The Activity of TroVax® Versus Placebo in Relapsed Asymptomatic Ovarian Cancer (TRIOC)
|ClinicalTrials.gov Identifier: NCT01556841|
Recruitment Status : Active, not recruiting
First Posted : March 16, 2012
Last Update Posted : December 15, 2017
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer Fallopian Tube Cancer Peritoneal Cancer||Biological: TroVax® Biological: Placebo||Phase 2|
A significant number of patients with advanced ovarian cancer develop a "CA-125 relapse" without clinical symptoms and with a low volume disease on the CT scan. For this group of patients, no survival benefit has been demonstrated from early chemotherapy treatment and, on average, the time to start of chemotherapy is 5 months. Such patients could benefit from immunotherapy and the time to chemotherapy could potentially be prolonged. Multiple immunotherapy agents, such as anti-CA-125 antibodies and various vaccines, have been tested and, although there is plenty of evidence of immune response, this has not translated to a definitive clinical benefit and is not recommended in clinical practice
5T4 appears to be highly expressed in ovarian cancer and correlates with more advanced stage of disease and poorly differentiated tumours. TroVax®, the vaccine targeting 5T4, has an extensive record of safety and efficacy in humans and vaccination in patients with colorectal, renal, and prostate cancer resulted in immune cellular and humoral responses and signs of clinical benefit.
We propose a trial of TroVax® vaccination in patients with CA-125-relapsed asymptomatic ovarian cancer to assess the clinical efficacy and immunological responses as outlined in this protocol. To allow for capture of any delayed response to immunotherapy, patients who progress on RECIST 1.1 criteria and who do not experience toxicity from treatment will continue on the vaccine/placebo injection until repeat imaging at 8 weeks in order for immune-related response criteria (irRC) to be evaluated in addition to RECIST 1.1 criteria (these patients as a standard of care would not receive any other therapeutic intervention).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||97 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase II Study to Assess the Activity of TroVax® (MVA-5T4) Versus Placebo in Patients With Relapsed Asymptomatic Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer|
|Study Start Date :||November 2013|
|Estimated Primary Completion Date :||May 2019|
|Estimated Study Completion Date :||May 2019|
TroVax® consists of a highly attenuated VV (Modified Vaccinia Ankara, MVA) containing the human TAA 5T4 under regulatory control of a modified VV promoter, mH5.
Patients will be randomised to receive either TroVax® 1 x 10↑9 TCID50/mL in 1mL (experimental arm) or matched placebo (control arm) on a 1:1 basis. A single dose will be given by intramuscular injection during the following weeks: 2, 4, 7, 10, 13, 19, 25, 31, 37, 43 and 49. No further treatment will be given beyond week 49.Treatment will be stopped early if confirmed progression or unacceptable toxicity.
Patients will be registered to receive TroVax 1 x 10↑9 TCID50/mL in 1mL only. A single dose will be given by intramuscular injection during the following weeks: 2, 4, 7, 10, 13, 19 and 25. No further treatment will be given beyond week 25.Treatment will be stopped early if confirmed progression or unacceptable toxicity.
|Placebo Comparator: Placebo||
Matched placebo will be administered as above.
TRI-70 onwards received TroVax only.
- Progression [ Time Frame: At 25 weeks ]Protocol-defined progression
- Immune-related response criteria (irRC) [ Time Frame: 8 weeks post evidence of progression by RECIST 1.1 ]irRC will be used to identify any delayed response.Patients will remain on treatment until irRc has confirmed progression (in the absence of unacceptable toxicity or the need for urgent chemotherapy).
- Progression-free survival [ Time Frame: Time from randomisation/registration to clinical intervention or confirmed evidence of progression or death, assessed for up to 2 years ]
- Time to clinical intervention [ Time Frame: Time from randomisation/registration to clinical intervention or death, assessed for up to 2 years ]
- Incidence of clinical intervention [ Time Frame: At 25 weeks from randomisation/registration ]
- CA-125 doubling time [ Time Frame: Assessed at treatment visits for up to 2 years from randomisation/registration. ]To investigate CA-125 doubling time as an independent prognostic factor.
- Overall survival [ Time Frame: Time between randomisation/registration and death assessed for up to 4 years ]
- Quality of Life [ Time Frame: For up to 2 years following randomisation/registration or until progression ]Patient reported outcome and health-related quality of life measured by standardised questionnaires (EORTC QLQ C-30, EORTC QLQ OV-28)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01556841
|Leeds Teaching Hospitals NHS Trust|
|Leeds, West Yorkshire, United Kingdom, LS9 7TF|
|The Clatterbridge Cancer Centre NHS Foundation Trust|
|Bebington, Wirral, United Kingdom, CH63 4JY|
|Brighton and Sussex NHS Foundation Trust|
|Brighton, United Kingdom, BN2 5BE|
|University Hospitals of Bristol NHS Foundation Trust|
|Bristol, United Kingdom, BS2 8ED|
|Velindre NHS Trust|
|Cardiff, United Kingdom, CF14 2TL|
|Beatson West of Scotland Cancer Centre|
|Glasgow, United Kingdom, G12 0YN|
|Royal Surrey County Hospital NHS Foundation Trust|
|Guildford, United Kingdom, GU2 7XX|
|University College London Hospitals NHS Foundation Trust|
|London, United Kingdom, NW1 2PG|
|The Christie NHS Foundation Trust|
|Manchester, United Kingdom, M20 4BX|
|Nottingham University Hospitals NHS Trust|
|Nottingham, United Kingdom, NG5 1PB|
|Oxford University Hospitals NHS Trust|
|Oxford, United Kingdom, OX3 7LE|
|Plymouth Hospitals NHS Trust|
|Plymouth, United Kingdom, PL6 8OH|
|Principal Investigator:||Agnieszka Michael, MBBS, PhD||University of Surrey; Royal Surrey County Hospital NHS Foundation Trust|