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

Ovarian Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02659384
• Other study ID #: EORTC-1508
• Secondary ID: 2015-004601-17
• Status: Completed
• Phase: Phase 2
• Start date: December 23, 2016
• Est. completion date: March 2022

Study information

• Verified date: March 2023
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: March 2022
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ovarian Neoplasms

Intervention

Drug:
• Bevacizumab

• atezolizumab

• acetylsalicylic acid

• placebo

Locations

Country	Name	City	State
France	Assistance Publique - Hopitaux de Paris - Hopital Europeen Georges Pompidou	Paris
France	Centre Hospitalier Privé Saint-Grégoire	Saint-Grégoire
Netherlands	Academisch Medisch Centrum - Universiteit van Amsterdam	Amsterdam
Netherlands	Leiden University Medical Centre	Leiden
Netherlands	Radboudumc - Radboud University Medical Center Nijmegen	Nijmegen
Spain	Institut Catala d'Oncologia - ICO Badalona - Hospital Germans Trias i Pujol (Institut Catala D'Oncologia)	Badalona
Spain	Hospital Universitario San Carlos	Madrid
Switzerland	Centre Hospitalier Universitaire Vaudois	Lausanne
Switzerland	Centre Hospitalier Universitaire Vaudois - Lausanne	Lausanne
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

Sponsors (1)

Lead Sponsor	Collaborator
European Organisation for Research and Treatment of Cancer - EORTC

Countries where clinical trial is conducted

France,  Netherlands,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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