Ovary CancerVALTIVE1NCT04523116
Validation of Tie2 as the First Tumour Vascular Response Biomarker for VEGF Inhibitors: VALTIVE1
An observational study of Ovary Cancer, run by University of Manchester at 4 sites in United Kingdom.
Trial summary
Tumours require a blood supply to provide them with oxygen and nutrients and to enable spread of cancer through blood vessels to other organs (metastasis). The formation of new blood vessels is known as angiogenesis, which is controlled by a growth factor (like a hormone) called Vascular Endothelial Growth Factor… Read more about this study
- Who is it for?
- Ages 16 years and older, women only
- Conditions the study is for
- Ovary Cancer
- How many people
- 176 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- 14 Jan 2021to Jun 2023
- Phase
- Observational
- 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 16 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Potential participants will be under the care of a consultant who specialises in the treatment of ovarian cancer. Patients who have been diagnosed with stage III/IV ovarian cancer within the routine clinics of participating centres and identified as requiring treatment with bevacizumab will be approached and screened.
Who may be able to join
- In order to be eligible for participation in this trial, the patient must:
- Be willing and able to provide written informed consent for the trial
- Age 16 years or over on day of signing informed consent
- 3. Histologically proven ovarian, primary peritoneal or fallopian tube cancer (henceforth referred to collectively as Ovarian Cancer - OC) FIGO stage III with residual disease of more than 1cm; or stage IV; or stage III at presentation treated with neoadjuvant chemotherapy; or stage III with contraindication to debulking surgery chemotherapy
- Planned to receive treatment with bevacizumab or biosimilar bevacizumab
- Be scheduled to receive at least 2 successive doses of bevacizumab with 6 or more weeks of follow up blood samples after the first dose of bevacizumab if given pre-operatively; or to start bevacizumab post-operatively
- Be eligible for receiving treatment with first line, 3-weekly carboplatin and paclitaxel chemotherapy
- Be willing to provide blood samples and comply with trial-specific procedures
Who cannot join
- The patient must be excluded from participating in the trial if the patient:
- Is unsuitable for treatment with VEGF inhibitors
- Is unable or unwilling to comply with study procedures
- Is participating in a clinical study with an investigational product other than carboplatin, paclitaxel and bevacizumab
- Is judged by the investigator to be unlikely to comply with study procedures
- Is pregnant or could become pregnant and is not using adequate contraception
- Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies)
- Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g. HCV RNA is detected). Testing only required if patient has a history of either of these
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites, 4 recruiting
- Recruiting
Royal United Hospitals Bath NHS Foundation Trust
Bath
Rebecca Bowen
- Recruiting
The Christie NHS Foundation Trust
Manchester
Gordon Jayson
- Recruiting
East and North Hertfordshire NHS Trust
Northwood
Marcia Hall
- Recruiting
University Hospital Southampton NHS Foundation Trust
Southampton
Clare Green
About this study
Official title: Validation of Tie2 as the First Tumour Vascular Response Biomarker for VEGF Inhibitors: Optimising the Design of a Subsequent Randomised Discontinuation Trial: VALTIVE1
Tumours require a blood supply to provide them with oxygen and nutrients and to enable spread of cancer through blood vessels to other organs (metastasis). The formation of new blood vessels is known as angiogenesis, which is controlled by a growth factor (like a hormone) called Vascular Endothelial Growth Factor (VEGF). Many drugs have been developed that block VEGF and, in most tumour types, including ovarian cancer, the addition of VEGF inhibitors (VEGFi) to conventional anti-cancer therapy postpones recurrence of the disease. In ovarian cancer, VEGFi improve the overall outcome from the cancer in patients who have advanced stage and high-risk disease. VEGFi are now widely used in cancer medicine, yet until now there have not been any biomarkers (tests) that could be used to tell patients and their doctors whether the drugs were working or not. This is important, as VEGFi have side effects that are unpleasant for the patient. Additionally, VEGFi treatments are expensive.
The VALTIVE team has discovered the first biomarker that informs doctors whether a VEGFi is blocking a tumour's blood supply. The test involves measuring a protein in the blood called Tie2, which can be measured from routine blood tests that patients have when going to the hospital. If the test shows that the amount of Tie2 decreases in the blood, it means that tumour blood vessels are blocked by VEGFi; if, on the contrary, the level increases, the blood vessels have escaped the control of VEGFi.
