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Trial Details
Trial status:
Active (recruiting)
Recruitment start date:
18/02/2019
Funder:
Merck Sharp & Dohme Ltd
Sponsor:
UCL
Chief Investigator:
Dr Rebecca Kristeleit
Recruitment target:
48
EudraCT number:
2017-004168-36
Contact details:
ctc.peacocc@ucl.ac.uk
Lay summary:
PEACOCC
A phase II study of pembrolizumab in patients with advanced gynaecological clear cell cancer
Description
Design: PEACOCC is a phase II, single Arm, UK multi-centre study. All patients will receive the same dose of Pembrolizumab. All eligible patients will have advanced gynecological clear cell cancer.  PEACOCC is an efficacy, blood and tissue exploratory study. 
Treatment: All patients start treatment with 200mg of pembrolizumab by I.V

Patients receive this treatment every 3 weeks, for a maximum of 2 years, unless any of the following occur:
  •  the patient has a protocol defined unacceptable side effect, 
  •  the patient's  disease worsens, 
  •  the patient wishes to stop treatment,
  •  the treating clinician makes a clinical decision to stop the treatment.
Key inclusion/exclusion criteria:
Patients will undergo clinical assessment with imaging and blood results checked before trial entry. 

Summarised patient eligibility is as follows; 
  • Advanced clear cell gynaecological cancer patients (including primary peritoneal and fallopian tube, endometrial, vaginal, vulval or cervical cancer).
  • Age 18 or over.
  • Reasonable performance status (ECOG 0 or 1).
  • Radiological measurable disease (RECIST v1.1).
  • Previous chemotherapy, and cancer is growing.
  • Patient is willing to provide mandatory cancer tissue biopsies.
  • Adequate organ function.
  • Has not received any live vaccines. 
  • Has no medical conditions / viruses detailed in the protocol that would prohibit the patient from receiving the trial treatment.
Duration of recruitment: Up to two years.
Actual start date: 18th February 2019.
Aim
  • The PEACOCC study will investigate the efficacy in treating advanced gynaecological clear cell cancer patients with pembrolizumab, where previous chemotherapy before trial entry has not stopped the patients' disease from growing.
  • The study aims to slow down the rate at which the patients' cancer grows. 
  • Important exploratory research will be conducted to analyse tumour behaviour, through tissue and blood samples gifted by the patients.
  • The patients' quality of life during their time on the trial will also be reported.


Trial protocols
Trial protocols must not be applied to patients treated outside trials. UCL CTC can only ensure that approved trial investigators are provided with amendments to protocols.
No protocols have been currently made available for download
Trial documents
No documents have been currently made available for download
Contact Us
Cancer Research UK & UCL Cancer Trials Centre
University College London
90 Tottenham Court Road
London
W1T 4TJ

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Email:
ctc.enquiries@ucl.ac.uk
Telephone:
+44 (0)20 7679 9898 (General CTC Enquiries)
Fax:
020 7679 9899
University College London, Gower Street, London, WC1E 6BT +44 (0)20 7679 2000

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