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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04675333




Registration number
NCT04675333
Ethics application status
Date submitted
15/12/2020
Date registered
19/12/2020

Titles & IDs
Public title
Evorpacept (ALX148) in Combination With Pembrolizumab and Chemotherapy in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-04)
Scientific 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)
Secondary ID [1] 0 0
KEYNOTE-B88
Secondary ID [2] 0 0
AT148004
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
Treatment: Drugs - Cisplatin/Carboplatin; 5FU

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

Active comparator: pembrolizumab + Chemotherapy - pembrolizumab 200 mg IV and chemotherapy given every 3 weeks.


Treatment: Drugs: evorpacept
IV Q3W

Treatment: Drugs: pembrolizumab
IV Q3W

Treatment: Drugs: Cisplatin/Carboplatin; 5FU
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
* 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.
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 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
10/05/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
Accrual to date
Final
172
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
Recruitment hospital [1] 0 0
Royal Brisbane and Womens Hospital - Herston
Recruitment hospital [2] 0 0
Ashford Cancer Centre - Adelaide
Recruitment hospital [3] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [4] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
4029 - Herston
Recruitment postcode(s) [2] 0 0
5037 - Adelaide
Recruitment postcode(s) [3] 0 0
3000 - Melbourne
Recruitment postcode(s) [4] 0 0
6009 - Nedlands
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
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Kentucky
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
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
Ohio
Country [8] 0 0
United States of America
State/province [8] 0 0
Oregon
Country [9] 0 0
United States of America
State/province [9] 0 0
Tennessee
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
Belgium
State/province [11] 0 0
Bruxelles
Country [12] 0 0
Belgium
State/province [12] 0 0
Kortrijk
Country [13] 0 0
Korea, Republic of
State/province [13] 0 0
Cheongju-si
Country [14] 0 0
Korea, Republic of
State/province [14] 0 0
Daegu
Country [15] 0 0
Korea, Republic of
State/province [15] 0 0
Incheon
Country [16] 0 0
Korea, Republic of
State/province [16] 0 0
Seongnam-si
Country [17] 0 0
Korea, Republic of
State/province [17] 0 0
Seongnam
Country [18] 0 0
Korea, Republic of
State/province [18] 0 0
Seoul
Country [19] 0 0
Netherlands
State/province [19] 0 0
Amsterdam
Country [20] 0 0
Netherlands
State/province [20] 0 0
Groningen
Country [21] 0 0
Singapore
State/province [21] 0 0
Singapore
Country [22] 0 0
Spain
State/province [22] 0 0
Badalona
Country [23] 0 0
Spain
State/province [23] 0 0
Barcelona
Country [24] 0 0
Spain
State/province [24] 0 0
L'Hospitalet De Llobregat
Country [25] 0 0
Spain
State/province [25] 0 0
Leganés
Country [26] 0 0
Spain
State/province [26] 0 0
Madrid
Country [27] 0 0
Spain
State/province [27] 0 0
Málaga
Country [28] 0 0
Spain
State/province [28] 0 0
Pamplona
Country [29] 0 0
United Kingdom
State/province [29] 0 0
London

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
info@alxoncology.com
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/NCT04675333