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

Mural Oncology, Inc14 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Nemvaleukin AlfaDRUG

Nemvaleukin alfa IV infusion.

PembrolizumabDRUG

Pembrolizumab IV infusion.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (7)

Mural Oncology Investigational Site

Miami, Florida, United States

Mural Oncology Investigational Site

Atlanta, Georgia, United States

Mural Oncology Investigational Site

Minneapolis, Minnesota, United States

Mural Oncology Investigational Site

New York, New York, United States

Outcomes

Primary Outcomes

Overall Response Rate (ORR) Based on RECIST v1.1

ORR was defined as percentage of participants with complete response (CR) or PR as assessed by investigator based on response evaluation criteria in solid tumors (RECIST) version (v) 1.1. CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis less than (\<) 10 millimeters (mm). PR was defined as at least a 30 percent (%) decrease in the sum of diameter (SOD) of target lesions, taking as reference the baseline sum diameters. PD was defined as at least 20% increase (including an absolute increase of at least 5 mm) in the SOD of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.

Time frame: From the first dose of study drug until first PD or death, whichever occurred first (up to 49 weeks)

Secondary Outcomes

Duration of Response (DOR) Based on RECIST v1.1

DOR was defined as time in months from the first documentation CR or PR until the first documentation of confirmed PD as assessed by investigator based on RECIST v1.1. CR: disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis \<10 mm. PR: at least a 30% decrease in the SOD of target lesions, taking as reference the baseline sum diameters. PD: at least 20% increase (including an absolute increase of at least 5 mm) in the SOD of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.

Time frame: From first documented CR or PR until first documentation of PD (up to 49 weeks)

Progression-free Survival (PFS) Based on RECIST v1.1

PFS was defined as the time (in months) from the date of first dose of study drug to the date of first documentation of objective tumor progression, start of alternate therapy or death due to any cause, whichever occurred first, based on RECIST v1.1. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the baseline SOD of target lesions.

Data from ClinicalTrials.gov

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