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New treatment option for Recurrent Head and Neck Squamous Cell Carcinoma
Official title 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
ClinicalTrials.gov ID: NCT06699212
What this study is testing
What is ASP-1929 Photoimmunotherapy?
ASP-1929 Photoimmunotherapy is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for recurrent head and neck squamous cell carcinoma.
Also referred to as cetuximab sarotalocan, PIT690 Laser System.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histological or cytological evidence of squamous cell carcinoma of a head and neck primary site (per American Joint Committee on Cancer [AJCC], other...
- 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.
You likely can't join if
- Diagnosed and/or treated for additional malignancy within 2 years before randomization except for those with a negligible risk of metastasis or death...
- 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...
See the full eligibility 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 at the time of screening
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Miami, Florida, United States
- Tampa, Florida, United States
- Lexington, Kentucky, United States
- Philadelphia, Pennsylvania, United States
- Providence, Rhode Island, United States
- Sioux Falls, South Dakota, United States
- Houston, Texas, United States
- Aichi, Japan
- Hiroshima, Japan
- Kyoto, Japan
- Tokyo, Japan
- Yonago, Japan
- Kaohsiung City, Taiwan
- Taichung, Taiwan
- Tainan, Taiwan
- Taipei, Taiwan
- Taoyuan City, Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; Miami, Florida, United States; Tampa, Florida, United States; Lexington, Kentucky, United States; Philadelphia, Pennsylvania, United States; Providence, Rhode Island, United States and 12 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.