- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03836157
Mirvetuximab Soravtansine (IMGN853) and Bevacizumab in Patients With Endometrial Cancer
Phase II Trial of Mirvetuximab Soravtansine (IMGN853) and Bevacizumab in Patients With Endometrial Cancer
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Oklahoma
-
Oklahoma City, Oklahoma, United States, 73104
- Stephenson Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
- 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:
- 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.
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Mirvetuximab and Bevacizumab
|
The dose will not be recalculated unless the patient has ±10% weight change.
Other Names:
Subject will receive IMGN853 first followed by bevacizumab.
There is no planned delay between the IMGN853 and bevacizumab administration.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Response rate of patients who remain progression free
Time Frame: 6 months
|
6 months
|
Percentage of patients who remain progression free
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall survival
Time Frame: up to 3 years
|
up to 3 years
|
Incidence of adverse events
Time Frame: up to 3 years
|
up to 3 years
|
Progression free survival
Time Frame: up to 3 years
|
up to 3 years
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Uterine Neoplasms
- Genital Neoplasms, Female
- Uterine Diseases
- Cystadenocarcinoma
- Neoplasms, Cystic, Mucinous, and Serous
- Adenocarcinoma
- Endometrial Neoplasms
- Cystadenocarcinoma, Serous
- Adenocarcinoma, Clear Cell
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Bevacizumab
- Maytansine
Other Study ID Numbers
- OUSCC-IMGN-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Endometrial Cancer
-
Assistance Publique - Hôpitaux de ParisUniversité Montpellier; Ecole d'econmie de Paris (PSE)-Hospinnomics; Université...CompletedEndometrial Cancer Stage I | Endometrial Cancer Stage IIFrance
-
Radboud University Medical CenterMaastricht University Medical Center; Erasmus Medical Center; Catharina Ziekenhuis... and other collaboratorsRecruitingEndometrial Cancer Recurrent | Endometrial Cancer Stage III | Endometrial Cancer Stage IVNetherlands
-
Batman Training and Research HospitalEskisehir Osmangazi UniversityCompletedGynecologic Cancer | Endometrial Cancer Stage
-
Samsung Medical CenterRecruitingEndometrial Cancer Stage IKorea, Republic of
-
Duke UniversityDuke Cancer InstituteCompleted
-
Far Eastern Memorial HospitalCompletedOutcome of Endometrial CancerTaiwan
-
Rambam Health Care CampusCompletedSerous Papillary Endometrial CancerIsrael
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.RecruitingAdvanced Endometrial CancerChina
-
Novartis PharmaceuticalsCompletedAdvanced Endometrial CancerBelgium, France, Italy, Canada, Spain, Australia, Germany, United States, Japan, Brazil, Singapore, Russian Federation, Poland
-
University of Southern DenmarkDanish Cancer Society; Region of Southern DenmarkRecruitingEmpowerment, Cervical Cancer, Endometrial Cancer, Follow-up, Nurse-led, PROMDenmark
Clinical Trials on Mirvetuximab Soravtansine
-
University of Alabama at BirminghamRecruitingOvarian Cancer | Primary Peritoneal Cancer | Fallopian TubeUnited States
-
ImmunoGen, Inc.CompletedFallopian Tube Cancer | Epithelial Ovarian Cancer | Peritoneal CancerUnited States, Belgium, Spain, Israel, Australia, Ireland, Germany, Italy, Bulgaria, Czechia, Poland
-
University of Colorado, DenverImmunoGen, Inc.RecruitingFallopian Tube Cancer | Peritoneal Cancer | Ovary CancerUnited States
-
ImmunoGen, Inc.GOG FoundationRecruitingOvarian Cancer | Fallopian Tube Cancer | Peritoneal CancerUnited States, Korea, Republic of, Australia, Canada, United Kingdom, Spain, Italy, Belgium, Czechia, Philippines, Israel
-
Alessandro SantinImmunoGen, Inc.RecruitingEndometrial CancerUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)CompletedRecurrent Fallopian Tube Carcinoma | Recurrent Ovarian Carcinoma | Recurrent Primary Peritoneal Carcinoma | Recurrent Uterine Corpus Carcinoma | Recurrent Breast Carcinoma | Triple-Negative Breast CarcinomaUnited States
-
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.RecruitingFallopian Tube Cancer | Epithelial Ovarian Cancer | Peritoneal CancerChina
-
Duke UniversityNational Comprehensive Cancer NetworkWithdrawnBreast Cancer Triple NegativeUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedAnatomic Stage II Breast Cancer AJCC v8 | Anatomic Stage IIA Breast Cancer AJCC v8 | Anatomic Stage IIB Breast Cancer AJCC v8 | Anatomic Stage III Breast Cancer AJCC v8 | Anatomic Stage IIIA Breast Cancer AJCC v8 | Anatomic Stage IIIB Breast Cancer AJCC v8 | Anatomic Stage IIIC Breast Cancer AJCC... and other conditionsUnited States