Clinical trial · Interventional
An Investigational Immuno-therapy Safety Trial of Nivolumab in Patients With Advanced or Metastatic Renal Cell Carcinoma
A Phase 3b/4 Safety Trial of Nivolumab (BMS-936558) in Subjects With Advanced or Metastatic Renal Cell Carcinoma (CheckMate 374: CHECKpoint Pathway and Nivolumab Clinical Trial Evaluation 374)
NCT02596035CI-TRIAL-00061771CheckMate 374completedPhase 4Results postedClinicalTrials.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)
This study will generate safety data on Nivolumab given by itself in treatment of advanced Renal Cell Carcinoma (RCC). The primary objective of this study is to assess immune related side effects, also known as immune-mediated adverse events (IMAEs), in patients treated with Nivolumab.
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 Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nivolumab | Drug | Nivolumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Nivolumab
- description
- Nivolumab dose as specified
- interventionNames
- Drug: Nivolumab
Primary outcomes (1)
- measure
- Percentage of Participants Who Experienced High-Grade (Grade 3-4 and Grade 5) Immune Mediated Adverse Events (IMAEs)
- timeFrame
- Up to 100 days of the last dose of study drug (Approximately 2 years)
- description
- IMAEs were tabulated using worst grade per Common Terminology Criteria for Adverse Events, National Cancer Institute (NCI CTCAE) Version 4.0 criteria by system organ class and MedDRA version 20.1 preferred term.
Secondary outcomes (6)
- measure
- Median Time to Onset of High Grade (Grade 3-5) Immune Mediated Adverse Events
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Advanced or Metastatic renal cell carcinoma (RCC) * Predominant clear cell histology: 1. At least 1 but no more than 2 prior systemic anti vascular endothelial growth factor (anti-VEGF) treatments 2. No more than 3 total prior systemic treatment regimens in the advanced or metastatic setting 3. Subjects with prior treatment with a mechanistic target of rapamycin (mTOR) are eligible * Non-clear cell histology: 0-3 prior systemic therapies and may include mTOR inhibitor * Brain metastases allowed if asymptomatic, without edema, and not receiving corticosteroids or radiation * Performance Status (PS): ≥ 70% Karnofsky Performance Scale (KPS) * All Memorial Sloan-Kettering Cancer Center (MSKCC) prognostic scores allowed Exclusion Criteria: * Subjects with any active autoimmune disease or a history of known autoimmune disease * History of severe hypersensitivity reaction to other monoclonal antibodies * Prior malignancy, active within the last 3 years, except for locally curable cancers which have been apparently cured * Known HIV or AIDS-related illness * Any positive tests for Hepatitis B or Hepatitis C virus indicating acute or chronic infection Other protocol-defined inclusion/exclusion criteria apply
References
Publications (0)
Data not yet available
No reference posted for this study.