NCT06223568View on ClinicalTrials.gov

Phase II Trial of Neoadjuvant Chemotherapy (NAC) Alone or in Combination With Immunotherapy Vaccine PRGN-2009 in Subjects With Newly Diagnosed HPV-Associated Oropharyngeal (Head and Neck) Cancer

PHASE2RecruitingINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

June 10, 2024

Primary Completion Date

January 10, 2028

Study Completion Date

January 10, 2028

Conditions
Squamous Cell Carcinoma of the Head and NeckOropharynxHuman Papillomavirus VirusesDrug TherapyCancer Vaccine
Interventions
DRUG

Docetaxel

Docetaxel 75 mg/m\^2 will be administered over 60 (+/-10) minutes.

DRUG

Cisplatin

Cisplatin 75 mg/m\^2 will be administered over 120 (+/-10) minutes.

DRUG

PRGN-2009

PRGN-2009 will be administered in Arm 2 participants only as an SQ injection in the arm at a dose of 1 mL nominally containing 5x10\^11 viral particles (VP) on Day -7 (+/-3 days) of Cycle 1, Day 11 (+/-3 days) of Cycles 1, 2, and 3.

Trial Locations (1)

20892

RECRUITING

National Institutes of Health Clinical Center, Bethesda

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH