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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

NCT06699212 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 412

Last updated 2025-10-15

No results posted yet for this study

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.

Conditions

  • Recurrent Head and Neck Squamous Cell Carcinoma

Interventions

COMBINATION_PRODUCT

ASP-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)

BIOLOGICAL

Pembrolizumab

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

DRUG

Carboplatin

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

DRUG

Cisplatin

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

DRUG

5-fluorouracil

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

DRUG

Paclitaxel

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

DRUG

Docetaxel

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

Sponsors & Collaborators

  • Rakuten Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Ethan Chen, MD · Rakuten Medical, Inc.

  • Rebecca Cheng, MD · Rakuten Medical, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-24
Primary Completion
2028-09-30
Completion
2028-09-30
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States
  • Japan
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06699212 on ClinicalTrials.gov