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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-004601-17 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bevacizumab | Experimental | 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 | Experimental | 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 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival (PFS) at 6 months assessed by Response Evaluation Criteria in Solid Tumors (RECIST) | Progression Free Survival at 6 months assessed by local investigator | 6 months |
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Susana- Banerjee | Royal Marsden Hospital - UK | Study Chair |
| George Coukos | Centre hospitalier universitaire vaudois, Lausanne | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assistance Publique - Hopitaux de Paris - Hopital Europeen Georges Pompidou | Paris | France | ||||
| Centre Hospitalier Privé Saint-Grégoire |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37185961 | Derived | Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3. |
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| atezolizumab | Drug |
|
| acetylsalicylic acid | Drug |
|
| placebo | Drug |
|
| Saint-Grégoire |
| France |
| Academisch Medisch Centrum - Universiteit van Amsterdam | Amsterdam | Netherlands |
| Leiden University Medical Centre | Leiden | 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 |
| Hospital Universitario San Carlos | Madrid | Spain |
| Centre Hospitalier Universitaire Vaudois - Lausanne | Lausanne | Switzerland |
| Centre Hospitalier Universitaire Vaudois | Lausanne | Switzerland |
| Guy's and St Thomas' NHS - Guy s and St Thomas' NHS - Guy's Hospital | London | United Kingdom |
| Royal Marsden Hospital - Chelsea, London | London | United Kingdom |
| Royal Marsden Hospital - Sutton, Surrey | Sutton | United Kingdom |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| C000594389 | atezolizumab |
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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