NCT04260126 - Study of PDS0101 and Pembrolizumab Combination I/O in Subjects With HPV16 + Recurrent and/or Metastatic HNSCC | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

March 29, 2021

Primary Completion Date

May 14, 2025

Study Completion Date

May 14, 2025

Conditions

Metastatic Head and Neck CancerRecurrent Head and Neck CancerHPV Positive Oropharyngeal Squamous Cell CarcinomaNeoplasms, Head and Neck

Interventions

COMBINATION_PRODUCT

Pembrolizumab (KEYTRUDA®) and PDS0101

IV infusion of pembrolizumab 200 mg + two 0.5mL sub-cutaneous injections of PDS0101 administered on Cycle 1, 2, 3, 4 and 12. IV infusion of Pembrolizumab 200 mg monotherapy will be administered Cycles 5 - 11 and 13 - 35.

Trial Locations (23)

19111

Fox Chase Cancer Center, Philadelphia

21201

University of Maryland Greenebaum Comprehensive Cancer Center, Baltimore

22908

The University of Virginia, Charlottesville

26506

West Virginia University, Morgantown

27599

University of North Carolina, Chapel Hill

29425

Medical University of South Carolina Hollings Cancer Center, Charleston

32224

Mayo Clinic, Jacksonville

33331

Cleveland Clinic Florida, Weston

37920

University of Tennessee, Knoxville

40536

University of Kentucky Chandler Medical Center - Markey Cancer Center, Lexington

43210

Ohio State University, Columbus

48109

University of Michigan, Ann Arbor

48201

Barbara Ann Karmanos Cancer Institute, Detroit

55902

Mayo Clinic, Rochester

75246

Texas Oncology - Sammons Cancer Center, Dallas

94158

University of California San Francisco, San Francisco

94904

Marin Cancer Center, Greenbrae

07962

Atlantic Health, Morristown

D08NHY1

St. James Hospital, Dublin

00927

FDI Clinical Research, San Juan

SW3 6JJ

The Royal Marsden NHS Foundation Trust (Chelsea), Chelsea

SM2 5PT

The Royal Marsden NHS Foundation Trust (Sutton), Sutton

UK EH4 2XU

Edinburgh Cancer Centre, Edinburgh