Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2019
Safety and Efficacy of Nivolumab in Brain Metastases From Renal Cell Carcinoma: Results of the GETUG-AFU 26 NIVOREN Multicenter Phase II Study.
Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03013335 (A Phase II Safety Trial of Nivolumab in Patients With Metastatic Renal Cell Carcinoma Who Have Progresses During or After Prior Systemic Anti-angiogenic Regimen), which is not on this map. Cited by 93 papers, 3 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase II Safety Trial of Nivolumab in Patients With Metastatic Renal Cell Carcinoma Who Have Progresses During or After Prior Systemic Anti-angiogenic Regimen
Who cites it
93 citing papers in PubMed, 3 syntheses or guidelines pooled it, 159 citations in OpenAlex.
- Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immunotherapy for the treatment of renal cell carcinoma, version 3.0.Journal for immunotherapy of cancer · 2026Guideline
- Optimal early endpoint for second-line or subsequent immune checkpoint inhibitors in previously treated advanced solid cancers: a systematic review.BMC cancer · 2025Pooled it
- Impact of Tyrosine Kinase Inhibitors (TKIs) Combined With Radiation Therapy for the Management of Brain Metastases From Renal Cell Carcinoma.Frontiers in oncology · 2020Pooled it
- Trial
- Brain metastasis: Opportunities for novel therapies.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2026Review
- Mixed Response to Nivolumab Among Different Metastatic Sites in Patients With Metastatic Renal Cell Carcinoma: Incidence and Clinical Implications.International journal of urology : official journal of the Japanese Urological Association · 2026Article
- Immuno-molecular features and therapeutic implications of brain metastases in clear cell renal cell carcinoma patients.Genes and immunity · 2026Article
- Single-Cell Atlas of Renal Cell Carcinoma Brain Metastasis Uncovers Mechanisms of Immune Dysfunction and Resistance.bioRxiv : the preprint server for biology · 2026Article
- Deciphering the Genomic Landscape of Renal Cell Carcinoma Brain Metastases.bioRxiv : the preprint server for biology · 2026Article
- Soluble MAdCAM-1 as a biomarker in metastatic renal cell carcinoma.Nature medicine · 2026Article
- Comparative efficacy of immune checkpoint inhibitor combination therapies by metastatic site in metastatic renal cell carcinoma.Scientific reports · 2026Article
- Survival of patients with metastatic renal cell carcinoma with or without brain metastases.The oncologist · 2025Article
- Article
- Immunotherapy in central nervous system tumors.International journal of surgery (London, England) · 2025Review
- The role of upfront radiation therapy for brain metastases in the era of CNS-active systemic therapies: a narrative review of clinical trial design and lessons learned.Journal of neuro-oncology · 2025Review
- Clinical Outcomes and Targeted Genomic Analysis of Renal Cell Carcinoma Brain Metastases Treated with Stereotactic Radiosurgery.European urology oncology · 2025Article
- Nephrotoxicity of Immune Checkpoint Inhibitors in Single and Combination Therapy-A Systematic and Critical Review.Biomedicines · 2025Review
- Tumor-to-tumor metastasis of clear cell renal cell carcinoma to meningioma: illustrative case.Journal of neurosurgery. Case lessons · 2025Article
- Multidisciplinary management strategies for recurrent brain metastasis after prior radiotherapy: An overview.Neuro-oncology · 2025Review
- Nivolumab plasma concentration and clearance associated with overall survival in patients with renal cell carcinoma.Journal for immunotherapy of cancer · 2025Article
33 more citing papers are in PubMed but not listed here.
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Authors and funding
26 authors at 20 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeNivolumab is standard of care for patients with metastatic clear cell renal cell carcinoma (ccRCC) after failure of antiangiogenic therapies, but its activity on brain metastases from ccRCC remains unknown, because these patients were excluded from pivotal studies. We aimed to assess the activity of nivolumab in this population.
methodsThe GETUG-AFU 26 NIVOREN phase II trial assessed the activity and safety of nivolumab in patients with metastatic ccRCC who failed vascular endothelial growth factor-directed therapies (ClinicalTrials.gov identifier: NCT03013335). Patients with asymptomatic brain metastases were prospectively identified and underwent dedicated brain evaluation. Two cohorts were constituted: cohort A comprised patients with previously untreated brain metastases, and cohort B comprised patients whose brain metastases underwent prior therapy. The primary end point was intracranial response rate in cohort A.
resultsSeventy-three patients with brain metastases were included: 39 in cohort A and 34 in cohort B. Intracranial response rate was 12% in cohort A; no objective response was reported in patients with brain lesions that were multiple or larger than 1 cm. Median intracranial progression-free survival was 2.7 months (95% CI, 2.3 to 4.6 months) in cohort A and 4.8 months (95% CI, 3.0 to 8.0 months) in cohort B, with adjusted hazard ratio of 2.04 (95% CI, 1.08 to 3.83). Overall survival rate at 12 months was 67% (95% CI, 49.6% to 79.1%) in cohort A and 59% (95% CI, 40.6% to 73.2%) in cohort B. Most patients in cohort A (72%) needed subsequent focal brain therapy. Nivolumab was well tolerated, with no unexpected toxicity.
conclusionNivolumab activity is limited in patients with untreated brain metastases from ccRCC. Brain imaging and focal therapy should be considered before immune checkpoint inhibitors in patients with metastatic ccRCC.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.