Randomised Phase III Colorectal Cancer Study with 3 Treatment Arms

• Research type

  Research Study

• Full title

  A Phase III, open-label, multicenter, three-arm,randomized study to investigate the efficacy and safety of cobimetinib plus atezolizumab and atezolizumab monotherapy vs. regorafenib in patients with previously treated unresectable locally advanced or metastatic colorectal adenocarcinoma

• IRAS ID

  205155

• Contact name

  Shobhit Baijal

• Contact email

  shobhit.baijal@heartofengland.nhs.uk

• Sponsor organisation

  F Hoffmann-La Roche Ltd

• Eudract number

  2016-000202-11

• Duration of Study in the UK

  2 years, 7 months, 3 days

• Research summary

  Colorectal cancer is the third most commonly diagnosed cancer in males and second in females. Patients previously treated for metastatic colorectal cancer have an overall survival of less than 6 months and treatment options are very limited and poorly tolerated. Therefore, there is a significant need for new treatment for this patient population.

  This phase III, study is designed to assess the efficacy and safety of three treatment regimens in patients with previously treated unresectable locally advanced or metastatic colorectal adenocarcinoma.

  The study will enrol approximately 360 patients globally who will be randomly allocated to one of three treatment arms:
  Arm A: Combimetinib plus Atezolizumab
  Arm B: Atezolizumab alone
  Arm C: Regorafenib

  The study will consist of the following stages:
  • Screening
  • Treatment
  • Survival Follow Up

  Eligible patients will be assessed for safety and efficacy which will include a tumour assessment at regular intervals.

  Patients randomised to Arm A will receive three cobimetinib tablets given daily for 21 days of a 28 day treatment cycle. Plus a 840 mg atezolizumab infusion given every 2 weeks. On Arm B, Patients will receive a 1200 mg atezolizumab infusion given every 3 weeks. Patients randomised to Arm C will receive Regorafenib 160 mg daily for 21 days of a 28 day treatment cycle.

  Patients will remain on treatment until the patient has disease progression, unacceptable toxicity, patient or doctor decides to withdraw from the study. Survival follow-up information will be collected via telephone and/or during clinic visits every 3 months until death or study termination by the Sponsor.

  The total length of the study is expected to be approximately 3 years.

  The study is expected to be conducted at 9 research sites in the UK.

  This study is sponsored by Roche Products Ltd in the UK.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  16/SC/0351

• Date of REC Opinion

  18 Aug 2016

• REC opinion

  Further Information Favourable Opinion