Pembrolizumab in Patients With Poor-Prognosis Carcinoma of Unknown Primary Site (CUP)

Official Title

A Multi-Centre, Single Arm, Phase 2 Trial of Pembrolizumab in Treatment Naïve Patients With Poor-Prognosis Carcinoma of Unknown Primary Site

Summary:

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

Trial Description

Primary Outcome:

• Number of participants that develop an objective response to treatment.
• Number of participants that develop an adverse event to treatment.

Secondary Outcome:

• The overall survival (OS) of participants.
• The progression free survival (PFS) of participants.
• The duration of response (DOR) of participants.

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 tumour 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 Tumours (RECIST) version 1.1

View this trial on ClinicalTrials.gov