Why balls are not put inside the basket? A reflection on testicular cancer clinical trial design

Area of Science:

• Oncology
• Clinical Trial Design
• Genitourinary Cancers

Background:

• Testicular germ cell tumors (TGCT) are rare and heterogeneous, presenting challenges for targeted therapy development.
• Biomarker-driven clinical trials, such as basket and umbrella designs, are emerging as innovative approaches in oncology.

Purpose of the Study:

• To identify limitations in applying basket trial designs to testicular germ cell tumors (TGCT).
• To propose an alternative clinical trial design optimized for TGCT and similar rare malignancies.

Main Methods:

• Review of current basket trial methodologies and their applicability to TGCT molecular profiles.
• Discussion of common reasons for patient exclusion from basket trials in the context of TGCT.
• Conceptualization of a novel trial design tailored to the specific characteristics of TGCT.

Main Results:

• Basket trials, while promising, face significant hurdles in adequately including TGCT patients due to disease heterogeneity and limited molecular alterations.
• Several factors commonly prevent the successful enrollment of TGCT patients into existing basket trial frameworks.

Conclusions:

• Existing basket trial designs are not always suitable for rare cancers like TGCT.
• A new, adapted trial design is proposed to improve the evaluation of molecular markers and targeted therapies in TGCT.