Evorpacept (ALX148) in Combination with Pembrolizumab and Chemotherapy in Patients with Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-04)
- Conditions
- Head and Neck CancerHead and Neck Squamous Cell Carcinoma
- Interventions
- Registration Number
- NCT04675333
- Lead Sponsor
- ALX Oncology Inc.
- Brief Summary
A Phase 2 Study of evorpacept (ALX148) in Combination With pembrolizumab and Chemotherapy 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 + 5FU + platinum and of pembrolizumab + 5FU + platinum in patients with metastatic or unresectable, recurrent HNSCC who have not yet been treated for their advanced disease. The study comprises of an initial safety lead-in followed by a randomized portion.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 172
- Previously untreated metastatic or unresectable, recurrent head and neck squamous cell carcinoma.
- 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 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 + Chemotherapy Cisplatin/Carboplatin; 5FU evorpacept (ALX148) 45 mg/kg IV, pembrolizumab 200 mg IV, and chemotherapy given every 3 weeks. pembrolizumab + Chemotherapy pembrolizumab pembrolizumab 200 mg IV and chemotherapy given every 3 weeks. pembrolizumab + Chemotherapy Cisplatin/Carboplatin; 5FU pembrolizumab 200 mg IV and chemotherapy given every 3 weeks. evorpacept (ALX148) + pembrolizumab + Chemotherapy pembrolizumab evorpacept (ALX148) 45 mg/kg IV, pembrolizumab 200 mg IV, and chemotherapy given every 3 weeks. evorpacept (ALX148) + pembrolizumab + Chemotherapy evorpacept evorpacept (ALX148) 45 mg/kg IV, pembrolizumab 200 mg IV, and chemotherapy 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 Duration of response Up to 36 months Progression-free survival Up to 36 months Overall survival Up to 36 months Adverse events Up to 36 months
Trial Locations
- Locations (44)
University of Miami, Sylvester Comprehensive Cancer Center
🇺🇸Miami, Florida, United States
Vanderbilt - Ingram Cancer Center
🇺🇸Nashville, Tennessee, United States
Oregon Health & Science University/ Knight Cancer Institute
🇺🇸Portland, Oregon, United States
Hoag Hospital
🇺🇸Irvine, California, United States
Cedar Sinai Medical Center
🇺🇸Los Angeles, California, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
University of Maryland Medical System
🇺🇸Baltimore, Maryland, United States
The Ohio State University
🇺🇸Columbus, Ohio, United States
Houston Methodist Cancer Center
🇺🇸Houston, Texas, United States
Ashford Cancer Centre
🇦🇺Adelaide, South Australia, Australia
Sir Charles Gairdner Hospital
🇦🇺Nedlands, Australia
Chungbuk National University Hospital
🇰🇷Cheongju-si, Korea, Republic of
Yeungnam University Medical Center
🇰🇷Daegu, Korea, Republic of
CHA University - Bundang CHA General Hospital (CHA Bundang Medical Center)
🇰🇷Seongnam-si, Korea, Republic of
Seoul National University, Bundang Hospital
🇰🇷Seongnam, Korea, Republic of
Seoul National University Hospital (SNUH) - SMG-SNU Boramae Medical Center
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Amsterdam UMC, Locatie VUMC
🇳🇱Amsterdam, Netherlands
Universitair Medisch Centrum Groningen
🇳🇱Groningen, Netherlands
National University Cancer Institute
🇸🇬Singapore, Singapore
Institut Catala d Oncologia (ICO)
🇪🇸Badalona, Spain
Hospital Universitario Severo Ochoa
🇪🇸Leganés, Spain
Hospital Universitari Dexeus
🇪🇸Barcelona, Spain
Institut Catala dOncologia
🇪🇸L'Hospitalet De Llobregat, Spain
Grupo Hospital de Madrid (HM) - Hospital Universitario Madrid Sanchinarro - Cent
🇪🇸Madrid, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Hospital Universitario de Navarra
🇪🇸Pamplona, Spain
The Royal Marsden Hospital - Surrey
🇬🇧London, United Kingdom
University College London Hospital
🇬🇧London, United Kingdom
The Royal Marsden Hospital- London
🇬🇧London, United Kingdom
Memorial Sloan Kettering
🇺🇸New York, New York, United States
Moffitt Cancer Center
🇺🇸Tampa, Florida, United States
University of California San Diego
🇺🇸La Jolla, California, United States
Royal Brisbane and Womens Hospital
🇦🇺Herston, Queensland, Australia
Peter MacCallum Cancer Centre
🇦🇺Melbourne, Victoria, Australia
AZ Groeninge
🇧🇪Kortrijk, Belgium
Gachon University (GCU) - Gil Medical Center (Gil Hospital)
🇰🇷Incheon, Korea, Republic of
Cliniques Universitaires Saint-Luc
🇧🇪Bruxelles, Belgium
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea - Eunpyeong St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Hospital Regional Universitario de Malaga
🇪🇸Málaga, Spain
National Cancer Centre Singapore
🇸🇬Singapore, Singapore
University of Louisville
🇺🇸Louisville, Kentucky, United States