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Evaluation of Mirvetuximab Soravtansine (IMGN853) in Women With Folate Receptor-α Positive Endometrial Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03832361
Recruitment Status : Not yet recruiting
First Posted : February 6, 2019
Last Update Posted : January 7, 2020
Sponsor:
Collaborator:
ImmunoGen, Inc.
Information provided by (Responsible Party):
Alessandro Santin, Yale University

Brief Summary:
The purpose of this study is to evaluate the activity and safety profile of mirvetuximab soravtansine (IMGN853) in patients with type II endometrial cancers that overexpress folate receptor alpha (FRα).

Condition or disease Intervention/treatment Phase
Endometrial Cancer Drug: IMGN853 Phase 2

Detailed Description:
This study will enroll patients with persistent or recurrent FRα-positive uterine serous carcinoma (pure or mixed), Grade 3 endometrial adenocarcinoma, or carcinosarcoma with high grade serous or Grade 3 endometrioid components. All patients must have measurable disease. The primary objective of the study is to assess the activity of IMGN853 as measured by objective response rate (ORR). The secondary objectives are to assess the duration of overall survival (OS), progression-free survival (PFS) and durable disease control rate (DDCR), as well as the safety profile of IMGN853 in endometrial carcinoma patients. Exploratory/correlative objectives are to correlate ORR, PFS, and OS with the level of folate receptor α expression and explore use of circulating tumor (ct) DNA as a biomarker for disease response and compare its performance to cancer antigen 125 (CA-125). All enrolled patients will receive IMGN853 at a dose of 6 mg/kg administered intravenously once every 3 weeks until unacceptable toxicity or progression of disease requiring discontinuation of treatment.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Evaluation of the Safety and Efficacy of Mirvetuximab Soravtansine (IMGN853) in Women With Folate Receptor-α Positive Persistent or Recurrent Endometrial Cancer
Estimated Study Start Date : February 2020
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : October 2028

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: IMGN853
IMGN853 administered 6 mg/kg adjusted ideal body weight (AIBW) once every three weeks (Q3W)
Drug: IMGN853
IMGN853 6 mg/kg intravenously every 3 weeks until disease progression
Other Name: mirvetuximab soravtansine




Primary Outcome Measures :
  1. Objective response rate (ORR) [ Time Frame: 5 Years ]
    Objective response rate (complete response and partial response rates) by RECIST 1.1 criteria of mirvetuximab soravtansine in patients with folate receptor α-positive persistent or recurrent endometrial cancer


Secondary Outcome Measures :
  1. Duration of overall survival (OS) [ Time Frame: 5 Years ]
    Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.

  2. Duration of progression free survival (PFS) [ Time Frame: 5 Years ]
    Progression-free survival is defined as the duration of time from study entry to time of progression, death, or the date of last contact, whichever occurs first.

  3. Durable disease control rate (DDCR) [ Time Frame: 5 Years ]
    The percentage of patients who have achieved complete response, partial response, and stable disease.

  4. Safety profile of mirvetuximab soravtansine (IMGN853) in endometrial cancer patients (adverse events as assessed by CTCAE v5.0) [ Time Frame: 5 Years ]
    Incidence of treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Radiologically confirmed (ie, CT scan and/or MRI) persistent or recurrent endometrial cancer
  • Patients must have one of the following pathologically documented, definitively diagnosed tumor types: Uterine serous carcinoma (Pure or Mixed), Grade 3 endometrial adenocarcinoma, or Carcinosarcoma with high grade serous or Grade 3 endometrioid components
  • Have measurable disease
  • FRα-positive tumor expression as defined in the protocol
  • Have at least one "target lesion" to be used to assess response as defined by RECIST v1.1
  • Patients must have received prior treatment with ≤ 2 prior lines of therapy for recurrent disease; hormonal agents are not considered a line of therapy; prior treatment with folate receptor-targeting investigational agents is not allowed
  • Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Time from prior therapy: Systemic anti-neoplastic therapy: five half-lives or four weeks, whichever is shorter; Radiotherapy: wide-field radiotherapy completed at least four weeks, or focal radiation completed at least two weeks, prior to starting study treatment
  • Patients must have resolution of toxic effect(s) of the most recent prior chemotherapy
  • Patients must have adequate hematologic, liver and kidney function as defined in the protocol
  • Women of child bearing potential (WCBP), must agree to use effective contraceptive methods during study treatment and for at least twelve weeks after the last dose of IMGN853
  • WCBP must have a negative pregnancy test within 3 days prior to the first dose of study treatment
  • At time of initial surgery, patient may have either been optimally or suboptimally debulked
  • Have signed the informed consent form, and willing to adhere to the study visit schedule and other protocol requirements
  • ≥ 18 years of age

Exclusion Criteria:

  • Active or chronic corneal disorder
  • Serious concurrent illness or clinically-relevant active infection as defined in the protocol
  • Clinically-significant cardiac disease such as recent myocardial infarction (≤ 6 months prior to day 1), unstable angina pectoris, uncontrolled congestive heart failure, uncontrolled hypertension, prior history of hypertensive crisis or hypertensive encephalopathy, uncontrolled cardiac arrhythmias, clinically-significant vascular disease, severe aortic stenosis, clinically significant peripheral vascular disease, or cardiac toxicity following prior chemotherapy
  • History of neurological conditions
  • History of hemorrhagic or ischemic stroke within the last 6 months
  • History of cirrhotic liver disease
  • Previous clinical diagnosis of non-infectious pneumonitis
  • Prior hypersensitivity to monoclonal antibodies
  • Women who are pregnant or breast feeding
  • Carcinomatous meningitis, untreated central nervous system (CNS) disease or symptomatic CNS metastasis
  • History or evidence of thrombotic or hemorrhagic disorders within 6 months before first study treatment
  • Required used of folate-containing supplements (e.g. folate deficiency)
  • Has a known additional malignancy that is progressing or required active treatment within 3 years of first dose of study treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03832361


Contacts
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Contact: Alessandro D. Santin, M.D. 203-737-4450 alessandro.santin@yale.edu
Contact: Lisa Baker, R.N. 203-785-6398 lisa.baker@yale.edu

Locations
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United States, Connecticut
Smilow Cancer Hospital at Yale New Haven
New Haven, Connecticut, United States, 06510
Contact: Alessandro D Santin, M.D.    203-737-4450    alessandro.santin@yale.edu   
Contact: Lisa Baker, R.N.    203-785-6398    lisa.baker@yale.edu   
Principal Investigator: Alessandro Santin, M.D.         
Sponsors and Collaborators
Alessandro Santin
ImmunoGen, Inc.
Investigators
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Principal Investigator: Alessandro D. Santin, M.D. Yale University

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Responsible Party: Alessandro Santin, Professor of Obstetrics, Gynecology, and Reproductive Sciences, Yale University
ClinicalTrials.gov Identifier: NCT03832361    
Other Study ID Numbers: 2000023841
First Posted: February 6, 2019    Key Record Dates
Last Update Posted: January 7, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female
Maytansine
Immunoconjugates
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunologic Factors