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Clinical Trial 20260

Cancer Type: Head & Neck
Study Type: Treatment
NCT#: NCT03937141

Phase: Phase II
Prinicipal Investigator:

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Overview

Study Title

A Phase 2 Efficacy and Safety Trial of ADU-S100 and Pembrolizumab in Adults with Head and Neck Cancer

Summary

This study is an open-label, multicenter Phase 2 clinical trial to evaluate the efficacy and safety of intratumoral ADU-S100 (also referred to as MIW815) administered with pembrolizumab in the first-line setting. The population will consist of adults with PD-L1 positive recurrent or metastatic HNSCC.

Objective

Primary: Evaluate the clinical efficacy of ADUS100 administered in combination with pembrolizumab. Secondary: Characterize safety and tolerability, Further evaluate clinical activity, Characterize the pharmacokinetics (PK) of ADU-S100 administered by intratumoral injection following a single dose and multiple doses. Exploratory: Assess pharmacodynamic, immunomodulatory, and potential prognostic and/or predictive biomarkers and Pharmacogenetic analysis

Treatments

Therapies

Medications

Inclusion Criteria

Inclusion Criteria:

  • Histological or cytological confirmation of recurrent or metastatic HNSCC
  • Measurable disease as defined by RECIST v1.1
  • PD-L1 positive
  • Can provide archival tissue (collected within 90 days prior to start of study treatment) or fresh tumor tissue from a core or excisional biopsy (preferred) for biomarker analyses. [Formalin-fixed, paraffin-embedded (FFPE) block is preferred, or a minimum of 15 unstained, consecutive FFPE slides of one archived block are required (cytology samples from fine needle aspirates are not sufficient)]
  • At least one lesion that is: Superficial (e.g. cutaneous, subcutaneous) and/or nodal, Measures ≥10 millimeters (mm; post-biopsy) and > Adequate organ and marrow function as defined by laboratory parameters outlined in protocol

  • Exclusion Criteria

    Exclusion Criteria:

  • Diagnosis of recurrent or metastatic carcinoma of the nasopharynx, squamous cell carcinoma of unknown primary histology; or salivary gland or non-squamous histologies (e.g. mucosal melanoma)
  • Disease amenable to local therapy with curative intent (surgery or radiation therapy with or without chemotherapy)
  • Prior systemic anti-cancer therapy (use of chemotherapeutic agents, targeted small molecules, immunotherapy, or monoclonal antibodies) for the treatment of recurrent or metastatic HNSCC
  • Other exclusions apply

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