A Randomized Phase II Study to Assess the Activity of TroVax® (MVA-5T4) Plus Docetaxel Versus Docetaxel Alone in Subjects With Progressive Hormone Refractory Prostate Cancer
Overview
- Phase
- Phase 2
- Intervention
- Docetaxel
- Conditions
- Hormone Refractory Prostate Cancer
- Sponsor
- Oxford BioMedica
- Enrollment
- 25
- Locations
- 7
- Primary Endpoint
- Progression-free survival
- Status
- Terminated
- Last Updated
- 5 years ago
Overview
Brief Summary
Based on both pre-clinical and clinical data, it may be advantageous to administer a cancer vaccine before chemotherapy to enhance immune responses, thus leading to a more effective therapeutic approach for subjects with metastatic HRPC. This clinical study will evaluate the role of combination therapy of TroVax® plus Docetaxel vs. Docetaxel alone on the progression free survival (PFS) of subjects with HRPC.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Docetaxel Alone
Subjects will receive 10 cycles of Docetaxel alone until toxicity or progression.
Intervention: Docetaxel
TroVax plus Docetaxel
Subjects will receive both TroVax plus 10 cycles of Docetaxel.
Intervention: Docetaxel
TroVax plus Docetaxel
Subjects will receive both TroVax plus 10 cycles of Docetaxel.
Intervention: TroVax
Outcomes
Primary Outcomes
Progression-free survival
Time Frame: Week 37
To establish whether the incidence of progression-free survival (as defined by the absence of progression assessed by both RECIST and PCWG2 criteria) at week 37 in the TroVax® plus Docetaxel treatment arm is higher than the incidence in the Docetaxel alone treatment arm.
Secondary Outcomes
- Clinical progression-free survival(37 weeks)