WO29636 ImVigor 010 - Atezolizumab in Bladder Cancer after Cystectomy
Research type
Research Study
Full title
A PHASE III, OPEN-LABEL, MULTICENTER, RANDOMIZED STUDY OF ATEZOLIZUMAB (ANTI-PD-L1 ANTIBODY) VERSUS OBSERVATION AS ADJUVANT THERAPY IN PATIENTS WITH PD-L1-SELECTED, HIGH-RISK MUSCLE-INVASIVE BLADDER CANCER AFTER CYSTECTOMY
IRAS ID
180135
Contact name
Inderjit Singh
Contact email
Sponsor organisation
F Hoffmann-La Roche Ltd
Eudract number
2014-005603-25
Duration of Study in the UK
6 years, 2 months, 8 days
Research summary
Bladder cancer presents as non-muscle-invasive, muscle-invasive (MIBC), or metastatic disease and is the most common cancer of the urinary system worldwide. For patients with MIBC, surgery involving resection of the bladder, adjacent organs, and regional lymph nodes (cystectomy), forms the backbone of disease management. Approximately half of the patients with MIBC will develop a local and/or metastatic recurrence of their disease within 2 years of cystectomy and will eventually die from their disease. For those with high-risk features, the overall 5-year survival ranges from 10% to 40%.\n\nBecause of the high risk of relapse with surgery alone, pre- and post-surgery (neo/adjuvant chemotherapy) treatments have been used in conjunction with radical cystectomy. Neoadjuvant chemotherapy has been shown to provide a small but statistically significant overall survival advantage. There is currently no standard treatment for those patients in the adjuvant setting, after cystectomy.\n\nTargeting the PD-L1 pathway with atezolizumab (MPDL3280A) has demonstrated activity with advanced cancers and most related toxicities observed are mild and transient in nature. It is anticipated that adjuvant treatment with atezolizumab will have a manageable safety profile and an acceptable benefit-risk assessment for the conduct of the study.\n\nThis study aims to discover whether atezolizumab is safe and effective in participants with PD-L1-selected MIBC who are at high risk for recurrence following cystectomy. \n\nA total of approximately 440 participants will be recruited into this study globally. Patients will be randomly assigned, for up to 1 year, to either receive atezolizumab (IV once every 3 weeks) or observation. Following atezolizumab treatment / observation; patients will be followed for potential disease recurrence and survival for up to 6 years.\n\nIn the UK it is expected that 44 participants will be enrolled at 9 participating study centres.\n\nThe study is sponsored by F. Hoffman La Roche.\nResearch Summary-Results\nhttps://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbRehJ-2Fi4xyo44sEgJVCl5Bdj8o1FpylFwbn362DUDJ-2FzIMhr9viDkqQixApRizYb-2FRg2CtRx0ifTqeForHAxOSB-2B-2Bb4yW4aaWU6jRIBjxrKGgabTgqbsKa9ig9rsUEVLlA-3D-3DJF06_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YJ3yo9chiD6iBEBCZVtZiZcG4st88SBUVTaMWAdGhKKEQbNEsDeznzpGPI46tVIYMIpzZrj56WfJtpQQDWYpCZEMnkHHFMtcsLVtKQKhh9CSHwWalBSoKt1yTQ6mBE5bVItS21paa5Eq3Fq3cbT2adHaqzCr6W-2BqysKRtA6lHY2zA-3D-3D&data=05%7C01%7Cleicestercentral.rec%40hra.nhs.uk%7C84b795610d484b3a4d1a08db76172b52%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638233614099317104%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=v%2FQ9qtMwPNID43fpsCohhH5LCmdmB4Cpl2%2FxE9uZiCw%3D&reserved=0\n\nResearch Summary-Lay\nhttps://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbSgv9uUS1wsd00iFWSZyptH89w1tcscJeKmImtXTgMdppT4g-2Fac7ov95t2cPLBy1TjPkCVyYMB2sWuTU3czuOJLebmpvXa37meQOwVpSaGsgJdv9RiPntP3b5WvUUJWhnvgmy5GUwQ-2F5YdKi9Rya1jZqjGEud4EWyN2a75I0LNANCyOE_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YJ3yo9chiD6iBEBCZVtZiZc5BfqTXrdZ-2B7KP1HvUd8HS6oZBIYZ9-2BuN1lMpYfwnVsVmrieINsdYH27fJo7MjnOZx8eoJZwYFP2bEFIZ7NCxgjuMmeHLG-2FN1oXIhnmtUUUHqe5cJW4QFFIXtefy1-2FOf08N8Kx-2F75BiFJ6BoV-2FWBfpw-3D-3D&data=05%7C01%7Cleicestercentral.rec%40hra.nhs.uk%7C84b795610d484b3a4d1a08db76172b52%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638233614099317104%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=chKaJmoQY6JWWvrbEvFGmkrYjN4I8MZQudC%2Fc6aZygo%3D&reserved=0\n\n
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
15/EM/0300
Date of REC Opinion
6 Aug 2015
REC opinion
Further Information Favourable Opinion