OCULE-01

• Research type

  Research Study

• Full title

  A Phase II, Multi-centre, Open label, Randomised Study to Evaluate the Anti-tumour Activity of Roginolisib in Patients with Advanced/Metastatic Ocular/Uveal Melanoma

• IRAS ID

  1010248

• Contact name

  Tracey Hammett

• Contact email

  info@ionctura.com

• Sponsor organisation

  iOnctura

• Eudract number

  2024-514333-37

• ISRCTN Number

  ISRCTN28449692

• Research summary

  Rationale for the study
  Roginolisib is a new tablet that uses the body's own immune system to attack cancer cells. Clinical studies and experiments already done show that it stops a specific type of cell (T-reg cells) lowering the body's own immune response.
  Objective of the study
  The main purpose of the study is to see whether a patient with a type of eye cancer (uveal melanoma), that has spread to other parts of the body, has an improved survival when taking roginolisib as compared to a standard treatment that would normally be prescribed for this disease.
  Secondary objectives of the study are:
  - to provide more information on how well tolerated roginolisib is across 2 dose levels
  - the impact the treatment may have on overall well being and the amount of healthcare resources needed to give this treatment.
  - the pharmacokinetics (how the body interacts with the treatment)
  - to assess any changes in the tumour cells and immune cells that infiltrate cancer tissue and in the blood

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  24/LO/0752

• Date of REC Opinion

  22 Oct 2024

• REC opinion

  Further Information Favourable Opinion