NCT06699212View on ClinicalTrials.gov

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

PHASE3RecruitingINTERVENTIONAL
Enrollment

412

Participants

Timeline

Start Date

December 24, 2024

Primary Completion Date

September 30, 2028

Study Completion Date

September 30, 2028

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

Trial Locations (22)

19107

RECRUITING

Thomas Jefferson University, Sidney Kimmel Cancer Center, Philadelphia

33136

RECRUITING

University of Miami, Miami

33606

RECRUITING

Tampa General Hospital, Tampa

40536

WITHDRAWN

University of Kentucky Medical Center, Lexington

57105

RECRUITING

Avera Cancer Institute, Sioux Falls

77030

RECRUITING

University of Texas, MD Anderson Cancer Center, Houston

91010

RECRUITING

City of Hope, Duarte

100225

RECRUITING

National Taiwan University Hospital, Taipei

104217

RECRUITING

MacKay Memorial Hospital, Taipei

112201

RECRUITING

Taipei Veterans General Hospital, Taipei

116081

RECRUITING

Taipei Municipal Wanfang Hospital, Taipei

333423

RECRUITING

Linkou Chang Gung Memorial Hospital, Taoyuan

404327

RECRUITING

China Medical University, Taichung

407219

RECRUITING

Taichung Veterans General Hospital, Taichung

736402

RECRUITING

Chi Mei Hospital, Tainan City

807377

RECRUITING

Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City

02903

RECRUITING

Rhode Island Hospital, Providence

464-8681

RECRUITING

Aichi Cancer Center, Aichi

734-8551

RECRUITING

Hiroshima University Hospital, Hiroshima

602-8566

RECRUITING

Kyoto Prefectural University of Medicine, Kyoto

160-0023

RECRUITING

Tokyo Medical University Hospital, Tokyo

683-8504

RECRUITING

Tottori University Hospital, Yonago

All Listed Sponsors
lead

Rakuten Medical, Inc.

INDUSTRY