Mirvetuximab Soravtansine (IMG853) in Folate Receptor Alpha-expressing TNBC (IMGN853)
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03045393|
Recruitment Status : Withdrawn (Inadequate enrollment)
First Posted : February 7, 2017
Last Update Posted : July 4, 2018
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Triple Negative||Drug: Mirvetuximab Soravtansine (IMGN853)||Phase 1|
The folate receptor alpha protein is important in tumor growth and can be over-expressed in some tumor cells. The word "over-expressed" in this situation means that there are too many copies of the protein on the surface of the cell when compared to a healthy, normal cell, and this helps the tumor continue to grow in size. Mirvetuximab soravtansine acts by targeting the folate receptor in tumor cells. In animal models, mirvetuximab soravtansine is highly effective in decreasing tumor size. This suggests that mirvetuximab soravtansine may help shrink or stop growth of folate receptor alpha positive breast cancer in this study.
In this study the investigator will be looking at how folate receptor alpha expression changes following 2 doses of neoadjuvant mirvetuximab soravtansine. The investigator will also look to evaluate the safety of this regimen, measure any change in tumor size, associate folate receptor alpha expression with a change in tumor size, and describe any changes in Ki-67 and percent of apoptotic cells in this population.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study of Mirvetuximab Soravtansine (IMGN853) in Folate Receptor Alpha (FRα)-Expressing, Triple Negative Breast Cancer (TNBC) With Residual Disease Post Standard Neoadjuvant Chemotherapy|
|Actual Study Start Date :||April 17, 2017|
|Actual Primary Completion Date :||February 28, 2018|
|Actual Study Completion Date :||February 28, 2018|
Experimental: Mirvetuximab Soravtansine
Participants will receive 2 doses of Mirvetuximab Soravtansine after neoadjuvant chemotherapy and before surgical resection of tumor.
Drug: Mirvetuximab Soravtansine (IMGN853)
Mirvetuximab Soravtansine is a targeted drug for tumors that express high levels of folate receptor alpha.
- Change in breast tumor FRα expression before and after treatment with mirvetuximab soravtansine [ Time Frame: Baseline up to 9 weeks ]Assessed by immunohistochemistry (IHC) (1) after completion of neoadjuvant chemotherapy, prior to treatment with mirvetuximab soravtansine; (2) at definitive surgery, after treatment with mirvetuximab soravtansine and scored (0 = no receptors, 1 = small number of receptors, 2 = medium number of receptors, 3 = large number of receptors).
- Change in breast tumor FRα expression before and after neoadjuvant chemotherapy [ Time Frame: Baseline up to 9 weeks ]Assessed by immunohistochemistry (IHC) (1) at initial cancer diagnosis, prior to initiation of neoadjuvant chemotherapy; (2) after completion of neoadjuvant chemotherapy and scored (0 = no receptors, 1 = small number of receptors, 2 = medium number of receptors, 3 = large number of receptors).
- Total number of grade 3 and 4 toxicities [ Time Frame: Baseline up to 9 weeks ]Graded via NCI CTCAE v4.03
- Number of treatment-emergent adverse events (TEAEs) precluding second dose [ Time Frame: Baseline up to 9 weeks ]Assessed by the number of subjects that cannot receive the second dose of mirvetuximab soravtansine
- Number of treatment-emergent adverse events (TEAEs) delaying surgery [ Time Frame: Baseline up to 9 weeks ]Assessed by the number of subjects that have surgery delayed past 9 weeks due to TEAE
- Total number of partial or complete responses [ Time Frame: Baseline up to 9 weeks ]Evaluated by the number of subjects that have either a partial or complete radiologic response by 2D ultrasound. (Partial response = reduction of the largest unidimensional tumor measurement of >30%; Complete response = no evidence of tumor remaining)
- Change in tumor cell proliferation, as measured by Ki67 expression [ Time Frame: Baseline up to 9 weeks ]Changes in Ki67 expression will be measured before and after 2 doses of mirvetuximab soravtansine.
- Change in tumor cell death markers [ Time Frame: Baseline up to 9 weeks ]Changes in apoptotic markers will be measured before and after 2 doses of mirvetuximab soravtansine.
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): NCT03045393
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Kimberly Blackwell, MD||Duke University|