Triage of Advanced Cervical Cancer Through Immunotherapy Induction (TRACTION)
brief summary
To learn if MGD019 can help to control cervical cancer in patients who have yet to receive treatment.
detailed description
Primary Objectives:
To estimate disease control rate (DCR) in patients with metastatic, recurrent, or persistent cervical cancer who have not received prior systemic chemotherapy and are undergoing induction immunotherapy with MGD019.
Secondary Objectives:
1. To determine overall survival (OS) 2. To determine progression-free survival (PFS) 3. To determine objective response rate (ORR) 4. To determine duration of response (DOR) 5. To evaluate safety of administering MGD019 in cervical cancer patients using the National Institute of Health Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Exploratory Objectives:
1. To investigate molecular and immunological changes in the tumor tissue prior to and on-treatment with MGD019 2. To identify treatment-induced tissue-based alterations in malignant and immune cells and their correlation with response, progression, and immune-related adverse events 3. To determine the utility of cell-free DNA for evaluation treatment response