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 : Not yet recruiting

First Posted : December 7, 2018

Last Update Posted : January 1, 2019

See Contacts and Locations

Sponsor:

Information provided by (Responsible Party):

Rakuten Aspyrian, Inc.

Study Description

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)

Study Design


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 :	January 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

MedlinePlus related topics: Head and Neck Cancer

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

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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.

Contacts and Locations

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

Contacts


Contact: Carla Hekman	844-458-9372	carla.hekman@rakutenaspyrian.com
Contact: Daniela Zaczek	844-458-9372	reginfo@rakutenaspyrian.com

Sponsors and Collaborators

Rakuten Aspyrian, Inc.

More Information


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:	January 1, 2019
Last Verified:	December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No


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:


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

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