Ovarian NeoplasmsPhase 2NCT02659384
Anti-programmed Cell Death-1 Ligand 1 (aPDL-1) Antibody Atezolizumab, Bevacizumab and Acetylsalicylic Acid in Recurrent Platinum Resistant Ovarian Cancer
A Phase 2 study testing Bevacizumab, atezolizumab and acetylsalicylic acid in people with Ovarian Neoplasms, run by European Organisation for Research and Treatment of Cancer - EORTC at 12 sites in 5 countries.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Neoplasms
- What is being tested?
- Bevacizumab, atezolizumab and acetylsalicylic acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 122 participants
- Where
- 12 sitesin 5 countries
- Study dates
- 23 Dec 2016to Mar 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
12 sites in 5 countries.
12 sites in 5 countries
Netherlands3 sites
Academisch Medisch Centrum - Universiteit van Amsterdam
Amsterdam
Leiden University Medical Centre
Leiden
Radboudumc - Radboud University Medical Center Nijmegen
Nijmegen
United Kingdom3 sites
Guy's and St Thomas' NHS - Guy s and St Thomas' NHS - Guy's Hospital
London
Royal Marsden Hospital - Chelsea, London
London
Royal Marsden Hospital - Sutton, Surrey
Sutton
France2 sites
Assistance Publique - Hopitaux de Paris - Hopital Europeen Georges Pompidou
Paris
Centre Hospitalier Privé Saint-Grégoire
Saint-Grégoire
Spain2 sites
Institut Catala d'Oncologia - ICO Badalona - Hospital Germans Trias i Pujol (Institut Catala D'Oncologia)
Badalona
Hospital Universitario San Carlos
Madrid
Switzerland2 sites
Centre Hospitalier Universitaire Vaudois - Lausanne
Lausanne
Centre Hospitalier Universitaire Vaudois
Lausanne
About this study
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
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.
- Conditions
- Ovarian Neoplasms
- Being tested
- Bevacizumab, atezolizumab, acetylsalicylic acid, placebo
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
Also called Avastin
atezolizumabDrug
acetylsalicylic acidDrug
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| Bevacizumab | Experimental | 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. Receives: Drug: Bevacizumab |
| atezolizumab + bevacizumab + placebo | Experimental | 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. Receives: Drug: Bevacizumab; Drug: atezolizumab; Drug: placebo |
| atezolizumab + bevacizumab + acetylsalicylic acid | Experimental | 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. Receives: Drug: Bevacizumab; Drug: atezolizumab; Drug: acetylsalicylic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2016 (estimated)
- Study start23 Dec 2016
- Primary completionJun 2021
- Study completionMar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ovarian NeoplasmsStudies of the same condition, open and under way.
- More trials run by European Organisation for Research and Treatment of Cancer - EORTCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Susana- Banerjee, Study chair, Royal Marsden Hospital - UKGeorge Coukos, Study chair, Centre hospitalier universitaire vaudois, Lausanne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02659384
- Sponsor's protocol ID
- EORTC-1508
- Other IDs
- 2015-004601-17, 2015
- Status last verified
- Mar 2023
- First submitted
- 14 Jan 2016
- Last updated
- 14 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3.
PubMed 37185961
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02659384
- Acronym / sponsor ID
- EORTC-1508
- Conditions
- Ovarian Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- European Organisation for Research and Treatment of Cancer - EORTCResearch network
- Study start
- 23 Dec 2016 (actual)
- Primary completion
- Jun 2021 (actual)
- Study completion
- Mar 2022 (actual)
- First posted
- 20 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bevacizumab | Experimental | Drug: BevacizumabBevacizumab 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. |
| atezolizumab + bevacizumab + placebo | Experimental | Drug: Bevacizumab, Drug: atezolizumab, Drug: placeboThe 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. |
| atezolizumab + bevacizumab + acetylsalicylic acid | Experimental | Drug: Bevacizumab, Drug: atezolizumab, Drug: acetylsalicylic acidThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BevacizumabAlso: Avastin | Drug | Bevacizumab, atezolizumab + bevacizumab + acetylsalicylic acid, atezolizumab + bevacizumab + placebo |
| atezolizumab | Drug | atezolizumab + bevacizumab + acetylsalicylic acid, atezolizumab + bevacizumab + placebo |
| acetylsalicylic acid | Drug | atezolizumab + bevacizumab + acetylsalicylic acid |
| placebo | Drug | atezolizumab + bevacizumab + placebo |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
- Derived from this study: PubMed 37185961Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susana- Banerjee study chair
Royal Marsden Hospital - UK
George Coukos study chair
Centre hospitalier universitaire vaudois, Lausanne
12 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bevacizumab, atezolizumab and acetylsalicylic acid in people with Ovarian Neoplasms, run by European Organisation for Research and Treatment of Cancer - EORTC at 12 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Netherlands, United Kingdom, France, Spain, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (PFS) at 6 months assessed by Response Evaluation Criteria in Solid Tumors (RECIST) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02659384, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2023.