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Note: This record shows only 21 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 9 January 2017
Main ID:  NCT02659384
Date of registration: 14/01/2016
Prospective Registration: Yes
Primary sponsor: European Organisation for Research and Treatment of Cancer - EORTC
Public title: Anti-programmed Cell Death-1 Ligand 1 (aPDL-1) Antibody Atezolizumab, Bevacizumab and Acetylsalicylic Acid in Recurrent Platinum Resistant Ovarian Cancer
Scientific 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
Date of first enrolment: December 2016
Target sample size: 160
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT02659384
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment  
Phase:  Phase 2
Countries of recruitment
Switzerland
Contacts
Name:     Ellen Peeters
Address: 
Telephone: 0032 2 772 1082
Email: ellen.peeters@eortc.be
Affiliation: 
Name:     Anita Wolfer
Address: 
Telephone:
Email:
Affiliation:  Centre Hospitalier Universitaire Vaudois - Lausanne
Name:     George Coukos
Address: 
Telephone:
Email:
Affiliation:  Centre Hospitalier Universitaire Vaudois - Lausanne
Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Female
Health Condition(s) or Problem(s) studied
Ovarian Neoplasms
Intervention(s)
Drug: acetylsalicylic acid
Drug: atezolizumab
Drug: Bevacizumab
Drug: placebo
Primary Outcome(s)
Progression free survival (PFS) at 6 months assessed by Response Evaluation Criteria in Solid Tumors (RECIST) [Time Frame: 6 months]
Secondary Outcome(s)
Secondary ID(s)
2015-004601-17
EORTC-1508
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Results
Results available:
Date Posted:
URL:
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