Back to resultsAnti-programmed Cell Death-1 Ligand 1 (aPDL-1) Antibody Atezolizumab, Bevacizumab and Acetylsalicylic Acid in Recurrent Platinum Resistant Ovarian Cancer
Ovarian Neoplasms
About this trial
This is an interventional treatment trial for Ovarian Neoplasms
Eligibility Criteria
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.
Sites / Locations
- Assistance Publique - Hopitaux de Paris - Hopital Europeen Georges Pompidou
- Centre Hospitalier Privé Saint-Grégoire
- Academisch Medisch Centrum - Universiteit van Amsterdam
- Leiden University Medical Centre
- Radboudumc - Radboud University Medical Center Nijmegen
- Institut Catala d'Oncologia - ICO Badalona - Hospital Germans Trias i Pujol (Institut Catala D'Oncologia)
- Hospital Universitario San Carlos
- Centre Hospitalier Universitaire Vaudois - Lausanne
- Centre Hospitalier Universitaire Vaudois
- Guy's and St Thomas' NHS - Guy s and St Thomas' NHS - Guy's Hospital
- Royal Marsden Hospital - Chelsea, London
- Royal Marsden Hospital - Sutton, Surrey
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Bevacizumab
atezolizumab + bevacizumab + placebo
atezolizumab + bevacizumab + acetylsalicylic acid
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.
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.
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.
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
2. Study Status
3. Sponsor/Collaborators
4. Oversight
5. Study Description
6. Conditions and Keywords
7. Study Design
8. Arms, Groups, and Interventions
10. Eligibility
12. IPD Sharing Statement
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