Clinical Trials /

SPEARHEAD 2 Study in Subjects With Recurrent or Metastatic Head and Neck Cancer

NCT04408898

Description:

This is a study to investigate the efficacy and safety of ADP-A2M4 in combination with pembrolizumab in HLA-A*02 eligible and MAGE-A4 positive subjects with recurrent or metastatic Head and Neck cancer.

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

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: SPEARHEAD 2 Study in Subjects With Recurrent or Metastatic Head and Neck Cancer
  • Official Title: A Phase 2 Pilot Study of ADP-A2M4 in Combination With Pembrolizumab in Subjects With Recurrent or Metastatic Head and Neck Cancer

Clinical Trial IDs

  • ORG STUDY ID: ADP 0044-003
  • NCT ID: NCT04408898

Conditions

  • Head and Neck Cancer

Purpose

This is a study to investigate the efficacy and safety of ADP-A2M4 in combination with pembrolizumab in HLA-A*02 eligible and MAGE-A4 positive subjects with recurrent or metastatic Head and Neck cancer.

Trial Arms

NameTypeDescriptionInterventions
ADP-A2M4 T cells in combination with pembrolizumabExperimental

    Eligibility Criteria

            Key Inclusion Criteria
    
              -  Age ≥18 and <75 years
    
              -  Diagnosis of head and neck squamous cell carcinoma with metastatic or unresectable,
                 recurrent disease. confirmed by cytogenetics.
    
              -  Checkpoint inhibitor naïve and may have received prior platinum containing
                 chemotherapy regimen.
    
              -  Measurable disease according to RECIST v1.1.
    
              -  HLA-A*02 positive
    
              -  Tumor shows MAGE-A4 expression confirmed by central laboratory.
    
              -  Tumors express PD-L1 [CPS ≥1]
    
              -  ECOG Performance Status of 0 or 1.
    
              -  Left ventricular ejection fraction (LVEF) ≥50%.
    
            Note: other protocol defined Inclusion criteria may apply
    
            Key Exclusion Criteria:
    
              -  Positive for any HLA-A*02 allele other than: one of the inclusion alleles,
                 HLA-A*02:07P or HLA-A*02 null alleles
    
              -  History of allergic reactions attributed to compounds of similar chemical or biologic
                 composition to fludarabine, cyclophosphamide or other agents used in the study or
                 history of severe hypersensitivity to another monoclonal antibody.
    
              -  History of autoimmune or immune mediated disease
    
              -  Leptomeningeal disease, carcinomatous meningitis or CNS metastases.
    
              -  Other prior malignancy that is not considered by the Investigator to be in complete
                 remission
    
              -  Clinically significant cardiovascular disease
    
              -  Uncontrolled intercurrent illness
    
              -  Active infection with human immunodeficiency virus, hepatitis B virus, hepatitis C
                 virus, or human T cell leukemia virus
    
              -  Pregnant or breastfeeding
    
            Note: other protocol defined Exclusion criteria may apply.
          
    Maximum Eligible Age:75 Years
    Minimum Eligible Age:18 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Efficacy: Overall Response Rate (ORR)
    Time Frame:2.5 years
    Safety Issue:
    Description:ORR is defined as the proportion of complete responses or partial responses as assessed by RECIST v1.1

    Secondary Outcome Measures

    Measure:Best overall response (BOR)
    Time Frame:2.5 years
    Safety Issue:
    Description:BOR defined as the best response recorded from the date of T cell infusion until disease progression.
    Measure:Time to response (TTR)
    Time Frame:2.5 years
    Safety Issue:
    Description:TTR defined as the duration between T cell infusion and the initial date of the confirmed response.
    Measure:Duration of response (DoR)
    Time Frame:2.5 years
    Safety Issue:
    Description:DoR defined as the duration from the initial date of the confirmed response to the date of PD (or death).
    Measure:Duration of stable disease (DoSD)
    Time Frame:2.5 years
    Safety Issue:
    Description:DoSD defined as the duration from the date of T cell infusion to the date of PD (or death).
    Measure:Progression- free survival (PFS)
    Time Frame:2.5 years
    Safety Issue:
    Description:PFS defined as the interval between the date T cell infusion and the earliest date of disease progression based on RECIST v1.1 or death due to any cause.
    Measure:Overall survival (OS)
    Time Frame:2.5 years
    Safety Issue:
    Description:OS defined the duration between T cell infusion and death due to any cause.
    Measure:To evaluate the safety and tolerability of ADP-A2M4 with pembrolizumab by determining incidence of Adverse events (AEs) including serious adverse events (SAEs)
    Time Frame:2.5 years
    Safety Issue:
    Description:Determination of incidence, severity and duration of adverse events through assessment of adverse events including SAEs. Adverse events will be collected and graded as per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
    Measure:To evaluate the safety and tolerability of ADP-A2M4 with pembrolizumab by determining the incidence, severity and duration of the AEs of special interest
    Time Frame:2.5 years
    Safety Issue:
    Description:Adverse events of special interest will be listed along with duration and toxicity grade.
    Measure:To evaluate safety of ADP-A2M4 with pembrolizumab through measurement of Replication-competent Lentivirus in genetically engineered T-cells
    Time Frame:15 years
    Safety Issue:
    Description:Evaluation of RCL using PCR-based assay in peripheral blood.

    Details

    Phase:Phase 2
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Adaptimmune

    Trial Keywords

    • Cell Therapy
    • T-cell Therapy
    • SPEAR T-Cell
    • Head and Neck Cancer
    • MAGE-A4
    • ADP-A2M4
    • Immuno-oncology

    Last Updated

    July 16, 2020