Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04144517
Recruitment Status : Recruiting
First Posted : October 30, 2019
Last Update Posted : August 25, 2020
Sponsor:
Collaborator:
Immune Oncology Network
Information provided by (Responsible Party):
Alkermes, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Non-cutaneous Squamous Cell Carcinoma of Head and Neck Drug: ALKS 4230 Drug: Pembrolizumab Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 31 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : February 5, 2020
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ALKS 4230 + pembrolizumab Drug: ALKS 4230
Intravenous (IV) infusion over 30 minutes given daily for 5 consecutive days followed by an off-treatment period

Drug: Pembrolizumab
IV infusion over 30 minutes administered on Day 1 of each cycle
Other Name: Keytruda




Primary Outcome Measures :
  1. 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 ]
    Response will be based on investigator review of radiographic and/or photographic images and RECIST criteria v1.1

  2. Proportion of patients with objective evidence of improvement to complete response among those patients who had stable disease or partial response 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 ]
    Response will be based on investigator review of radiographic and/or photographic images and RECIST criteria v1.1

  3. Proportion of patients with objective evidence of improvement to partial response among those patients who had disease progression 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 ]
    Response will be based on investigator review of radiographic and/or photographic images and RECIST criteria v1.1

  4. Proportion of patients with objective evidence of improvement to complete response among those patients who had disease progression 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 ]
    Response will be based on investigator review of radiographic and/or photographic images and RECIST criteria v1.1


Secondary Outcome Measures :
  1. 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) ]
  2. 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) ]
  3. 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) ]
  4. Rate of non-progression (ie, disease control rate) at 6 months [ Time Frame: Assessed PFS at 6 months ]
  5. Overall survival [ Time Frame: Time from first dose of study drug to the time of death (estimated up to 24 months) ]
  6. Incidence of drug-related AEs [ Time Frame: Time from first dose of study drug to the end of study (up to 36 months) ]
  7. Incidence of drug-related SAEs [ Time Frame: Time from first dose of study drug to the end of study (up to 36 months) ]
  8. 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) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT04144517


Contacts
Layout table for location contacts
Contact: James Corkery 781-530-6439 james.corkery@alkermes.com

Locations
Layout table for location information
United States, Florida
Alkermes Investigational Site Recruiting
Miami, Florida, United States, 33136
United States, Georgia
Alkermes Investigational Site Recruiting
Atlanta, Georgia, United States, 30308
United States, Minnesota
Alkermes Investigational Site Recruiting
Minneapolis, Minnesota, United States, 55455
United States, New York
Alkermes Investigational Site Recruiting
New York, New York, United States, 10029
United States, Ohio
Alkermes Investigational Site Recruiting
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Alkermes, Inc.
Immune Oncology Network
Investigators
Layout table for investigator information
Study Director: Timothy Leach, MD Alkermes, Inc.
Layout table for additonal information
Responsible Party: Alkermes, Inc.
ClinicalTrials.gov Identifier: NCT04144517    
Other Study ID Numbers: ION-01-ALKS 4230
First Posted: October 30, 2019    Key Record Dates
Last Update Posted: August 25, 2020
Last Verified: August 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alkermes, Inc.:
Alkermes
IL-2
Interleukin-2
Oncology
Immuno-oncology
Cytokine Immunotherapy
ALKS 4230
Pembrolizumab
Keytruda
PD-L1
Solid Tumors
Additional relevant MeSH terms:
Layout table for MeSH terms
Squamous Cell Carcinoma of Head and Neck
Carcinoma, Squamous Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents