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Ovarian CancerPhase 2TRIOCNCT01556841

The Activity of TroVax® Versus Placebo in Relapsed Asymptomatic Ovarian Cancer

A Phase 2 study testing TroVax® in people with Ovarian Cancer and Fallopian Tube Cancer, run by University College, London at 12 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this trial is to assess the effectiveness of TroVax® compared to placebo in extending the time to progression in patients with asymptomatic relapsed platinum resistant ovarian, fallopian tube or primary peritoneal cancer.The trial will also look at overall survival times and quality of life. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
TroVax®
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
94 participants
Where
12 sitesUnited Kingdom
Study dates
Nov 2013to 19 Apr 2019
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

  • Aged ≥18 years with histologically or cytologically proven advanced epithelial ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma
  • Stage IC1 - III or Stage IVA (pleural effusion only) at diagnosis. (According to new FIGO staging effective 01/01/2014)
  • Completed cytoreductive surgery during the phase of first-line therapy including removal of bulky tumour masses and adequate surgical staging including a minimum of bilateral salpingo-oophorectomy, hysterectomy and omentectomy
  • Completed first line platinum-based chemotherapy OR Completed first line platinum-based chemotherapy and second line chemotherapy of any type with complete response to second line treatment according to RECIST 1.1
  • Have developed relapse ≥6 months after platinum-based chemotherapy (in the case of second relapse, the disease free interval should also be ≥6 months)
  • Normal CA-125 following platinum-based chemotherapy
Show all 17Show fewer
  • Have developed asymptomatic relapse as defined by:
  • CA125 ≥ 2xULN OR
  • Low volume radiological disease and CA125>ULN Low volume radiological disease is defined as radiologically visible disease excluding intra-hepatic (parenchymal) liver or splenic metastases, ascites or pleural effusion thought to require drainage within the next 2 months. The following are acceptable: Subcapsular liver and splenic lesions, benign lesions or cysts, any suspicious lesions that may represent metastases have to be confirmed by further imaging to be non-metastatic.
  • Currently asymptomatic and does not require chemotherapy.
  • Subject is assumed to be clinically immunocompetent and is free of clinically apparent/active autoimmune disease (i.e. no prior confirmed diagnosis or treatment for autoimmune disease including Systemic Lupus Erythematosis, Grave's disease, Hashimoto's thyroiditis, multiple sclerosis, and rheumatoid arthritis). Note: subjects with type I or type II diabetes mellitus can be included, as can subjects with controlled and rarely flaring rheumatoid disease (defined as recent flare within 6 months prior to randomisation/registration)
  • Subject has adequate bone marrow function as defined by Haemoglobin ≥ 110 g/L, white cell count ≥ 3.0 x 10^9/L, Absolute Lymphocyte Count (ALC) ≥ 1.0 x 10^9/L, Absolute Neutrophil Count (ANC) ≥1.5 x 10^9/L , Platelet Count ≥ 100 x 10^9/L and <400 x 10^9/L, Monocytes <0.8 x 10^9/L (for patients who have undergone previous splenectomy monocyte counts can be < 1.2 x 10^9/L)
  • Adequate end-organ function: plasma creatinine ≤ 2x upper limit of normal, AST and/or ALT ≤ 2x upper limit of normal, Total Bilirubin ≤ 1.5x upper limit normal
  • ECOG performance status 0-1
  • Life expectancy ≥6 months and willing to be available to attend clinic visits for treatment and for follow-up
  • Ability to give written informed consent
  • To be treated no later than 14 days from randomisation/registration

Who cannot join

  • Carcino-sarcoma/MMMT
  • Cancer related symptoms, or disease recurrence requiring immediate treatment
  • Patients with low volume radiological disease in any of the following sites at trial entry:
  • Accumulating ascites thought to require drainage within the next 2 months
  • Pleural effusion thought to require drainage within the next 2 months
  • Intraparenchymal Liver and/or splenic metastases
Show all 18Show fewer
  • CT scan showing bulky disease requiring chemotherapy, as judged by the investigator
  • Major surgery/radiation therapy, immunotherapy or chemotherapy completed < 4 weeks prior to randomisation/registration
  • Patients who are deemed as being immunosuppressed, receiving > 4 weeks parenteral or oral steroids, (nasal sprays and inhalers are permitted), or receiving immunosuppressive therapy following transplant
  • Chronic (≥ 6 months) oral corticosteroid use except when prescribed as replacement therapy in the case of adrenal insufficiency. If previously used for ≥6 months then must have discontinued ≥3 months prior to randomisation/registration.
  • "Currently active" second malignancy, other than non-melanoma skin cancer. Subjects are not considered to have a "currently active" malignancy if they have completed therapy ≥3 years previously and have no known evidence of residual or recurrent disease
  • Concomitant use of complementary medicines/botanicals. Supplements and conventional multivitamins are acceptable.
  • Evidence of significant clinical disorder or laboratory finding which in the opinion of the investigator makes it undesirable for the patient to participate in the trial. No participant should have a serious or uncontrolled intercurrent infection (including those positive for HIV, hepatitis B or C)
  • Psychiatric illnesses/social situations that limit compliance with protocol requirements
  • Allergy to egg proteins or history of allergic response to vaccinia vaccines
  • Prior exposure to TroVax®
  • Cerebral metastases (known from previous investigations or clinically detectable, surgically resected)
  • Patients on active treatment as part of another clinical trial

