Evidence map›Paper›PMID 39567211›Full record

Trial reportJournal for immunotherapy of cancer2024

Nemvaleukin alfa, a modified interleukin-2 cytokine, as monotherapy and with pembrolizumab in patients with advanced solid tumors (ARTISTRY-1).

Ulka N Vaishampayan, Jameel Muzaffar, Ira Winer, Seth D Rosen, Christoper J Hoimes, Aman Chauhan, Anna Spreafico, Karl D Lewis, Debora S Bruno, Olivier Dumas and 10 more

Registry-linked trialAbstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Journal for immunotherapy of cancer, 2024. 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 24 papers.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

NCT02799095 phase1 / phase2completednot on this map

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

TypeinterventionalSponsorMural Oncology, IncRan2016 to 2023Enrolled243ConditionsAdvanced Solid TumorsArmsALKS 4230, ALKS 4230 + pembrolizumab
3 · Its place in the literature

Who cites it

24 citing papers in PubMed.

  1. Trial
  2. Review
  3. First-In-Human Trial of Encapsulated Cells Constitutively Expressing Localized IL2 in Patients with High-Grade Serous Ovarian Carcinoma.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
    Article
  4. Review
  5. Review
  6. T-Cell Immunity and Lung Cancer.Respirology (Carlton, Vic.) · 2026
    Review
  7. Review
  8. Review
  9. Review
  10. Review
  11. Review
  12. Review
  13. Article
  14. Review
  15. Review
  16. Review
  17. Emerging Immunotherapy Targets in Early Drug Development.International journal of molecular sciences · 2025
    Review
  18. Article
  19. Review
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors.

Ulka N VaishampayanDivison of Hematology/Oncology, University of Michigan, Ann Arbor, Michigan, USA vaishamu@med.umich.edu.ORCID 0000-0001-5800-4571
Jameel MuzaffarDepartment of Medicine, Duke University School of Medicine, Durham, North Carolina, USA.
Ira WinerBarbara Ann Karmanos Cancer Institute, Wayne State University, Detroit, Michigan, USA.
Seth D RosenHematology Oncology Association of the Treasure Coast, Port St. Lucie, Florida, USA.
Christoper J HoimesPhase I Program, Case Comprehensive Cancer Center, University Hospitals, Cleveland, Ohio, USA.
Aman ChauhanSylvester Comprehensive Cancer Center, University of Miami, Miami, Florida, USA.
Anna SpreaficoDepartment of Medicine, Division of Medical Oncology and Hematology, Princess Margaret Hospital Cancer Centre, Toronto, Ontario, Canada.ORCID 0000-0002-3034-3042
Karl D LewisUniversity of Colorado School of Medicine, Aurora, Colorado, USA.
Debora S BrunoDepartment of Medicine, University Hospitals Cleveland Medical Center, Seidman Cancer Center, Cleveland, Ohio, USA.
Olivier DumasCHU de Québec-Université Laval, Quebec City, Quebec, Canada.
David F McDermottBeth Israel Deaconess Medical Center, Boston, Massachusetts, USA.
James F StraussMary Crowley Cancer Research Center, Dallas, Texas, USA.
Quincy S ChuUniversity of Alberta/Alberta Health Services, Cross Cancer Institute, Edmonton, Alberta, Canada.
Lucy GilbertDivision of Gynecologic Oncology, The Gerald Bronfman Department of Oncology, McGill University Health Centre, Montreal, Quebec, Canada.
Arvind ChaudhrySummit Cancer Centers, Spokane, Washington, USA.
Emiliano CalvoSTART Madrid-CIOCC, Centro Integral Oncológico Clara Campal, Madrid, Spain.ORCID 0000-0003-4921-829X
Rita DalalMural Oncology, Inc, Waltham, Massachusetts, USA.
Valentina BoniSTART Madrid-CIOCC, Centro Integral Oncológico Clara Campal, Madrid, Spain.
Marc S ErnstoffDivision of Cancer Treatment & Diagnosis, National Cancer Institute, NIH, Bethesda, Maryland, USA.ORCID 0000-0002-8132-7069
Vamsidhar VelchetiLaura and Isaac Perlmutter Cancer Center, New York University, New York, New York, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundNemvaleukin alfa (nemvaleukin, ALKS 4230) is a novel, engineered cytokine that selectively binds to the intermediate-affinity interleukin-2 receptor, preferentially activating CD8

methodsThis was a three-part, open-label, phase 1/2 study: part A, dose-escalation monotherapy, part B, dose-expansion monotherapy, and part C, combination therapy with pembrolizumab. The study was conducted at 32 sites in 7 countries. Adult patients with advanced solid tumors were enrolled and received intravenous nemvaleukin once daily on days 1-5 (21-day cycle) at 0.1-10 µg/kg/day (part A), or at the RP2D (part B), or with pembrolizumab (part C). Primary endpoints were RP2D selection and dose-limiting toxicities (part A), and overall response rate (ORR) and safety (parts B and C).

resultsFrom July 2016 to March 2023, 243 patients were enrolled and treated (46, 74, and 166 in parts A, B, and C, respectively). The maximum tolerated dose was not reached. RP2D was determined as 6 µg/kg/day. ORR with nemvaleukin monotherapy was 10% (7/68; 95% CI 4 to 20), with seven partial responses (melanoma, n=4; renal cell carcinoma, n=3). Robust CD8

conclusionsNemvaleukin was well tolerated and demonstrated promising antitumor activity across heavily pretreated advanced solid tumors. Phase 2/3 studies of nemvaleukin are ongoing. TRIAL REGISTRATION NUMBER: NCT02799095.

Indexed as

Antibodies, Monoclonal, HumanizedInterleukin-2NeoplasmsAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsFemaleHumansMaleMiddle AgedAntibodies, Monoclonal, HumanizedInterleukin-2pembrolizumabCytokineImmunotherapyOvarian CancerSkin CancerSolid tumor

Identifiers

PMID39567211
PMCPMC11580269

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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.