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

March 13, 2023 updated by: European Organisation for Research and Treatment of Cancer - EORTC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

122

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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 Names:
  • 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: placebo
Drug: Bevacizumab
Other Names:
  • Avastin
Drug: atezolizumab
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 Names:
  • Avastin
Drug: acetylsalicylic acid
Drug: atezolizumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Investigators

  • Study Chair: Susana- Banerjee, Royal Marsden Hospital - UK
  • Study Chair: George Coukos, Centre hospitalier universitaire vaudois, Lausanne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 23, 2016

Primary Completion (Actual)

June 1, 2021

Study Completion (Actual)

March 1, 2022

Study Registration Dates

First Submitted

January 14, 2016

First Submitted That Met QC Criteria

January 15, 2016

First Posted (Estimate)

January 20, 2016

Study Record Updates

Last Update Posted (Actual)

March 14, 2023

Last Update Submitted That Met QC Criteria

March 13, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EORTC-1508
  • 2015-004601-17 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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