CLARA: Somatic and Germline Mechanisms That Impact Renal Cancer Immunotherapy

CLARA: Characterization of Somatic and Germline Mechanisms That Impact the Immunotherapy Treatment and Prognosis of Patients With Renal Cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05215470

Enrollment

100

Registered

2022-01-31

Start date

2022-01-18

Completion date

2026-11-30

Last updated

2024-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Cancer Metastatic

Keywords

Renal Cancer, Nivolumab, Ipilimumab, Immunotherapy, molecular profiling

Brief summary

The study is studying the joint contribution and interactions of germline variants and somatic mutations and their impact on Renal Cell Carcinoma (RCC) development and treatment (immunotherapy).

Detailed description

One hundred newly diagnosticated stage IV RCC patients will be recruited in the Ribeirao Preto Medical School. Patients will be treated with immune checkpoint inhibitors (ICI) combination: nivolumab (3 mg/kg of body weight) plus ipilimumab (1 mg/kg) intravenously every three weeks for four doses, followed by nivolumab 480mg every four weeks, until progression, toxicity or complete two years of treatment. Patients will be followed up for the clinical outcome (progression-free survival, best response, and overall survival). Fresh-frozen primary tumor tissue will be collected for somatic genomic characterization. Blood DNA will be genotyped for the identification of common germline variation, as well as ancestry determination.

Interventions

DRUGNivolumab

Nivolumab is called an anti-PD-1 (Programmed Cell Death Ligand 1) or a checkpoint inhibitor and is an antibody (a type of human protein) designed to allow the body's own immune system to destroy tumors

DRUGIpilimumab

Ipilimumab is called an anti-CTLA-4 (cytotoxic T-lymphocyte-associated protein 4) and is a type of antibody that works to prevent the body's immune system from stopping to fight a specific cancer

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Renal cell carcinoma patient: histological confirmed clear cell tumor; * First-line metastatic treatment; * Stage IV with at least one measured lesion; * Fresh-frozen primary tumor tissue available; * No previous immunotherapy or tyrosine kinase inhibitor treatment; * All International Metastatic RCC Database Consortium (IMDC) Risk Score; * Karnofsky Performance Scale (KPS) \>=70; * \>=18 years old.

Exclusion criteria

* History of a known or suspected autoimmune disease; * Any condition requiring systemic treatment with corticosteroids; * Creatinine clearance \< 40mL/min; * Alanine aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) \> 5 x ULN; * Pregnant women.

Design outcomes

Primary

Measure	Time frame
Overall Survival	3 years
Progression-free survival	2 years

Secondary

Measure	Time frame
Overall Response Rate	2 years

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026