Anti-programmed Cell Death-1 Ligand 1 (aPDL-1) Antibody Atezolizumab, Bevacizumab and Acetylsalicylic Acid in Recurrent Platinum Resistant Ovarian Cancer
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ClinicalTrials.gov Identifier: NCT02659384 |
Recruitment Status :
Active, not recruiting
First Posted : January 20, 2016
Last Update Posted : July 31, 2020
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Condition or disease | Intervention/treatment | Phase |
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Ovarian Neoplasms | Drug: Bevacizumab Drug: atezolizumab Drug: acetylsalicylic acid Drug: placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 122 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Phase II Study of the Anti-PDL1 Antibody Atezolizumab, Bevacizumab and Acetylsalicylic Acid to Investigate Safety and Efficacy of This Combination in Recurrent Platinum-resistant Ovarian, Fallopian Tube or Primary Peritoneal Adenocarcinoma |
Study Start Date : | December 2016 |
Estimated Primary Completion Date : | February 2021 |
Estimated Study Completion Date : | February 2023 |

Arm | Intervention/treatment |
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Experimental: 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.
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Drug: Bevacizumab
Other Name: Avastin |
Experimental: atezolizumab + bevacizumab + 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.
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Drug: Bevacizumab
Other Name: Avastin Drug: atezolizumab Drug: placebo |
Experimental: atezolizumab + bevacizumab + 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.
|
Drug: Bevacizumab
Other Name: Avastin Drug: atezolizumab Drug: acetylsalicylic acid |
- Progression free survival (PFS) at 6 months assessed by Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: 6 months ]Progression Free Survival at 6 months assessed by local investigator

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02659384
France | |
Assistance Publique - Hopitaux de Paris - Hopital Europeen Georges Pompidou | |
Paris, France | |
Centre Hospitalier Privé Saint-Grégoire | |
Saint-Grégoire, France | |
Netherlands | |
Academisch Medisch Centrum - Universiteit van Amsterdam | |
Amsterdam, Netherlands | |
Leiden University Medical Centre | |
Leiden, Netherlands | |
Radboudumc - Radboud University Medical Center Nijmegen | |
Nijmegen, Netherlands | |
Spain | |
Institut Catala d'Oncologia - ICO Badalona - Hospital Germans Trias i Pujol (Institut Catala D'Oncologia) | |
Badalona, Spain | |
Hospital Universitario San Carlos | |
Madrid, Spain | |
Switzerland | |
Centre Hospitalier Universitaire Vaudois - Lausanne | |
Lausanne, Switzerland | |
Centre Hospitalier Universitaire Vaudois | |
Lausanne, Switzerland | |
United Kingdom | |
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 |
Study Chair: | Susana- Banerjee | Royal Marsden Hospital - UK | |
Study Chair: | George Coukos | Centre Hospitalier Universitaire Vaudois - Lausanne |
Responsible Party: | European Organisation for Research and Treatment of Cancer - EORTC |
ClinicalTrials.gov Identifier: | NCT02659384 |
Other Study ID Numbers: |
EORTC-1508 2015-004601-17 ( EudraCT Number ) |
First Posted: | January 20, 2016 Key Record Dates |
Last Update Posted: | July 31, 2020 |
Last Verified: | March 2020 |
Ovarian Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Aspirin Bevacizumab Atezolizumab Antineoplastic Agents, Immunological Antineoplastic Agents |
Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Anti-Inflammatory Agents Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action |