Clinical trial · Interventional
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
NCT05215470CI-TRIAL-00078491active not recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Renal Cancer Metastatic | Kidney Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ipilimumab | Drug | Ipilimumab | ALIAS |
| Nivolumab | Drug | Nivolumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Nivolumab+Ipilimumab
- description
- Nivolumab IV 3mg/kg 3/3w + Ipilimumab 1mg/kg 3/3w 4 doses, followed by Nivolumab IV 480mg 4/4w until progression, toxicity, or up to 2 years of use.
- interventionNames
- Drug: Nivolumab
- Drug: Ipilimumab
Primary outcomes (2)
- measure
- Overall Survival
- timeFrame
- 3 years
- measure
- Progression-free survival
- timeFrame
- 2 years
Secondary outcomes (1)
- measure
- Overall Response Rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.