ArticleOncoimmunology2021
Safety, Tolerability, and Long-Term Clinical Outcomes of an IL-15 analogue (N-803) Admixed with Bacillus Calmette-Guérin (BCG) for the Treatment of Bladder Cancer.
Article in Oncoimmunology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 32 papers.
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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.
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Who cites it
32 citing papers in PubMed, 45 citations in OpenAlex.
- Prolonged Progression-Free Survival, Disease-Free Survival, and Cystectomy Avoidance With IL-15 Receptor Lymphocyte-Stimulating Agent NAI Plus Bacillus Calmette-Guérin in Bacillus Calmette-Guérin-Unresponsive Papillary-Only Nonmuscle-Invasive Bladder Cancer.The Journal of urology · 2026Trial
- A phase 1 study of interleukin-15 in combination with mogamulizumab in relapsed and refractory T-cell malignancies.Blood neoplasia · 2025Trial
- N-803, an IL-15 Superagonist Complex as Maintenance Therapy After Allogeneic Donor Stem Cell Transplant for Acute Myeloid Leukemia or Myelodysplastic Syndrome; A Phase 2 Trial.Transplantation and cellular therapy · 2024Trial
- IL-15 trans-presentation at the innate-adaptive interface: mechanisms and translation in cancer immunotherapy.Oncoimmunology · 2026Review
- Narrative Review of Potential Non-Surgical Treatments for BCG-Unresponsive Non-Muscle Invasive Bladder Cancer.Journal of clinical medicine · 2026Review
- Review
- PD1-IL2v expands and induces effector CD8Journal of experimental & clinical cancer research : CR · 2026Article
- Recent advances in immunotherapy for bladder cancer: mechanisms, clinical applications, and future perspectives.Frontiers in oncology · 2026Review
- State of the art of adjuvant immunotherapy in urothelial cancer: New developments and upcoming changes.Human vaccines & immunotherapeutics · 2025Review
- Natural Killer Cell-Mediated Antitumor Immunity: Molecular Mechanisms and Clinical Applications.MedComm · 2025Review
- Cytokine Therapy in Bladder Cancer: Mechanisms, Efficacy, and Future Prospects.Current issues in molecular biology · 2025Review
- Nogapendekin alfa Inbakicept-pmln (Anktiva) with BCG: A Promising Arsenal in BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer Intervention.Advanced pharmaceutical bulletin · 2025Article
- Recurrent pancreatic cancer treated with N-803 and PD-L1 t-haNK followed by an EGFR-targeted nanocell drug conjugate.The oncologist · 2025Article
- IL-15: from discovery to FDA approval.Journal of hematology & oncology · 2025Article
- Senescence-associated signature based on immunotherapy response sequencing reveals PPIL3 as target for bladder cancer treatment and prognosis prediction.Frontiers in immunology · 2025Article
- Isotretinoin promotes elimination of translation-competent HIV latent reservoirs in CD4T cells.PLoS pathogens · 2024Article
- Contemporary Treatment of NMIBC-Is It Time to Move on from BCG?Journal of clinical medicine · 2024Review
- Nogapendekin alfa Inbakicept: First Approval.Drugs · 2024Review
- Development of a prognostic signature for immune-associated genes in bladder cancer and exploring potential drug findings.International urology and nephrology · 2024Article
- Therapeutic approaches to enhance natural killer cell cytotoxicity.Frontiers in immunology · 2024Review
Corrections and comments
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Authors and funding
7 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Intravesical BCG is active against non-muscle invasive bladder cancer (NMIBC), but bladder cancer will recur and even progress in a significant number of patients. To improve the response rate, N-803, an IL-15 superagonist was administered in combination with BCG. To evaluate the safety and efficacy associated with the use of intravesical N-803 and BCG in patients with BCG-naïve NMIBC. This phase 1b clinical trial used a 3 + 3 dose-escalation design. Participants were enrolled from July 2014 and July 2015, with follow-up and analyses through January 15, 2021. Eligibility criteria included histologically confirmed non-muscle invasive urothelial carcinoma of intermediate or high risk who had not received prior treatment with intravesical BCG (ie, BCG-naïve). All 9 participants met the eligibility criteria, received treatment according to the protocol, and were included in all analyses. Treatment was done once weekly for 6 consecutive weeks with bladder infusion of the standard dose of BCG, 50 mg/instillation, in combination with increasing doses of N-803 (100, 200, or 400 µg N-803 per instillation). No DLTs were noted in any of the dose cohorts. All adverse events (AEs) were manageable and less than grade 3. During the 2-year follow-up, all 9 participants were disease free. Furthermore, 6 y after treatment, all 9 participants (100%) were disease free with no evidence of disease progression and an intact bladder. This phase 1b trial found the combination of intravesical N-803 and BCG to be associated with modest toxic effects, low immunogenicity, and substantial prolonged antitumoral activity; phase 2 trials are in progress.
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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.