STELLAR

• Research type

  Research Study

• Full title

  A Randomized Open-Label Phase 3 Study of XL092 + Nivolumab vs Sunitinib in Subjects with Advanced or Metastatic Non-Clear Cell Renal Cell Carcinoma

• IRAS ID

  1007408

• Contact name

  Anna Gruzman

• Contact email

  agruzman@exelixis.com

• Sponsor organisation

  Exelixis Inc.

• Eudract number

  2022-501703-27

• Clinicaltrials.gov Identifier

  NCT05678673

• Research summary

  Renal cell carcinoma is a form of kidney cancer. Nivolumab and Sunitinib are drugs approved by the UK Medicines and Healthcare products Regulatory Agency for the treatment of renal cell carcinoma; however, the clinical data to support these therapies in people with non-clear cell renal carcinoma (nccRCC) are limited. There is therefore an increased need for new treatments with demonstrated benefit for this population.
  The purpose of the EXELIXIS study is to find out if the experimental drug XL092, in combination with Nivolumab, is effective in treating unresectable (unable to remove by surgery), locally advanced or metastatic nccRCC compared with Sunitinib alone among patients who have never received systemic anti-cancer treatment.
  Approximately 291 eligible participants are planned to take part in the study at approximately 170 sites globally. Participants will be randomised (like rolling the dice) in a 2:1 ratio to one of two treatment groups:
  • Group 1 - XL092 100mg: one tablet once daily by mouth with additional to Standard of care treatment Nivolumab: 480mg infusion delivered into the vein every 4 weeks.
  • Group 2 - Sunitinib 50mg: two capsules of 25mg once daily by mouth for 4 weeks, followed by 2 weeks off, continuously.
  Participants will have an approximately 67% chance of receiving XL092 plus Nivolumab and an approximately 33% chance of receiving Sunitinib.
  The total treatment duration in this study is expected to be about 12-18 months for each participant.
  The study will have 3 periods:
  • Pre-Treatment Period
  • Treatment Period
  • Post-Treatment Period

  When the final results of the study are known, participants may have an opportunity to continue to receive study drug(s) (Maintenance Phase). If this phase of the study occurs, participants will discuss with the study doctor whether this option is right for them.

• REC name

  East of England - Essex Research Ethics Committee

• REC reference

  23/EE/0101

• Date of REC Opinion

  16 Aug 2023

• REC opinion

  Further Information Favourable Opinion