Evorpacept + Immunotherapy + Chemotherapy for Head and Neck Cancer
Recruiting at44 trial locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: ALX Oncology Inc.
No Placebo Group
Prior Safety Data
Breakthrough Therapy
Trial Summary
What is the purpose of this trial?
A Phase 2 Study of evorpacept (ALX148) in Combination With pembrolizumab and Chemotherapy in Patients With Advanced Head and Neck Squamous Cell Carcinoma.
Research Team
Eligibility Criteria
This trial is for adults with advanced head and neck squamous cell carcinoma who haven't been treated before. They should be physically able to undergo treatment (good ECOG status) and have their major organs like kidneys, liver, and bone marrow working well. People can't join if they've had certain previous cancer treatments or have brain metastases needing steroids.Inclusion Criteria
My kidney and liver are working well.
I am able to care for myself and perform daily activities.
My head or neck cancer has not been treated and cannot be removed by surgery.
See 1 more
Exclusion Criteria
I have brain metastases or leptomeningeal disease and need steroids.
I have been treated with anti-PD-1 or PD-L1 therapy before.
I have not been treated with anti-CD47 or anti-SIRPα agents.
See 1 more
Treatment Details
Interventions
- Cisplatin/Carboplatin; 5FU (Other)
- Evorpacept (Monoclonal Antibodies)
- Pembrolizumab (Monoclonal Antibodies)
Trial OverviewThe study tests Evorpacept combined with Pembrolizumab (an immunotherapy drug) and chemotherapy drugs Cisplatin/Carboplatin; 5FU in patients with advanced head and neck cancer. It's a Phase 2 trial, which means it's checking the effectiveness of this combination therapy.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: evorpacept (ALX148) + pembrolizumab + ChemotherapyExperimental Treatment3 Interventions
evorpacept (ALX148) 45 mg/kg IV, pembrolizumab 200 mg IV, and chemotherapy given every 3 weeks.
Group II: pembrolizumab + ChemotherapyActive Control2 Interventions
pembrolizumab 200 mg IV and chemotherapy given every 3 weeks.
Find a Clinic Near You
Who Is Running the Clinical Trial?
ALX Oncology Inc.
Lead Sponsor
Trials
9
Recruited
1,200+
Merck Sharp & Dohme LLC
Industry Sponsor
Trials
4,096
Recruited
5,232,000+
Chirfi Guindo
Merck Sharp & Dohme LLC
Chief Marketing Officer since 2022
Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme LLC
Chief Executive Officer since 2021
JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University