Efficacy and Safety Trial of ADU-S100 and Pembrolizumab in Head and Neck Cancer

Purpose

ADU-CL-20 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.

Conditions

  • Metastatic Head and Neck Cancer
  • Recurrent Head and Neck Cancer

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Histological or cytological confirmation of recurrent or metastatic HNSCC - Measurable disease as defined by RECIST v1.1 - PD-L1 positive

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
ADU-S100 and pembrolizumab 		All eligible subjects will receive intravenous (IV) infusions of pembrolizumab and intratumoral injections of ADU-S100.
  • Drug: ADU-S100
    intratumoral
    Other names:
    • MIW815

More Details

Status
Terminated
Sponsor
Chinook Therapeutics, Inc. (formerly Aduro)

Study Contact