BO43936 - AXITINIB IN PATIENTS WITH RENAL CELL CARCINOMA
Research type
Research Study
Full title
A RANDOMIZED OPEN LABEL PHASE II STUDY OF IMMUNE CHECKPOINT INHIBITOR COMBINATIONS WITH AXITINIB IN PATIENTS WITH PREVIOUSLY UNTREATED LOCALLY ADVANCED UNRESECTABLE OR METASTATIC RENAL CELL CARCINOMA.
IRAS ID
1005406
Contact name
Emma Learmond
Contact email
Sponsor organisation
F.Hoffmann-La Roche Ltd
Eudract number
2021-006430-39
Clinicaltrials.gov Identifier
Research summary
Renal Cell Carcinoma (RCC) was diagnosed in more than 400,000 people and was associated with approximately 175,000 deaths worldwide in 2018. RCC is the 9th most common cancer occurring in men, and the 14th most common cancer in women.
While the majority of patients will present with localized disease, approximately 30% of those treated with curative intent will develop disease in other organs and approximately 20%-25% of patients present with metastatic disease at initial diagnosis.
Despite significant advances with combination immunotherapy and the combination of immunotherapy with tyrosine kinase inhibitors (TKIs e.g., axitinib) cures remain rare. Even with response rates as high as 60%, the durability of these responses is inconsistent, and most patients will progress within 2 years,
Combinations targeting novel immune checkpoints are attractive because they target distinct mechanisms that could increase the number of patients that respond to immunotherapy and have benefit-risk profiles that are tolerable while also improving long-term outcomes for patients with RCC.
This study will evaluate the efficacy, safety, and pharmacokinetics of RO7247669 and axitinib (Arm A); or tiragolumab in combination with RO7247669 and axitinib (Arm B). In each case experimental treatment will be compared with pembrolizumab and axitinib (Control Arm)
Approximately 210 participants will take part in this study globally
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
23/SC/0007
Date of REC Opinion
11 Aug 2023
REC opinion
Further Information Favourable Opinion