Evorpacept (ALX148) in Combination With Pembrolizumab in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-03)
Primary Purpose
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Evorpacept
Pembrolizumab
Sponsored by
About this trial
This is an interventional treatment trial for Head and Neck Cancer focused on measuring ALX148, CD47, SIRPα, HNSCC, Pembrolizumab, Evorpacept
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.
Sites / Locations
- Hoag HospitalRecruiting
- University of California San DiegoRecruiting
- H. Lee Moffitt Cancer CenterRecruiting
- Rush University Medical CenterRecruiting
- Blessing Cancer CenterRecruiting
- University of Maryland Medical SystemRecruiting
- University of MarylandRecruiting
- Massachusetts General HospitalRecruiting
- Rutgers Cancer Institute of New JerseyRecruiting
- Memorial Sloan-Kettering Cancer CenterRecruiting
- The Ohio State UniversityRecruiting
- Oregon Health & Science UniversityRecruiting
- Vanderbilt - Ingram Cancer CenterRecruiting
- Houston Methodist Cancer CenterRecruiting
- St. Vincent'sRecruiting
- Royal Brisbane and Womens HospitalRecruiting
- Peter MacCallum Cancer CentreRecruiting
- Sir Charles Gairdner HospitalRecruiting
- Cliniques Universitaires Saint-LucRecruiting
- AZ GroeningeRecruiting
- UZ LeuvenRecruiting
- Hamilton Health Sciences - Juravinski Cancer CentreRecruiting
- LHSC - Victoria HospitalRecruiting
- Ottawa Hospital Cancer CentreRecruiting
- Princess Margaret Cancer CentreRecruiting
- Chungbuk National University HospitalRecruiting
- Yeungnam University Medical CenterRecruiting
- CHA University of BundangRecruiting
- Gachon University - Gil Medical CenterRecruiting
- Seoul National University Bundang HospitalRecruiting
- Seoul National University HospitalRecruiting
- The Catholic University of Korea - Eunpyeong St. Mary's HospitalRecruiting
- Samsung Medical CenterRecruiting
- SNU Boramae Medical CenterRecruiting
- Severance Hospital Yonsei UniversityRecruiting
- VUMC GoederenontvangstRecruiting
- Universitair Medisch Centrum GroningenRecruiting
- National University Cancer InstituteRecruiting
- National Cancer Centre SingaporeRecruiting
- Hospital Universitari DexeusRecruiting
- Institud Catala d´OncologiaRecruiting
- Hospital Universitario La PazRecruiting
- HM SanchinarroRecruiting
- Hospital Severo OchoaRecruiting
- Hospital Regional Universitario de MalagaRecruiting
- Hospital Universitario de NavarraRecruiting
- Royal Marsden NHS Foundation TrustRecruiting
- Royal Marsden NHS Foundation TrustRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Evorpacept (ALX148) + Pembrolizumab
Pembrolizumab
Arm Description
Evorpacept (ALX148) 45 mg/kg IV and pembrolizumab 200 mg IV given every 3 weeks.
Pembrolizumab 200 mg IV given every 3 weeks.
Outcomes
Primary Outcome Measures
Objective response rate per RECIST 1.1
12-month overall survival rate
Secondary Outcome Measures
Duration of response
Progression-free survival
Overall survival
Adverse events
Full Information
NCT ID
NCT04675294
First Posted
December 15, 2020
Last Updated
July 20, 2023
Sponsor
ALX Oncology Inc.
Collaborators
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT04675294
Brief Title
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 Evorpacept (ALX148) in Combination With Pembrolizumab in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-03)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 2, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ALX Oncology Inc.
Collaborators
Merck Sharp & Dohme LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Keywords
ALX148, CD47, SIRPα, HNSCC, Pembrolizumab, Evorpacept
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
183 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Evorpacept (ALX148) + Pembrolizumab
Arm Type
Experimental
Arm Description
Evorpacept (ALX148) 45 mg/kg IV and pembrolizumab 200 mg IV given every 3 weeks.
Arm Title
Pembrolizumab
Arm Type
Active Comparator
Arm Description
Pembrolizumab 200 mg IV given every 3 weeks.
