Register a trial

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04675294




Registration number
NCT04675294
Ethics application status
Date submitted
15/12/2020
Date registered
19/12/2020

Titles & IDs
Public title
Evorpacept (ALX148) in Combination With Pembrolizumab in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-03)
Scientific title
A Phase 2 Study of ALX148 in Combination With Pembrolizumab in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-03)
Secondary ID [1] 0 0
KEYNOTE-B87
Secondary ID [2] 0 0
AT148003
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Head and Neck Cancer 0 0
Head and Neck Squamous Cell Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - evorpacept
Treatment: Drugs - pembrolizumab

Experimental: evorpacept (ALX148) + pembrolizumab - evorpacept (ALX148) 45 mg/kg IV and pembrolizumab 200 mg IV given every 3 weeks.

Active comparator: pembrolizumab - pembrolizumab 200 mg IV given every 3 weeks.


Treatment: Drugs: evorpacept
IV Q3W

Treatment: Drugs: pembrolizumab
IV Q3W
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective response rate per RECIST 1.1
Timepoint [1] 0 0
Last randomized patient reaching at least 24 weeks of follow-up
Primary outcome [2] 0 0
12-month overall survival rate
Timepoint [2] 0 0
Last randomized patient reaching 12 months of follow-up
Secondary outcome [1] 0 0
Duration of response
Timepoint [1] 0 0
Up to 36 months
Secondary outcome [2] 0 0
Progression-free survival
Timepoint [2] 0 0
Up to 36 months
Secondary outcome [3] 0 0
Overall survival
Timepoint [3] 0 0
Up to 36 months
Secondary outcome [4] 0 0
Adverse events
Timepoint [4] 0 0
Up to 36 months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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-SIRPa agent.
* Prior treatment with anti-PD-1 or PD-L1.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/04/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
Accrual to date
Final
189
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
St. Vincent's - Sydney
Recruitment hospital [2] 0 0
Royal Brisbane and Womens Hospital - Brisbane
Recruitment hospital [3] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [4] 0 0
Sir Charles Gairdner Hospital - Perth
Recruitment hospital [5] 0 0
Ashford Cancer Centre Research - Windsor Gardens
Recruitment postcode(s) [1] 0 0
2146 - Sydney
Recruitment postcode(s) [2] 0 0
4029 - Brisbane
Recruitment postcode(s) [3] 0 0
3051 - Melbourne
Recruitment postcode(s) [4] 0 0
6009 - Perth
Recruitment postcode(s) [5] 0 0
5087 - Windsor Gardens
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
Country [7] 0 0
United States of America
State/province [7] 0 0
New Jersey
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Oregon
Country [11] 0 0
United States of America
State/province [11] 0 0
Tennessee
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
Belgium
State/province [13] 0 0
Brussels
Country [14] 0 0
Belgium
State/province [14] 0 0
Kortrijk
Country [15] 0 0
Belgium
State/province [15] 0 0
Leuven
Country [16] 0 0
Canada
State/province [16] 0 0
Ontario
Country [17] 0 0
Korea, Republic of
State/province [17] 0 0
Cheongju
Country [18] 0 0
Korea, Republic of
State/province [18] 0 0
Daegu
Country [19] 0 0
Korea, Republic of
State/province [19] 0 0
Daejeon
Country [20] 0 0
Korea, Republic of
State/province [20] 0 0
Gyeonggi-do
Country [21] 0 0
Korea, Republic of
State/province [21] 0 0
Incheon
Country [22] 0 0
Korea, Republic of
State/province [22] 0 0
Seongnam
Country [23] 0 0
Korea, Republic of
State/province [23] 0 0
Seoul
Country [24] 0 0
Korea, Republic of
State/province [24] 0 0
Suwon
Country [25] 0 0
Korea, Republic of
State/province [25] 0 0
Wonju
Country [26] 0 0
Netherlands
State/province [26] 0 0
Amsterdam
Country [27] 0 0
Netherlands
State/province [27] 0 0
Groningen
Country [28] 0 0
Singapore
State/province [28] 0 0
Singapore
Country [29] 0 0
Spain
State/province [29] 0 0
Barcelona
Country [30] 0 0
Spain
State/province [30] 0 0
Madrid
Country [31] 0 0
Spain
State/province [31] 0 0
Málaga
Country [32] 0 0
Spain
State/province [32] 0 0
Pamplona
Country [33] 0 0
United Kingdom
State/province [33] 0 0
London
Country [34] 0 0
United Kingdom
State/province [34] 0 0
Sutton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
ALX Oncology Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Merck Sharp & Dohme LLC
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Harry Liu, MD, MPH, MBA
Address 0 0
Country 0 0
Phone 0 0
1 650.502.4697
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04675294