Spots Global Cancer Trial Database for Study of Pembrolizumab and Concurrent Radiation in Patients With Previously Treated Carcinoma of Unknown Primary

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Trial Identification

Brief Title: Study of Pembrolizumab and Concurrent Radiation in Patients With Previously Treated Carcinoma of Unknown Primary

Official Title: Single-arm Phase 2 Study to Examine Pembrolizumab and Concurrent Radiation to Induce an Abscopal Effect in Patients With Previously Treated Carcinoma of Unknown Primary (CUP16-268)

Study ID: NCT03396471

Conditions

Carcinoma, Unspecified Site

Interventions

Pembrolizumab

External Beam Radiation Therapy

Study Description

Brief Summary: Single-arm phase 2 study to examine pembrolizumab and concurrent radiation to induce an abscopal effect in patients with previously treated carcinoma of unknown primary (CUP16-268)

Detailed Description: This is a proof-of-principle single-arm phase 2 study in patients with previously treated CUP. All patients receive pembrolizumab combined with Radiation Therapy (RT) to a metastatic site, so as to induce an abscopal tumor response. The treatment combination will be repeated with RT delivery to a second metastatic site in a non-overlapping RT field. The results will be compared with historical control. The primary endpoint is the confirmed response rate (RR) in a non-irradiated site based on best responding abscopal lesion. This study will also evaluate the following secondary endpoints: RR in a non-irradiated site based on RECIST 1.1, adverse events, progression-free survival (PFS), overall survival (OS), time-to-progression (TTP), and disease control rate (DCR).