RECRUITING

A Study of ASP-1929 Photoimmunotherapy in Combination With Pembrolizumab in First-line Treatment of Locoregional Recurrent Squamous Cell Carcinoma of the Head and Neck With No Distant Metastases

Conditions

Recurrent Head and Neck Squamous Cell Carcinoma HNSCC Squamous Cell Carcinoma of Head and Neck Head and Neck Squamous Cell Carcinoma Oral Cavity Squamous Cell Carcinoma Squamous Cell Carcinoma of the Head and Neck immunotherapy medical device laser phototherapy Epidermal Growth Factor Receptor PD-1 Inhibitor Immune Checkpoint Inhibitor Alluminox Rakuten Medical ASP-1929 photoimmunotherapy head and neck

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this clinical trial is to learn if ASP-1929 photoimmunotherapy (PIT) in combination with pembrolizumab works to treat recurrent squamous cell cancer of the head and neck (HNSCC) with no distant metastases. It will also learn about the safety of ASP-1929 PIT in combination with pembrolizumab. Researchers will compare ASP-1929 PIT in combination with pembrolizumab to pembrolizumab alone or pembrolizumab plus chemotherapy (carboplatin or cisplatin, plus 5-fluorouracil or paclitaxel or docetaxel) according to physician's choice (control arm). The overall primary study hypothesis being tested is whether ASP-1929 PIT plus pembrolizumab combination treatment improves the overall survival (OS) of the population defined by the inclusion/exclusion criteria over the control arm.

Official Title

A Phase 3 Multicenter, Randomized, Open-label Study of ASP-1929 Photoimmunotherapy in Combination With Pembrolizumab Versus Standard of Care in the First-line Treatment of Patients With Locoregional Recurrence of Squamous Cell Carcinoma of the Head and Neck (HNSCC) With No Distant Metastases

Quick Facts

Study Start:2024-12-24

Study Completion:2028-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06699212

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Histological or cytological evidence of squamous cell carcinoma of a head and neck primary site (per American Joint Committee on Cancer \[AJCC\], other than nasopharynx or cuSCC). * Appropriate for SOC first-line treatment of their recurrent head and neck cancer with pembrolizumab ± chemotherapy. * No known history of any distant metastatic disease (M1 by AJCC eighth edition). * Tumors with at least one PIT-accessible and RECIST 1.1 measurable lesion as assessed by investigator. * Anti-PD-1 and anti-PD-L1-treatment naïve. * Combined positive score (CPS) ≥ 1 as determined locally by an FDA-approved test * Have results from testing of human papillomavirus (HPV) status for oropharyngeal cancer * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Adequate hematologic, renal, and hepatic organ function * Women of childbearing potential (WOCBP) must have a negative pregnancy test at screening and must be willing to use a highly effective birth control while on study or be surgically sterile or abstain from heterosexual sexual activity for the course of the study through 180 days after the last dose of study treatment. Male patients must agree to use a highly effective method of contraception starting with the first dose of study medication through 120 days after the last dose of study treatment.	* Diagnosed and/or treated for additional malignancy within 2 years before randomization except for those with a negligible risk of metastasis or death (such as adequately treated carcinoma in situ of the cervix, basal cell skin cancer, localized prostate cancer, or ductal carcinoma in situ). Patients with a history of other prior cancer treated with complete surgical resection and with no evidence of disease may be eligible based on discussion with the Medical Monitor. * History of significant (Grade ≥ 3) cetuximab infusion reactions * Prior allogeneic tissue/solid organ transplant * Known or active central nervous system metastases and/or carcinomatous meningitis * Life expectancy of less than 3 months * Active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs); replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment. * Evidence of interstitial lung disease or current active, noninfectious pneumonitis * Active infection requiring systemic therapies such as antibiotic, antifungal, or antiviral intervention * Known or active bacterial, viral, or fungal infection including tuberculosis, Hepatitis B (e.g., HBV DNA is detected), or Hepatitis C (e.g., RNA \[qualitative\] is detected) * Known history of testing positive for human immunodeficiency virus or acquired immunodeficiency syndrome (AIDS)-related illness * Prior or ongoing Grade ≥ 3 tumor hemorrhage within 12 weeks of randomization * Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Prior systemic chemotherapy or targeted small molecule therapy or radiation therapy within 2 weeks of C1D1 or has not recovered (i.e., Grade ≤ 1 or at baseline) from adverse events (AEs) due to previously administered agent * Prior anticancer monoclonal antibody therapy or investigational agent or intervention within 4 weeks of C1D1 or has not recovered (i.e., Grade ≤ 1 or at baseline) from AEs due to previously administered agent * Prior receipt of ASP-1929 at any time * Receiving chronic systemic steroid therapy (in doses exceeding 10 mg per day of prednisone equivalent) or any other form of immunosuppressive therapy within 14 days prior to randomization * Received a live vaccine within 4 weeks of randomization; seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed * Requiring future examinations or treatments within 4 weeks after an ASP-1929 PIT treatment exposing the patient to significant light (e.g., eye examinations, surgical procedures, endoscopy) that is unrelated to the ASP-1929 PIT treatment * Major surgery or significant traumatic injury within 4 weeks before randomization, or anticipation of the need for major surgery during the course of study treatment

