Trial reportJournal for immunotherapy of cancer2025
Nemvaleukin alfa monotherapy in patients with advanced melanoma and renal cell carcinoma: results from the phase 1/2 non-randomized ARTISTRY-1 trial.
Trial report in Journal for immunotherapy of cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02799095 (A Phase 1/2 Study of ALKS 4230 Administered Intravenously as Monotherapy and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors - ARTISTRY-1), which is not on this map. Cited by 8 papers.
What it found
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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.
A Phase 1/2 Study of ALKS 4230 Administered Intravenously as Monotherapy and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors - ARTISTRY-1
Who cites it
8 citing papers in PubMed.
- Hematological Toxicities in the Modern Era of Melanoma Therapy.Journal of clinical medicine · 2026Review
- Immune tolerance versus cancer surveillance: an ongoing challenge.Journal for immunotherapy of cancer · 2026Review
- Immune Checkpoint Inhibitors and Immunomodulators for Cancer Immunotherapy: Insights Into Resistance and Therapeutic Strategies.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2026Review
- Advanced Mucosal Melanoma Therapies: Current Status and Future Directions.Current treatment options in oncology · 2026Review
- Rewiring tumor cytokine networks to enhance immune checkpoint blockade: mechanisms, engineering, and clinical translation.Journal of experimental & clinical cancer research : CR · 2026Review
- Advances in IL-2 Family Cytokine-Based Cancer Therapies: Overcoming Challenges Through Molecular Engineering and Delivery Strategies.Immune network · 2026Review
- First-Line Treatment Strategies in IMDC Favourable-Risk Metastatic Clear Cell Renal Cell Carcinoma.Oncology research · 2026Review
- Characteristics of the tumor microenvironment and potential immunotherapy strategies in renal cell carcinoma.Frontiers in immunology · 2025Review
Corrections and comments
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Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundDespite improved outcomes with immune checkpoint inhibitors (ICIs) and their combinations in advanced solid tumors, a subset of patients remains unresponsive or progresses, highlighting an unmet need for novel treatments with durable benefit. Nemvaleukin alfa (nemvaleukin, ALKS 4230) demonstrated manageable safety and antitumor activity, alone and in combination with pembrolizumab, across heavily pretreated advanced solid tumors in the ARTISTRY-1 study. We report in-depth antitumor activity, safety, pharmacokinetics, and pharmacodynamics of nemvaleukin monotherapy at the recommended phase 2 dose (RP2D) in advanced melanoma and renal cell carcinoma (RCC) cohorts from ARTISTRY-1.
methodsARTISTRY-1 was a three-part (A, B, and C), multicenter, open-label, phase 1/2 study. Adult patients who had received prior treatment, including ICIs, and had advanced melanoma or RCC were enrolled in Part B. Patients received intravenous nemvaleukin once daily on days 1-5 (21-day cycle) at 6 µg/kg/day (RP2D determined from Part A). Primary endpoints for Part B were overall response rate (ORR) and safety. Secondary endpoints included pharmacokinetic and pharmacodynamic measures.
resultsFrom July 2016 to March 2023, 74 patients in Part B received nemvaleukin monotherapy (melanoma, n=47; RCC, n=27). ORR in melanoma and RCC cohorts was 9% (95% CI, 2% to 21%; n=4) and 14% (95% CI, 3% to 35%; n=3), respectively; disease control rate was 50% (95% CI, 35% to 65%; n=23) and 50% (95% CI, 28% to 72%, n=11), respectively, with stable disease ≥6 months observed in 3 (7%) and 2 (9%) patients, respectively. The most common nemvaleukin-related treatment-emergent adverse event of grade 3-4 was neutropenia (melanoma, n=27 (57%); RCC, n=9 (33%)). No patients in either cohort experienced grade ≥3 treatment-emergent adverse events (TEAEs) of cytokine release syndrome or infusion-related reaction. There were no reported capillary leak syndrome TEAEs. Pharmacokinetic parameters for extent and duration of nemvaleukin exposure were similar between the two cohorts. Increases in peripheral CD8
conclusionsNemvaleukin demonstrated pharmacodynamic proof of mechanism, with single-agent antitumor activity and manageable safety in patients with advanced melanoma and RCC. TRIAL REGISTRATION NUMBER: NCT02799095.
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