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)

Study summary

This study will characterize the safety and tolerability and identify the recommended Phase 2 dose (RP2D) of subcutaneous (SC) ALKS 4230 as monotherapy and in combination with pembrolizumab.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedALKS 4230 and Pembrolizumab

The study team can explain what participation involves.

Who it may be forMetastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Mar 5, 2024 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?48 U.S. locations

Locations may change over time.

Who runs it?Mural Oncology, Inc

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1 / Phase 2
Sponsor: Mural Oncology, Inc
Interventions being studied: Biological: ALKS 4230; Biological: Pembrolizumab

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Disease setting

Metastatic or stage IV→

Treatment approach

Immunotherapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

For Phase I the subject has histological or cytological evidence of a solid tumor. For Phase II the subject must have 1 of the specified adult solid tumor types: gastric, ovarian, lung, head and neck.
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

Reasons someone may not be able to joinExclusion criteria

Subject is currently pregnant, planning to become pregnant, or breastfeeding
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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Mural Oncology Investigational SiteLos Angeles, California
Mural Oncology Investigational SiteLos Angeles, California
Mural Oncology Investigational SiteWashington D.C., District of Columbia
Mural Oncology Investigational SiteAtlanta, Georgia
Mural Oncology Investigational SiteChicago, Illinois
Mural Oncology Investigational SiteBethesda, Maryland
Mural Oncology Investigational SiteDetroit, Michigan
Mural Oncology Investigational SiteSaint Paul, Minnesota
Mural Oncology Investigational SiteMorristown, New Jersey
Mural Oncology Investigational SiteBuffalo, New York
Mural Oncology Investigational SiteHuntersville, North Carolina
Mural Oncology Investigational SiteCincinnati, Ohio

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 5, 2024. Always confirm current availability with the study team.

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