Clinical Trials /

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

NCT04675333

Description:

A Phase 2 Study of ALX148 in Combination With Pembrolizumab and Chemotherapy in Patients With Advanced Head and Neck Squamous Cell Carcinoma.

Related Conditions:
  • Head and Neck Squamous Cell Carcinoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: 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 ALX148 in Combination With Pembrolizumab and Chemotherapy in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-04)

Clinical Trial IDs

  • ORG STUDY ID: AT148004
  • SECONDARY ID: KEYNOTE-B88
  • NCT ID: NCT04675333

Conditions

  • Head and Neck Cancer
  • Head and Neck Squamous Cell Carcinoma

Interventions

DrugSynonymsArms
ALX148ALX148 + Pembrolizumab + Chemotherapy
PembrolizumabKeytrudaALX148 + Pembrolizumab + Chemotherapy
Cisplatin/Carboplatin; 5FUPlatinol/Paraplatin; AdrucilALX148 + Pembrolizumab + Chemotherapy

Purpose

A Phase 2 Study of 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
      ALX148 + pembrolizumab + 5FU and platinum and of pembrolizumab + 5FU and platinum alone 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.
    

Trial Arms

NameTypeDescriptionInterventions
ALX148 + Pembrolizumab + ChemotherapyExperimentalALX148 45 mg/kg IV, pembrolizumab 200 mg IV, and chemotherapy given every 3 weeks.
  • ALX148
  • Pembrolizumab
  • Cisplatin/Carboplatin; 5FU
Pembrolizumab + ChemotherapyActive ComparatorPembrolizumab 200 mg IV and chemotherapy given every 3 weeks.
  • Pembrolizumab
  • Cisplatin/Carboplatin; 5FU

Eligibility Criteria

        Inclusion Criteria:

          -  Previously untreated metastatic or unresectable, recurrent head and neck squamous cell
             carcinoma.

          -  Adequate Bone Marrow Function.

          -  Adequate Renal & Liver Function.

          -  Adequate 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Objective response rate per RECIST 1.1
Time Frame:Last randomized patient reaching at least 24 weeks of follow-up.
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:ALX Oncology Inc.

Trial Keywords

  • ALX148
  • CD47
  • SIRPα
  • HNSCC
  • Pembrolizumab

Last Updated

January 19, 2021