August 24, 2020
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October 19, 2020
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October 19, 2020
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September 30, 2020
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March 2022 (Final data collection date for primary outcome measure)
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- 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 ]
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Same as current
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No Changes Posted
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- 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
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Same as current
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Not Provided
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Not Provided
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A Study of ALKS 4230 on the Tumor Microenvironment
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Clinical and Immunologic Activity of ALKS 4230 on Tumor Microenvironment in Solid Tumor Patients - ARTISTRY-3
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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.
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Not Provided
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Interventional
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Phase 2
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Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment
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Advanced Solid Tumor
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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
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Not Provided
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Recruiting
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36
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Same as current
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March 2022
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March 2022 (Final data collection date for primary outcome measure)
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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
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Sexes Eligible for Study: |
All |
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18 Years and older (Adult, Older Adult)
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No
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United States
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|
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NCT04592653
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ALKS 4230-003
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No
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Studies a U.S. FDA-regulated Drug Product: |
Yes |
Studies a U.S. FDA-regulated Device Product: |
No |
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Plan to Share IPD: |
Undecided |
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Alkermes, Inc.
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Alkermes, Inc.
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Not Provided
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Study Director: |
Bruce Dezube, MD |
Alkermes, Inc. |
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Alkermes, Inc.
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October 2020
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