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Updated: May 6, 2026

A Syngeneic Mouse Model of Metastatic Renal Cell Carcinoma for Quantitative and Longitudinal Assessment of Preclinical Therapies
Published on: April 12, 2017
Considerations for the design of future clinical trials in metastatic renal cell carcinoma
Bernard Escudier1, Daniel Y C Heng2, Arthur Smyth-Medina3
1Institut Gustave Roussy, Villejuif, France.
Abstract:
Metastatic renal cell carcinoma (mRCC) remains incurable in most cases, and there is a need to improve outcomes through clinical research, which will include development of novel molecularly targeted or immunotherapeutic agents. There are also many remaining questions regarding the optimization of currently available regimens, including the utility of dose escalation, the benefit of combination therapy, and the optimal sequences of therapies. Addressing these clinical questions will require careful planning and the inclusion of novel elements in trial designs. Future trials should include molecular phenotyping and selection of patients most likely to benefit from targeted therapies. In this article, we consider lessons learned from previous trials in mRCC and discuss how these lessons might be implemented in the design of future trials that focus on clinically useful questions and provide results that can be readily interpreted. The ultimate aim of the next generation of mRCC trials will be rapid cost-effective identification, testing, and approval of agents that can improve prognosis in this challenging disease.
Insights
Metastatic renal cell carcinoma (mRCC) research needs novel agents and optimized therapies. Future clinical trials will focus on molecular phenotyping and patient selection for better outcomes in this challenging cancer.
Area of Science:
- Oncology
- Clinical Research Design
- Translational Medicine
Background:
- Metastatic renal cell carcinoma (mRCC) presents significant challenges, with most cases remaining incurable.
- Current treatment paradigms require optimization regarding dose escalation, combination therapies, and sequencing.
Purpose of the Study:
- To review lessons learned from past mRCC clinical trials.
- To propose strategies for designing future mRCC trials that address key clinical questions and yield interpretable results.
- To accelerate the identification, testing, and approval of novel agents for mRCC.
Main Methods:
- Analysis of historical mRCC clinical trial data.
- Discussion of innovative trial design elements, including molecular phenotyping and patient stratification.
- Consideration of cost-effective approaches for drug development and approval.
Main Results:
- Previous trials provide valuable insights into treatment efficacy and challenges.
- Future trial designs should incorporate molecular profiling to personalize therapy.
- Optimized trial designs can expedite the development of effective mRCC treatments.
Conclusions:
- Next-generation mRCC trials must be carefully designed to address critical clinical questions.
- Integrating molecular phenotyping will enhance the selection of patients likely to benefit from targeted therapies.
- The goal is the rapid and cost-effective approval of agents that improve mRCC prognosis.

