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

NCT01556841 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2019-05-09

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

TroVax®

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.

BIOLOGICAL

Placebo

Pre-amendment 10: Matched placebo will be administered as above. Post-amendment 10: TRI-70 onwards received TroVax only.

Sponsors & Collaborators

  • Oxford BioMedica

    collaborator INDUSTRY

  • Cancer Research UK

    collaborator OTHER

  • University College, London

    lead OTHER

Principal Investigators

  • Agnieszka Michael, MBBS, PhD · University of Surrey; Royal Surrey County Hospital NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2019-04-19
Completion
2019-04-19

Countries

  • United Kingdom

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01556841 on ClinicalTrials.gov