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)

March 1, 2024 updated by: Mural Oncology, Inc

A Phase 1/2 Study of ALKS 4230 Administered Subcutaneously as Monotherapy and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors - ARTISTRY-2 (001)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study will evaluate ALKS 4230 administered SC as lead-in monotherapy and in combination with pembrolizumab in subjects with advanced solid tumors.

Study Type

Interventional

Enrollment (Actual)

116

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Mural Oncology Investigational Site
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
        • Mural Oncology Investigational Site
    • Quebec
      • Montréal, Quebec, Canada, H2X 0C1
        • Mural Oncology Investigational Sites
      • Montréal, Quebec, Canada, H3A 3J1
        • Mural Oncology Investigational Site
      • Montréal, Quebec, Canada, H3T 1E2
        • Mural Oncology Investigational Site
      • Québec, Quebec, Canada, G1R 2J6
        • Mural Oncology Investigational Site
  • Korea, Republic of
      • Goyang, Korea, Republic of, 10408
        • National Cancer Center
      • Incheon, Korea, Republic of, 22332
        • Inha University Hospital
      • Seongnam, Korea, Republic of, 13620
        • Seoul National University Bundang Hospital
      • Seoul, Korea, Republic of, 03080
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 6351
        • Samsung Medical Center
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center
      • Seoul, Korea, Republic of, 03722
        • Yonsei University Health System - Severance Hospital
      • Suwon, Korea, Republic of, 16247
        • The Catholic University Of Korea St. Vincent's Hospital
  • Netherlands
      • Rotterdam, Netherlands, 3000 CA
        • Mural Oncology Investigational Site
      • Utrecht, Netherlands, 3508 GA
        • Mural Oncology Investigational Site
  • Spain
      • Badalona, Spain, 08916
        • Mural Oncology Investigational Site
      • Córdoba, Spain, 14004
        • Mural Oncology Investigational Site
      • Madrid, Spain, 28007
        • Mural Oncology Investigational Site
      • Madrid, Spain, 28040
        • Mural Oncology Investigational Site
      • Madrid, Spain, 28041
        • Mural Oncology Investigational Site
      • Madrid, Spain, 28050
        • Mural Oncology Investigational Site
      • Madrid, Spain, 28222
        • Mural Oncology Investigational Site
      • Málaga, Spain, 29010
        • Mural Oncology Investigational Site
      • Valencia, Spain, 46010
        • Mural Oncology Investigational Site
  • Taiwan
      • Kaohsiung, Taiwan, 83301
        • Mural Oncology Investigational Site
      • Taichung, Taiwan, 40447
        • Mural Oncology Investigational Site
      • Tainan, Taiwan, 704
        • Mural Oncology Investigational Site
      • Taipei, Taiwan, 100
        • Mural Oncology Investigational Site
      • Taipei, Taiwan, 11217
        • Mural Oncology Investigational Site
      • Taipei, Taiwan, 11259
        • Mural Oncology Investigational Site
  • United States
    • California
      • Los Angeles, California, United States, 90025
        • Mural Oncology Investigational Site
      • Los Angeles, California, United States, 90211
        • Mural Oncology Investigational Site
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Mural Oncology Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Mural Oncology Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Mural Oncology Investigational Site
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • Mural Oncology Investigational Site
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Mural Oncology Investigational Site
    • Minnesota
      • Saint Paul, Minnesota, United States, 55101
        • Mural Oncology Investigational Site
    • New Jersey
      • Morristown, New Jersey, United States, 07962
        • Mural Oncology Investigational Site
    • New York
      • Buffalo, New York, United States, 14263
        • Mural Oncology Investigational Site
    • North Carolina
      • Huntersville, North Carolina, United States, 28078
        • Mural Oncology Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Mural Oncology Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Mural Oncology Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Mural Oncology Investigational Site
    • Texas
      • Houston, Texas, United States, 77030
        • Mural Oncology Investigational Site
    • Utah
      • Salt Lake City, Utah, United States, 84119
        • Mural Oncology Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Mural Oncology Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion 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

Exclusion 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ALKS 4230
Administered via SC injection once every 7 days or once every 21 days at escalating doses
Biological: ALKS 4230
SC injection administered in the back of the arm or the abdomen
Experimental: 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.
Biological: ALKS 4230
SC injection administered in the back of the arm or the abdomen
Biological: Pembrolizumab
Administered as an intravenous (IV) infusion over 30 minutes
Other Names:
  • Keytruda

