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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
Date last updated
22/07/2024

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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
A Phase 2 Study of evorpacept (ALX148) in Combination With pembrolizumab and Chemotherapy in Patients With Advanced Head and Neck Squamous Cell Carcinoma.
Trial website
https://clinicaltrials.gov/study/NCT04675333
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
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04675333