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

United Kingdom12 sites

  • The Clatterbridge Cancer Centre NHS Foundation Trust

    Bebington, Wirral, CH63 4JY

  • Brighton and Sussex NHS Foundation Trust

    Brighton, BN2 5BE

  • University Hospitals of Bristol NHS Foundation Trust

    Bristol, BS2 8ED

  • Velindre NHS Trust

    Cardiff, CF14 2TL

  • Beatson West of Scotland Cancer Centre

    Glasgow, G12 0YN

  • Royal Surrey County Hospital NHS Foundation Trust

    Guildford, GU2 7XX

  • Leeds Teaching Hospitals NHS Trust

    Leeds, West Yorkshire, LS9 7TF

  • University College London Hospitals NHS Foundation Trust

    London, NW1 2PG

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX

  • Nottingham University Hospitals NHS Trust

    Nottingham, NG5 1PB

  • Oxford University Hospitals NHS Trust

    Oxford, OX3 7LE

  • Plymouth Hospitals NHS Trust

    Plymouth, PL6 8OH

Other trials in United Kingdom

About this study

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

The purpose of this trial is to assess the effectiveness of TroVax® compared to placebo in extending the time to progression in patients with asymptomatic relapsed platinum resistant ovarian, fallopian tube or primary peritoneal cancer.The trial will also look at overall survival times and quality of life.

Read the detailed description

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).

Being tested
TroVax®, Placebo
Keywords
Randomised, Controlled, Trovax, MVA-5T4, 5T4, Immunotherapy, Relapsed, Asymptomatic, Epithelial, Ovarian, Fallopian, Peritoneal
Medical subject headings
Ovarian Neoplasms, Fallopian Tube Neoplasms, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TroVax®Biological

    Pre-amendment 10:

    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.

    Post-amendment 10:

    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.

  • PlaceboBiological

    Pre-amendment 10:

    Matched placebo will be administered as above.

    Post-amendment 10:

    TRI-70 onwards received TroVax only.

Study groups in NCT01556841
Study groupRoleWhat they receive
TroVax®ExperimentalTroVax® consists of a highly attenuated VV (Modified Vaccinia Ankara, MVA) containing the human TAA 5T4 under regulatory control of a modified VV promoter, mH5.
Receives: Biological: TroVax®
PlaceboPlacebo comparatorNot described
Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression

    Protocol-defined progression

    Measured: At 25 weeks

Secondary outcomes (7)

  1. Immune-related response criteria (irRC)

    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).

    Measured: 8 weeks post evidence of progression by RECIST 1.1

  2. Progression-free survival

    Measured: Time from randomisation/registration to clinical intervention or confirmed evidence of progression or death, assessed for up to 2 years

  3. Time to clinical intervention

    Measured: Time from randomisation/registration to clinical intervention or death, assessed for up to 2 years

  4. Incidence of clinical intervention

    Measured: At 25 weeks from randomisation/registration

  5. CA-125 doubling time

    To investigate CA-125 doubling time as an independent prognostic factor.

    Measured: Assessed at treatment visits for up to 2 years from randomisation/registration.

  6. Overall survival

    Measured: Time between randomisation/registration and death assessed for up to 4 years

  7. Quality of Life

    Patient reported outcome and health-related quality of life measured by standardised questionnaires (EORTC QLQ C-30, EORTC QLQ OV-28)

    Measured: For up to 2 years following randomisation/registration or until progression

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Mar 2012 (estimated)
  2. Study startNov 2013
  3. Primary completion19 Apr 2019
  4. Study completion19 Apr 2019

Resources

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
94 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01556841
Sponsor's protocol ID
UCL/11/0119
Acronym
TRIOC
Status last verified
Jan 2018
First submitted
14 Mar 2012
Last updated
9 May 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • Michael A, Wilson W, Sunshine S, Annels N, Harrop R, Blount D, Pandha H, Lord R, Ngai Y, Nicum S, Stylianou L, Gwyther S, McNeish IA, Hackshaw A, Ledermann J. A randomized phase II trial to examine modified vaccinia Ankara-5T4 vaccine in patients with relapsed asymptomatic ovarian cancer (TRIOC). Int J Gynecol Cancer. 2024 Aug 5;34(8):1225-1231. doi: 10.1136/ijgc-2023-005200.

    PubMed 38760075

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TroVax® in people with Ovarian Cancer and Fallopian Tube Cancer, run by University College, London at 12 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 17 inclusion and 18 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 9 May 2019. 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 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. Some participants in this study may receive a placebo. 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 (time frame: At 25 weeks). 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 NCT01556841, 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 9 May 2019.

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