Vaccine Therapy and Pembrolizumab in Treating Patients With Solid Tumors That Have Failed Prior Therapy
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 12
Summary
- Conditions
- Colon Carcinoma
- Adult Solid Neoplasm
- TP53 Gene Mutation
- Triple-Negative Breast Carcinoma
- Soft Tissue Sarcoma
- Bladder Carcinoma
- Unresectable Solid Neoplasm
- Estrogen Receptor Negative
- Head and Neck Squamous Cell Carcinoma
- Hepatocellular Carcinoma
- HER2/Neu Negative
- Melanoma
- Renal Cell Carcinoma
- Non Small Cell Lung Carcinoma
- Pancreatic Carcinoma
- Progesterone Receptor Negative
- Rectal Carcinoma
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 evaluat...
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.
Tracking Information
- NCT #
- NCT02432963
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Vincent Chung City of Hope Medical Center
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