P53MVA and Pembrolizumab in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
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|ClinicalTrials.gov Identifier: NCT03113487|
Recruitment Status : Not yet recruiting
First Posted : April 13, 2017
Last Update Posted : February 21, 2018
|Condition or disease||Intervention/treatment||Phase|
|PD-L1 Positive Recurrent Fallopian Tube Carcinoma Recurrent Ovarian Carcinoma Recurrent Primary Peritoneal Carcinoma TP53 Gene Mutation||Other: Laboratory Biomarker Analysis Biological: Modified Vaccinia Virus Ankara Vaccine Expressing p53 Biological: Pembrolizumab||Phase 2|
I. To assess response rate (complete response [CR] + partial response [PR]) after treatment with p53MVA and pembrolizumab.
I. To assess median progression free survival (PFS), clinical benefit (CR+PR+ stable disease [SD] > 6 months), overall survival, safety and tolerability and biological correlates which remain exploratory in nature.
OUTLINE: This is a dose-escalation study of modified vaccinia virus ankara vaccine expressing p53.
Patients receive pembrolizumab intravenously (IV) over 30 minutes every 3 weeks and modified vaccinia virus ankara vaccine expressing p53 subcutaneously (SC) every 3 weeks for up to 3 vaccines. Courses with pembrolizumab repeat every 3 weeks for up to 49 weeks 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 :||28 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of a P53MVA Vaccine in Combination With Pembrolizumab in Platinum Resistant Ovarian Cancer|
|Anticipated Study Start Date :||March 2018|
|Estimated Primary Completion Date :||February 2020|
|Estimated Study Completion Date :||February 2020|
Experimental: Treatment (pembrolizumab, p53MVA)
Patients receive pembrolizumab IV over 30 minutes every 3 weeks and modified vaccinia virus ankara vaccine expressing p53 SC every 3 weeks for up to 3 vaccines. Courses with pembrolizumab repeat every 3 weeks for up to 49 weeks in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
Correlative studiesBiological: Modified Vaccinia Virus Ankara Vaccine Expressing p53
Other Names:Biological: Pembrolizumab
- Response rate (CR+PR) [ Time Frame: Up to 24 months ]
- Biomarker analysis [ Time Frame: Up to 24 months ]Peripheral blood samples will be collected pre- and post-immunization for assessment of anti-p53 T cell responses and immunophenotyping. Immunosuppressive cell types (myeloid-derived suppressor cell, regulatory T cells) and other selected lymphocyte subsets and markers including PD-1, PDL-1 and PDL-2 will be quantified. Will evaluate if CD8+ T cell signal exceeds that detected in the single agent p53MVA trial. Estimates will be obtained using Wilcoxon rank-sum test based on residual re-sampling simulations based on historic area under the curve values.
- Clinical benefit (CR+PR+SD > 6 months) [ Time Frame: Up to 6 months ]
- Incidence of adverse events assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.3 [ Time Frame: Up to 24 months ]
- Overall survival [ Time Frame: From start of the treatment until death, assessed up to 24 months ]
- PFS [ Time Frame: From start of treatment to time of progression or death, whichever occurs first, assessed up to 24 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03113487
|United States, California|
|City of Hope Medical Center||Not yet recruiting|
|Duarte, California, United States, 91010|
|Contact: Mihaela C. Cristea, MD 626-256-4673|
|Principal Investigator: Mihaela C. Cristea, MD|
|Principal Investigator:||Mihaela Cristea, MD||City of Hope Medical Center|