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Adverse Events (AEs), and identify the RP2D of ALKS 4230 in Part A
Time Frame: From time of initiation of therapy until 30 days after last dose of study drug, assessed up to 24 months
Includes AEs that are both serious and drug-related
From time of initiation of therapy until 30 days after last dose of study drug, assessed up to 24 months
Number of subjects experiencing AEs that are both serious and drug-related in Part B
Time Frame: From time of initiation of therapy until 30 days after last dose of study drug, assessed up to 24 months
Includes AEs that are both serious and drug-related
From time of initiation of therapy until 30 days after last dose of study drug, assessed up to 24 months
Clinical Activity of combination treatment with ALKS 4230 and pembrolizumab in each Part B tumor type.
Time Frame: From time of therapy until the date of first documented tumor progression, assessed up to 24 months
Overall Response rate (ORR) will be based on investigator review of radiographic and photographic images
From time of therapy until the date of first documented tumor progression, assessed up to 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of subjects with objective evidence of Complete Response (CR)/immune CR (iCR)
Time Frame: From time of initiation of therapy until the date of first documented tumor progression, assessed up to 24 months
Overall response rate (ORR) will be based on investigator review of radiographic or photographic images
From time of initiation of therapy until the date of first documented tumor progression, assessed up to 24 months
Proportion of subjects with objective evidence of Partial Response (PR)/immune PR (iPR)
Time Frame: From time of initiation of therapy until the date of first documented tumor progression, assessed up to 24 months
ORR will be based on investigator review of radiographic or photographic images
From time of initiation of therapy until the date of first documented tumor progression, assessed up to 24 months
Duration of response in subjects with CR/iCR
Time Frame: Time from the first documentation of complete response, measured approximately every 6 weeks, to the first documentation of objective tumor progression or death due to any cause (estimated up to 24 months)
CR/iCR duration
Time from the first documentation of complete response, measured approximately every 6 weeks, to the first documentation of objective tumor progression or death due to any cause (estimated up to 24 months)
Duration of response in subjects with PR/iPR
Time Frame: Time from the first documentation of complete response, measured approximately every 6 weeks, to the first documentation of objective tumor progression or death due to any cause (estimated up to 24 months)
PR/iPR duration
Time from the first documentation of complete response, measured approximately every 6 weeks, to the first documentation of objective tumor progression or death due to any cause (estimated up to 24 months)
Non-progression for Part B
Time Frame: Assessed up to 24 months
Time from first dose of SC ALKS 4230 to the time of progression or death
Assessed up to 24 months
Overall survival for Part B
Time Frame: Assessed up to 24 months
Time from first dose of SC ALKS 4230 to the time of death
Assessed up to 24 months
Serum concentrations of ALKS 4230 will be determined at various time points
Time Frame: From time of initiation of therapy until the last treatment cycle (each cycle is 21 days), assessed up to 24 months
Concentration vs time and standard pharmacokinetic (PK) parameters will be summarized by dose level
From time of initiation of therapy until the last treatment cycle (each cycle is 21 days), assessed up to 24 months
Serum will be assayed for the presence of anti-ALKS 4230 antibodies
Time Frame: From time of initiation of therapy until the last treatment cycle (each cycle is 21 days), assessed up to 24 months
Results will be summarized by dose level
From time of initiation of therapy until the last treatment cycle (each cycle is 21 days), assessed up to 24 months
Immunophenotyping of peripheral blood mononuclear cells will be performed by flow cytometry at various time points
Time Frame: From time of initiation of therapy until the last treatment cycle (each cycle is 21 days), assessed up to 24 months
Results will be summarized by dose level
From time of initiation of therapy until the last treatment cycle (each cycle is 21 days), assessed up to 24 months
Serum concentrations of proinflammatory cytokines will be assessed using a multiplex method at various time points
Time Frame: From time of initiation of therapy until the last treatment cycle (each cycle is 21 days), assessed up to 24 months
Results will be summarized by dose level
From time of initiation of therapy until the last treatment cycle (each cycle is 21 days), assessed up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mural Oncology, Inc

Investigators

  • Study Director: Mural Oncology Medical Director, Mural Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 26, 2019

Primary Completion (Actual)

March 1, 2023

Study Completion (Actual)

March 1, 2023

Study Registration Dates

First Submitted

February 25, 2019

First Submitted That Met QC Criteria

March 1, 2019

First Posted (Actual)

March 4, 2019

Study Record Updates

Last Update Posted (Actual)

March 5, 2024

Last Update Submitted That Met QC Criteria

March 1, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALKS 4230-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

At this time, IPD sharing has not been defined and/or decided if it will be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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