Anti-PD-L1/TGF-beta Trap (M7824) Alone and in Combination With TriAd Vaccine and N-803 for Resectable Head and Neck Squamous Cell Carcinoma Not Associated With Human Papillomavirus Infection

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

21

Participants

Timeline

Start Date

June 9, 2020

Primary Completion Date

August 24, 2021

Study Completion Date

June 12, 2023

Conditions
Head and Neck CancerHead and Neck Neoplasms
Interventions
DRUG

M7824

M7824 (1200 mg) will be administered intravenously on day 1 and 15 to patients enrolled in arm 1-3 (all three arms).

DRUG

N803

N-803 (15 mcg/kg, subcutaneously) will be given on day 1 to patients enrolled in arm 3.

BIOLOGICAL

TriAd vaccine

TriAd vaccine (5 x 10e(11) viral particles (VP); subcutaneous injection) will be given on day 1 to patients enrolled in arm 2 and arm 3

Trial Locations (1)

20892

National Institutes of Health Clinical Center, Bethesda

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH

NCT04247282 - Anti-PD-L1/TGF-beta Trap (M7824) Alone and in Combination With TriAd Vaccine and N-803 for Resectable Head and Neck Squamous Cell Carcinoma Not Associated With Human Papillomavirus Infection | Biotech Hunter | Biotech Hunter