Vaccine Therapy and Pembrolizumab in Treating Patients With Solid Tumors That Have Failed Prior Therapy

Hepatocellular Carcinoma Clinical Trial

Official title: A Phase I Study of a p53MVA Vaccine in Combination With Pembrolizumab

Status Active, not recruiting

Clinical Trial Summary

This phase I trial studies the side effects of vaccine therapy and pembrolizumab in treating patients with solid tumors that have spread to other places in the body and usually cannot be cured or controlled with treatment, that have failed prior therapy, and that cannot be removed by surgery. Vaccines made from a gene-modified virus may help the body build an effective immune response to kill tumor cells. Monoclonal antibodies, such as pembrolizumab, may block tumor growth in different ways by targeting certain cells. Giving vaccine therapy together with pembrolizumab may be a better treatment in patients with solid tumors.

Clinical Trial Description

PRIMARY OBJECTIVES:

I. To determine the safety and tolerability of combined p53MVA vaccine (modified vaccinia virus Ankara vaccine expressing p53) and pembrolizumab that are well-tolerated in patients with refractory, tumor protein 53 (p53) over expressing cancer.

SECONDARY OBJECTIVES:

I. To evaluate clinical response and anti-p53 T cell immune responses.

OUTLINE: Patients receive pembrolizumab intravenously (IV) over 30 minutes followed by modified vaccinia virus Ankara vaccine expressing p53 subcutaneously (SC) at least 30 minutes later once in weeks 1, 4, and 7.

Patients may receive additional doses of pembrolizumab in weeks 10, 13, 16, and 19, for a maximum of 7 doses if there are no signs of progressive disease. Treatment continues in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up periodically. ;

Related Conditions & MeSH terms

• Adult Solid Neoplasm
• Bladder Carcinoma
• Breast Neoplasms
• Carcinoma
• Carcinoma, Non-Small-Cell Lung
• Colon Carcinoma
• Estrogen Receptor Negative
• Head and Neck Squamous Cell Carcinoma
• Hepatocellular Carcinoma
• HER2/Neu Negative
• Melanoma
• Neoplasms
• Non-Small Cell Lung Carcinoma
• Pancreatic Carcinoma
• Pancreatic Neoplasms
• Progesterone Receptor Negative
• Rectal Carcinoma
• Renal Cell Carcinoma
• Sarcoma
• Soft Tissue Sarcoma
• Squamous Cell Carcinoma of Head and Neck
• TP53 Gene Mutation
• Triple-Negative Breast Carcinoma
• Unresectable Solid Neoplasm
• Urinary Bladder Neoplasms

• NCT number: NCT02432963
• Study type: Interventional
• Source: City of Hope Medical Center
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: June 14, 2016
• Completion date: December 31, 2024