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Trial Details
Trial status:
Active (recruiting)
Recruitment start date:
06/02/2018
Funder:
Bristol-Meyers Squibb
Sponsor:
UCL
Chief Investigator:
Doctor Mark Linch
Recruitment target:
175 (prescreened) for 35 on trial treatment
EudraCT number:
2016-004091-21
Contact details:
ctc.neptunes@ucl.ac.uk
Lay summary:
NEPTUNES
Nivolumab and Ipilimumab treatment in prostate cancer with an immunogenic signature
Description
Design:

NEPTUNES is a single arm, multicentre phase II study for patients with metastatic prostate adenocarcinoma which has not responded to 1st line treatments with androgen blockage.

There are 2 stages.

The first stage is Pre-screening where patients will have a sample of their cancer tissue tested for the specific immunogenic signature which is thought to be most amenable to immunotherapy.

If the cancer tissue is positive, and the patient is eligible to continue, they will be enrolled into the Main Study. Here they will receive treatment with combination therapy of Ipilimumab and Nivolumab, followed by monotherapy with Nivolumab.

Treatment:

Patients registered to the Main Study will receive up to 4 doses of the combination therapy of Nivolumab and Ipilimumab over 9 weeks, after which they will receive up to 10 cycles of Nivolumab therapy over 1 year.

Patient will be followed up for up to 5 years following registration to the Main Study. This follow up consists of 12 weekly visits for the first 2 years and 6 monthly visits thereafter.

Key inclusion/exclusion criteria:

Patients must have histologically confirmed metastatic prostate adenocarcinoma, undergone at least one line of systemic treatment and have documented progression of the cancer in the past 6 months.

Patients cannot be included if they have had prior treatment with Sipuleucel-T, immune checkpoint targeting agents or other novel immune-oncology agents.

Duration of recruitment: 18 months.
Aim
The primary objective is to test whether patients with metastatic castrate resistant prostate cancer that have progressed following at least one line of therapy and have an immunogenic signature will respond to combined PD-1 and CTLA-4 inhibition.
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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