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A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of Vigil/Bevacizumab vs. Vigil placebo/Bevacizumab in Subjects with Stage IIIb-IV,BRCA-wt HRP Ovarian Cancer in Clinical Complete Response following Surgery and Frontline Chemotherapy (VITAL-V)
Primary Objective:
The primary objective of this study is to evaluate the efficacy of Vigil / bevacizumab (or
bevacizumab biosimilar) versus Vigil placebo / bevacizumab (or bevacizumab biosimilar), as
measured by progression free survival in individuals with Stage IIIb-IV, BRCA-wt HRP ovarian
cancer following cCR to surgery and frontline platinum-based chemotherapy with
bevacizumab (or bevacizumab biosimilar), from the time of randomization.
Key Secondary Objective:
The key secondary objective of this study is to evaluate the efficacy of Vigil / bevacizumab (or
bevacizumab biosimilar) versus Vigil placebo / bevacizumab (or bevacizumab biosimilar), as
measured by overall survival in individuals with Stage IIIb-IV, BRCA-wt HRP ovarian cancer
following cCR to surgery and frontline platinum-based chemotherapy with bevacizumab (or
bevacizumab biosimilar), from the time of randomization.
Secondary Objectives:
To evaluate additional measures of clinical benefit of Vigil / bevacizumab (or bevacizumab
biosimilar) vs. Vigil placebo / bevacizumab (or bevacizumab biosimilar) as maintenance
treatment, such as:
OS from procurement
PFS from procurement
Restricted Mean Survival Time (RMST) for PFS
RMST for OS
2 year OS rate
Time to First Subsequent Therapy (TFST)
Safety and tolerability Vigil / bevacizumab (or bevacizumab biosimilar) vs. Vigil
placebo / bevacizumab (or bevacizumab biosimilar)
Exploratory Objectives:
To compare quality of life following administration of the study regimens utilizing
change from baseline in Patient Reported Outcome (PRO): Functional Assessment of
Cancer Therapy-Ovarian Symptom Index (FOSI)
To assess and evaluate potential biomarkers (including CA-125) and immune function
related to ovarian cancer response to treatment via Nanostring technology (including
ENTPD1 high versus low) to correlate with PFS and OS
To explore the relationship of TP53 mutation status and PFS and OS
Primary Objective:
The primary objective of this study is to evaluate the efficacy of Vigil / bevacizumab (or
bevacizumab biosimilar) versus Vigil placebo / bevacizumab (or bevacizumab biosimilar), as
measured by progression free survival in individuals with Stage IIIb-IV, BRCA-wt HRP ovarian
cancer following cCR to surgery and frontline platinum-based chemotherapy with
bevacizumab (or bevacizumab biosimilar), from the time of randomization.
Key Secondary Objective:
The key secondary objective of this study is to evaluate the efficacy of Vigil / bevacizumab (or
bevacizumab biosimilar) versus Vigil placebo / bevacizumab (or bevacizumab biosimilar), as
measured by overall survival in individuals with Stage IIIb-IV, BRCA-wt HRP ovarian cancer
following cCR to surgery and frontline platinum-based chemotherapy with bevacizumab (or
bevacizumab biosimilar), from the time of randomization.
Secondary Objectives:
To evaluate additional measures of clinical benefit of Vigil / bevacizumab (or bevacizumab
biosimilar) vs. Vigil placebo / bevacizumab (or bevacizumab biosimilar) as maintenance
treatment, such as:
OS from procurement
PFS from procurement
Restricted Mean Survival Time (RMST) for PFS
RMST for OS
2 year OS rate
Time to First Subsequent Therapy (TFST)
Safety and tolerability Vigil / bevacizumab (or bevacizumab biosimilar) vs. Vigil
placebo / bevacizumab (or bevacizumab biosimilar)
Exploratory Objectives:
To compare quality of life following administration of the study regimens utilizing
change from baseline in Patient Reported Outcome (PRO): Functional Assessment of
Cancer Therapy-Ovarian Symptom Index (FOSI)
To assess and evaluate potential biomarkers (including CA-125) and immune function
related to ovarian cancer response to treatment via Nanostring technology (including
ENTPD1 high versus low) to correlate with PFS and OS
To explore the relationship of TP53 mutation status and PFS and OS
Recruitment Status
Coming Soon