A Phase 1 Study in Patients With HPV16+ Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

85

Participants

Timeline

Start Date

July 30, 2019

Primary Completion Date

January 31, 2026

Study Completion Date

January 31, 2026

Conditions
Head and Neck CancerHPV Positive Oropharyngeal Squamous Cell CarcinomaHPV-Related Carcinoma
Interventions
DRUG

CUE-101

CUE-101 is a novel biologic to treat HPV - driven recurrent / metastatic head and neck cancer given as monotherapy in parts A\&B and in combination in Parts C\&D according to the schedule described in the protocol.

DRUG

KEYTRUDA®, Pembrolizumab

KEYTRUDA® is first-line therapy in HPV16 and HLA A\*0201-positive recurrent and/or metastatic HNSCC patients given in combination with CUE-101 in Parts C\&D according to the schedule described in the protocol.

Trial Locations (17)

10017

Memorial Sloan Kettering Cancer Center, New York

20037

George Washington University Cancer Center, Washington D.C.

20231

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore

30322

Emory University School of Medicine, Atlanta

33612

Moffitt Cancer Center, Tampa

Affiliated Oncologists, LLC, Chicago

37232

Vanderbilt-Ingram Cancer Center (VICC), Nashville

44718

Gabrail Cancer Center, Canton

48197

University of Michigan, Ann Arbor

48201

Barbara Karmanos Cancer Center/ Wayne State University School of Medicine, Detroit

63110

Washington University, St Louis

77030

University of Texas MD Anderson Cancer Center, Houston

85719

University of Arizona, Tucson

94305

Stanford University Medical Center, Palo Alto

98195

University of Washington School of Medicine, Seattle

06510

Yale School of Medicine, New Haven

02114

Massachusetts General Hospital, Boston

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

Cue Biopharma

INDUSTRY

NCT03978689 - A Phase 1 Study in Patients With HPV16+ Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma | Biotech Hunter | Biotech Hunter