Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    artistry 3
Previous Study | Return to List | Next Study

A Study of ALKS 4230 (Nemvaleukin Alfa) on the Tumor Microenvironment (ARTISTRY-3)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04592653
Recruitment Status : Recruiting
First Posted : October 19, 2020
Last Update Posted : April 27, 2021
Sponsor:
Information provided by (Responsible Party):
Alkermes, Inc.

Tracking Information
First Submitted Date  ICMJE August 24, 2020
First Posted Date  ICMJE October 19, 2020
Last Update Posted Date April 27, 2021
Actual Study Start Date  ICMJE September 30, 2020
Estimated Primary Completion Date March 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 12, 2020)
  • Changes in density (cell counts per mm2) of immune cell (including total T cells, CD8+ T cells, CD56+ cells and Treg cells) [ Time Frame: From the time of the Patient's pre-treatment biopsy to the time of the Patient's on-treatment biopsy ]
    Changes in density (cell counts per mm2) of immune cell (including total T cells, CD8+ T cells, CD56+ cells and Treg cells) based on immunohistochemistry (IHC) and/or immunofluorescence (IF) in the TME between pretreatment and on-treatment (Cycle 2 Day 8) paired tumor biopsies
  • Changes in ratios (including T/Treg, CD8+/Treg, CD56+/Treg) based on immunohistochemistry (IHC) and/or immunofluorescence (IF) in the TME between pretreatment and on-treatment (Cycle 2 Day 8) paired tumor biopsies [ Time Frame: From the time of the Patient's pre-treatment biopsy to the time of the Patient's on-treatment biopsy ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 12, 2020)
  • 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 ]
  • Duration of response in subjects with Complete Response (CR)/immune 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) ]
  • 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 ]
  • Duration of response in subjects with Partial Response (PR)/immune PR (iPR) [ Time Frame: Time from the first documentation of partial 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) ]
  • Incidence of drug-related Adverse Events [ Time Frame: Time from first dose of study drug to the end of study (estimated up to 24 months) ]
  • Incidence of drug-related Serious Adverse Events [ Time Frame: Time from first dose of study drug to the end of study (estimated up to 24 months) ]
  • Incidence of drug-related Adverse Events leading to discontinuation [ Time Frame: Time from first dose of study drug to the end of study (estimated up to 24 months) ]
  • Serum concentrations of ALKS 4230 [ Time Frame: From time of initiation of therapy until the last treatment cycle (each cycle is 14 or 21 days), assessed up to 24 months ]
    Concentration data will be summarized by dose level
  • 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 14 or 21 days), assessed up to 24 months ]
    Results will be summarized by dose level
  • Changes in absolute cell numbers (including total T cells, CD8+ T cells, NK cells and Treg cells) [ Time Frame: From time of initiation of therapy until the last treatment cycle (each cycle is 14 or 21 days), assessed up to 24 months ]
    Changes in absolute cell numbers (including total T cells, CD8+ T cells, NK cells and Treg cells) between pretreatment and on-treatment serial peripheral blood samples obtained from patients being treated with ALKS 4230 monotherapy and with the combination of ALKS 4230 plus pembrolizumab
  • Changes in ratios (including T/Treg, CD8+/Treg, NK/Treg) between pretreatment and on treatment [ Time Frame: From time of initiation of therapy until the last treatment cycle (each cycle is 14 or 21 days), assessed up to 24 months ]
    Changes in ratios (including T/Treg, CD8+/Treg, NK/Treg) between pretreatment and on-treatment serial peripheral blood samples obtained from patients being treated with ALKS 4230 monotherapy and with the combination of ALKS 4230 plus pembrolizumab
  • Serum concentrations of proinflammatory cytokines, including IFNγ, TNF-α, IL-1B, IL-6, IL-10, will be assessed using a multiplex method from initiation of therapy [ Time Frame: From time of initiation of therapy until the last treatment cycle (each cycle is 14 or 21 days), assessed up to 24 months ]
  • Changes in absolute numbers of circulating leukocytes [ Time Frame: From time of initiation of therapy until the last treatment cycle (each cycle is 14 or 21 days), assessed up to 24 months ]
    Changes in absolute numbers of circulating leukocytes between pretreatment and on-treatment serial peripheral blood samples obtained from patients being treated with ALKS 4230 monotherapy and with the combination of ALKS 4230 plus pembrolizumab
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of ALKS 4230 (Nemvaleukin Alfa) on the Tumor Microenvironment
Official Title  ICMJE Clinical and Immunologic Activity of ALKS 4230 on Tumor Microenvironment in Solid Tumor Patients - ARTISTRY-3
Brief Summary The primary objective of this study is to evaluate the effects of ALKS 4230 monotherapy on the tumor microenvironment of a variety of advanced, malignant solid tumors.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Solid Tumor
Intervention  ICMJE
  • Drug: ALKS 4230
    IV infusion over 30 minutes
  • Drug: Pembrolizumab
    IV infusion over 30 minutes
    Other Name: Keytruda
Study Arms  ICMJE Experimental: ALKS 4230 + pembrolizumab
ALKS 4230 will be administered via Intravenous (IV) infusion given daily for 5 consecutive days followed by an off-treatment period. Starting on Cycle 3, Day 1 of each cycle, Pembrolizumab will be administered via IV infusion followed by IV infusion of ALKS 4230.
Interventions:
  • Drug: ALKS 4230
  • Drug: Pembrolizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 12, 2020)
36
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2022
Estimated Primary Completion Date March 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients must have histologically or cytologically confirmed diagnosis of an advanced solid malignancy (cutaneous melanoma, RCC, TNBC, Microsatellite-stable (MSS) colorectal cancer, Microsatellite-high (MSI-H) solid tumors [not otherwise specified], or ovarian cancer) after treatment failure or intolerance to at least one established, indication-specific therapy.
  • Patients must be willing to provide tumor tissue biopsy and have accessible lesions for biopsy.
  • All patients must provide a baseline biopsy from no more than 3 months prior to screening, and at least 4 weeks after completion of last anti-cancer therapy.
  • Patients must have disease that is measurable by RECIST 1.1.
  • Patients must demonstrate adequate organ function
  • Female patients of childbearing potential should have a negative pregnancy test within 72 hours prior to receiving the first dose of study medication
  • Patients must agree to follow contraceptive requirements defined in the protocol
  • Additional criteria may apply

