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 : April 5, 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|
|Estimated Study Start Date :||June 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
Biological: Modified Vaccinia Virus Ankara Vaccine Expressing p53
- 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 ]
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): 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|