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).
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
IMGN853 6 mg/kg intravenously every 3 weeks until disease progression
Smilow Cancer Hospital at Yale New Haven
New Haven, Connecticut, United States
RECRUITINGObjective response rate (ORR)
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
Time frame: 5 Years
Duration of overall survival (OS)
Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.
Time frame: 5 Years
Duration of progression free survival (PFS)
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.
Time frame: 5 Years
Durable disease control rate (DDCR)
The percentage of patients who have achieved complete response, partial response, and stable disease.
Time frame: 5 Years
Safety profile of mirvetuximab soravtansine (IMGN853) in endometrial cancer patients (adverse events as assessed by CTCAE v5.0)
Incidence of treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time frame: 5 Years
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