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Evorpacept (ALX148) in Combination With Pembrolizumab and Chemotherapy in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-04)

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
Cisplatin/Carboplatin; 5FU
Sponsored by
ALX Oncology Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hoag HospitalRecruiting
  • University of California San DiegoRecruiting
  • Sylvester Comprehensive Cancer CenterRecruiting
  • Rush University Medical CenterRecruiting
  • University of LouisvilleRecruiting
  • University of Maryland Medical SystemRecruiting
  • Vanderbilt - Ingram Cancer CenterRecruiting
  • Ashford Cancer CentreRecruiting
  • Cliniques Universitaires Saint-LucRecruiting
  • Hospital Universitari DexeusRecruiting
  • Hospital Universitario La PazRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Evorpacept (ALX148) + Pembrolizumab + Chemotherapy

Pembrolizumab + Chemotherapy

Arm Description

Evorpacept (ALX148) 45 mg/kg IV, pembrolizumab 200 mg IV, and chemotherapy given every 3 weeks.

Pembrolizumab 200 mg IV and chemotherapy 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

First Posted
December 15, 2020
Last Updated
July 6, 2023
Sponsor
ALX Oncology Inc.
Collaborators
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04675333
Brief Title
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 Evorpacept (ALX148) in Combination With Pembrolizumab and Chemotherapy in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-04)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 10, 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 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.

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
168 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Evorpacept (ALX148) + Pembrolizumab + Chemotherapy
Arm Type
Experimental
Arm Description
Evorpacept (ALX148) 45 mg/kg IV, pembrolizumab 200 mg IV, and chemotherapy given every 3 weeks.
Arm Title
Pembrolizumab + Chemotherapy
Arm Type
Active Comparator
Arm Description
Pembrolizumab 200 mg IV and chemotherapy 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
Intervention Type
Drug
Intervention Name(s)
Cisplatin/Carboplatin; 5FU
Other Intervention Name(s)
Platinol/Paraplatin; Adrucil
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: 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.
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
First Name & Middle Initial & Last Name or Official Title & Degree
Richard J Morishige, MS
Phone
1 650.666.0492
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
Sylvester Comprehensive Cancer Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
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
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
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
Vanderbilt - Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Name
Ashford Cancer Centre
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5037
Country
Australia
Individual Site Status
Recruiting
Facility Name
Cliniques Universitaires Saint-Luc
City
Bruxelles
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Hospital Universitari Dexeus
City
Barcelona
ZIP/Postal Code
08028
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario La Paz
City
Madrid
Country
Spain
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Evorpacept (ALX148) in Combination With Pembrolizumab and Chemotherapy in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-04)

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