Overview

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

Status:
Active, not recruiting
Trial end date:
2022-10-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Alkermes, Inc.
Collaborator:
Immune Oncology Network
Treatments:
Pembrolizumab
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