RecruitingPhase 3NCT06699212

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

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

Sponsor

Rakuten Medical, Inc.

Enrollment

412 participants

Start Date

Dec 24, 2024

Study Type

INTERVENTIONAL

Conditions

Recurrent Head and Neck Squamous Cell Carcinoma

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a light-activated treatment called photoimmunotherapy (ASP-1929) combined with the immunotherapy drug pembrolizumab can improve outcomes for people with head and neck squamous cell carcinoma (cancer of the throat, mouth, or voice box area) that has come back locally. **You may be eligible if...** - You have squamous cell carcinoma in a head and neck area (not the nasopharynx), confirmed by biopsy - Your cancer has returned locally but has not spread to distant parts of the body - You have not previously received PD-1 or PD-L1 immunotherapy - Your tumor is accessible for the light treatment procedure - Your tumor tests positive for the relevant immune marker (CPS score of 1 or higher) **You may NOT be eligible if...** - Your cancer has spread to distant organs - You have previously received anti-PD-1 or anti-PD-L1 therapy - You have active autoimmune disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTASP-1929 Photoimmunotherapy

ASP-1929 IV infusion followed by illumination with light dose of 50 J/cm\^2 for superficial lesions and 100 J/cm for interstitial lesions within 24 +/- 4 hours after the end of ASP-1929 infusion (up to 24 months)

BIOLOGICALPembrolizumab

200 mg Q3W or 400 mg Q6W, IV infusion over 30 minutes (up to 24 months)

DRUGCarboplatin

Area under the curve (AUC) 5 mg/mL/min IV infusion, Q3W up to 6 cycles

DRUGCisplatin

100 mg/m\^2 IV infusion, Q3W up to 6 cycles

DRUG5-fluorouracil

1000 mg/m\^2 per day from Days 1-4 of each cycle, IV infusion, Q3W up to 6 cycles

DRUGPaclitaxel

100 mg/m\^2 IV infusion given on Days 1 and 8, Q3W up to 6 cycles or 175 mg/m\^2 IV infusion given on Day 1, Q3W up to 6 cycles

DRUGDocetaxel

75 mg/m\^2 IV Infusion, Q3W up to 6 cycles

Locations(22)

City of Hope

Duarte, California, United States

University of Miami

Miami, Florida, United States

Tampa General Hospital

Tampa, Florida, United States

University of Kentucky Medical Center

Lexington, Kentucky, United States

Thomas Jefferson University, Sidney Kimmel Cancer Center

Philadelphia, Pennsylvania, United States

Rhode Island Hospital

Providence, Rhode Island, United States

Avera Cancer Institute

Sioux Falls, South Dakota, United States

University of Texas, MD Anderson Cancer Center

Houston, Texas, United States

Aichi Cancer Center

Aichi, Japan

Hiroshima University Hospital

Hiroshima, Japan

Kyoto Prefectural University of Medicine

Kyoto, Japan

Tokyo Medical University Hospital

Tokyo, Japan

Tottori University Hospital

Yonago, Japan

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

China Medical University

Taichung, Taiwan

Taichung Veterans General Hospital

Taichung, Taiwan

Chi Mei Hospital

Tainan, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

MacKay Memorial Hospital

Taipei, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

Taipei Municipal Wanfang Hospital

Taipei, Taiwan

Linkou Chang Gung Memorial Hospital

Taoyuan City, Taiwan

View Full Details on ClinicalTrials.gov

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