NCT04144517|CompletedPhase 2ResultsFDA Drug

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

Mural Oncology, Inc ClinicalTrials.gov

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1 other identifier

ION-01-ALKS 4230

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredOct 2019

StartedFeb 2020

CompletionJan 2022

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_2

Timeline

Completed

Started Feb 2020

Geographic Reach

1 country

7 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.9 years study duration

First Submitted

Initial submission to the registry

October 24, 2019

Completed

6 days until next milestone

First Posted

Study publicly available on registry

October 30, 2019

Completed

3 months until next milestone

Study Start

First participant enrolled

February 5, 2020

Completed

1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 8, 2021

Completed

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 7, 2022

Completed

2.8 years until next milestone

Results Posted

Study results publicly available

October 16, 2024

Completed

Last Updated

October 16, 2024

Status Verified

September 1, 2024

Enrollment Period

1.7 years

First QC Date

October 24, 2019

Results QC Date

August 9, 2024

Last Update Submit

September 24, 2024

Conditions

Squamous Cell Carcinoma of Head and Neck

Keywords

AlkermesIL-2Interleukin-2OncologyImmuno-oncologyCytokine ImmunotherapyALKS 4230PembrolizumabKeytrudaPD-L1Solid Tumors

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (7)

Duration of Response (DOR) Based on RECIST v1.1
From first documented CR or PR until first documentation of PD (up to 49 weeks)
Progression-free Survival (PFS) Based on RECIST v1.1
From the first dose of study drug to date of PD, start of alternate therapy or death, whichever occurred first (up to 49 weeks)
Time to Progression (TTP) Based on RECIST v1.1
From first dose of study drug to the date of the first documentation of PD (up to 49 weeks)
Disease Control Rate (DCR) Based on RECIST v1.1
From first dose of study drug until PD or death, whichever occurred first (up to 49 weeks)
Overall Survival (OS)
From date of first dose of study drug up to death from any cause (up to 89 weeks)
+2 more secondary outcomes

Study Arms (2)

Group 1: Nemvaleukin 3 mcg/kg + Pembrolizumab 200 mg

EXPERIMENTAL

Participants with current stable disease (SD) or partial response (PR) (Cohorts 1 and 2) who were not progressing or further demonstrating reductions in tumor size were to receive nemvaleukin alfa 3 microgram per kilogram (mcg/kg), intravenous (IV) infusion, daily from Days 1 to 5 of the first week of each 3-week treatment cycle in combination with pembrolizumab 200 milligram (mg), IV infusion, once, every three weeks (Q3W) on Day 1 of each 21-day cycle until confirmed progression, unacceptable toxicity or met other criteria for discontinuation.

Drug: Nemvaleukin AlfaDrug: Pembrolizumab

Group 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg

EXPERIMENTAL

Participants with progressive disease (PD) (Cohorts 3 and 4) received nemvaleukin alfa 3 mcg/kg, IV infusion, daily from Days 1 to 5 of the first week of each 3-week treatment cycle in combination with pembrolizumab 200 mg, IV infusion, once, Q3W on Day 1 of each 21-day cycle until confirmed progression, unacceptable toxicity or met other criteria for discontinuation.

Drug: Nemvaleukin AlfaDrug: Pembrolizumab

Interventions

Nemvaleukin AlfaDRUG

Nemvaleukin alfa IV infusion.

Group 1: Nemvaleukin 3 mcg/kg + Pembrolizumab 200 mgGroup 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg

PembrolizumabDRUG

Pembrolizumab IV infusion.

Also known as: Keytruda

Group 1: Nemvaleukin 3 mcg/kg + Pembrolizumab 200 mgGroup 2: Nemvaleukin Alfa 3 mcg/kg + Pembrolizumab 200 mg

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.