Study on Evorpacept (ALX148) with Pembrolizumab and Chemotherapy for Advanced Head and Neck Cancer
Sponsor: ALX Oncology Inc.
ClinicalTrials ID:NCT04675333
This clinical trial is testing a new combination of treatments, including evorpacept (ALX148), pembrolizumab, and chemotherapy, to see if it can help patients with advanced head and neck cancer that has spread or cannot be removed by surgery.
Patient Parameters
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Program Overview
The purpose of this Phase 2 study is to evaluate the effectiveness of a new treatment combination for patients with advanced head and neck squamous cell carcinoma (HNSCC). The study will compare the effects of adding evorpacept (ALX148) to pembrolizumab and chemotherapy against using pembrolizumab and chemotherapy alone. This trial is for patients whose cancer has spread or cannot be surgically removed and who have not yet received treatment for their advanced disease.
Description
This study is designed to test the effectiveness of a new treatment combination for advanced head and neck cancer. It involves using evorpacept (ALX148) along with pembrolizumab and chemotherapy drugs (5FU and platinum) to see if this combination can better control the cancer compared to pembrolizumab and chemotherapy alone. The trial is open-label, meaning both the researchers and participants know which treatments are being given. It includes an initial phase to ensure safety, followed by a randomized phase where participants are assigned to different treatment groups to compare outcomes.
Eligibility Criteria
Inclusion Criteria
- Have advanced head and neck squamous cell carcinoma that has spread or cannot be removed by surgery and has not been treated yet.
- Have good bone marrow function.
- Have good kidney and liver function.
- Be in good overall health, as measured by a standard performance status scale.
Exclusion Criteria
- Have known brain cancer or cancer in the membranes covering the brain that requires steroid treatment.
- Have a history of lung inflammation that needed steroid treatment or currently have lung inflammation.
- Have previously been treated with any drugs targeting CD47 or SIRPα.
- Have previously been treated with drugs targeting PD-1 or PD-L1.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Hoag Hospital | 92618 | Irvine | California |
| University of California San Diego | 92037 | La Jolla | California |
| Cedar Sinai Medical Center | 90048 | Los Angeles | California |
| University of Miami, Sylvester Comprehensive Cancer Center | 33136 | Miami | Florida |
| Moffitt Cancer Center | 33612 | Tampa | Florida |
| Rush University Medical Center | 60612 | Chicago | Illinois |
| University of Louisville | 40202 | Louisville | Kentucky |
| University of Maryland Medical System | 21201 | Baltimore | Maryland |
| Memorial Sloan Kettering | 10021 | New York | New York |
| The Ohio State University | 43235 | Columbus | Ohio |
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