PHASE 3 STUDY OF AVELUMAB COMBINED WITH AXITINIB VS SUTINIB IN RCC

• Research type

  Research Study

• Full title

  A PHASE 3, MULTINATIONAL, RANDOMIZED, OPEN-LABEL, PARALLEL-ARM STUDY OF AVELUMAB (MSB0010718C) IN COMBINATION WITH AXITINIB (INLYTA®) VERSUS SUNITINIB (SUTENT®) MONOTHERAPY IN THE FIRST-LINE TREATMENT OF PATIENTS WITH ADVANCED RENAL CELL CARCINOMA

• IRAS ID

  199224

• Contact name

  James Larkin

• Contact email

  james.larkin@rmh.nhs.uk

• Sponsor organisation

  Pfizer Inc, 235 East 42nd Street, New York, NY 10017

• Eudract number

  2015-002429-20

• Clinicaltrials.gov Identifier

  NCT02684006

• Clinicaltrials.gov Identifier

  126065, US IND

• Duration of Study in the UK

  1 years, 8 months, 22 days

• Research summary

  Renal cell carcinoma (RCC) is the most common kidney cancer and constitutes about 3% of all malignant tumours in adults. RCC is often first detected at an advanced stage, with 25-30% of all patients with metastatic disease at diagnosis.

  The main purpose of this study is to evaluate the effects of the study drug avelumab (MSB0010718C) in combination with axitinib (INLYTA®, AG 013736) versus sunitinib (SUTENT®) to find out which is better in prolonging progression free survival of patients with advanced RCC previously untreated for advanced/metastatic disease.

  Participants will be randomised in a 1:1 ratio to receive either avelumab in combination with axitinib or sunitinib monotherapy.

  Participants in Arm A will receive avelumab 10mg/kg IV every 2 weeks (Q2W) + axitinib 5mg orally twice a day (BID) in 6-week cycles.

  Participants in Arm B will receive sunitinib 50mg orally once daily (QD)on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (schedule 4/2 in 6-week cycles).

  This study is open-label, so both the participants and the study doctors will know the treatment assignment.

  The duration of participation in this study will depend on the participant's ability to safely tolerate the treatment, on how the participant's cancer responds to treatment, and on the participant's/ study doctor's decision to continue study treatment.

  Procedures include: vital signs, physical examination, ECOG scoring, ECG, LVEF (by MUGA/ECHO), tumour assessments (by CT/MRI and/or bone scans), tumour biopsy, urine and blood samples for laboratory tests pharmacokinetic, anti-drug antibody, biomarker analysis and questionnaires to monitor participant’s health and side effects of the drug.

  This study is being sponsored by Pfizer. Approximately 583 participants will take part in the study, with approximately 36 participants in the UK.
  Lay summary of study results: Lay summary of study results will be available at https://eur03.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.pfizer.com%2F&data=05%7C02%7CTracy.Hamrang%40hra.nhs.uk%7C880fb54d88034dba5bc908dd192c9600%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638694401466668269%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=CruXwHGO5x4lnyAbzrJdOytMGDtaOiN1hEz4J0qPl%2FM%3D&reserved=0

• REC name

  London - City & East Research Ethics Committee

• REC reference

  16/LO/1180

• Date of REC Opinion

  23 Aug 2016

• REC opinion

  Further Information Favourable Opinion