Clinical trials are an important way to improve treatment for people with cancer. While most are continuing during the COVID-19 pandemic, the period of time that clinical trials are available and recruiting may change quickly. If you would like to get involved in a clinical trial, speak to your treatment team or the health service where the clinical trial is being undertaken, to confirm it is open and appropriate for you. For cancer information and support, call Cancer Council's experienced cancer nurses on 13 11 20 Monday to Friday from 9am-5pm.

NCT04675333 : 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)

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

TwoPhase Two

18+Age Over 18

Head and Neck<br/>CancersCancer LocationHead and Neck
Cancers

Systemic therapy | Head and neckHead and neck

Trial Overview Read MoreRead more

This phase II trial is trying to understand the effectiveness of immunotherapy (Pembrolizumab) and chemotherapy (Cisplatin/Carboplatin, 5FU) with or without targeted therapy (Evorpacept) in people with head and neck squamous cell carcinoma.
 

This trial is treating patients with advanced head and neck squamous cell carcinoma.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You have had treatment, but your cancer has come back.
  • Your cancer has spread to other parts of the body.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

  • NCT04675333
  • 21/172 ALX ONCOLOGY - AT148004 - ASPEN-04 - CT1424

Scientific 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)

Commercial Sponsor

ALX Oncology Inc.

Summary

This is a randomised trial with two arms for people with metastatic or unresectable, recurrent head and neck squamous cell carcinoma who have not yet been treated for their advanced disease. In the Experimental Arm, participants will receive Evorpacept (ALX148) + Pembrolizumab + Chemotherapy (Cisplatin/Carboplatin; 5FU). Evorpacept will be administered intravenously (via IV) at a dose of 45mg/kg every three weeks. Pembrolizumab will be administered via IV at a dose of 200mg every three weeks. Chemotherapy will be given every three weeks via IV. In the Active Comparator Arm, participants will receive Pembrolizumab + Chemotherapy. Pembrolizumab will be administered via IV every three weeks at a dose of 200mg. Chemotherapy will be given every three weeks via IV.

Recruiting Hospitals Read MoreRead more

PCCTU (Parkville Cancer Clinical Trials Unit) *
Parkville
Enquiries Line Coordinator
clinicaltrials.enquiries@petermac.org
03 8559 7456 (9am-2pm, Mon-Fri)

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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