A Dose Escalation and Cohort Expansion Study of Subcutaneously-Administered Cytokine ALKS 4230 (Nemvaleukin Alfa) as a Single Agent and in Combination With Anti-PD-1 Antibody (Pembrolizumab) in Subjects With Select Advanced or Metastatic Solid Tumors (ARTISTRY-2)
NCT ID: NCT03861793
Last Updated: 2024-03-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
116 participants
INTERVENTIONAL
2019-02-26
2023-03-01
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
Administered via SC injection once every 7 days or once every 21 days at escalating doses
ALKS 4230
SC injection administered in the back of the arm or the abdomen
ALKS 4230 + pembrolizumab
ALKS 4230 will be administered via SC injection once every 7 or 21 days at escalating doses or at the recommended phase 2 dose and schedule; pembrolizumab will be administered as an intravenous infusion given over 30 minutes; the dose level for pembrolizumab will be 200 mg per the approved label. In December 2020, an RP2D of 3 mg with an administration schedule of q7d was determined for SC ALKS 4230.
ALKS 4230
SC injection administered in the back of the arm or the abdomen
Pembrolizumab
Administered as an intravenous (IV) infusion over 30 minutes
Interventions
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ALKS 4230
SC injection administered in the back of the arm or the abdomen
Pembrolizumab
Administered as an intravenous (IV) infusion over 30 minutes
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject must have at least one target lesion based on RECIST
* Subject has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1
* 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 radiation therapy must wait at least 4 weeks after their last radiation treatment before enrollment into the study
* 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
* Subject will agree to follow contraceptive requirements defined in the protocol
* Additional criteria may apply
Exclusion Criteria
* Subjects with an active infection or with a fever ≥ 38.5°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 with known hypersensitivity to any components of ALKS 4230 or to pembrolizumab or any of its excipients
* Subjects who require pharmacologic doses of systemic corticosteroids are excluded; replacement doses, topical, ophthalmologic, and inhalational steroids are permitted
* Subjects who developed autoimmune disorders while on prior immunotherapy, including pneumonitis, nephritis, and/or neuropathy
* Subjects with any other concurrent uncontrolled illness, including mental illness or substance abuse, which may interfere with the ability of the subjects 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
* 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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Mural Oncology Medical Director
Role: STUDY_DIRECTOR
Mural Oncology
Locations
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Mural Oncology Investigational Site
Los Angeles, California, United States
Mural Oncology Investigational Site
Los Angeles, California, United States
Mural Oncology Investigational Site
Washington D.C., District of Columbia, United States
Mural Oncology Investigational Site
Atlanta, Georgia, United States
Mural Oncology Investigational Site
Chicago, Illinois, United States
Mural Oncology Investigational Site
Bethesda, Maryland, United States
Mural Oncology Investigational Site
Detroit, Michigan, United States
Mural Oncology Investigational Site
Saint Paul, Minnesota, United States
Mural Oncology Investigational Site
Morristown, New Jersey, United States
Mural Oncology Investigational Site
Buffalo, New York, United States
Mural Oncology Investigational Site
Huntersville, North Carolina, United States
Mural Oncology Investigational Site
Cincinnati, Ohio, United States
Mural Oncology Investigational Site
Philadelphia, Pennsylvania, United States
Mural Oncology Investigational Site
Charleston, South Carolina, United States
Mural Oncology Investigational Site
Houston, Texas, United States
Mural Oncology Investigational Site
Salt Lake City, Utah, United States
Mural Oncology Investigational Site
Milwaukee, Wisconsin, United States
Mural Oncology Investigational Site
Edmonton, Alberta, Canada
Mural Oncology Investigational Site
Hamilton, Ontario, Canada
Mural Oncology Investigational Sites
Montreal, Quebec, Canada
Mural Oncology Investigational Site
Montreal, Quebec, Canada
Mural Oncology Investigational Site
Montreal, Quebec, Canada
Mural Oncology Investigational Site
Québec, Quebec, Canada
Mural Oncology Investigational Site
Rotterdam, , Netherlands
Mural Oncology Investigational Site
Utrecht, , Netherlands
National Cancer Center
Goyang, , South Korea
Inha University Hospital
Incheon, , South Korea
Seoul National University Bundang Hospital
Seongnam, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Yonsei University Health System - Severance Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
The Catholic University of Korea St. Vincent's Hospital
Suwon, , South Korea
Mural Oncology Investigational Site
Badalona, , Spain
Mural Oncology Investigational Site
Córdoba, , 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
Madrid, , Spain
Mural Oncology Investigational Site
Málaga, , Spain
Mural Oncology Investigational Site
Valencia, , Spain
Mural Oncology Investigational Site
Kaohsiung City, , Taiwan
Mural Oncology Investigational Site
Taichung, , Taiwan
Mural Oncology Investigational Site
Tainan City, , Taiwan
Mural Oncology Investigational Site
Taipei, , Taiwan
Mural Oncology Investigational Site
Taipei, , Taiwan
Mural Oncology Investigational Site
Taipei, , Taiwan
Countries
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Other Identifiers
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ALKS 4230-001
Identifier Type: -
Identifier Source: org_study_id
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