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

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

Timeline

Start

2018-08-24

Primary completion

2023-06-16

Completion

2026-02-12

Outcome

Missed primary endpoint

paper Some responses were observed, but this primary endpoint was not met. PMID 41935492 ↗

Publications

• Monzon JG, Karachiwala H, Walker J, Goel R, Wheatley-Price P, Asmis TR, Navani V, Tang PA, Vickers MM. A non-randomized phase 2 trial of pembrolizumab in untreated patients with carcinoma of unknown primary site. Eur J Cancer. 2026 May 15;239:116709. doi: 10.1016/j.ejca.2026.116709. Epub 2026 Mar 31.

Drugs

Indications