Clinical Trials /

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

NCT03937141

Description:

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.

Related Conditions:
  • Head and Neck Squamous Cell Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Efficacy and Safety Trial of ADU-S100 and Anti-PD1 in Head and Neck Cancer
  • Official Title: A Phase 2 Efficacy and Safety Trial of ADU-S100 and Anti-PD1 in Adults With Head and Neck Cancer

Clinical Trial IDs

  • ORG STUDY ID: ADU-CL-20
  • NCT ID: NCT03937141

Conditions

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

Interventions

DrugSynonymsArms
ADU-S100MIW815

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.

Trial Arms

NameTypeDescriptionInterventions

Eligibility Criteria

        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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure: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
Time Frame:25 months
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Aduro Biotech, Inc.

Last Updated