MX39795: A phase II prospective molecular profiling study in CUP

• Research type

  Research Study

• Full title

  A PHASE II, RANDOMIZED, ACTIVE-CONTROLLED, MULTI-CENTER STUDY COMPARING THE EFFICACY AND SAFETY OF TARGETED THERAPY OR CANCER IMMUNOTHERAPY GUIDED BY GENOMIC PROFILING VERSUS PLATINUM-BASED CHEMOTHERAPY IN PATIENTS WITH CANCER OF UNKNOWN PRIMARY SITE WHO HAVE RECEIVED THREE CYCLES OF PLATINUM DOUBLET CHEMOTHERAPY

• IRAS ID

  241447

• Contact name

  Kai-Keen Shiu

• Contact email

  k.shiu@ucl.ac.uk

• Sponsor organisation

  F Hoffmann-La Roche Ltd

• Eudract number

  2017-003040-20

• Clinicaltrials.gov Identifier

  NCT03498521

• Clinicaltrials.gov Identifier

  NA, NA

• Duration of Study in the UK

  4 years, 0 months, 1 days

• Research summary

  MX39795: A phase II prospective molecular profiling study in cancer of unknown primary site (CUP)

  The purpose of this study is to compare the effects, good or bad, of a personalised treatment approach versus the usual chemotherapy treatment approach (which is not personalised) in patients with CUP. In patients with CUP and other types of cancer, personalised treatment involves two steps: first, the genomic makeup of the cancer cells is determined; and second, this information is used by doctors to choose a matching therapy option.

  In this study, patients will initially receive a combination of any of the following three chemotherapy-based treatments as per standard of care (SOC)/investigator choice:
  Cisplatin and gemcitabine
  Carboplatin and gemcitabine
  Carboplatin and paclitaxel

  After they have received one of the prior chemotherapy-based treatments, their doctor may then have the choice to select one of the below therapies based on their tumour’s genomic makeup, or an additional three cycles of the chemotherapy listed above. All of the personalised treatment options that will be examined in this study are experimental, which means health authorities have not approved them for the treatment of CUP.

  The personalised treatment options examined in this study that are approved in some countries for the treatment of other types of cancers, but not for CUP, include:
  Alectinib
  Atezolizumab alone
  Vemurafenib and cobimetinib
  Erlotinib and bevacizumab
  Olaparib
  Pertuzumab, trastuzumab and chemotherapy
  Vismodegib

  The personalised treatment options examined in this study that are not currently approved for the treatment of cancer include:
  Atezolizumab and chemotherapy
  Ipatasertib

  Approximately 76 patients will be recruited across 8 sites in the UK, with at least 790 being enrolled to the study globally.

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  18/LO/0858

• Date of REC Opinion

  20 Jun 2018

• REC opinion

  Further Information Favourable Opinion