Trial reportThe oncologist2025
Less frequent intravenous dosing of nemvaleukin alfa in patients with advanced solid tumors: the phase 1/2 ARTISTRY-3 trial.
Trial report in The oncologist, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04592653 (Clinical and Immunologic Activity of Nemvaleukin Alfa With Less Frequent IV Dosing Schedule as Monotherapy and in Combination With Pembrolizumab and Impact on Tumor Microenvironment in Solid Tumor Patients - ARTISTRY-3), which is not on this map. Cited by 1 paper.
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.
Clinical and Immunologic Activity of Nemvaleukin Alfa With Less Frequent IV Dosing Schedule as Monotherapy and in Combination With Pembrolizumab and Impact on Tumor Microenvironment in Solid Tumor Patients - ARTISTRY-3
Who cites it
1 citing paper in PubMed.
- Hematological Toxicities in the Modern Era of Melanoma Therapy.Journal of clinical medicine · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
Abstract
backgroundIntravenous (IV) nemvaleukin alfa (nemvaleukin, ALKS 4230) administered daily on days 1-5 in 21‑day cycles demonstrated antitumor activity and manageable safety in heavily pretreated advanced solid tumors. We present results from cohort 2 of the open-label phase I/II ARTISTRY-3 (NCT04592653) study, which evaluated less frequent IV dosing of nemvaleukin in advanced solid tumors.
methodsEligible patients received escalating IV nemvaleukin doses in 21-day cycles on 3 schedules: day 1, days 1 and 8, and days 1 and 4. The primary endpoint was the incidence of dose-limiting toxicities (DLTs).
resultsFrom April 2022 to June 2024, 52 patients received nemvaleukin. No DLTs were reported. Most treatment-related adverse events (TRAEs) were grade 1-2. Six patients (12%) experienced grade 3 TRAEs, the most common being neutropenia. Nemvaleukin exposure increased with escalating doses. Natural killer (NK) cell and CD8+ T-cell expansion in whole blood was observed, with minimal regulatory T-cell expansion. Nemvaleukin at 30 μg/kg on days 1 and 8 was the recommended phase II dose. No objective responses were observed; 16 (31%) patients had stable disease (6 [12%] for ≥3 months). Increased tumor microenvironment infiltration of NK cells and CD8+ T-cells was observed in on-treatment biopsies.
conclusionsLess frequent IV doses of nemvaleukin demonstrated pharmacodynamic proof of mechanism and were tolerable with some disease stabilization.
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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.