Anti-programmed Cell Death-1 Ligand 1 (aPDL-1) Antibody Atezolizumab, Bevacizumab and Acetylsalicylic Acid in Recurrent Platinum Resistant Ovarian Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 27 March 2023
• 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 23, 2016
• Target sample size: 122
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02659384
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 2

Countries of recruitment

France, Netherlands, Spain, Switzerland, United Kingdom

Contacts

• Name: Susana- Banerjee
• Affiliation: Royal Marsden Hospital - UK

• Name: George Coukos
• 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: placebo

Drug: atezolizumab

Drug: Bevacizumab

Drug: acetylsalicylic acid

Primary Outcome(s)

Progression free survival (PFS) at 6 months assessed by Response Evaluation Criteria in Solid Tumors (RECIST) [Time Frame: 6 months]

Secondary ID(s)

2015-004601-17

EORTC-1508

Source(s) of Monetary Support

Please refer to primary and secondary sponsors