Pepinemab in Combination With Pembrolizumab in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

49

Participants

Timeline

Start Date

August 9, 2021

Primary Completion Date

July 24, 2024

Study Completion Date

July 24, 2024

Conditions
Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (HNSCC)
Interventions
DRUG

pepinemab + pembrolizumab

The Safety Run-in phase will begin at 20 mg/kg pepinemab with a fixed dose of 200 mg pembrolizumab. The dose of pepinemab may be reduced to 15 mg/kg or 10 mg/kg with a fixed dose of 200 mg pembrolizumab if the initial pepinemab dose of 20 mg/kg is found to not be well tolerated. Once a recommended phase II dose of pepinemab is determined it will be utilized in the Dose Expansion phase in combination with 200 mg pembrolizumab.

Trial Locations (15)

11042

Northwell Health - Centers for Advanced Medicine, Lake Success

14642

University of Rochester, Rochester

15212

Allegheny General Hospital, Pittsburgh

20817

American Oncology Partners of Maryland, PA, Bethesda

22031

Virginia Cancer Specialists - Fairfax, Fairfax

28806

Messino Cancer Centers, Asheville

30308

Emory Saint Joseph's Hospital, Atlanta

32803

AdventHealth Orlando, Orlando

34747

AdventHealth Celebration, Celebration

44718

Gabrail Cancer Research Center, Canton

63110

Siteman Cancer Center - Washington University Medical Campus, St Louis

72762

Highlands Oncology Group, PA - North Hills, Springdale

93720

California Cancer Associates for Research and Excellence (CCARE)-Fresno, Fresno

94158

UCSF Medical Center at Mission Bay, San Francisco

06510

Yale Cancer Center, New Haven

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

Vaccinex Inc.

INDUSTRY

NCT04815720 - Pepinemab in Combination With Pembrolizumab in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck | Biotech Hunter | Biotech Hunter