Read more
The investigators have shown that the Tie2 test works in their initial studies in ovarian and bowel cancer. In these studies, the Tie2 blood test was based in the research laboratories. The investigators now wish to establish the test in the Christie Hospital NHS Biochemistry laboratory in Manchester so that it can be used in clinical practice rather than just as a research tool. The investigators wish to measure the relationship between loss of control of VEGF inhibitors as measured by TIE 2 and other standard ways of measuring loss of control of the tumour like increases on CT scans. There are several reasons why this test is needed for patients with ovarian cancer:
- VEGFi are effective during a patient's first or subsequent treatments for advanced ovarian cancer, but it is not clear which individuals are benefitting from treatment whilst they are on treatment.
- Patients who have already had one course of VEGFi can be re-treated successfully.
- Patients can avoid needless side effects, if there is a way of demonstrating that the treatment is of no benefit to them.
- This test will help doctors choose the best drug to control ovarian cancer and how long to continue treatment. This is very important, since other maintenance therapies are now available and the optimal duration of VEGFi therapy is well known.
- Around the world many teams are developing new combination treatments including VEGFi. If these new combinations prove effective, it would be possible to use them as efficiently as possible, as they will be very expensive and may therefore be less accessible to patients.
These issues highlight the critical need to establish a test in the NHS that tells patients and their doctors when VEGFi are working and when they stop working.
In VALTIVE1 study, blood samples will be taken from patients who are receiving a VEGFi called bevacizumab for ovarian cancer. Patients' management will not change during their participation to the trial. The analysis of the blood sample will support the hypothesis that patients whose Tie2 level decreases in response to bevacizumab will have ovarian cancer that is controlled for much longer than those where the Tie2 level does not decrease. These results will be used to design a second trial where the investigators will prove conclusively the value of the Tie2 test.
The purpose of VALTIVE1 is to optimise sample acquisition time points and analytical algorithms to support the design of VALTIVE2, a randomised discontinuation trial. In VALTIVE2, Tie2-defined, vascular non-responding patients will be randomly allocated to stop bevacizumab after 9 weeks, by when a response can be detected, or to continue bevacizumab for the conventional year of treatment.
Both VALTIVE 1 and VALTIVE2 will test the theory that there is no advantage in continuing bevacizumab in a patient whose Tie2 level does not reduce in response to VEGFi.
Read the detailed description
VALTIVE1 is a multi-centre, single arm, non-interventional biomarker study, which will enrol 176 participants who are 16 years or older and who have FIGO stage IIIc/ IV ovarian cancer on treatment with first-line platinum-based chemotherapy and bevacizumab. Potential participants will be identified at their treating hospital.
The definition of vascular response is either (i) stable or reduced concentrations of Tie2 after 6 weeks of treatment or (ii) a confirmed reduction in plasma Tie2 of >10% within 9 weeks of starting treatment.
Patients enrolled into the VALTIVE 1 study will provide blood samples twice before treatment with bevacizumab and then at the end Cycles 1, 2, and 3, at the end of cytotoxic chemotherapy, at 3 months, 6 months, 9 months, at the end of treatment, and at disease progression. The early samples will be used to refine the definition and number of required samples needed to define a Tie2-vascular response. Samples collected at 3 months, 6 months, 9 months, at the end of treatment, and at disease progression will be used to investigate the relationship between Tie2-defined vascular progression and RECIST1.1- or clinically-defined Progression Disease (PD).
While the patients receive single agent maintenance bevacizumab, patients will undergo RECIST1.1 scanning at 3 months, 6 months, 9 months, end of treatment and at disease progression, if not before. These scans will also be reported to RECIST 1.1.
Progressive disease will be defined by the date of radiological or clinically identified progressive disease or death.
- Conditions
- Ovary Cancer
- Keywords
- VEGF inhibitors, Bevacizumab, Tie2, Biomarker, Ovarian
- Medical subject headings
- Ovarian Neoplasms, Venous Malformations, Multiple Cutaneous and Mucosal
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS)
To establish the validity of the Tie2 test as measured by progression free survival by showing the difference in terms of PFS between Tie2 vascular responders and Tie2 vascular non- responders.
Measured: Up to 12 months after completion of the last Participant's follow up visit
Secondary outcomes (4)
Definition of Tie2 defined vascular response Definition of Tie2 defined vascular response Definition of Tie2 defined vascular response Definition of Tie2 defined vascular response
To optimise the definition of Tie2-defined vascular response by analysing its relation with progression free survival as measured according to Response Evaluation Criteria in Solid Tumors(RECIST) v1.1 criteria.
Measured: Up to 12 months after completion of the last Participant's follow up visit
Optimum number of blood samples
To define the optimum number of blood samples that need to be taken and tested for informing doctors whether their patients are responding to treatment (low level of Tie2) or are likely to progress (high level of Tie2).
Measured: Up to 12 months after completion of the last Participant's follow up visit
Relation between surgery and Tie2
Patients with advanced ovarian cancer have surgery which stimulates the formation of new blood vessels and, consequently, may increase the level of Tie2 in the blood. The measurement of Tie level in blood samples to be taken from 2 weeks before surgery until 4 weeks after surgery will show whether the surgery has any impact on plasma Tie2 concentrations.
Measured: Up to 12 months after completion of the last Participant's follow up visit
Design of the subsequent trial, VALTIVE2
The definition of vascular response as assessed by measurement of Tie2 levels in plasma and its relation with PFS as per RECIST criteria will be validated in the randomised discontinuation non-inferiority trial VALTIVE2.
Measured: Up to 12 months after completion of the last Participant's follow up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2020
- Study start14 Jan 2021
- Primary completionMay 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ovary CancerStudies of the same condition, open and under way.
- More trials run by University of ManchesterThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Research UK, Centre for Trials Research, Cardiff University
- Responsible party
- Principal investigator, Prof Gordon Jayson, University of Manchester
- Investigators
- Gordon Jayson, PhD, FRCP, Principal investigator, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04523116
- Sponsor's protocol ID
- A29832
- Acronym
- VALTIVE1
- Status last verified
- Oct 2021
- First submitted
- 13 Aug 2020
- Last updated
- 5 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Holland-Hart D, Carucci M, Slusarczyk M, Longo M, Campbell S, Irving A, Noble S, Jayson G, Hopewell-Kelly N. Participants' perspectives of the advanced ovarian cancer biomarker study VALTIVE1: a qualitative study. BMJ Open. 2025 Jul 13;15(7):e088474. doi: 10.1136/bmjopen-2024-088474.
PubMed 40659403Carucci M, Clamp A, Zhou C, Hurt C, Glasspool R, Monaghan PJ, Thirkettle S, Wheatley M, Mahmood M, Narasimham M, Cox T, Morrison H, Campbell S, Nelson A, Holland-Hart D, Hopewell-Kelly N, Thomas A, Porter C, Slusarczyk M, Irving A, Dive C, Adams R, Jayson GC. The VALTIVE1 study protocol: a study for the validation of Tie2 as the first tumour vascular response biomarker for VEGF inhibitors. BMC Cancer. 2024 Oct 24;24(1):1309. doi: 10.1186/s12885-024-13073-0.
PubMed 39448911
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Tie2 as the First Tumour Vascular Response Biomarker for VEGF Inhibitors: Optimising the Design of a Subsequent Randomised Discontinuation Trial: VALTIVE1
- ClinicalTrials.gov ID
- NCT04523116
- Acronym / sponsor ID
- VALTIVE1 / A29832
- Conditions
- Ovary Cancer
- Keywords
- VEGF inhibitors, Bevacizumab, Tie2, Biomarker, Ovarian
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Collaborators
- Cancer Research UK, Centre for Trials Research, Cardiff University
- Study start
- 14 Jan 2021 (actual)
- Primary completion
- May 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 21 Aug 2020 (actual)
- 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.
Tumours require a blood supply to provide them with oxygen and nutrients and to enable spread of cancer through blood vessels to other organs (metastasis). The formation of new blood vessels is known as angiogenesis, which is controlled by a growth factor (like a hormone) called Vascular Endothelial Growth Factor (VEGF). Many drugs have been developed that block VEGF and, in most tumour types, including ovarian cancer, the addition of VEGF inhibitors (VEGFi) to conventional anti-cancer therapy postpones recurrence of the disease. In ovarian cancer, VEGFi improve the overall outcome from the cancer in patients who have advanced stage and high-risk disease. VEGFi are now widely used in cancer medicine, yet until now there have not been any biomarkers (tests) that could be used to tell patients and their doctors whether the drugs were working or not. This is important, as VEGFi have side effects that are unpleasant for the patient. Additionally, VEGFi treatments are expensive.
The VALTIVE team has discovered the first biomarker that informs doctors whether a VEGFi is blocking a tumour's blood supply. The test involves measuring a protein in the blood called Tie2, which can be measured from routine blood tests that patients have when going to the hospital. If the test shows that the amount of Tie2 decreases in the blood, it means that tumour blood vessels are blocked by VEGFi; if, on the contrary, the level increases, the blood vessels have escaped the control of VEGFi.
The investigators have shown that the Tie2 test works in their initial studies in ovarian and bowel cancer. In these studies, the Tie2 blood test was based in the research laboratories. The investigators now wish to establish the test in the Christie Hospital NHS Biochemistry laboratory in Manchester so that it can be used in clinical practice rather than just as a research tool. The investigators wish to measure the relationship between loss of control of VEGF inhibitors as measured by TIE 2 and other standard ways of measuring loss of control of the tumour like increases on CT scans. There are several reasons why this test is needed for patients with ovarian cancer:
- VEGFi are effective during a patient's first or subsequent treatments for advanced ovarian cancer, but it is not clear which individuals are benefitting from treatment whilst they are on treatment.
- Patients who have already had one course of VEGFi can be re-treated successfully.
- Patients can avoid needless side effects, if there is a way of demonstrating that the treatment is of no benefit to them.
- This test will help doctors choose the best drug to control ovarian cancer and how long to continue treatment. This is very important, since other maintenance therapies are now available and the optimal duration of VEGFi therapy is well known.
- Around the world many teams are developing new combination treatments including VEGFi. If these new combinations prove effective, it would be possible to use them as efficiently as possible, as they will be very expensive and may therefore be less accessible to patients.
These issues highlight the critical need to establish a test in the NHS that tells patients and their doctors when VEGFi are working and when they stop working.
In VALTIVE1 study, blood samples will be taken from patients who are receiving a VEGFi called bevacizumab for ovarian cancer. Patients' management will not change during their participation to the trial. The analysis of the blood sample will support the hypothesis that patients whose Tie2 level decreases in response to bevacizumab will have ovarian cancer that is controlled for much longer than those where the Tie2 level does not decrease. These results will be used to design a second trial where the investigators will prove conclusively the value of the Tie2 test.
The purpose of VALTIVE1 is to optimise sample acquisition time points and analytical algorithms to support the design of VALTIVE2, a randomised discontinuation trial. In VALTIVE2, Tie2-defined, vascular non-responding patients will be randomly allocated to stop bevacizumab after 9 weeks, by when a response can be detected, or to continue bevacizumab for the conventional year of treatment.
Both VALTIVE 1 and VALTIVE2 will test the theory that there is no advantage in continuing bevacizumab in a patient whose Tie2 level does not reduce in response to VEGFi.
Detailed description
VALTIVE1 is a multi-centre, single arm, non-interventional biomarker study, which will enrol 176 participants who are 16 years or older and who have FIGO stage IIIc/ IV ovarian cancer on treatment with first-line platinum-based chemotherapy and bevacizumab. Potential participants will be identified at their treating hospital.
The definition of vascular response is either (i) stable or reduced concentrations of Tie2 after 6 weeks of treatment or (ii) a confirmed reduction in plasma Tie2 of >10% within 9 weeks of starting treatment.
Patients enrolled into the VALTIVE 1 study will provide blood samples twice before treatment with bevacizumab and then at the end Cycles 1, 2, and 3, at the end of cytotoxic chemotherapy, at 3 months, 6 months, 9 months, at the end of treatment, and at disease progression. The early samples will be used to refine the definition and number of required samples needed to define a Tie2-vascular response. Samples collected at 3 months, 6 months, 9 months, at the end of treatment, and at disease progression will be used to investigate the relationship between Tie2-defined vascular progression and RECIST1.1- or clinically-defined Progression Disease (PD).
While the patients receive single agent maintenance bevacizumab, patients will undergo RECIST1.1 scanning at 3 months, 6 months, 9 months, end of treatment and at disease progression, if not before. These scans will also be reported to RECIST 1.1.
Progressive disease will be defined by the date of radiological or clinically identified progressive disease or death.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Potential participants will be under the care of a consultant who specialises in the treatment of ovarian cancer. Patients who have been diagnosed with stage III/IV ovarian cancer within the routine clinics of participating centres and identified as requiring treatment with bevacizumab will be approached and screened.
Key inclusion criteria (8 listed)
- Be willing and able to provide written informed consent for the trial
- Age 16 years or over on day of signing informed consent
- 3. Histologically proven ovarian, primary peritoneal or fallopian tube cancer (henceforth referred to collectively as Ovarian Cancer - OC) FIGO stage III with residual disease of more than 1cm; or stage IV; or stage III at presentation treated with neoadjuvant chemotherapy; or stage III with contraindication to debulking surgery chemotherapy
- Planned to receive treatment with bevacizumab or biosimilar bevacizumab
- Be scheduled to receive at least 2 successive doses of bevacizumab with 6 or more weeks of follow up blood samples after the first dose of bevacizumab if given pre-operatively; or to start bevacizumab post-operatively
Key exclusion criteria (8 listed)
- Is unsuitable for treatment with VEGF inhibitors
- Is unable or unwilling to comply with study procedures
- Is participating in a clinical study with an investigational product other than carboplatin, paclitaxel and bevacizumab
- Is judged by the investigator to be unlikely to comply with study procedures
- Is pregnant or could become pregnant and is not using adequate contraception
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Progression free survival (PFS)
Time frame: Up to 12 months after completion of the last Participant's follow up visit
To establish the validity of the Tie2 test as measured by progression free survival by showing the difference in terms of PFS between Tie2 vascular responders and Tie2 vascular non- responders.
4 secondary outcomes
Definition of Tie2 defined vascular response Definition of Tie2 defined vascular response Definition of Tie2 defined vascular response Definition of Tie2 defined vascular response
Time frame: Up to 12 months after completion of the last Participant's follow up visit
Optimum number of blood samples
Time frame: Up to 12 months after completion of the last Participant's follow up visit
Relation between surgery and Tie2
Time frame: Up to 12 months after completion of the last Participant's follow up visit
Design of the subsequent trial, VALTIVE2
Time frame: Up to 12 months after completion of the last Participant's follow up visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2021.
- Derived from this study: PubMed 40659403Holland-Hart D, Carucci M, Slusarczyk M, Longo M, Campbell S, Irving A, Noble S, Jayson G, Hopewell-Kelly N. Participants' perspectives of the advanced ovarian cancer biomarker study VALTIVE1: a qualitative study. BMJ Open. 2025 Jul 13;15(7):e088474. doi: 10.1136/bmjopen-2024-088474.
- Derived from this study: PubMed 39448911Carucci M, Clamp A, Zhou C, Hurt C, Glasspool R, Monaghan PJ, Thirkettle S, Wheatley M, Mahmood M, Narasimham M, Cox T, Morrison H, Campbell S, Nelson A, Holland-Hart D, Hopewell-Kelly N, Thomas A, Porter C, Slusarczyk M, Irving A, Dive C, Adams R, Jayson GC. The VALTIVE1 study protocol: a study for the validation of Tie2 as the first tumour vascular response biomarker for VEGF inhibitors. BMC Cancer. 2024 Oct 24;24(1):1309. doi: 10.1186/s12885-024-13073-0.
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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.
Gordon Jayson, PhD, FRCP principal investigator
University of Manchester
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovary Cancer, run by University of Manchester at 4 sites in United Kingdom.
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 8 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 5 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Margherita Carucci, PhD (+442920687900, VALTIVE@cardiff.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (PFS) (time frame: Up to 12 months after completion of the last Participant's follow up visit). 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 NCT04523116, which also lists 2 linked publications.
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 5 Oct 2021.