Anti-programmed Cell Death-1 Ligand 1 (aPDL-1) Antibody Atezolizumab, Bevacizumab and Acetylsalicylic Acid in Recurrent Platinum Resistant Ovarian Cancer
- Conditions
- Ovarian Neoplasms
- Interventions
- Registration Number
- NCT02659384
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 122
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.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description atezolizumab + bevacizumab + placebo atezolizumab The randomized treatment regimen (atezolizumab + bevacizumab + placebo) will be continued until treatment failure or upon treatment withdrawal, whichever occurs first. Patients then go off protocol treatment and further treatment is left to the investigator's decision. atezolizumab + bevacizumab + placebo placebo The randomized treatment regimen (atezolizumab + bevacizumab + placebo) will be continued until treatment failure or upon treatment withdrawal, whichever occurs first. Patients then go off protocol treatment and further treatment is left to the investigator's decision. atezolizumab + bevacizumab + acetylsalicylic acid atezolizumab The randomized treatment regimen (atezolizumab + bevacizumab + acetylsalicylic acid) will be continued until treatment failure or upon treatment withdrawal, whichever occurs first. Patients then go off protocol treatment and further treatment is left to the investigator's decision. Bevacizumab Bevacizumab Bevacizumab monotherapy treatment in arm 1 will be discontinued upon RECIST documented progression or upon treatment withdrawal, whichever occurs first. Patients will cross-over to the combination of bevacizumab and atezolizumab upon progression as long as they meet cross-over criteria. atezolizumab + bevacizumab + placebo Bevacizumab The randomized treatment regimen (atezolizumab + bevacizumab + placebo) will be continued until treatment failure or upon treatment withdrawal, whichever occurs first. Patients then go off protocol treatment and further treatment is left to the investigator's decision. atezolizumab + bevacizumab + acetylsalicylic acid Bevacizumab The randomized treatment regimen (atezolizumab + bevacizumab + acetylsalicylic acid) will be continued until treatment failure or upon treatment withdrawal, whichever occurs first. Patients then go off protocol treatment and further treatment is left to the investigator's decision. atezolizumab + bevacizumab + acetylsalicylic acid acetylsalicylic acid The randomized treatment regimen (atezolizumab + bevacizumab + acetylsalicylic acid) will be continued until treatment failure or upon treatment withdrawal, whichever occurs first. Patients then go off protocol treatment and further treatment is left to the investigator's decision.
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (12)
Leiden University Medical Centre
🇳🇱Leiden, Netherlands
Centre Hospitalier Universitaire Vaudois
🇨🇭Lausanne, Switzerland
Guy's and St Thomas' NHS - Guy s and St Thomas' NHS - Guy's Hospital
🇬🇧London, United Kingdom
Assistance Publique - Hopitaux de Paris - Hopital Europeen Georges Pompidou
🇫🇷Paris, France
Royal Marsden Hospital - Sutton, Surrey
🇬🇧Sutton, United Kingdom
Hospital Universitario San Carlos
🇪🇸Madrid, Spain
Centre Hospitalier Privé Saint-Grégoire
🇫🇷Saint-Grégoire, France
Academisch Medisch Centrum - Universiteit van Amsterdam
🇳🇱Amsterdam, Netherlands
Radboudumc - Radboud University Medical Center Nijmegen
🇳🇱Nijmegen, Netherlands
Institut Catala d'Oncologia - ICO Badalona - Hospital Germans Trias i Pujol (Institut Catala D'Oncologia)
🇪🇸Badalona, Spain
Royal Marsden Hospital - Chelsea, London
🇬🇧London, United Kingdom
Centre Hospitalier Universitaire Vaudois - Lausanne
🇨🇭Lausanne, Switzerland