A Phase II Study of ALX148 plus Pembrolizumab Immunotherapy and Chemotherapy in People with Advanced Head and Neck Cancer

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Full 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/AT148004)

Purpose

Combining pembrolizumab immunotherapy with chemotherapy is a standard treatment for squamous cell cancer of the head and neck. In this study, researchers are assessing the safety and effectiveness of adding the investigational drug ALX148 to this treatment in people with advanced head and neck cancer.

ALX148 works by blocking a protein called CD47. By blocking this protein, ALX148 may improve the immune response against cancer cells and help other treatments work effectively against head and neck cancer.

Participants in this study will receive pembrolizumab and chemotherapy with or without ALX148. All of these treatments are given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have head and neck cancer that cannot be removed with surgery, has come back after treatment, or has spread (metastasized).
  • Patients may not have received treatment for advanced head and neck cancer.
  • At least 2 weeks must pass since the completion of prior radiation therapy and 4 weeks since chemotherapy and receipt of the study treatment. Previous immunotherapy is not allowed.
  • Patients must be physically well enough that they are able to be mobile, take care of themselves, and engage in all but physically strenuous activities. For example, they must be well enough that they could carry out office work or light housework
  • This study is for people age 18 and older.

For more information about this study and to ask about eligibility, please contact Dr. Loren Michel at 646-689-2584.

Protocol

21-363

Phase

II

Investigator

Co-Investigators