A Randomized, Phase II/III Study of Pegylated Liposomal Doxorubicin and CTEP-Supplied Atezolizumab Versus Pegylated Liposomal Doxorubicin/Bevacizumab and CTEP-Supplied Atezolizumab Versus Pegylated Liposomal Doxorubicin/Bevacizumab in Platinum Resistant Ovarian Cancer
Categories (click each to see list of all clinical trials associated with that category): Gynecology (GYN)
Current Status: Open to accrual
Phase: II/III
Principal Investigator: Rodabaugh, Kerry
Contact Information:
Pamela Nielsen
pnielsen@nebraskamed.com
Eligibility: https://clinicaltrials.gov/ct2/show/NCT02839707?cond=NCT02839707&draw=2&rank=1#eligibility
Summary
Primary Objectives
Safety Lead-in: Estimate the probability of a dose limiting toxicity (DLT) following cycle 1 of experimental regimens (PLD and atezolizumab and PLD/bevacizumab and atezolizumab).
Phase II Study: Estimate and compare the hazard of first progression or death (PFS) of each experimental regimen relative to the reference regimen, PLD and bevacizumab.
Phase III Study: Estimate and compare the hazard of death and the hazard of first progression or death (PFS) of each experimental regimen relative to the reference regimen. If the relative hazards of death (or the hazards of first progression or death) are significantly lower on both experimental regimens, then the hazards of death (the hazards of first progression or death) on the two experimental regimens will be compared to each other.
Secondary Objectives
Phase II Study: Secondary efficacy endpoint: Estimate and compare the probabilities of response rate (ORR, either partial or complete response) defined by RECIST v1.1 criteria on each study regimen.
Safety endpoint: Estimate the frequency and severity of adverse events as classified and graded with Common Terminology Criteria for Adverse Events (CTCAE) in those patients who initiate their randomly assigned study treatment.
Phase III Study: Secondary efficacy endpoints: Estimate and compare ORR in each treatment group.
Safety endpoints: Estimate the frequency and severity of adverse events in those patients who initiate their randomly assigned study treatment.
Patient Reported outcomes (PRO): Estimate and compare mean patient reported outcome scores (PROs) as measured by NFOSI-18 Disease-related symptoms (DRS).
Exploratory endpoints: Estimate and compare the treatment groups on the basis of the PROs: Treatment Side Effects (TSE), Function/well-being (FWB), Fatigue (FACIT-Fatigue subscale-) and Abdominal Discomfort (FACT/GOG-AD subscale).