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Center for Global Research Data

Evaluation of CRP (c-reactive protein) flare phenomena as an early predictor of response to the Atezolizumab + Bevacizumab therapy in renal cell carcinoma

Lead Investigator: Jörg Ellinger, University Hospital Bonn
Title of Proposal Research: Evaluation of CRP (c-reactive protein) flare phenomena as an early predictor of response to the Atezolizumab + Bevacizumab therapy in renal cell carcinoma
Vivli Data Request: 7164
Funding Source: None
Potential Conflicts of Interest: None

Summary of the Proposed Research:
First-line treatment of metastatic renal cell carcinoma (mRCC) has changed substantially in recent years due to the introduction of immune checkpoint inhibition. Immune checkpoint inhibitors work by blocking checkpoint proteins from binding with their partner proteins. This prevents the “off” signal from being sent, allowing the T cells to kill cancer cells. The combination of immune checkpoint inhibitors as well as a combination of tyrosine kinase inhibitors are nowadays standard therapies in mRCC. The success of immunotherapy is based on the induction of an anti-tumor immune response. C-reactive protein (CRP) is a substance produced by the liver in response to inflammation and is widely used as a surrogate biomarker for the assessment of systemic inflammation.

The occurrence and kinetics of systemic inflammatory response reflected by serum CRP has been implicated with treatment response in various cancer entities. Recently, Fukuda et al. described the CRP “flare-response” phenomenon defined by an early CRP increase after immunotherapy initiation with a subsequent drop below baseline. These early CRP changes appear to mirror the dynamic phase of systemic inflammation after inducing the desired antitumoral immune response on immunotherapy. We observed in a retrospective multi-center cohort with patients undergoing immunotherapy (nivolumab/ipilimumab or pembrolizumab/axitinib) as first line therapy for mRCC.

This research proposal is designed to study the relevance of the CRP flare-response phenomenon in patients treated with the combination therapy Bevacizumab/Atezolizumab versus sunitinib in the IMmotion 151 trial as predictor of patients’ outcome.

Requested Studies:
A Phase III, Open-Label, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Bevacizumab Versus Sunitinib in Patients With Untreated Advanced Renal Cell Carcinoma
Sponsor: Roche
Study ID: NCT02420821
Sponsor ID: WO29637