NCT03391973

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

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: AHS Cancer Control Alberta · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Detailed description

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

Conditions

• Carcinoma of Unknown Primary

Interventions

Type	Name	Description
DRUG	Pembrolizumab Injection	Pembrolizumab 200 mg will be administered as a 30 minute IV infusion Q3W.

Timeline

• Start date: 2018-08-24
• Primary completion: 2023-06-16
• Completion: 2025-12-30
• First posted: 2018-01-05
• Last updated: 2025-04-25

Locations

3 sites across 1 country: Canada

Regulatory

• FDA-regulated drug study