Clinical trial NCT04675294: Evorpacept (ALX148) in Combination with Pembrolizumab in Patients with Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-03)
Official title: A Phase 2 Study of ALX148 in Combination with Pembrolizumab in Patients with Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-03)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Head and Neck Cancer
Head and Neck Squamous Cell Carcinoma
Keywords: ALX148
CD47
SIRPα
HNSCC
pembrolizumab
evorpacept
Lead sponsor: ALX Oncology Inc.
Sponsor class: INDUSTRY
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2020-12-19
Enrollment: 189
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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-SIRPα agent.
* Prior treatment with anti-PD-1 or PD-L1.

Primary outcomes:
measure: Objective response rate per RECIST 1.1
timeFrame: Last randomized patient reaching at least 24 weeks of follow-up
Secondary outcomes:
measure: Duration of response
timeFrame: Up to 36 months
measure: Progression-free survival
timeFrame: Up to 36 months
measure: Overall survival
timeFrame: Up to 36 months
measure: Adverse events
timeFrame: Up to 36 months
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Hoag Hospital
state: California
city: La Jolla
country: United States
facility: University of California San Diego
state: California
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center
state: Florida
city: Marietta
country: United States
facility: Northwest Georgia Oncology Centers
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Quincy
country: United States
facility: Blessing Cancer Center
state: Illinois
city: Baltimore
country: United States
facility: University of Maryland Medical System
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Newark
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
city: Long Island City
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Nashville
country: United States
facility: Vanderbilt - Ingram Cancer Center
state: Tennessee
city: Houston
country: United States
facility: Houston Methodist Cancer Center
state: Texas
city: Sydney
country: Australia
facility: St. Vincent's
state: New South Wales
city: Brisbane
country: Australia
facility: Royal Brisbane and Womens Hospital
state: Queensland
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
state: Victoria
city: Perth
country: Australia
facility: Sir Charles Gairdner Hospital
state: Western Australia
city: Windsor Gardens
country: Australia
facility: Ashford Cancer Centre Research
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Kortrijk
country: Belgium
facility: AZ Groeninge
city: Leuven
country: Belgium
facility: UZ Leuven
city: Hamilton
country: Canada
facility: Hamilton Health Sciences - Juravinski Cancer Centre
state: Ontario
city: London
country: Canada
facility: LHSC - Victoria Hospital
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospital Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
city: Cheongju
country: Korea, Republic of
facility: Chungbuk National University Hospital
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Medical Center
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: CHA University of Bundang
city: Incheon
country: Korea, Republic of
facility: Gachon University - Gil Medical Center
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Medical Center (KUMC) - Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea - Eunpyeong St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: SNU Boramae Medical Center
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University
city: Suwon
country: Korea, Republic of
facility: Catholic University of Korea, St. Vincent's Hospital Suwon
city: Wŏnju
country: Korea, Republic of
facility: Yonsei University - Wonju Severance Christian Hospital
city: Amsterdam
country: Netherlands
facility: VUMC Goederenontvangst
city: Groningen
country: Netherlands
facility: Universitair Medisch Centrum Groningen
city: Singapore
country: Singapore
facility: National University Cancer Institute
city: Singapore
country: Singapore
facility: National Cancer Centre Singapore
city: Barcelona
country: Spain
facility: Hospital Universitari Dexeus
city: Barcelona
country: Spain
facility: Institud Catala d´Oncologia
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: HM Sanchinarro
city: Madrid
country: Spain
facility: Hospital Severo Ochoa
city: Málaga
country: Spain
facility: Hospital Regional Universitario de Malaga
city: Pamplona
country: Spain
facility: Hospital Universitario de Navarra
city: London
country: United Kingdom
facility: Royal Marsden NHS Foundation Trust
city: Sutton
country: United Kingdom
facility: Royal Marsden NHS Foundation Trust
Study officials:
References: