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Trial record 1 of 1 for:    NCT02799095
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A Study of the Effects of ALKS 4230 (Nemvaleukin Alfa) on Subjects With Solid Tumors

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ClinicalTrials.gov Identifier: NCT02799095
Recruitment Status : Active, not recruiting
First Posted : June 14, 2016
Last Update Posted : September 28, 2021
Sponsor:
Information provided by (Responsible Party):
Alkermes, Inc.

Tracking Information
First Submitted Date  ICMJE June 1, 2016
First Posted Date  ICMJE June 14, 2016
Last Update Posted Date September 28, 2021
Study Start Date  ICMJE July 2016
Estimated Primary Completion Date March 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 7, 2020)
  • 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
  • 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
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: June 9, 2016)
  • Characterization of adverse events (AEs) and dose-limiting toxicities (DLT) in study Part A [ Time Frame: From date of randomization until the date of first documented tumor progression, assessed up to 24 months ]
    Incidence of AEs that are both serious and drug-related
  • Incidence of drug-related AEs in study Part B [ Time Frame: From date of randomization until the date of first documented tumor progression, assessed up to 24 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 7, 2020)
  • 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)
  • 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
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: June 9, 2016)
  • Overall response rate (ORR) based on investigator review of radiographic or photographic images [ Time Frame: From date of randomization until the date of first documented tumor progression, assessed up to 24 months ]
    Proportion of subjects with objective evidence of Complete Response (CR/irCR) or Partial Response (PR/irPR)
  • Disease Control Rate [ Time Frame: From date of randomization 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)
  • Duration of response in subjects with CR or PR [ Time Frame: From date of randomization until the date of first documented tumor progression, assessed up to 24 months ]
    Time from the first documentation of response (CR or PR) to the first documentation of objective tumor progression or death due to any cause
  • Serum concentrations of ALKS 4230 will be determined at various time points [ Time Frame: From date of randomization until the date of first documented tumor progression, assessed up to 24 months ]
    Concentration vs time and standard pharmacokinetic (PK) parameters will be summarized by dose level
  • Serum will be assayed for the presence of anti-ALKS 4230 antibodies [ Time Frame: From date of randomization until the date of first documented tumor progression, assessed up to 24 months ]
    Results will be summarized by dose level
  • Immunophenotyping of peripheral blood mononuclear cells will be performed by flow cytometry at various time points [ Time Frame: From date of randomization until the date of first documented tumor progression, assessed up to 24 months ]
    Results will be summarized by dose level
  • Serum concentrations of proinflammatory cytokines will be assessed using a multiplex method at various time points [ Time Frame: From date of randomization until the date of first documented tumor progression, assessed up to 24 months ]
    Results will be summarized by dose level
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of the Effects of ALKS 4230 (Nemvaleukin Alfa) on Subjects With Solid Tumors
Official Title  ICMJE 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
Brief Summary To better understand the safety and tolerability of ALKS 4230 in humans
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Solid Tumors
Intervention  ICMJE
  • Drug: ALKS 4230
    Intravenous (IV) infusion over 30 minutes given daily for 5 consecutive days followed by an off-treatment period
  • 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
Study Arms  ICMJE
  • Experimental: ALKS 4230
    Intervention: Drug: ALKS 4230
  • Experimental: ALKS 4230 + pembrolizumab
    Intervention: Drug: ALKS 4230 + 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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: September 27, 2021)
243
Original Estimated Enrollment  ICMJE
 (submitted: June 9, 2016)
120
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:

  • 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
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 information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Canada,   Korea, Republic of,   Poland,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02799095
Other Study ID Numbers  ICMJE ALK4230-A101
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: At this time, IPD sharing has not been defined and/or decided if it will be shared.
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 September 2021

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