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Trial Summary

This is a open-label, randomized phase 2 multi-center study of the anti-tumor efficacy of ALX148 + pembrolizumab and of pembrolizumab alone in patients with metastatic or unresectable, recurrent HNSCC that is PD-L1 positive (CPS ≥1 by an FDA-approved test) who have not yet been treated for their advanced disease. The study comprises an initial safety lead-in cohort followed by a randomized portion.

Acronym:

ASPEN-03

ACTRN/NCT /ethics:

NCT04675294

Scientific title:

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

Sponsor / Cooperative group:

ALX Oncology Inc.

Trial & Patient Characteristics

Cancer TypeHead and Neck
Trial TypeTreatment
PhasePhase II
Age RangeInsert18 years and older
SexBoth
Tumour Stream -
Cancer StageLocally Recurrent or Locally Advanced, Metastatic or Widespread
Anticipated Start Date2021-02-01
Anticipated End Date2024-01-10

Participating Hospitals

HospitalAshford Cancer Centre Research
Clinical Trial CoordinatorSue Yeend
Emailsyeend@adelaidecancercentre.com.au
Phone08 8292 2240
Principal InvestigatorDr Dainik Patel
Recruitment StatusNot Yet Recruiting