Inclusion Criteria

Exclusion Criteria

* Histological or cytological evidence of squamous cell carcinoma of a head and neck primary site (per American Joint Committee on Cancer \[AJCC\], other than nasopharynx or cuSCC).
* Appropriate for SOC first-line treatment of their recurrent head and neck cancer with pembrolizumab ± chemotherapy.
* No known history of any distant metastatic disease (M1 by AJCC eighth edition).
* Tumors with at least one PIT-accessible and RECIST 1.1 measurable lesion as assessed by investigator.
* Anti-PD-1 and anti-PD-L1-treatment naïve.
* Combined positive score (CPS) ≥ 1 as determined locally by an FDA-approved test
* Have results from testing of human papillomavirus (HPV) status for oropharyngeal cancer
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Adequate hematologic, renal, and hepatic organ function
* Women of childbearing potential (WOCBP) must have a negative pregnancy test at screening and must be willing to use a highly effective birth control while on study or be surgically sterile or abstain from heterosexual sexual activity for the course of the study through 180 days after the last dose of study treatment. Male patients must agree to use a highly effective method of contraception starting with the first dose of study medication through 120 days after the last dose of study treatment.

* Diagnosed and/or treated for additional malignancy within 2 years before randomization except for those with a negligible risk of metastasis or death (such as adequately treated carcinoma in situ of the cervix, basal cell skin cancer, localized prostate cancer, or ductal carcinoma in situ). Patients with a history of other prior cancer treated with complete surgical resection and with no evidence of disease may be eligible based on discussion with the Medical Monitor.
* History of significant (Grade ≥ 3) cetuximab infusion reactions
* Prior allogeneic tissue/solid organ transplant
* Known or active central nervous system metastases and/or carcinomatous meningitis
* Life expectancy of less than 3 months
* Active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs); replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.
* Evidence of interstitial lung disease or current active, noninfectious pneumonitis
* Active infection requiring systemic therapies such as antibiotic, antifungal, or antiviral intervention
* Known or active bacterial, viral, or fungal infection including tuberculosis, Hepatitis B (e.g., HBV DNA is detected), or Hepatitis C (e.g., RNA \[qualitative\] is detected)
* Known history of testing positive for human immunodeficiency virus or acquired immunodeficiency syndrome (AIDS)-related illness
* Prior or ongoing Grade ≥ 3 tumor hemorrhage within 12 weeks of randomization
* Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Prior systemic chemotherapy or targeted small molecule therapy or radiation therapy within 2 weeks of C1D1 or has not recovered (i.e., Grade ≤ 1 or at baseline) from adverse events (AEs) due to previously administered agent
* Prior anticancer monoclonal antibody therapy or investigational agent or intervention within 4 weeks of C1D1 or has not recovered (i.e., Grade ≤ 1 or at baseline) from AEs due to previously administered agent
* Prior receipt of ASP-1929 at any time
* Receiving chronic systemic steroid therapy (in doses exceeding 10 mg per day of prednisone equivalent) or any other form of immunosuppressive therapy within 14 days prior to randomization
* Received a live vaccine within 4 weeks of randomization; seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed
* Requiring future examinations or treatments within 4 weeks after an ASP-1929 PIT treatment exposing the patient to significant light (e.g., eye examinations, surgical procedures, endoscopy) that is unrelated to the ASP-1929 PIT treatment
* Major surgery or significant traumatic injury within 4 weeks before randomization, or anticipation of the need for major surgery during the course of study treatment

Contacts and Locations

Study Contact

ASP-1929-381 Study Team

CONTACT

858-207-3113

clinicaltrialinfo@rakuten-med.com

Principal Investigator

Bogdan Veresh, MD

STUDY_DIRECTOR

Rakuten Medical, Inc.

Ethan Chen, MD

STUDY_DIRECTOR

Rakuten Medical, Inc.

Study Locations (Sites)

Cancer Clinic

Tampa, Florida, 33606

United States

Cancer Clinic

Lexington, Kentucky, 40536

United States

Cancer Clinic

Providence, Rhode Island, 02903

United States

Cancer Clinic

Sioux Falls, South Dakota, 57105

United States

Cancer Clinic

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: Rakuten Medical, Inc.

Bogdan Veresh, MD, STUDY_DIRECTOR, Rakuten Medical, Inc.
Ethan Chen, MD, STUDY_DIRECTOR, Rakuten Medical, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-24

Study Completion Date2028-09

Study Record Updates

Study Start Date2024-12-24

Study Completion Date2028-09

Terms related to this study

Keywords Provided by Researchers

HNSCC
Squamous Cell Carcinoma of Head and Neck
Head and Neck Squamous Cell Carcinoma
Oral Cavity Squamous Cell Carcinoma
Squamous Cell Carcinoma of the Head and Neck
immunotherapy
medical device
laser phototherapy
Epidermal Growth Factor Receptor
PD-1 Inhibitor
Immune Checkpoint Inhibitor
Alluminox
Rakuten Medical
ASP-1929
photoimmunotherapy
head and neck

Additional Relevant MeSH Terms

Recurrent Head and Neck Squamous Cell Carcinoma