Ovarian Neoplasms
Conditions
Brief summary
This is a randomized phase II study, aimed at evaluating the efficacy (through progression free survival at 6 months) and safety of 5 different treatments involving atezolizumab, bevacizumab and/or acetylsalicylic acid in advanced recurrent platinum-resistant ovarian cancer patients in order to select the optimal treatments for further development in Phase III.
Interventions
DRUGBevacizumab
DRUGatezolizumab
DRUGacetylsalicylic acid
DRUGplacebo
Sponsors
European Organisation for Research and Treatment of Cancer - EORTC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Recurrent, histologically proven, platinum-resistant, epithelial ovarian, fallopian tube and primary peritoneal cancer in advanced or metastatic stage. Histological diagnosis by image guided biopsy, laparoscopy or laparotomy. Tumors diagnosed on cytology only and borderline tumors are excluded. At least one lesion accessible to biopsy without putting patient at risk WHO PS: 0-2 for patients having received no more than two previous lines of therapy. WHO PS: 0-1 for patients having received \>2 previous lines of therapy Prior chemotherapy or bevacizumab: Any number of platinum-based chemotherapy lines are allowed but a maximum of 2 previous non-platinum containing lines Prior treatment with bevacizumab or other targeted agents against Vascular Endothelial Growth Factor (VEGF) or VEGF receptor is allowed, but at least 18 weeks must have elapsed since their last administration Eligible patients with ≤ 2 previous treatment lines must have been previously exposed to bevacizumab or other targeted agents against VEGF or VEGF receptor Patients may have had prior therapy providing the following conditions are met: Radiation therapy: wash-out period of 14 days prior to the first study treatment; exception: single fraction radiotherapy with the indication of pain control Systemic anti-tumor therapy: wash-out period of 21 days prior to the first study treatment Recovery from any toxic effects of prior therapy to ≤ Grade 1 per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v4.03) except fatigue or alopecia.
Exclusion criteria
Age \<18 years Life expectancy of \< 12 weeks No adequate hematologic and end organ function Use of acetylsalicylic acid, NSAIDs or other COX-2 inhibitors that cannot be stopped at baseline and for the whole duration of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival (PFS) at 6 months assessed by Response Evaluation Criteria in Solid Tumors (RECIST) | 6 months | Progression Free Survival at 6 months assessed by local investigator |
Countries
France, Netherlands, Spain, Switzerland, United Kingdom
Outcome results
None listed