NCT03003195

The P10s-PADRE Basket Trial: Vaccination of Metastatic Cancer Patients

A Combined Phase I/II Study of a Carbohydrate Mimotope-Based Vaccine with MONTANIDE™ ISA 51 VG STERILE for Metastatic Cancer

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Arkansas · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the clinical efficacy of an investigational agent, P10s-PADRE, a peptide mimotope-based vaccine in subjects with metastatic cancer.

Detailed description

After signing Institutional Review Board (IRB) approved consent, subjects with metastatic cancer will be enrolled. The vaccine doses will be prepared and dispensed by the University of Arkansas for Medical Sciences (UAMS) Pharmacy following the manufacturer's instructions. Subjects will receive 1.0 mL subcutaneous injections of the vaccine on 4 separate occasions. The vaccine will be administered at rotating sites on the limbs or abdomen. The study will last approximately 12 months.

Conditions

• Neoplasms by Site
• Metastatic Cancer

Interventions

Type	Name	Description
DRUG	P10s-PADRE	All research participants will receive the Mimotope P10s-PADRE/MONTANIDE ISA 51 VG vaccine via subcutaneous (SC) injection for a total of 4 vaccinations.

Timeline

• Start date: 2021-03-01
• Primary completion: 2021-03-01
• Completion: 2021-03-01
• First posted: 2016-12-26
• Last updated: 2024-09-03

Regulatory

• FDA-regulated drug study