NCT06046482

Phase II Trial of Magrolimab and Cetuximab With Pembrolizumab or Docetaxel for Recurrent/Metastatic Head Neck Squamous Cell Carcinoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To learn if magrolimab, along with a combination of commercially-available drugs (cetuximab, pembrolizumab, and docetaxel) can help to control HNSCC in combination with other drugs. The safety of magrolimab will also be studied.

Detailed description

Primary Objectives: -Objective response rate (ORR) per RECIST v1.1 Secondary Objectives: * Adverse events rates per CTCAE V5.0 (appendix) * Duration of response (DOR) * Progression free survival (PFS) per RECIST v1.1 * Overall survival (OS) per RECIST v1.1 Exploratory Objectives: -Assessment of blood and tissue-based biomarkers predictive of response to therapy

Conditions

• Head Neck
• Squamous Cell Carcinoma of Head and Neck

Interventions

Type	Name	Description
DRUG	Pembrolizumab	Given by IV (vein)
DRUG	Magrolimab	Given by IV (vein)
DRUG	cetuximab	Given by IV (vein)
DRUG	Docetaxel	Given by IV (vein)

Timeline

• Start date: 2023-11-28
• Primary completion: 2024-08-26
• Completion: 2024-08-26
• First posted: 2023-09-21
• Last updated: 2025-10-22
• Results posted: 2025-10-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study