Evorpacept (ALX148) in Combination with Pembrolizumab in Patients with Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-03)
- Conditions
- Head and Neck Squamous Cell CarcinomaHead and Neck Cancer
- Interventions
- Registration Number
- NCT04675294
- Lead Sponsor
- ALX Oncology Inc.
- Brief Summary
A Phase 2 Study of evorpacept (ALX148) in Combination With pembrolizumab in Patients With Advanced Head and Neck Squamous Cell Carcinoma.
- Detailed 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 & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 189
- 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.
- 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-SIRPα agent.
- Prior treatment with anti-PD-1 or PD-L1.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description evorpacept (ALX148) + pembrolizumab pembrolizumab evorpacept (ALX148) 45 mg/kg IV and pembrolizumab 200 mg IV given every 3 weeks. pembrolizumab pembrolizumab pembrolizumab 200 mg IV given every 3 weeks. evorpacept (ALX148) + pembrolizumab evorpacept evorpacept (ALX148) 45 mg/kg IV and pembrolizumab 200 mg IV given every 3 weeks.
- Primary Outcome Measures
Name Time Method Objective response rate per RECIST 1.1 Last randomized patient reaching at least 24 weeks of follow-up
- Secondary Outcome Measures
Name Time Method Progression-free survival Up to 36 months Duration of response Up to 36 months Overall survival Up to 36 months Adverse events Up to 36 months
Trial Locations
- Locations (52)
The Ohio State University
🇺🇸Columbus, Ohio, United States
Rutgers Cancer Institute of New Jersey
🇺🇸Newark, New Jersey, United States
Cliniques Universitaires Saint-Luc
🇧🇪Brussels, Belgium
National University Cancer Institute
🇸🇬Singapore, Singapore
Vanderbilt - Ingram Cancer Center
🇺🇸Nashville, Tennessee, United States
VUMC Goederenontvangst
🇳🇱Amsterdam, Netherlands
UZ Leuven
🇧🇪Leuven, Belgium
AZ Groeninge
🇧🇪Kortrijk, Belgium
Memorial Sloan-Kettering Cancer Center
🇺🇸Long Island City, New York, United States
H. Lee Moffitt Cancer Center
🇺🇸Tampa, Florida, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
Hoag Hospital
🇺🇸Irvine, California, United States
University of California San Diego
🇺🇸La Jolla, California, United States
Northwest Georgia Oncology Centers
🇺🇸Marietta, Georgia, United States
Blessing Cancer Center
🇺🇸Quincy, Illinois, United States
University of Maryland Medical System
🇺🇸Baltimore, Maryland, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Royal Brisbane and Womens Hospital
🇦🇺Brisbane, Queensland, Australia
Houston Methodist Cancer Center
🇺🇸Houston, Texas, United States
St. Vincent's
🇦🇺Sydney, New South Wales, Australia
Sir Charles Gairdner Hospital
🇦🇺Perth, Western Australia, Australia
Ashford Cancer Centre Research
🇦🇺Windsor Gardens, Australia
Hamilton Health Sciences - Juravinski Cancer Centre
🇨🇦Hamilton, Ontario, Canada
Ottawa Hospital Cancer Centre
🇨🇦Ottawa, Ontario, Canada
LHSC - Victoria Hospital
🇨🇦London, Ontario, Canada
Chungnam National University Hospital
🇰🇷Daejeon, Korea, Republic of
Yeungnam University Medical Center
🇰🇷Daegu, Korea, Republic of
Princess Margaret Cancer Centre
🇨🇦Toronto, Ontario, Canada
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
SNU Boramae Medical Center
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea - Eunpyeong St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Severance Hospital Yonsei University
🇰🇷Seoul, Korea, Republic of
Yonsei University - Wonju Severance Christian Hospital
🇰🇷Wŏnju, Korea, Republic of
National Cancer Centre Singapore
🇸🇬Singapore, Singapore
Institud Catala d´Oncologia
🇪🇸Barcelona, Spain
Hospital Regional Universitario de Malaga
🇪🇸Málaga, Spain
Royal Marsden NHS Foundation Trust
🇬🇧Sutton, United Kingdom
Hospital Severo Ochoa
🇪🇸Madrid, Spain
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Gachon University - Gil Medical Center
🇰🇷Incheon, Korea, Republic of
Peter MacCallum Cancer Centre
🇦🇺Melbourne, Victoria, Australia
Chungbuk National University Hospital
🇰🇷Cheongju, Korea, Republic of
CHA University of Bundang
🇰🇷Gyeonggi-do, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Catholic University of Korea, St. Vincent's Hospital Suwon
🇰🇷Suwon, Korea, Republic of
Hospital Universitario de Navarra
🇪🇸Pamplona, Spain
Hospital Universitari Dexeus
🇪🇸Barcelona, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Universitair Medisch Centrum Groningen
🇳🇱Groningen, Netherlands
HM Sanchinarro
🇪🇸Madrid, Spain