Ovarian Cancer Clinical Trial
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.
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).
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