Trial | NCT04144517  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    14
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 Started
Feb 05
2020
Primary Completion
Oct 08
2021
Study Completion
Feb 23
2022
Last Update
Nov 21
2022

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

ALKS 4230 + pembrolizumab Experimental

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
No Results Posted