Clinical trial NCT04144517: A Study of ALKS 4230 (Nemvaleukin Alfa) With Pembrolizumab in Head and Neck Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Squamous Cell Carcinoma of Head and Neck
Keywords: Alkermes
IL-2
Interleukin-2
Oncology
Immuno-oncology
Cytokine Immunotherapy
ALKS 4230
Pembrolizumab
Keytruda
PD-L1
Solid Tumors
Lead sponsor: Mural Oncology, Inc
Sponsor class: INDUSTRY
Collaborators: name: Immune Oncology Network (ION)
First posted: 2019-10-30
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Overall Response Rate (ORR) Based on RECIST v1.1
timeFrame: From the first dose of study drug until first PD or death, whichever occurred first (up to 49 weeks)
Secondary outcomes:
measure: Duration of Response (DOR) Based on RECIST v1.1
timeFrame: From first documented CR or PR until first documentation of PD (up to 49 weeks)
measure: Progression-free Survival (PFS) Based on RECIST v1.1
timeFrame: From the first dose of study drug to date of PD, start of alternate therapy or death, whichever occurred first (up to 49 weeks)
measure: Time to Progression (TTP) Based on RECIST v1.1
timeFrame: From first dose of study drug to the date of the first documentation of PD (up to 49 weeks)
measure: Disease Control Rate (DCR) Based on RECIST v1.1
timeFrame: From first dose of study drug until PD or death, whichever occurred first (up to 49 weeks)
measure: Overall Survival (OS)
timeFrame: From date of first dose of study drug up to death from any cause (up to 89 weeks)
measure: Number of Participants With Drug-related Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
timeFrame: From the first dose of study drug through 90 days after the last dose of study drug (up to 62 weeks)
measure: Number of Participants With Drug-related TEAEs Leading to Discontinuation of Treatment
timeFrame: From first dose of study drug through 90 days after the last dose of study drug (up to 62 weeks)
Other outcomes:
Locations:
city: Miami
country: United States
facility: Mural Oncology Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Mural Oncology Investigational Site
state: Georgia
city: Minneapolis
country: United States
facility: Mural Oncology Investigational Site
state: Minnesota
city: New York
country: United States
facility: Mural Oncology Investigational Site
state: New York
city: New York
country: United States
facility: Mural Oncology Investigational Site
state: New York
city: Cleveland
country: United States
facility: Mural Oncology Investigational Site
state: Ohio
city: Austin
country: United States
facility: Mural Oncology Investigational Site
state: Texas
Study officials:
affiliation: Mural Oncology, Inc
name: Medical Director
role: STUDY_DIRECTOR
References: