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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 : Recruiting
First Posted : January 20, 2016
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

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.

Condition or disease Intervention/treatment Phase
Ovarian Neoplasms Drug: Bevacizumab Drug: atezolizumab Drug: acetylsalicylic acid Drug: placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 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 : January 2021
Estimated Study Completion Date : November 2021


Arm Intervention/treatment
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.
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.
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



Primary Outcome Measures :
  1. 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
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.


Information from the National Library of Medicine

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


Contacts
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Contact: EORTC HQ +32 2 774 1611 1508@eortc.org

Locations
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France
Assistance Publique - Hopitaux de Paris - Hopital Europeen Georges Pompidou Recruiting
Paris, France
Centre Hospitalier Privé Saint-Grégoire Recruiting
Saint-Grégoire, France
Netherlands
Academisch Medisch Centrum - Universiteit van Amsterdam Recruiting
Amsterdam, Netherlands
Leiden University Medical Centre Recruiting
Leiden, Netherlands
Radboudumc - Radboud University Medical Center Nijmegen Recruiting
Nijmegen, Netherlands
Spain
Institut Catala d'Oncologia - ICO Badalona - Hospital Germans Trias i Pujol (Institut Catala D'Oncologia) Recruiting
Badalona, Spain
Hospital Universitario San Carlos Recruiting
Madrid, Spain
Switzerland
Centre Hospitalier Universitaire Vaudois - Lausanne Recruiting
Lausanne, Switzerland
Centre Hospitalier Universitaire Vaudois Recruiting
Lausanne, Switzerland
United Kingdom
Guy's and St Thomas' NHS - Guy s and St Thomas' NHS - Guy's Hospital Recruiting
London, United Kingdom
Royal Marsden Hospital - Chelsea, London Recruiting
London, United Kingdom
Royal Marsden Hospital - Sutton, Surrey Recruiting
Sutton, United Kingdom
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
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Study Chair: Susana- Banerjee Royal Marsden Hospital - UK
Study Chair: George Coukos Centre Hospitalier Universitaire Vaudois - Lausanne

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Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT02659384     History of Changes
Other Study ID Numbers: EORTC-1508
2015-004601-17 ( EudraCT Number )
First Posted: January 20, 2016    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019

Additional relevant MeSH terms:
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Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Aspirin
Bevacizumab
Atezolizumab
Antibodies
Antibodies, Monoclonal
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Immunologic Factors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents