PRGN-2009 and Pembrolizumab Trial
Phase 2
46
about 2.9 years
18+
3 sites in AR, MD, WA
What this study is about
Researchers are testing whether PRGN-2009, given with pembrolizumab, is more effective than pembrolizumab alone in treating recurrent or metastatic cervical cancer. The trial will last for 1045 days and involve approximately 46 patients.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Receive PRGN-2009 plus Pembrolizumab
- 2.Take Pembrolizumab alone
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
You are randomly assigned, but you will know your treatment.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
pembrolizumab (Immune checkpoint inhibitor; blocks PD-1 to boost T-cell attack on cancer), immunotherapy (Immune checkpoint inhibitor; blocks PD-1 to boost T-cell attack on cancer)
infusion
Primary: Determine the Objective Response Rate (ORR) following treatment with PRGN-2009 in combination with pembrolizumab or pembrolizumab alone in patients with pembrolizumab-resistant recurrent or metastatic cervical cancer.
Secondary: Best Overall Responses (BOR) and Disease Control Rate (DCR) per RECIST v1.1 following treatment with PRGN-2009 in combination with pembrolizumab or pembrolizumab alone, Progression-Free Survival (PFS) and Overall Survival (OS) following treatment with PRGN-2009 in combination with pembrolizumab or pembrolizumab alone
Oncology