A Study of the Effects of ALKS 4230 (Nemvaleukin Alfa) on Subjects With Solid Tumors
NCT ID: NCT02799095
Last Updated: 2025-05-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
243 participants
INTERVENTIONAL
2016-09-14
2023-08-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ALKS 4230
ALKS 4230
Intravenous (IV) infusion over 30 minutes given daily for 5 consecutive days followed by an off-treatment period
ALKS 4230 + pembrolizumab
ALKS 4230 + pembrolizumab
IV infusion of ALKS 4230 over 30 minutes given daily for 5 consecutive days followed by an off-treatment period; pembrolizumab administered IV once with ALKS 4230 on the first day of each cycle
Interventions
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ALKS 4230
Intravenous (IV) infusion over 30 minutes given daily for 5 consecutive days followed by an off-treatment period
ALKS 4230 + pembrolizumab
IV infusion of ALKS 4230 over 30 minutes given daily for 5 consecutive days followed by an off-treatment period; pembrolizumab administered IV once with ALKS 4230 on the first day of each cycle
Eligibility Criteria
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Inclusion Criteria
* All subjects must have advanced solid tumors that have returned after treatment with established approved therapies or be intolerant of established therapies
* Subjects enrolled in Part B or Part C must have at least 1 lesion that may qualify as a target lesion
* Subject can move around on their own, has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and has an estimated life expectancy of at least 3 months
* Subject must have adequate hematologic reserve
* Subjects must have adequate liver function
* Subjects must have adequate kidney function
* Subjects must be recovered from the effects of any prior chemotherapy, immunotherapy, other prior systemic anticancer therapy, radiotherapy or surgery
* Subjects who have received investigational agents must wait at least 4 weeks
* Females of childbearing potential must have a negative pregnancy test within 7 days of the start of treatment and on Day 1 before the first dose is administered. A female not of childbearing potential is one who has undergone bilateral oophorectomies or who is postmenopausal, defined as \>45 years of age and without a menstrual period for 12 consecutive months
* Meets contraceptive requirements defined in the protocol
* Additional criteria may apply
Exclusion Criteria
* Subjects with an active infection or with a fever \>/= 38.5 degrees C within 3 days of the first scheduled day of dosing for Cycle 1
* Subjects with active or symptomatic central nervous system metastases are excluded. Subjects with central nervous system metastases are eligible for the study if the metastases have been treated by surgery and/or radiation therapy, the subject is off corticosteroids for at least 2 weeks and the subject is neurologically stable
* Subjects have a mean QT interval corrected by the Fridericia Correction formula value of \>470 msec (in females) or \>450 msec (in males)
* Subjects with known hypersensitivity to any components of ALKS 4230
* Subjects with known hypersensitivity to any components of pembrolizumab (for patients in combination arm only)
* Subjects who require pharmacologic doses of corticosteroids; replacement doses, topical, ophthalmologic, and inhalational steroids are permitted
* Subjects who developed autoimmune disorders while on prior immunotherapy, including pneumonitis, nephritis, and neuropathy
* Subjects with any other concurrent uncontrolled illness, including mental illness or substance abuse, which may interfere with the ability of the subject to cooperate and participate in the study
* The subject is known to be positive for human immunodeficiency virus (HIV), hepatitis B or C, or active tuberculosis, or has a known history of tuberculosis
* Subjects with dyspnea at rest of requiring oxygen therapy
* Subjects active autoimmune disease requiring systemic treatment within the past 30 days
* Subjects who received radiotherapy within the last 4 weeks before start of study treatment administration with the exception of limited field palliative radiotherapy
* Subjects who have received systemic immunomodulatory agents within 28 days prior to C1D1.
* Subjects who have received administration of a live, attenuated vaccine within 4 weeks of Cycle 1, Day1.
* Prior solid organ and/or non-autologous hematopoietic stem cell or bone marrow transplant recipients
* Subjects who have received prior IL-2 based or IL-15 based cytokine therapy
* Additional criteria may apply
18 Years
ALL
No
Sponsors
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Mural Oncology, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Mural Oncology
Locations
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Mural Oncology Investigational Site
Denver, Colorado, United States
Mural Oncology Investigational Site
Port Saint Lucie, Florida, United States
Mural Oncology Investigational Site
Tampa, Florida, United States
Mural Oncology Investigational Site
Lexington, Kentucky, United States
Mural Oncology Investigational Site
Boston, Massachusetts, United States
Mural Oncology Investigational Site
Detroit, Michigan, United States
Mural Oncology Investigational Site
Buffalo, New York, United States
Mural Oncology Investigational Site
New York, New York, United States
Mural Oncology Investigational Site
Cleveland, Ohio, United States
Mural Oncology Investigational Site
Dallas, Texas, United States
Mural Oncology Investigational Site
Fairfax, Virginia, United States
Mural Oncology Investigational Site
Spokane, Washington, United States
Mural Oncology Investgational Site
Albury, New South Wales, Australia
Mural Oncology Investigational Site
Waratah, New South Wales, Australia
Mural Oncology Investigational Site
Brussels, MO, Belgium
Mural Oncology Investigational Site
Kortrijk, West-Vlaanderen, Belgium
Mural Oncology Investigational Site
Edmonton, Alberta, Canada
Mural Oncology Investigational Site
Hamilton, Ontario, Canada
Alkermes Investigational Site
Toronto, Ontario, Canada
Mural Oncology Investigational Site
Montreal, Quebec, Canada
Mural Oncology Investigational Site
Québec, Quebec, Canada
Mural Oncology Investigational Site
Skorzewo, Poznan, Poland
Mural Oncology Investigational Site
Daejeon, , South Korea
Mural Oncology Investigational Site
Seoul, , South Korea
Mural Oncology Investigational Site
Seoul, , South Korea
Mural Oncology Investigational Site
Barcelona, , Spain
Mural Oncology Investigational Site
Madrid, , Spain
Mural Oncology Investigational Site
Madrid, , Spain
Mural Oncology Investigational Site
Madrid, , Spain
Mural Oncology Investigational Site
Madrid, , Spain
Mural Oncology Investigational Site
Valencia, , Spain
Countries
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References
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Calvo E, Boni V, Dumas O, Shin SJ, Rosen SD, Chaudhry A, Debruyne PR, He X, Vaishampayan UN, McDermott DF. Nemvaleukin alfa monotherapy in patients with advanced melanoma and renal cell carcinoma: results from the phase 1/2 non-randomized ARTISTRY-1 trial. J Immunother Cancer. 2025 Aug 4;13(8):e010777. doi: 10.1136/jitc-2024-010777.
Vaishampayan UN, Muzaffar J, Winer I, Rosen SD, Hoimes CJ, Chauhan A, Spreafico A, Lewis KD, Bruno DS, Dumas O, McDermott DF, Strauss JF, Chu QS, Gilbert L, Chaudhry A, Calvo E, Dalal R, Boni V, Ernstoff MS, Velcheti V. Nemvaleukin alfa, a modified interleukin-2 cytokine, as monotherapy and with pembrolizumab in patients with advanced solid tumors (ARTISTRY-1). J Immunother Cancer. 2024 Nov 20;12(11):e010143. doi: 10.1136/jitc-2024-010143.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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ALK4230-A101
Identifier Type: -
Identifier Source: org_study_id
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