WO41994-Atezo with Chemo after progression with immunotherapy in Renal
Research type
Research Study
Full title
A PHASE III, MULTICENTER, RANDOMIZED, OPEN-LABEL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ATEZOLIZUMAB GIVEN IN COMBINATION WITH CABOZANTINIB VERSUS CABOZANTINIB ALONE IN PATIENTS WITH INOPERABLE, LOCALLY ADVANCED, OR METASTATIC RENAL CELL CARCINOMA WHO EXPERIENCED RADIOGRAPHIC TUMOR PROGRESSION DURING OR AFTER IMMUNE CHECKPOINT INHIBITOR TREATMENT
IRAS ID
278283
Contact name
Guy Faust
Contact email
Sponsor organisation
F. Hoffman-La Roche Ltd.
Eudract number
2020-000502-29
Duration of Study in the UK
4 years, 5 months, 1 days
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.
With the rapidly evolving landscape of treatments for metastatic RCC, the use of ICI-based regimens is moving to earlier lines of therapy and is becoming the standard of care for first and second lines in most countries. Thus, there remains a need to better understand the sequential use of all available RCC treatments and develop effective treatments that fit this evolving landscape.
Both cabozantinib and atezolizumab have shown clinical activity in aRCC. Cabozantinib single agent and atezolizumab in combination with bevacizumab have shown clinical activity in the post-ICI setting in subgroup analysis of prior studies as described in previous sections. These two agents are also active for patients with clear as well as non-clear cell RCC.
The combination of a VEGFR-TKI with immunotherapy may offer an advantage over individual treatment. Cabozantinib contributes to modulation of the immune tumor microenvironment and may enhance activity of immunotherapy.
This study will evaluate the efficacy and safety of atezolizumab when given in combination with cabozantinib (Atezo + Cabo) compared with cabozantinib alone in patients with advanced clear cell or non-clear cell RCC (papillary or unclassified only) who experienced radiographic tumor progression during or after ICI treatment in the metastatic setting. Patients with RCC with sarcomatoid features are also allowed.
The study will enroll approximately 500 patients at approximately 140-180 sites globally.
Patients will be randomized in a 1:1 ratio to recive atezolizumab with Cabozantinib or Cabozantinib alone.
Patients will receive atezolizumab and/or cabozantinib until disease progression unacceptable toxicity or symptomatic deterioration attributed to disease progression.The study is sponsored by F. Hoffman La Roche
Research Summary; Version Number 2 24Jun2020
REC name
HSC REC A
REC reference
20/NI/0131
Date of REC Opinion
9 Oct 2020
REC opinion
Further Information Favourable Opinion