A safety study of pazopanib and MK-3475 in Renal Cell Carcinoma
Research type
Research Study
Full title
A Phase I/II Study to Assess the Safety and Efficacy of Pazopanib and MK 3475 in Patients with Advanced Renal Cell Carcinoma
IRAS ID
138749
Contact name
Simon Chowdhury
Contact email
Sponsor organisation
Novartis
Eudract number
2013-003785-14
Duration of Study in the UK
6 years, 3 months, 13 days
Research summary
The prognosis for subjects with locally advanced and/or metastatic Renal Cell Cancer(RCC) is poor with a 5-year survival rate of less than 10%. A strong rationale already exists for treating this tumour type with medicines called anti-angiogenic agents and over the past several decades, immune-based therapies have also been studied. It is thought that combining an anti-angiogenic treatment with immunotherapy may potentiate its effect in treating advanced renal cell cancer.
This is an open-label, 2 part study of pazopanib (an orally-taken anti-angiogenic agent already indicated for the treatment of advanced RCC), and/or MK 3475 (a highly-selective, humanized monoclonal antibody that may enhance the immune response against cancerous cells)in subjects that have not had treatment before for their advanced RCC.
Part 1, in which approximately 30 subjects will participate, consists of a Phase I dose escalation of pazopanib + MK 3475 followed by an expansion cohort to determine the maximum tolerated regimen and the recommended dose that is suitable to use in Phase ll.
Part 2 is a randomized 3-arm Phase II study to look at the clinical efficacy and safety of pazopanib given alone compared to MK 3475 given alone compared to pazopanib and MK 3475 given in combination together.
Approximately 66 subjects will participate in each arm (198 in total). Part 1 will take place at one site in the UK and further sites will be invited to participate in Part 2.
Subjects will continue receiving the study drugs in the absence of any unacceptable side effects until disease progression, though MK3475 will only be taken for a maximum of 24 months.REC name
East of England - Cambridge East Research Ethics Committee
REC reference
13/EE/0436
Date of REC Opinion
24 Feb 2014
REC opinion
Further Information Favourable Opinion