Intervention Type
Drug
Intervention Name(s)
Evorpacept
Other Intervention Name(s)
ALX148
Intervention Description
IV Q3W
Intervention Type
Drug
Intervention Name(s)
Pembrolizumab
Other Intervention Name(s)
Keytruda
Intervention Description
IV Q3W
Primary Outcome Measure Information:
Title
Objective response rate per RECIST 1.1
Time Frame
Last randomized patient reaching at least 24 weeks of follow-up
Title
12-month overall survival rate
Time Frame
Last randomized patient reaching 12 months of follow-up
Secondary Outcome Measure Information:
Title
Duration of response
Time Frame
Up to 36 months
Title
Progression-free survival
Time Frame
Up to 36 months
Title
Overall survival
Time Frame
Up to 36 months
Title
Adverse events
Time Frame
Up to 36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Harry Liu, MD, MPH, MBA
Phone
1 650.502.4697
Email
info@alxoncology.com
Facility Information:
Facility Name
Hoag Hospital
City
Irvine
State/Province
California
ZIP/Postal Code
92618
Country
United States
Individual Site Status
Recruiting
Facility Name
University of California San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Individual Site Status
Recruiting
Facility Name
H. Lee Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Recruiting
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Name
Blessing Cancer Center
City
Quincy
State/Province
Illinois
ZIP/Postal Code
62301
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Maryland Medical System
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Recruiting
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Name
Rutgers Cancer Institute of New Jersey
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Individual Site Status
Recruiting
Facility Name
Memorial Sloan-Kettering Cancer Center
City
Long Island City
State/Province
New York
ZIP/Postal Code
11101
Country
United States
Individual Site Status
Recruiting
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Name
Vanderbilt - Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Name
Houston Methodist Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
St. Vincent's
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2146
Country
Australia
Individual Site Status
Recruiting
Facility Name
Royal Brisbane and Womens Hospital
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Individual Site Status
Recruiting
Facility Name
Peter MacCallum Cancer Centre
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3051
Country
Australia
Individual Site Status
Recruiting
Facility Name
Sir Charles Gairdner Hospital
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Individual Site Status
Recruiting
Facility Name
Cliniques Universitaires Saint-Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Recruiting
Facility Name
AZ Groeninge
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium
Individual Site Status
Recruiting
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
B - 3000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Hamilton Health Sciences - Juravinski Cancer Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L9G2X1
Country
Canada
Individual Site Status
Recruiting
Facility Name
LHSC - Victoria Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6A5W9
Country
Canada
Individual Site Status
Recruiting
Facility Name
Ottawa Hospital Cancer Centre
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Individual Site Status
Recruiting
Facility Name
Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Name
Chungbuk National University Hospital
City
Cheongju
ZIP/Postal Code
28644
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Yeungnam University Medical Center
City
Daegu
ZIP/Postal Code
42415
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
CHA University of Bundang
City
Gyeonggi-do
ZIP/Postal Code
13496
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Gachon University - Gil Medical Center
City
Incheon
ZIP/Postal Code
21565
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
ZIP/Postal Code
13620
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
The Catholic University of Korea - Eunpyeong St. Mary's Hospital
City
Seoul
ZIP/Postal Code
03312
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
SNU Boramae Medical Center
City
Seoul
ZIP/Postal Code
07061
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Severance Hospital Yonsei University
City
Seoul
ZIP/Postal Code
3722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
VUMC Goederenontvangst
City
Amsterdam
ZIP/Postal Code
1081
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Universitair Medisch Centrum Groningen
City
Groningen
ZIP/Postal Code
9713
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
National University Cancer Institute
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Individual Site Status
Recruiting
Facility Name
National Cancer Centre Singapore
City
Singapore
ZIP/Postal Code
169610
Country
Singapore
Individual Site Status
Recruiting
Facility Name
Hospital Universitari Dexeus
City
Barcelona
ZIP/Postal Code
08028
Country
Spain
Individual Site Status
Recruiting
Facility Name
Institud Catala d´Oncologia
City
Barcelona
ZIP/Postal Code
08908
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Name
HM Sanchinarro
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Severo Ochoa
City
Madrid
ZIP/Postal Code
28911
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Regional Universitario de Malaga
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario de Navarra
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Recruiting
Facility Name
Royal Marsden NHS Foundation Trust
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Royal Marsden NHS Foundation Trust
City
Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evorpacept (ALX148) in Combination With Pembrolizumab in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-03)
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