Trial of Pembrolizumab in Cancer of Unknown Primary
Status:
Recruiting
Trial end date:
2022-11-30
Target enrollment:
Participant gender:
Summary
Abbreviated Title : CUPem Clinical Indication : A Phase II, Two-Stage, Trial of Pembrolizumab
in Cancer of unknown primary Trial Type : Single Arm, non-randomised; Two-stage; Hypothesis
generating Type of control : None Route of administration : IV Trial Blinding : N/A
Treatment Groups :Two cohorts:
(i) First Cohort: One or more lines of prior therapy (ii) Second Cohort: First Line untreated
CUP patients Number of trial subjects : i) First Cohort: 20 ii) Second Cohort: 57 Eligibility
Criteria : The Eligibility Criteria are the same as used in the A trial of chemotherapy for
cancer of unknown primary (CUP-ONE) trial in the United Kingdom (UK), please see below.
- Histologically confirmation of a diagnosis of CUP, with imaging and all diagnostic
investigations confirmed as CUP within a CUP Multidisciplinary Team (MDT).
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
- Patients must have disease that is not amenable to potentially curative options such as
resection or radical radiotherapy
- If patient's disease presentation precludes tumour biopsy (inaccessible or biopsy
thought not to be in the patient's best interest), the patient is not study eligible.
Estimated recruitment period : 2 years Estimated duration of trial : 3.9 years including set
up, recruitment, follow up and close down.
Duration of Participation : Cohort 1 = 6-8 months; Cohort 2 = 8-18 months Estimated average
length of treatment per patient =6 months