A Study of ALKS 4230 (Nemvaleukin Alfa) With Pembrolizumab in Head and Neck Cancer

January 23, 2024 updated by: Mural Oncology, Inc

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • Mural Oncology Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Mural Oncology Investigational Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Mural Oncology Investigational Site
    • New York
      • New York, New York, United States, 10029
        • Mural Oncology Investigational Site
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Mural Oncology Investigational Site
    • Texas
      • Austin, Texas, United States, 78712
        • Mural Oncology Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Keytruda

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From time of initiation of therapy until the date of first documented tumor progression, assessed up to 12 months
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
From time of initiation of therapy until the date of first documented tumor progression, assessed up to 12 months
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
From time of initiation of therapy until the date of first documented tumor progression, assessed up to 12 months
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
From time of initiation of therapy until the date of first documented tumor progression, assessed up to 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
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)
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)
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)
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)
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)
Rate of non-progression (ie, disease control rate) at 6 months
Time Frame: Assessed PFS at 6 months
Assessed PFS at 6 months
Overall survival
Time Frame: Time from first dose of study drug to the time of death (estimated up to 24 months)
Time from first dose of study drug to the time of death (estimated up to 24 months)
Incidence of drug-related AEs
Time Frame: Time from first dose of study drug to the end of study (up to 36 months)
Time from first dose of study drug to the end of study (up to 36 months)
Incidence of drug-related SAEs
Time Frame: Time from first dose of study drug to the end of study (up to 36 months)
Time from first dose of study drug to the end of study (up to 36 months)
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)
Time from first dose of study drug to the end of study (up to 36 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mural Oncology, Inc

Collaborators

Immune Oncology Network

Investigators

  • Study Director: Medical Director, Mural Oncology, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 5, 2020

Primary Completion (Actual)

October 8, 2021

Study Completion (Actual)

February 23, 2022

Study Registration Dates

First Submitted

October 24, 2019

First Submitted That Met QC Criteria

October 28, 2019

First Posted (Actual)

October 30, 2019

Study Record Updates

Last Update Posted (Estimated)

January 25, 2024

Last Update Submitted That Met QC Criteria

January 23, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ION-01-ALKS 4230

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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