Clinical Trials /

A Study of the Effects of ALKS 4230 on Subjects With Solid Tumors

NCT02799095

Description:

To better understand the safety and tolerability of ALKS 4230 in humans

Related Conditions:
  • Malignant Solid Tumor
  • Melanoma
  • Renal Cell Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study of the Effects of ALKS 4230 on Subjects With Solid Tumors
  • 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

Clinical Trial IDs

  • ORG STUDY ID: ALK4230-A101
  • NCT ID: NCT02799095

Conditions

  • Advanced Solid Tumors

Interventions

DrugSynonymsArms
ALKS 4230ALKS 4230
ALKS 4230 + pembrolizumabALKS 4230 + pembrolizumab

Purpose

To better understand the safety and tolerability of ALKS 4230 in humans

Trial Arms

NameTypeDescriptionInterventions
ALKS 4230Experimental
  • ALKS 4230
ALKS 4230 + pembrolizumabExperimental
  • ALKS 4230 + pembrolizumab

Eligibility 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

          -  Additional criteria may apply
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure: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
Safety Issue:
Description:Incidence of AEs that are both serious and drug-related

Secondary Outcome Measures

Measure:Disease Control Rate
Time Frame:From time of initiation of therapy until the date of first documented tumor progression, assessed up to 24 months
Safety Issue:
Description:Proportion of subjects with objective evidence of CR, PR, or Stable Disease (SD)
Measure:Duration of response in subjects with CR or PR
Time Frame:From time of initiation of therapy until the date of first documented tumor progression, assessed up to 24 months
Safety Issue:
Description:Time from the first documentation of response (CR or PR) to the first documentation of objective tumor progression or death due to any cause
Measure: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
Safety Issue:
Description:Concentration vs time and standard pharmacokinetic (PK) parameters will be summarized by dose level
Measure: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
Safety Issue:
Description:Results will be summarized by dose level
Measure: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
Safety Issue:
Description:Results will be summarized by dose level
Measure: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
Safety Issue:
Description:Results will be summarized by dose level

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Alkermes, Inc.

Trial Keywords

  • Immunotherapy
  • IL-2
  • Interleukin-2
  • Solid tumors
  • Melanoma
  • Renal cell carcinoma
  • Non-small-cell lung cancer
  • Squamous cell carcinoma of the head and neck

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