A Companion Diagnostic Study to Develop Circulating Exosomes as Predictive Biomarkers for the Response to Immunotherapy in Renal Cell Carcinoma

University of Chinese Academy Sciences

Status: Enrolling

Conditions: Renal Cell Carcinoma

Treatments: Other: Other: Blood and Urine Collection

Study type: Observational

Funder types: Other

Identifiers

NCT05705583

RCC-CDx-001

Details and patient eligibility

About

Immune checkpoint inhibitors targeting PD-1 or PD-L1 have been developed and clinical trials showning better response in unselected patients with metastatic renal cell carcinoma (RCC). At the moment, no clear biomarker exists to accurately predict anti-PD1/PDL1 RCC responsiveness. The objective of this study is to develop and evaluate the utility of circulating exosomes as companion diagnostic biomarker for predicting response to immunotherapy in patients with RCC.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Advanced Metastatic RCC
• Scheduled to initiate an immunocheckpoint inhibitors or in combination with them
• Age >= 18 years
• Able to provide informed consent

Exclusion criteria

• Other, unrelated, concomitant active, invasive malignancy