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Trial Details
Trial status:
Active (recruiting)
Recruitment start date:
16/05/2019
Funder:
Merck Sharp & Dohme Ltd
Sponsor:
UCL
Chief Investigator:
Professor Jonathan Ledermann
Recruitment target:
28
EudraCT number:
2017-003792-63
Contact details:
ctc.prompt@ucl.ac.uk
Lay summary:
PROMPT
A phase II study of maintenance pembrolizumab following weekly paclitaxel for recurrent ovarian, fallopian tube or peritoneal cancer
Description
Design:

PROMPT is a phase II single-arm, UK multi-centre study. All patients will receive the same dose of Pembrolizumab. All eligible patients will have recurrent ovarian, fallopian tube or peritoneal cancer upon trial entry. PROMPT is an efficacy, blood & tissue exploratory study.

Treatment:

200mg pembrolizumab by I.V. infusion over 30 minutes.

Patients receive this treatment every 3 weeks, for a maximum of 24 months (2 years), unless 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, histologoical and blood results checked before trial entry.

Summarised patient eligibility is as follows:

  • Diagnosis of high grade recurrent ovarian/fallopian tube or primary non-mucinous peritoneal cancer
  • Age 18 or over
  • Reasonable performance status (ECOG 0 OR 1)
  • Radiological measurable disease (RECIST v1.1)
  • Can have had three lines of platinum-based chemotherapy for ovarian cancer before starting paclitaxel
  • Achieved at least a stable disease following a minimum of four cycles of weekly paclitaxel (measured by CT/MR)
  • Patient willing to privide mandatory cancer tissue biopsy
  • Adequate organ function
  • Has not recevied 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 18 months
Aim

The overall aim of PROMPT is to investigate whether patients with ovarian cancer who have recently been treated with paclitaxel (a type of chemotherapy) will benefit from pembrolizumab therapy given as a maintenance treatment. Researches want to see if pembrolizumab can slow the growth/return of cancer after treatment with paclitaxel.

  •  Important exploratory research will be conducted to analyse tumour behaviour, through tissue and blood samples provided by the patients 
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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