Clinical Trial 21078
- Cancer Type: Head & Neck
- Study Type: Treatment
- NCT#: NCT04675333
- Phase: Phase II
- Principal Investigator: Chung, Christine
- 813-745-6100
- Or 1-800-679-0775
-
Overview
Study Title:
A Phase 2 Study of ALX148 in Combination with Pembrolizumab and chemotherapy in Patients with Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-04)
Summary:
A Phase 2 Study of Evorpacept (ALX148) in Combination With Pembrolizumab and Chemotherapy in Patients With Advanced Head and Neck Squamous Cell Carcinoma.
Objective:
Primary Objective * To assess the effect of ALX148 plus pembrolizumab + chemotherapy on overall response rate (ORR) in patients with metastatic or unresectable, recurrent HNSCC who have not yet been treated for their advanced disease. Secondary Objectives * To assess secondary measures of efficacy for ALX148 administered in combination with pembrolizumab + chemotherapy and for pembrolizumab + chemotherapy alone. * To assess the safety and tolerability of ALX148 administered in combination with pembrolizumab + chemotherapy and for pembrolizumab + chemotherapy alone.
-
Treatments
Therapies:
Immunotherapy; Therapy (NOS)
Medications:
5-fluorouracil (); ALX148 (); Paraplatin (carboplatin); Pembrolizumab (Keytruda); carboplatin (); cisplatin ()
-
Inclusion Criteria
- Inclusion Criteria:
- Previously untreated metastatic or unresectable, recurrent head and neck squamous cell carcinoma.
- Adequate bone marrow function.
- Adequate renal and liver function.
- Adequate ECOG performance status.
- Other criteria may apply
-
Exclusion Criteria
- Exclusion Criteria:
- Patients with known symptomatic CNS metastases or leptomeningeal disease requiring steroids.
- History of (non-infectious) pneumonitis that required steroids or current pneumonitis.
- Prior treatment with any anti-CD47 or anti-SIRPα agent.
- Prior treatment with anti-PD-1 or PD-L1
- Other criteria may apply
If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.