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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.

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.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Combination Product: ASP-1929 Drug: Physician's Choice SOC Phase 3

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)


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 275 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : May 15, 2019
Estimated Primary Completion Date : December 15, 2020
Estimated Study Completion Date : December 15, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: ASP-1929 Combination Product: ASP-1929
Use of ASP-1929 PIT therapy

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
Drug: Physician's Choice SOC
Use of docetaxel, cetuximab or methotrexate




Primary Outcome Measures :
  1. Progression-Free Survival [ Time Frame: 24 months ]
    Time to progression of disease

  2. Overall survival [ Time Frame: 24 months ]
    Duration of survival between the two treatment arms



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03769506


Locations
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United States, Minnesota
Virginia Piper Cancer Institute, Part of Allina Health Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Stephanie Erickson    612-863-1752    stephanie.erickson2@allina.com   
United States, Oregon
Providence Portland Medical Center Recruiting
Portland, Oregon, United States, 97213
Contact: George Morris    503-215-7503    george.morris@providence.org   
Sponsors and Collaborators
Rakuten Aspyrian, Inc.
Investigators
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Study Director: Merrill Biel, MD, Ph.D. Rakuten Aspyrian, Inc.

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Responsible Party: Rakuten Aspyrian, Inc.
ClinicalTrials.gov Identifier: NCT03769506     History of Changes
Other Study ID Numbers: ASP-1929-301
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Keywords provided by Rakuten Aspyrian, Inc.:
ASP-1929 Head and Neck Cancer Locoregional PIT Rakuten Aspyrian

Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Docetaxel
Methotrexate
Cetuximab
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Antineoplastic Agents, Immunological