NCT02432963

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

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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
OTHER	Laboratory Biomarker Analysis	Correlative studies
BIOLOGICAL	Modified Vaccinia Virus Ankara Vaccine Expressing p53	Given SC
BIOLOGICAL	Pembrolizumab	Given IV

Timeline

• Start date: 2016-06-14
• Primary completion: 2017-12-04
• Completion: 2026-10-02
• First posted: 2015-05-04
• Last updated: 2026-01-28

Locations

1 site across 1 country: United States