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

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

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