Pembrolizumab, Lenvatinib and IL-15 Superagonist N-803 in Combination With HER2 Targeting Autologous Dendritic Cell (AdHER2DC) Vaccine in Participants With Advanced or Metastatic Endometrial Cancer

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

May 14, 2024

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2028

Conditions
Endometrial CancerCancer of EndometriumCarcinoma of EndometriumEndometrial Carcinoma
Interventions
BIOLOGICAL

AdHER2DC vaccine

AdHER2DC vaccine is given by intradermal injections on Day 1 of cycles 1-3 (priming) followed by optional boost doses (up to 3), on Day 1 of cycles 6, 9, 12

BIOLOGICAL

Pembrolizumab

Pembrolizumab is given by IV infusion on Day 8 of cycle 1 and Day 1 of cycles 2-16

BIOLOGICAL

N-803

N-803 is given by subcutaneous injections on Day 1 of cycles 1-16

DRUG

Lenvatinib

Lenvatinib is taken orally on Days 8-28 on cycle 1 and every day of cycles 2-16

DEVICE

PATHWAY HER2 (4B5) assay

Used during screening to estimate eligibility

Trial Locations (1)

20892

RECRUITING

National Institutes of Health Clinical Center, Bethesda

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH