Vaccine Therapy and Pembrolizumab in Treating Patients With Solid Tumors That Have Failed Prior Therapy
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|ClinicalTrials.gov Identifier: NCT02432963|
Recruitment Status : Active, not recruiting
First Posted : May 4, 2015
Last Update Posted : April 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|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||Other: Laboratory Biomarker Analysis Biological: Modified Vaccinia Virus Ankara Vaccine Expressing p53 Biological: Pembrolizumab||Phase 1|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||19 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of a p53MVA Vaccine in Combination With Pembrolizumab|
|Study Start Date :||November 2015|
|Estimated Primary Completion Date :||February 2020|
|Estimated Study Completion Date :||February 2020|
Experimental: Treatment (p53MVA, pembrolizumab)
Patients receive pembrolizumab IV over 30 minutes followed by modified vaccinia virus Ankara vaccine expressing p53 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.
Other: Laboratory Biomarker Analysis
Biological: Modified Vaccinia Virus Ankara Vaccine Expressing p53
- Tolerability of combined modified vaccinia virus Ankara vaccine expressing p53 and pembrolizumab, using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.3 [ Time Frame: Up to week 20 ]
- Clinical responses, assessed by the modified Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Up to week 19 ]Evaluated using immune-related response criteria (irRECIST, irRC).
- T cell reactivity to p53, assessed by flow cytometry [ Time Frame: Up to week 19 ]Immunosuppressive cell types (MDSC, Tregs) and other selected lymphocyte subsets and markers including PD-1, PDL-1 and PDL-2 will be quantified. The Wilcoxon rank-sum test will be used, and are based on residual re-sampling simulations based on historical AUC values (subtracting baseline) and a hypothesized increase in that AUC.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02432963
|United States, California|
|City of Hope Medical Center|
|Duarte, California, United States, 91010|
|Principal Investigator:||Vincent Chung||City of Hope Medical Center|