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

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ClinicalTrials.gov Identifier: NCT03769506
Recruitment Status : Recruiting
First Posted : December 7, 2018
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Rakuten Aspyrian, Inc.

Tracking Information
First Submitted Date  ICMJE December 6, 2018
First Posted Date  ICMJE December 7, 2018
Last Update Posted Date April 4, 2019
Estimated Study Start Date  ICMJE May 15, 2019
Estimated Primary Completion Date December 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 28, 2018)
  • Progression-Free Survival [ Time Frame: 24 months ]
    Time to progression of disease
  • Overall survival [ Time Frame: 24 months ]
    Duration of survival between the two treatment arms
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT03769506 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Photoimmunotherapy (PIT) Study in Recurrent Head/Neck Cancer for Patients Who Have Failed at Least Two Lines of Therapy
Official Title  ICMJE 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
Brief Summary 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)

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Head and Neck Cancer
Intervention  ICMJE
  • Combination Product: ASP-1929
    Use of ASP-1929 PIT therapy
  • Drug: Physician's Choice SOC
    Use of docetaxel, cetuximab or methotrexate
Study Arms  ICMJE
  • Active Comparator: ASP-1929
    Intervention: Combination Product: ASP-1929
  • Active Comparator: Physician's Choice SOC - docetaxel, cetuximab, methotrexate
    • docetaxel 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
    Intervention: Drug: Physician's Choice SOC
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 28, 2018)
275
Original Enrollment  ICMJE Not Provided
Estimated Study Completion Date  ICMJE December 15, 2021
Estimated Primary Completion Date December 15, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03769506
Other Study ID Numbers  ICMJE ASP-1929-301
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Rakuten Aspyrian, Inc.
Study Sponsor  ICMJE Rakuten Aspyrian, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Merrill Biel, MD, Ph.D. Rakuten Aspyrian, Inc.
PRS Account Rakuten Aspyrian, Inc.
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP