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

Phase 2TerminatedNCT03937141

Chinook Therapeutics, Inc. (formerly Aduro)16 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Metastatic Head and Neck Cancer Recurrent Head and Neck Cancer

Interventions

ADU-S100DRUG

intratumoral

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (17)

University of Alabama Comprehensive Cancer Center

Birmingham, Alabama, United States

University of Arizona Cancer Center

Tucson, Arizona, United States

Outcomes

Primary Outcomes

Evaluation of Clinical Activity by the Objective Response Rate (ORR; Complete Response [CR] and Partial Response [PR]) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

To determine ORR of ADU-S100 in combination with pembrolizumab in subjects with recurrent or metastatic head and neck squamous cell cancer (HNSCC). ORR is defined as the percentage of subjects with evidence of a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 and as assessed by the investigator.

Time frame: Up to 25 months

Data from ClinicalTrials.gov

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