J16161 - A randomized phase II study of chemoradiation and pembrolizumab for locally advanced cervical cancer
Johns Hopkins Kimmel Cancer Center in Baltimore
This study will help determine if adding pembrolizumab to the standard treatment is safe and if providing this study drug at the same time as the standard treatment will be more effective in treating advanced cervical cancer than providing pembrolizumab after chemoradiation.
Women over the age of 18 with histologically confirmed cervical cancer with no evidence of metastases and no recurrence. No prior radiation, chemotherapy, targeted therapy, or investigational therapy for cervical cancer.
This is a two arm study where both groups will receive cisplatin, the standard chemotherapy drug for treatment of advanced cervical cancer; radiation treatments for 5-6 weeks; and pembrolizumab, the study drug. If you are in Group A, you will receive the study drug after chemotherapy and radiation. Group B will receive the study drug during chemotherapy and radiation. During screening, 3-4 teaspoons of blood will be drawn for biomarker testing and fresh tumor tissue will be collected by biopsy. You will receive the study drug every 3 weeks. Around your 6th week of radiation treatment and about 3 months after your last radiation treatment, we will collect 3-4 teaspoons of blood for biomarker tests and fresh tumor tissue through biopsy.
08/08/2020 05:02 AM