  up to 3 years

• Overall survival

  up to 3 years

Study Arms (1)

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.

Drug: Mirvetuximab Soravtansine; Drug: Bevacizumab

Interventions

Mirvetuximab Soravtansine DRUG

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

Also known as: IMGN853

Mirvetuximab and Bevacizumab

Bevacizumab DRUG

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

Mirvetuximab and Bevacizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• Previous treatment with mirvetuximab.
• 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.
• 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:

Sponsors & Collaborators

• University of Oklahoma: lead
• ImmunoGen, Inc.: collaborator

Study Sites (1)

Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

mirvetuximab soravtansine; Bevacizumab

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2019
• First Posted: February 11, 2019
• Study Start: May 31, 2019
• Primary Completion: November 30, 2021
• Study Completion: May 1, 2022
• Last Updated: June 27, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)