Evorpacept (ALX148) in Combination With Pembrolizumab in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-03)

Conditions

Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma

Keywords

ALX148, CD47, SIRPα, HNSCC, pembrolizumab, evorpacept

Brief summary

A Phase 2 Study of evorpacept (ALX148) in Combination With pembrolizumab 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 and of pembrolizumab alone in patients with metastatic or unresectable, recurrent HNSCC that is PD-L1 positive (CPS ≥1 by an FDA-approved test) and who have not yet been treated for their advanced disease. The study comprises an initial safety lead-in cohort followed by a randomized portion.

Kevin J. Harrington, Ezra E.W. Cohen, Bhumsuk Keam, Jean‐Pascal Machiels, Sjoukje F. Oosting et al. (14 authors)

Regular and Young Investigator Award Abstracts2022-11-01

10.1136/jitc-2022-sitc2022.0678

439 A phase 2 study of evorpacept (ALX148) in combination with pembrolizumab in patients with advanced head and neck squamous cell carcinoma (HNSCC); ASPEN-03

Jong Chul Park, Kevin J. Harrington, Bhumsuk Keam, Jean‐Pascal Machiels, Sjoukje F. Oosting et al. (14 authors)

Regular and Young Investigator Award Abstracts2021-11-01

10.1136/jitc-2021-sitc2021.439

Antitumor immune effects of preoperative sitravatinib and nivolumab in oral cavity cancer: SNOW window-of-opportunity study

Marc Oliva, Douglas B. Chepeha, Daniel Vilarim Araújo, J. Javier Díaz-Mejía, Peter Olson et al. (32 authors)

Journal for ImmunoTherapy of Cancer2021-10-0151 citations

10.1136/jitc-2021-003476

Interventions

DRUGevorpacept

IV Q3W

DRUGpembrolizumab

IV Q3W

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

* Patients with metastatic or unresectable, recurrent head and neck squamous cell carcinoma (HNSCC) that is PD-L1 positive (CPS \> 1) and who have not received prior systemic therapy for their advanced disease. * 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 has current pneumonitis. * Prior treatment with any anti-CD47 or anti-SIRPα agent. * Prior treatment with anti-PD-1 or PD-L1.

Design outcomes

Primary

Measure	Time frame
Objective response rate per RECIST 1.1	Last randomized patient reaching at least 24 weeks of follow-up

Secondary

Measure	Time frame
Duration of response	Up to 36 months
Progression-free survival	Up to 36 months
Overall survival	Up to 36 months
Adverse events	Up to 36 months

Countries

Australia, Belgium, Canada, Netherlands, Singapore, South Korea, Spain, United Kingdom, United States

Outcome results

None listed