Abbreviated Title: Pembrolizumab in Patients with Poor-Prognosis Carcinoma of Unknown Primary
Site (CUP) Trial Phase: 2 Clinical Indication: Treatment naïve patients with poor prognosis
carcinoma of unknown primary site Trial Type: Single arm phase 2 Type of control: Not
applicable Route of administration: Intravenous Trial Blinding: Not applicable Treatment
Groups: 1) Pembrolizumab 200 mg IV every 3 weeks for up to 24 months. Total Number of trial
subjects:25 Estimated enrollment period: 24 months Estimated duration of trial: 48 months
Duration of Participation: 24 months
This is a multi-centre, single arm phase 2 study of Pembrolizumab (Keytruda™ or MK-3475) in
treatment naïve patients with poor prognosis carcinoma of unknown primary site (CUP).
Participants will receive Pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week
cycle for up to 24 months. Patients will be evaluated for response every 9 weeks. Patients
with objective response to treatment and those with stable disease will continue to receive
Pembrolizumab. Patients with tumor progression will be discontinued from the study. Patients
with progressive disease (PD), but showing a clinical benefit, may continue on Pembrolizumab,
as per the discretion of the responsible Qualified Investigator. Response will be evaluated
as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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