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NCT04675294 Clinical Trial

Evorpacept (ALX148) in Combination With Pembrolizumab in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-03)

Head and Neck Cancer Clinical Trial

Official title:
A Phase 2 Study of ALX148 in Combination With Pembrolizumab in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-03)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04675294
Other study ID # AT148003
Secondary ID KEYNOTE-B87MK-34
Status Recruiting
Phase Phase 2
First received
Last updated
Start date April 2, 2021
Est. completion date December 31, 2025

Study information
Verified date February 2024
Source ALX Oncology Inc.
Contact Harry Liu, MD, MPH, MBA
Phone 1 650.502.4697
Email info@alxoncology.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A Phase 2 Study of evorpacept (ALX148) in Combination With pembrolizumab in Patients With Advanced Head and Neck Squamous Cell Carcinoma.

Description:

This is a open-label, randomized phase 2 multi-center study of the anti-tumor efficacy of evorpacept (ALX148) + pembrolizumab and of pembrolizumab alone in patients with metastatic or unresectable, recurrent HNSCC that is PD-L1 positive (CPS ≥1 by an FDA-approved test) and who have not yet been treated for their advanced disease. The study comprises an initial safety lead-in cohort followed by a randomized portion.

Recruitment information / eligibility
Status Recruiting
Enrollment 183
Est. completion date December 31, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients with metastatic or unresectable, recurrent head and neck squamous cell carcinoma (HNSCC) that is PD-L1 positive (CPS > 1) and who have not received prior systemic therapy for their advanced disease. - Adequate bone marrow function. - Adequate renal and liver function. - Adequate ECOG performance status. Exclusion Criteria: - Patients with known symptomatic CNS metastases or leptomeningeal disease requiring steroids. - History of (non-infectious) pneumonitis that required steroids or has current pneumonitis. - Prior treatment with any anti-CD47 or anti-SIRPa agent. - Prior treatment with anti-PD-1 or PD-L1.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• evorpacept
IV Q3W
• pembrolizumab
IV Q3W

Locations
Country Name City State
Australia Royal Brisbane and Womens Hospital Brisbane Queensland
Australia Peter MacCallum Cancer Centre Melbourne Victoria
Australia Sir Charles Gairdner Hospital Perth Western Australia
Australia St. Vincent's Sydney New South Wales
Belgium Cliniques Universitaires Saint-Luc Brussels
Belgium AZ Groeninge Kortrijk
Belgium UZ Leuven Leuven
Canada Hamilton Health Sciences - Juravinski Cancer Centre Hamilton Ontario
Canada LHSC - Victoria Hospital London Ontario
Canada Ottawa Hospital Cancer Centre Ottawa Ontario
Canada Princess Margaret Cancer Centre Toronto Ontario
Korea, Republic of Chungbuk National University Hospital Cheongju
Korea, Republic of Yeungnam University Medical Center Daegu
Korea, Republic of Chungnam National University Hospital Daejeon
Korea, Republic of CHA University of Bundang Gyeonggi-do
Korea, Republic of Gachon University - Gil Medical Center Incheon
Korea, Republic of Seoul National University Bundang Hospital Seongnam
Korea, Republic of Korea University Medical Center (KUMC) - Korea University Anam Hospital Seoul
Korea, Republic of Samsung Medical Center Seoul
Korea, Republic of Seoul National University Hospital Seoul
Korea, Republic of Severance Hospital Yonsei University Seoul
Korea, Republic of SNU Boramae Medical Center Seoul
Korea, Republic of The Catholic University of Korea - Eunpyeong St. Mary's Hospital Seoul
Korea, Republic of Catholic University of Korea, St. Vincent's Hospital Suwon Suwon
Korea, Republic of Yonsei University - Wonju Severance Christian Hospital Wonju
Netherlands VUMC Goederenontvangst Amsterdam
Netherlands Universitair Medisch Centrum Groningen Groningen
Singapore National Cancer Centre Singapore Singapore
Singapore National University Cancer Institute Singapore
Spain Hospital Universitari Dexeus Barcelona
Spain Institud Catala d´Oncologia Barcelona
Spain HM Sanchinarro Madrid
Spain Hospital Severo Ochoa Madrid
Spain Hospital Universitario La Paz Madrid
Spain Hospital Regional Universitario de Malaga Málaga
Spain Hospital Universitario de Navarra Pamplona
United Kingdom Royal Marsden NHS Foundation Trust London
United Kingdom Royal Marsden NHS Foundation Trust Sutton
United States University of Maryland Baltimore Maryland
United States University of Maryland Medical System Baltimore Maryland
United States Massachusetts General Hospital Boston Massachusetts
United States Rush University Medical Center Chicago Illinois
United States The Ohio State University Columbus Ohio
United States Houston Methodist Cancer Center Houston Texas
United States Hoag Hospital Irvine California
United States University of California San Diego La Jolla California
United States Memorial Sloan-Kettering Cancer Center Long Island City New York
United States Northwest Georgia Oncology Centers Marietta Georgia
United States Vanderbilt - Ingram Cancer Center Nashville Tennessee
United States Rutgers Cancer Institute of New Jersey Newark New Jersey
United States Oregon Health & Science University Portland Oregon
United States Blessing Cancer Center Quincy Illinois
United States H. Lee Moffitt Cancer Center Tampa Florida

Sponsors (2)
Lead Sponsor Collaborator
ALX Oncology Inc. Merck Sharp & Dohme LLC

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  Korea, Republic of,  Netherlands,  Singapore,  Spain,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Objective response rate per RECIST 1.1 Last randomized patient reaching at least 24 weeks of follow-up
Primary 12-month overall survival rate Last randomized patient reaching 12 months of follow-up
Secondary Duration of response Up to 36 months
Secondary Progression-free survival Up to 36 months
Secondary Overall survival Up to 36 months
Secondary Adverse events Up to 36 months
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