Uterine Cervical Neoplasms Clinical Trial
Official title:
A Phase II Clinical Trial of Chemo-radiotherapy in Combination With INO-3112 in Patients With Locally Advanced Cervical Cancer
The aim of this study is to assess the potential benefit of the addition of immunotherapy
with VGX-3100 and INO-9012 (i.e. INO-3112) to concomitant CRT or, to concomitant CRT and
continued as adjuvant in patients with locally advanced cervical cancer.
Safety run-in: To test the safety of CRT combined with immunotherapy with INO-3112. This
safety run-in phase will include the first 3 patients treated in each of the two INO-3112
combination arms who are exposed to at least two immunotherapy doses and evaluate whether
the combination does not pose undue immediate risks to the patients further enrolled in the
trial.
Phase II:To demonstrate sufficient activity in the experimental combination arms to warrant
a further phase III conclusive trial based on progression free survival (PFS) at 18 months
assessed by RECIST by the local investigator. The efficacy will be assessed within each
experimental arm while the standard arm will serve as a reference arm to check the
reliability of the results.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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