Clinical Trials /

Photoimmunotherapy (PIT) Study in Recurrent Head/Neck Cancer for Patients Who Have Failed at Least Two Lines of Therapy

NCT03769506

Description:

This study will evaluate the efficacy and safety of ASP-1929 Photoimmunotherapy as a monotherapy for the treatment of locoregional, recurrent head and neck squamous cell carcinoma in patients who have failed or progressed on or after at least two lines of therapy.

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

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Photoimmunotherapy (PIT) Study in Recurrent Head/Neck Cancer for Patients Who Have Failed at Least Two Lines of Therapy
  • Official Title: Phase 3 Randomized, Double-Arm, Open-Label, Controlled Trial of ASP-1929 Photoimmunotherapy Versus Standard of Care for Locoregional Recurrent Head/Neck Squamous Cell Carcinoma in Patients Who Have Failed After at Least Two Lines of Therapy

Clinical Trial IDs

  • ORG STUDY ID: ASP-1929-301
  • NCT ID: NCT03769506

Conditions

  • Head and Neck Cancer

Interventions

DrugSynonymsArms
Physician's Choice SOCPhysician's Choice SOC - docetaxel, cetuximab, methotrexate

Purpose

This study will evaluate the efficacy and safety of ASP-1929 Photoimmunotherapy as a monotherapy for the treatment of locoregional, recurrent head and neck squamous cell carcinoma in patients who have failed or progressed on or after at least two lines of therapy.

Detailed Description

      The study will have an Experimental Arm and a Control Arm.

      Experimental Arm:

      Patients may receive repeated ASP-1929 PIT interventions for a period of up to 12 months
      after randomization until one of the following outcomes is noted:

        -  The target and non-target tumor(s) achieve a complete remission

        -  The progressive disease is no longer amenable to further study interventions

        -  The patient experiences intolerable side effects or chooses to withdraw. Repeat
           intervention cycles should be administered ≥ 4 weeks from the prior ASP-1929 infusion.
           For recurrent or new target and non-target tumor(s), intervention cycles should be
           administered within 28 days of clinical, pathological, or radiological confirmation of
           recurrent or new target and non-target tumor(s).

      Control Arm:

      Patients may be treated with physician's choice SOC until the following outcome is noted:

      • Progressive Disease (PD) (SOC arm only)
    

Trial Arms

NameTypeDescriptionInterventions
ASP-1929Active Comparator
    Physician's Choice SOC - docetaxel, cetuximab, methotrexateActive Comparatordocetaxel 30 mg/m² IV every week, or docetaxel 40 mg/m² IV every week, or docetaxel 60 mg/m² IV every 3-4 weeks, or docetaxel 75 mg/m² IV every 3-4 weeks cetuximab 400 mg/m² IV loading dose followed by weekly 250 mg/m² IV, or methotrexate 40 mg/m² IV every week, or methotrexate 60 mg/m² IV every week
    • Physician's Choice SOC

    Eligibility Criteria

            Inclusion Criteria including but not limited to:
    
              -  Patients with histologically confirmed locoregional persistent, recurrent or second
                 primary squamous cell carcinoma of the head and neck, not amenable to curative
                 treatment.
    
              -  Patient must have failed or progressed on or after at least 2 lines of therapy for
                 squamous cell carcinoma of the head and neck, one of which must be prior systemic
                 chemotherapy for treatment of their primary or recurrent head and neck cancer.
    
              -  Patients must have completed prior curative radiation therapy for treatment of their
                 head and neck cancer.
    
              -  All locoregional head and neck tumor site(s) are accessible for light illumination
                 treatment.
    
              -  Target tumors are clearly measurable by contrast enhanced CT scan.
    
              -  Life expectancy > 6 months.
    
              -  Male patients at least 18 years old.
    
              -  Female patients at least 18 years old.
    
              -  Patients must have an ECOG score of 0 - 1.
    
              -  Patients must understand the investigational nature of the trial, be willing to sign a
                 written informed consent, and be willing to comply with all study procedures and
                 follow-up.
    
            Exclusion Criteria including but not limited to:
    
              -  Patients with a history of significant (≥ Grade 3) cetuximab infusion reactions.
    
              -  Patients who have been treated with prior systemic chemotherapy or targeted small
                 molecule therapy or radiation therapy within 2 weeks of trial Day 1 or who have not
                 recovered from adverse events due to previously administered agent.
    
              -  Patients who have been treated with an anticancer monoclonal antibody therapy within 4
                 weeks of trial Day 1 or who have not recovered from adverse events due to previously
                 administered agent.
    
              -  Patients who have been treated with an investigational agent or intervention within 4
                 weeks of trial Day 1 or who have not recovered from adverse events, due to previously
                 administered agent or intervention.
    
              -  Present history of distant metastatic disease (M1).
    
              -  Patients who are actively undergoing treatment of or have a diagnosis of an active
                 cancer other than nonmelanoma skin cancer or HNSCC.
    
              -  Tumor invading a major blood vessel unless the vessel has been embolized, stented or
                 surgically ligated to prevent potential bleeding from a blood vessel.
    
              -  Patients must have a Hemoglobin ≥ 9.0 g/dL, WBC ≥ 2000/μL, and Platelets ≥ 100 x
                 10³/μL.
    
              -  Patients with impaired hepatic function.
    
              -  Patients with impaired renal function.
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Progression-Free Survival
    Time Frame:24 months
    Safety Issue:
    Description:Time to progression of disease

    Details

    Phase:Phase 3
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Rakuten Aspyrian, Inc.

    Trial Keywords

    • ASP-1929 Head and Neck Cancer Locoregional PIT Rakuten Aspyrian

    Last Updated