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

NCT ID: NCT04144517

Last Updated: 2024-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-05
• Study Completion Date: 2022-01-07

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.

Conditions

Squamous Cell Carcinoma of Head and Neck

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

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.

Group Type: EXPERIMENTAL

Nemvaleukin Alfa

Intervention Type: DRUG

Nemvaleukin alfa IV infusion.

Pembrolizumab

Intervention Type: DRUG

Pembrolizumab IV infusion.

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

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.

Group Type: EXPERIMENTAL

Nemvaleukin Alfa

Intervention Type: DRUG

Nemvaleukin alfa IV infusion.

Pembrolizumab

Intervention Type: DRUG

Pembrolizumab IV infusion.

Interventions

Nemvaleukin Alfa

Nemvaleukin alfa IV infusion.

Intervention Type: DRUG

Pembrolizumab

Pembrolizumab IV infusion.

Intervention Type: DRUG

Other Intervention Names

Keytruda

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Immune Oncology Network (ION)

UNKNOWN

Sponsor Role: collaborator

Mural Oncology, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Mural Oncology, Inc

Locations

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

Mural Oncology Investigational Site

New York, New York, United States

Mural Oncology Investigational Site

Cleveland, Ohio, United States

Mural Oncology Investigational Site

Austin, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

ION-01-ALKS 4230

Identifier Type: -

Identifier Source: org_study_id