NCT06790966 - Phase 3 Study of PDS0101 and Pembrolizumab in HPV16+ Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma | Biotech Hunter

Enrollment

351

Participants

Timeline

Start Date

May 30, 2025

Primary Completion Date

February 28, 2029

Study Completion Date

February 28, 2029

Conditions

Recurrent Head and Neck CancerMetastatic Head and Neck CancerHPV Positive Oropharyngeal Squamous Cell CarcinomaNeoplasms, Head and NeckUnresectable Head and Neck Squamous Cell Carcinoma

Interventions

COMBINATION_PRODUCT

Combination Treatment of PDS0101 and Pembrolizumab

"* Pembrolizumab (IV) every 3 weeks for up to 35 Cycles~* PDS0101 (SC) during Cycles 1, 2, 3, 4, and 12"

DRUG

Pembrolizumab Monotherapy

Pembrolizumab (IV) every 3 weeks for up to 35 cycles.

Trial Locations (21)

19103

RECRUITING

Fox Chase Cancer Center, Philadelphia

21201

RECRUITING

University of Maryland, Baltimore

22903

RECRUITING

University of Virginia Health System, Charlottesville

23502

RECRUITING

Virginia Oncology Associates, Norfolk

26506

RECRUITING

West Virginia University Cancer Center, Morgantown

32224

RECRUITING

Mayo Clinic Florida, Jacksonville

32827

RECRUITING

SCRI - Florida Cancer Specialists, Orlando

34474

RECRUITING

Florida Cancer Affiliates - Ocala Oncology, Ocala

37920

RECRUITING

University of Tennessee Medical Center, Knoxville

40202

RECRUITING

University of Louisville, Louisville

43210

RECRUITING

The Ohio State University- James Cancer Hospital, Columbus

48201

RECRUITING

Karmanos Cancer Institute, Detroit

55905

RECRUITING

Mayo Clinic Rochester, Rochester

75702

RECRUITING

Texas Oncology-Northeast Texas, Tyler

78229

RECRUITING

UT Health San Antonio, San Antonio

78705

RECRUITING

Texas Oncology, Austin

85054

RECRUITING

Mayo Clinic Arizona, Phoenix

92686

RECRUITING

University of California, Orange, Orange

94904

RECRUITING

Marin Cancer Care, Greenbrae

06510

RECRUITING

Yale University, New Haven

27599-7025

RECRUITING

University of North Carolina, Chapel Hill