Tavokinogene Telseplasmid With Electroporation, Pembrolizumab, and Epacadostat in Treating Patients With Unresectable Squamous Cell Carcinoma of the Head and Neck
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|ClinicalTrials.gov Identifier: NCT03823131|
Recruitment Status : Not yet recruiting
First Posted : January 30, 2019
Last Update Posted : January 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Head and Neck Squamous Cell Carcinoma Recurrent Head and Neck Squamous Cell Carcinoma Unresectable Head and Neck Squamous Cell Carcinoma||Device: Electroporation Drug: Epacadostat Drug: Pembrolizumab||Phase 2|
I. Determine whether the combination of tavokinogene telseplasmid (tavo)-electroporation (EP), pembrolizumab, and epacadostat increases the best overall response rate (BORR) in squamous cell carcinoma of the head and neck (SCCHN) compared with historical data for pembrolizumab monotherapy.
I. Assess the safety of tavo-EP and pembrolizumab in combination with epacadostat (Common Terminology Criteria for Adverse Events [CTCAE] version 4).
II. Determine the durability of clinical benefits in patients treated with tavo-EP, pembrolizumab, and epacadostat as assessed by time to progression, median progression-free survival (PFS), median overall survival (OS).
I. Determine whether the combination of tavo-EP, pembrolizumab, and epacadostat increases the objective response rate in SCCHN compared with emerging data for pembrolizumab in combination with epacadostat.
II. Determine the effects of combination therapy on treated and untreated lesions by examining paired biopsy specimens for changes in inflammatory gene expression, relative proportion of effector versus regulatory T cells, evaluation of inflammatory cytokines, T-cell activation, clonality, and other hallmarks of immune activation.
III. Explore systemic markers of immune activation by examining circulating T-cell populations for changes in the frequency and effector function of short-lived effector cells and memory T cells.
IV. Explore changes in functional immune responses using enzyme-linked immunosorbent spot (Elispot) and other assays.
V. To explore biomarkers that inform scientific understanding of this therapeutic treatment through analysis of specimens retained for Future Biomedical Research.
Patients receive tavokinogene telseplasmid intratumorally (IT) and undergo electroporation on days 1, 5 and 8. Patients also receive pembrolizumab intravenously (IV) over 30 minutes on days 1 and 22, and epacadostat orally (PO) twice daily (BID). Treatment repeats every 42 days (6 weeks) for up to 9 courses or 12 months in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days, then every 3 months for up to 36 months or 30 days after disease progression.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||34 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Trifecta Study: Optimizinging Antitumor Immunity Using Tavokinogene Telseplasmid With Electroporation, Pembrolizumab, and Epacadostat in Squamous Cell Carcinoma of the Head and Neck|
|Estimated Study Start Date :||February 1, 2019|
|Estimated Primary Completion Date :||January 1, 2022|
|Estimated Study Completion Date :||January 1, 2024|
Experimental: Treatment (tavo-EP, pembrolizumab, epacadostat)
Patients receive tavokinogene telseplasmid IT and undergo electroporation on days 1, 5 and 8. Patients also receive pembrolizumab IV over 30 minutes on days 1 and 22, and epacadostat PO BID. Treatment repeats every 42 days (6 weeks) for up to 9 courses or 12 months in the absence of disease progression or unacceptable toxicity.
- Best overall response rate by Response Evaluation Criteria in Solid Tumors version 1.1 [ Time Frame: Up to 36 months ]The best overall response(BOR) is the best response recorded from the start of treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurement recorded since the treatment started).
- Incidence of adverse events (AEs) by Common Terminology Criteria for Adverse Events version 4 [ Time Frame: Up to 36 months ]AEs will be graded and reported descriptively.
- Progression free survival (PFS) [ Time Frame: From enrollment to progression or last assessment, assessed up to 36 months ]PFS is defined as the number of days from enrollment to progression (for subjects who have progression) and the number of days from enrollment to last assessment (for subjects who do not have progression).
- Overall survival (OS) [ Time Frame: From enrollment to death, or date last known alive, assessed up to 36 months ]OS is defined as the number of days from enrollment to death, or from enrollment to date last known alive.
- Time to progression [ Time Frame: Up to 36 months ]Will be summarized using the Kaplan-Meier method.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03823131
|United States, California|
|UCSF Medical Center-Mount Zion||Not yet recruiting|
|San Francisco, California, United States, 94115|
|Contact: Chase M. Heaton 415-502-1889 email@example.com|
|Principal Investigator: Chase M. Heaton|
|Principal Investigator:||Chase Heaton||UCSF Medical Center-Mount Zion|