Clinical Trials /

A Study of ALKS 4230 With Pembrolizumab in Head and Neck Cancer

NCT04144517

Description:

The primary objective of this study is to estimate the response rate to ALKS 4230 in combination with pembrolizumab in patients with HNSCC who have previously received anti-PD-(L)1 therapy but who have not achieved a CR.

Related Conditions:
  • Cutaneous Squamous Cell Carcinoma of the Head and Neck
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study of ALKS 4230 With Pembrolizumab in Head and Neck Cancer
  • Official Title: A Phase 2 Study of ALKS 4230 in Combination With Anti-PD-1 (Pembrolizumab) in Patients With Advanced or Recurrent Head and Neck Squamous Cell Cancer Currently on Treatment With Anti-PD-(L)1 Without Having Achieved a Complete Remission

Clinical Trial IDs

  • ORG STUDY ID: ION-01-ALKS 4230
  • NCT ID: NCT04144517

Conditions

  • Non-cutaneous Squamous Cell Carcinoma of Head and Neck

Interventions

DrugSynonymsArms
ALKS 4230ALKS 4230 + pembrolizumab
PembrolizumabKeytrudaALKS 4230 + pembrolizumab

Purpose

The primary objective of this study is to estimate the response rate to ALKS 4230 in combination with pembrolizumab in patients with HNSCC who have previously received anti-PD-(L)1 therapy but who have not achieved a CR.

Trial Arms

NameTypeDescriptionInterventions
ALKS 4230 + pembrolizumabExperimental
  • ALKS 4230
  • Pembrolizumab

Eligibility Criteria

        Inclusion Criteria:

          -  Patients must have histologically or cytopathologically confirmed diagnosis of
             non-cutaneous squamous cell carcinoma of the head and neck region that is locally
             advanced and/or recurrent and no longer amenable to local surgical or radiation
             therapy and/or with evidence of distant metastatic disease

          -  Patients must have had anti-PD-(L)1 therapy as the most recent systemic therapy with
             either stable disease or partial response on prior anti-PD-(L)1 therapy, or
             progressive disease on prior anti-PD-(L)1 therapy

          -  Patients must have disease that is measurable by RECIST v1.1

          -  Patients must be willing to provide tumor tissue biopsy

          -  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 apply

        Exclusion Criteria:

          -  Patient is pregnant or breastfeeding or expecting to conceive or father children

          -  Patient has an active major infection requiring systemic therapy within 1 week of
             starting study drug

          -  Patient has known active central nervous system (CNS) metastases and/or carcinomatous
             meningitis. Patients with previously treated brain metastases may participate,
             provided that they are stable, have no evidence of new or enlarging brain metastases,
             and are not using steroids for at least 7 days prior to study drug

          -  Patient has hypersensitivity to pembrolizumab, ALKS 4230, or any of their excipients

          -  Patient has a diagnosis of immunodeficiency or is receiving systemic steroid therapy
             (inhaled or topical steroids and steroid replacement at physiologic doses are
             allowable)

          -  Patient has prior Grade ≥3 immune-related toxicities requiring systemic
             immunosuppressant treatment that were attributable or possibly attributable to PD-1
             immune checkpoint blockade

          -  Patient has active tuberculosis or known active infection with hepatitis B or
             hepatitis C

          -  Patient has known psychiatric or substance abuse disorders or a social situation that
             would interfere with cooperation with the requirements of the study

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

Primary Outcome Measures

Measure:Proportion of patients with objective evidence of improvement to partial response among those patients who had stable disease at baseline on prior anti-PD-(L)1 therapy
Time Frame:From time of initiation of therapy until the date of first documented tumor progression, assessed up to 12 months
Safety Issue:
Description:Response will be based on investigator review of radiographic and/or photographic images and RECIST criteria v1.1

Secondary Outcome Measures

Measure:Duration of response in subjects with CR or PR
Time Frame:Time from the first documentation of complete response or 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)
Safety Issue:
Description:
Measure:Progression-free survival (PFS)
Time Frame:Time from first dose of study drug to the time of first documentation of objective tumor progression or death due to any cause (estimated up to 24 months)
Safety Issue:
Description:
Measure:Time to progression
Time Frame:Time from first dose of study drug to the time of first documentation of objective tumor progression or death due to disease progression (estimated up to 24 months)
Safety Issue:
Description:
Measure:Rate of non-progression (ie, disease control rate) at 6 months
Time Frame:Assessed PFS at 6 months
Safety Issue:
Description:
Measure:Overall survival
Time Frame:Time from first dose of study drug to the time of death (estimated up to 24 months)
Safety Issue:
Description:
Measure:Incidence of drug-related AEs
Time Frame:Time from first dose of study drug to the end of study (up to 36 months)
Safety Issue:
Description:
Measure:Incidence of drug-related SAEs
Time Frame:Time from first dose of study drug to the end of study (up to 36 months)
Safety Issue:
Description:
Measure:Incidence of drug-related AEs leading to discontinuation
Time Frame:Time from first dose of study drug to the end of study (up to 36 months)
Safety Issue:
Description:

Details

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

Trial Keywords

  • Alkermes
  • IL-2
  • Interleukin-2
  • Oncology
  • Immuno-oncology
  • Cytokine Immunotherapy
  • ALKS 4230
  • Pembrolizumab
  • Keytruda
  • PD-L1
  • Solid Tumors

Last Updated

August 24, 2020