Clinical trial NCT04675333: Evorpacept (ALX148) in Combination with Pembrolizumab and Chemotherapy in Patients with Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-04)
Official title: A Phase 2 Study of ALX148 in Combination with Pembrolizumab and Chemotherapy in Patients with Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-04)
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: 172
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 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

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: Los Angeles
country: United States
facility: Cedar Sinai Medical Center
state: California
city: Miami
country: United States
facility: University of Miami, Sylvester Comprehensive Cancer Center
state: Florida
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Baltimore
country: United States
facility: University of Maryland Medical System
state: Maryland
city: New York
country: United States
facility: Memorial Sloan Kettering
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/ Knight Cancer Institute
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: Herston
country: Australia
facility: Royal Brisbane and Womens Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Ashford Cancer Centre
state: South Australia
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
state: Victoria
city: Nedlands
country: Australia
facility: Sir Charles Gairdner Hospital
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Kortrijk
country: Belgium
facility: AZ Groeninge
city: Cheongju-si
country: Korea, Republic of
facility: Chungbuk National University Hospital
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Medical Center
city: Incheon
country: Korea, Republic of
facility: Gachon University (GCU) - Gil Medical Center (Gil Hospital)
city: Seongnam-si
country: Korea, Republic of
facility: CHA University - Bundang CHA General Hospital (CHA Bundang Medical Center)
city: Seongnam
country: Korea, Republic of
facility: Seoul National University, Bundang 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: Seoul National University Hospital (SNUH) - SMG-SNU Boramae Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC, Locatie VUMC
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: Badalona
country: Spain
facility: Institut Catala d Oncologia (ICO)
city: Barcelona
country: Spain
facility: Hospital Universitari Dexeus
city: L'Hospitalet De Llobregat
country: Spain
facility: Institut Catala dOncologia
city: Leganés
country: Spain
facility: Hospital Universitario Severo Ochoa
city: Madrid
country: Spain
facility: Grupo Hospital de Madrid (HM) - Hospital Universitario Madrid Sanchinarro - Cent
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
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: The Royal Marsden Hospital - Surrey
city: London
country: United Kingdom
facility: University College London Hospital
city: London
country: United Kingdom
facility: The Royal Marsden Hospital- London
Study officials:
References: