The aim of this study is to find possible biomarkers (predictive or prognostic) for the treatment of patients with advanced renal cell carcinoma. This will require that changes in the tumor and peripheral blood components are studied before and…
ID
Source
Brief title
Condition
- Renal disorders (excl nephropathies)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To study the longitudinal effects of treatment (e.g. anti-CTLA4, BRAF
inhibition, and other treatments) for advanced stage renal cell carcinoma on
tumor material obtained by surgical removal/biopsies and on peripheral blood
components.
To find predictive markers and/or prognostic markers in biopsied tumor material
and peripheral blood
To improve current TIL expansion protocols
Secondary outcome
Not applicable.
Background summary
The treatment of metastatic renal cell carcinoma has experienced a clear
improvement in the last couple of years. Targeted treatment, such as TKIs or
mTOR inhibitors, achieved in many patients responses of 1-2 years.
Unfortunately, with these treatments a total cure can not be achieved.
Immunotherapy, such as IFN or IL-2, has lower response rates, but when the
patient responds it may be long-term (several years), and often the patient is
fully healed. Because of the low response probability, these therapies are not
standard in the treatment of RCC. Adoptive cell therapy in melanoma patients
has a high response rate which is possibly durable. ACT or T cell checkpoint
blockade therapies (eg, ipilimumab, anti-PD-1) are promising and can probably
also stabilize the responses in RCC patients.
Study objective
The aim of this study is to find possible biomarkers (predictive or prognostic)
for the treatment of patients with advanced renal cell carcinoma. This will
require that changes in the tumor and peripheral blood components are studied
before and during the treatment of RCC.
For these analyses, both tumor tissue and peripheral blood samples of RCC
patients are needed. These samples will be used for 1) analysis of mechanisms
of resistance to treatment with targeted agents such as VEGF (R) and / or mTOR
inhibitors and other drugs, 2) finding new targets predictive of response to
treatment, and 3) changes in the immune system during immunotherapy like
anti-CTLA4 or anti-PD-1/PD-L1 and other resources.
Study design
150 patients are asked to provide blood and tumor tissue to allow further
translational research in the laboratory.
Intervention
At some time points blood and biopsies will be taken.
Study burden and risks
The blood tests have no serious risks. The biopsies can cause bleeding or
infection.
Plesmanlaan 121
Amsterdam 1066CX
NL
Plesmanlaan 121
Amsterdam 1066CX
NL
Listed location countries
Age
Inclusion criteria
Histologically or cytologically proven renal cell carcinoma
Measurable metastatic lesion(s), according to RECIST 1.1 criteria
Metastatic lesion(s) of which a histological biopsy can safely be obtained
Age above 18 years
Performance score: WHO 0, 1 or 2
Written informed consent
Exclusion criteria
see inclusion criteria
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL41815.031.12 |