Exclusion Criteria:

  • Patient is pregnant or breastfeeding or is planning to become pregnant during the study period.
  • Patients with an active infection or with a fever ≥38.5°C within 3 days of the first scheduled day of dosing
  • Patients with primary CNS malignancy
  • Patients with active or symptomatic central nervous system metastases unless the metastases have been treated by surgery and/or radiation therapy and/or gamma knife, the subject has been tapered to a dose of 10 mg of prednisone (or equivalent) or less of corticosteroids for at least 2 weeks before the first dose, and the subject is neurologically stable. Patients with leptomeningeal disease are excluded.
  • Patients with hypersensitivity to pembrolizumab, ALKS 4230, or any of their excipients
  • Patients who have received systemic immunomodulatory agents within 6 weeks prior to the first scheduled day of dosing
  • Patients who have received prior IL-2-based or IL-15-based cytokine therapy at any time in the past
  • Patients who require pharmacologic doses of systemic corticosteroids (greater than 10 mg of prednisone daily or equivalent); however, topical, ophthalmologic, and inhalational steroids are permitted
  • Patients with an uncontrollable bleeding disorder
  • Patients known to be positive for human immunodeficiency virus and/or history of hepatitis B, or C infections or is known to be positive for hepatitis B antigen (HBsAg)/hepatitis B virus (HBV) DNA or hepatitis C antibody (Hep C Ab) or RNA.
  • Patients 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.
  • Additional criteria may apply
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Senior Director, Global Clinical Services 888-235-8008 (US Only) clinicaltrials@alkermes.com
Contact: Senior Director, Global Clinical Services 1-571-599-2702 (Global) clinicaltrials@alkermes.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04592653
Other Study ID Numbers  ICMJE ALKS 4230-003
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Alkermes, Inc.
Study Sponsor  ICMJE Alkermes, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Alkermes, Inc.
PRS Account Alkermes, Inc.
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP