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A Study of the Effects of ALKS 4230 (Nemvaleukin Alfa) on Subjects With Solid Tumors

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02799095
Recruitment Status : Active, not recruiting
First Posted : June 14, 2016
Last Update Posted : November 25, 2022
Sponsor:
Information provided by (Responsible Party):
Alkermes, Inc.

Study Description
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Brief Summary:
To better understand the safety and tolerability of ALKS 4230 in humans

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Drug: ALKS 4230 Drug: ALKS 4230 + pembrolizumab Phase 1 Phase 2

Detailed Description:
To investigate the safety and tolerability of ALKS 4230, determine the recommended Phase 2 dose (RP2D) and assess anti-tumor activity in Monotherapy and ALKS 4230 in Combination with pembrolizumab.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 243 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Study of ALKS 4230 Administered Intravenously as Monotherapy and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors - ARTISTRY-1
Study Start Date : July 2016
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: ALKS 4230 Drug: ALKS 4230
Intravenous (IV) infusion over 30 minutes given daily for 5 consecutive days followed by an off-treatment period
Experimental: ALKS 4230 + pembrolizumab Drug: ALKS 4230 + pembrolizumab
IV infusion of ALKS 4230 over 30 minutes given daily for 5 consecutive days followed by an off-treatment period; pembrolizumab administered IV once with ALKS 4230 on the first day of each cycle


Outcome Measures
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Primary Outcome Measures :
  1. Characterization of adverse events (AEs) and dose-limiting toxicities (DLT) in study Part A [ Time Frame: From time of initiation of therapy until 30 days after last dose of study drug, assessed up to 24 months ]
    Incidence of AEs that are both serious and drug-related

  2. Incidence of drug-related AEs in study Part B [ Time Frame: From time of initiation of therapy until 30 days after last dose of study drug, assessed up to 24 months ]
    Incidence of AEs that are drug-related

  3. Overall response rate (ORR) of ALKS 4230 monotherapy in patients with melanoma or renal cell carcinoma (Part B) and in combination with pembrolizumab in patients with advanced solid tumors (Part C) [ Time Frame: From time of initiation of therapy until 30 days after last dose of study drug assessed up to 24 months ]
    Proportion of patients with the confirmed overall response of complete response or partial response


Secondary Outcome Measures :
  1. Disease Control Rate [ Time Frame: 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 CR, PR, or Stable Disease (SD)

  2. Duration of response in subjects with CR/iCR or PR/iPR [ Time Frame: From time of initiation of therapy until the date of first documented tumor progression, assessed up to 24 months ]
    Time from the first documentation of response (CR/iCR or PR/iPR) to the first documentation of objective tumor progression or death due to any cause

  3. 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, assessed up to 24 months ]
    Concentration vs time and standard pharmacokinetic (PK) parameters will be summarized by dose level

  4. 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, assessed up to 24 months ]
    Results will be summarized by dose level

  5. 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, assessed up to 24 months ]
    Results will be summarized by dose level

  6. Serum concentrations of proinflammatory cytokines will be assessed using a multiplex method at various time points [ Time Frame: From time of initiation of therapy during the first two treatment cycles, assessed up to 2 months ]
    Results will be summarized by dose level


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • For Part A, the subject has histological or cytological evidence of a solid tumor; for Part B, the subject has a diagnosis of melanoma or renal cell carcinoma
  • All subjects must have advanced solid tumors that have returned after treatment with established approved therapies or be intolerant of established therapies
  • Subjects enrolled in Part B or Part C must have at least 1 lesion that may qualify as a target lesion
  • Subject can move around on their own, has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and has an estimated life expectancy of at least 3 months
  • Subject must have adequate hematologic reserve
  • 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 investigational agents must wait at least 4 weeks
  • 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. A female not of childbearing potential is one who has undergone bilateral oophorectomies or who is postmenopausal, defined as >45 years of age and without a menstrual period for 12 consecutive months
  • Meets contraceptive requirements defined in the protocol
  • Additional criteria may apply

Exclusion Criteria:

  • Subject is currently pregnant or breastfeeding, or is planning to become pregnant during the study
  • Subjects with an active infection or with a fever >/= 38.5 degrees 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 have a mean QT interval corrected by the Fridericia Correction formula value of >470 msec (in females) or >450 msec (in males)
  • Subjects with known hypersensitivity to any components of ALKS 4230
  • Subjects with known hypersensitivity to any components of pembrolizumab (for patients in combination arm only)
  • Subjects who require pharmacologic doses of corticosteroids; replacement doses, topical, ophthalmologic, and inhalational steroids are permitted
  • Subjects who developed autoimmune disorders while on prior immunotherapy, including pneumonitis, nephritis, and neuropathy
  • Subjects 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
  • 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
  • Subjects with dyspnea at rest of requiring oxygen therapy
  • Subjects active autoimmune disease requiring systemic treatment within the past 30 days
  • Subjects who received radiotherapy within the last 4 weeks before start of study treatment administration with the exception of limited field palliative radiotherapy
  • Subjects who have received systemic immunomodulatory agents within 28 days prior to C1D1.
  • Subjects who have received administration of a live, attenuated vaccine within 4 weeks of Cycle 1, Day1.
  • Prior solid organ and/or non-autologous hematopoietic stem cell or bone marrow transplant recipients
  • Subjects who have received prior IL-2 based or IL-15 based cytokine therapy
  • Additional criteria may apply
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02799095


Locations
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United States, Colorado
Alkermes Investigational Site
Denver, Colorado, United States, 80045
United States, Florida
Alkermes Investigational Site
Port Saint Lucie, Florida, United States, 34952
Alkermes Investigational Site
Tampa, Florida, United States, 33610
United States, Kentucky
Alkermes Investigational Site
Lexington, Kentucky, United States, 40536
United States, Massachusetts
Alkermes Investigational Site
Boston, Massachusetts, United States, 02215
United States, Michigan
Alkermes Investigational Site
Detroit, Michigan, United States, 47201
United States, New York
Alkermes Investigational Site
Buffalo, New York, United States, 14203
Alkermes Investigational Site
New York, New York, United States, 10016
United States, Ohio
Alkermes Investigational Site
Cleveland, Ohio, United States, 44106
United States, Texas
Alkermes Investigational Site
Dallas, Texas, United States, 75230
United States, Virginia
Alkermes Investigational Site
Fairfax, Virginia, United States, 22031
United States, Washington
Alkermes Investigational Site
Spokane, Washington, United States, 99208
Australia, New South Wales
Alkermes Investgational Site
Albury, New South Wales, Australia, 2640
Alkermes Investigational Site
Waratah, New South Wales, Australia, 2298
Belgium
Alkermes Investigational Site
Brussels, MO, Belgium, 1200
Alkermes Investigational Site
Kortrijk, West-Vlaanderen, Belgium, 8500
Canada, Alberta
Alkermes Investigational Site
Edmonton, Alberta, Canada
Canada, Ontario
Alkermes Investigational Site
Hamilton, Ontario, Canada
Alkermes Investigational Site
Toronto, Ontario, Canada
Canada, Quebec
Alkermes Investigational Site
Montréal, Quebec, Canada
Alkermes Investigational Site
Québec, Quebec, Canada, G1R 2J6
Korea, Republic of
Alkermes Investigational Site
Daejeon, Korea, Republic of, 35015
Alkermes Investigational Site
Seoul, Korea, Republic of, 02841
Alkermes Investigational Site
Seoul, Korea, Republic of, 03722
Poland
Alkermes Investigational Site
Skorzewo, Poznan, Poland, 60-185
Spain
Alkermes Investigational Site
Barcelona, Spain, 8036
Alkermes Investigational Site
Madrid, Spain, 28033
Alkermes Investigational Site
Madrid, Spain, 28040
Alkermes Investigational Site
Madrid, Spain, 28041
Alkermes Investigational Site
Madrid, Spain, 28050
Alkermes Investigational Site
Valencia, Spain, 46010
Sponsors and Collaborators
Alkermes, Inc.
Investigators
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Study Director: Medical Director Alkermes, Inc.
More Information
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Responsible Party: Alkermes, Inc.
ClinicalTrials.gov Identifier: NCT02799095    
Other Study ID Numbers: ALK4230-A101
First Posted: June 14, 2016    Key Record Dates
Last Update Posted: November 25, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: At this time, IPD sharing has not been defined and/or decided if it will be shared.
Keywords provided by Alkermes, Inc.:
Immunotherapy
IL-2
Interleukin-2
Solid tumors
Melanoma
 Renal cell carcinoma
Non-small-cell lung cancer
Squamous cell carcinoma of the head and neck
in combination with pembrolizumab
Additional relevant MeSH terms:
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Neoplasms
Pembrolizumab
Antineoplastic Agents, Immunological
 Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action