Trial reportThe oncologist2023
Avelumab Plus Axitinib as First-Line Therapy for Advanced Renal Cell Carcinoma: Long-Term Results from the JAVELIN Renal 100 Phase Ib Trial.
Trial report in The oncologist, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02493751 (A PHASE 1B, OPEN-LABEL, DOSE-FINDING STUDY TO EVALUATE SAFETY, PHARMACOKINETICS AND PHARMACODYNAMICS OF AVELUMAB), which is not on this map. Cited by 9 papers.
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 1b, open-label, dose-finding study to evaluate safety, pharmacokinetics and pharmacodynamics of avelumab (msb0010718c) in combination with axitinib (ag-013736) in patients with previously untreated advanced renal cell cancer
Who cites it
9 citing papers in PubMed, 13 citations in OpenAlex.
- Review
- Dual Pathway Inhibition in Patients With mRCC: A Case Series From Kuwait Highlighting the Role of Avelumab and Axitinib.Case reports in oncological medicine · 2026Article
- Application of Machine Learning for Predicting Progression-Free and Overall Survival in Patients With Renal Cell Carcinoma.Clinical and translational science · 2025Article
- Avelumab + axitinib treatment in older patients with advanced renal cell carcinoma in Japan: Subgroup analyses of post-marketing surveillance data by age.Cancer medicine · 2025Article
- Assessing hemorrhagic risks in combination therapy: implications of angiogenesis inhibitors and immune checkpoint inhibitors.Frontiers in immunology · 2025Article
- Vascular Endothelial Growth Factor (VEGF) Family and the Immune System: Activators or Inhibitors?Biomedicines · 2024Review
- Immunologic tumor microenvironment modulators for turning cold tumors hot.Cancer communications (London, England) · 2024Review
- Pericytes: jack-of-all-trades in cancer-related inflammation.Frontiers in pharmacology · 2024Review
- CombinationThyroid : official journal of the American Thyroid Association · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
19 authors at 17 institutions in 4 countries.
Funding
Abstract
backgroundProgression-free survival was significantly longer in patients who received avelumab plus axitinib versus sunitinib as first-line treatment for advanced renal cell carcinoma (aRCC) in a randomized phase III trial. We report long-term safety and efficacy of avelumab plus axitinib as first-line treatment for patients with aRCC from the JAVELIN Renal 100 phase Ib trial (NCT02493751). MATERIALS AND
methodsIn this open-label, multicenter, phase Ib study, patients with untreated aRCC received avelumab 10 mg/kg every 2 weeks plus axitinib 5 mg twice daily or with axitinib for 7 days followed by avelumab plus axitinib. Safety and efficacy were assessed in all patients receiving at least one dose of avelumab or axitinib.
resultsOverall, 55 patients were enrolled and treated. Median follow-up was 55.7 months (95% CI, 54.5-58.7). Treatment-related adverse events of any grade or grade ≥3 occurred in 54 (98.2%) and 34 (61.8%) patients, respectively. The confirmed objective response rate was 60.0% (95% CI, 45.9-73.0), including complete response in 10.9% of patients. Median duration of response was 35.9 months (95% CI, 12.7-52.9); the probability of response was 65.8% (95% CI, 46.7-79.4) at 2 years. Median progression-free survival was 8.3 months (95% CI, 5.3-32.0). Median overall survival was not reached (95% CI, 40.8-not estimable); the 5-year overall survival rate was 57.3% (95% CI, 41.2-70.5).
conclusionFive-year follow-up for combination treatment with avelumab plus axitinib in previously untreated patients with aRCC showed long-term clinical activity with no new safety signals, supporting use of this regimen within its approved indication in clinical practice (Clinicaltrials.gov NCT02493751).
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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.