Study of Carboplatin and Mirvetuximab Soravtansine in First-Line Treatment of Patients Receiving Neoadjuvant Chemotherapy With Advanced-Stage Ovarian, Fallopian Tube or Primary Peritoneal Cancer
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|ClinicalTrials.gov Identifier: NCT04606914|
Recruitment Status : Not yet recruiting
First Posted : October 28, 2020
Last Update Posted : October 28, 2020
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer Fallopian Tube Primary Peritoneal Cancer||Drug: mirvetuximab soravtansine (MIRV; IMGN853)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Single-Arm Phase II Study of Carboplatin and Mirvetuximab Soravtansine in First-Line Treatment of Patients Receiving Neoadjuvant Chemotherapy With Advanced-Stage Ovarian, Fallopian Tube or Primary Peritoneal Cancer Who Are Folate Receptor α Positive|
|Estimated Study Start Date :||March 31, 2021|
|Estimated Primary Completion Date :||August 31, 2023|
|Estimated Study Completion Date :||August 31, 2025|
Experimental: neoadjuvant chemotherapy regimen
Drug: mirvetuximab soravtansine (MIRV; IMGN853)
Mirvetuximab soravtansine (also known as IMGN853 and MIRV) is an antibody-drug conjugate (ADC) that consists of a high affinity humanized monoclonal antibody against folate receptor α (FRα, the protein product of the folate receptor 1 [FOLR1] gene) that is conjugated to a cytotoxic maytansinoid by the hindered disulfide succinimidyl 4-(pyridin-2-yl)disulfanyl)-2-sulfo-butyrate linker (sulfo-SPDB) linker. FRα is a glycosyl-phosphatidylinositol (GPI)-linked protein, which shows limited normal tissue expression and high expression on the surface of solid tumors, particularly epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer (referenced herein collectively as EOC), endometrial cancer, non-small cell lung cancer (NSCLC), and renal cell cancer.
- progression free survival (PFS) [ Time Frame: Baseline through 2 years ]To assess percentage of patients with advanced-stage ovarian, fallopian tube, and peritoneal cancers per Response Evaluation Criteria in Solid Tumors (RACIST)1.1 and Gynecological Cancer Intergroup Cancer antigen 125 (GCIG CA-125) criteria.
- Objective response rate (ORR) [ Time Frame: Baseline through 2 years ]To assess ORR per iRECIST 1.1 and GCIG CA-125 criteria
- Radiographic tumor assessment per RECIST v1.1 criteria [ Time Frame: Baseline through 2 years ]Radiographic tumor response by CT or MRI of chest, abdomen, and pelvis using RECIST v1.1
- Serum Cancer Antigen 125 (CA-125) assessments [ Time Frame: Baseline through 2 years ]Serum CA-125 will be assessed by the same laboratory throughout the study.
- Safety profile of treatment with carboplatin-mirvetuximab soravtansine according to CTCAE v4.03 [ Time Frame: Baseline through 2 years ]To determine the nature and degree of toxicity oftreatment with carboplatin-mirvetuximab soravtansine according to Common Terminology Criteria for Adverse Events (CTCAE) v4.03
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): NCT04606914
|Contact: Rebecca Arend, M.D.||firstname.lastname@example.org|
|United States, Alabama|
|University of Alabama at Birmingham Womens & Infants Center|
|Birmingham, Alabama, United States, 35233|
|Contact: Rebecca Arend|
|Principal Investigator:||Rebecca Arend, M.D.||University of Alabama at Birmingham|