Trial intelligence / Profile preview

Pox Vector PSA Vaccine +/- Docetaxel in mCRPC

NCT00045227Phase 2

Key facts

Status: Completed
Start: Aug 2002
Countries: 1
Sponsor: National Cancer Institute
Modality: Viral Vectors, Vaccines & Immunotherapeutics

Drugs: rilimogene galvacirepvec
Conditions: metastatic castration-resistant prostate cancer (mCRPC)

Overview

Phase 2, randomised, open-label trial of rilimogene galvacirepvec in metastatic castration-resistant prostate cancer (mCRPC) (2 arms), sponsored by National Cancer Institute. Primary endpoint: Relative change in PSA-specific T-cell precursors (CD8) at Day 85. Started Aug 2002; status: completed.

Design

2 arms

Study design: RandomizedOpen-label

Concurrent
Vaccine + Docetaxel concurrently
Sequential
Vaccine alone, then Docetaxel on progression

Who it enrols

Patients with metastatic androgen-independent prostate cancer, HLA-A2 positive, ECOG 0-2, no prior taxanes, and adequate organ function.

Endpoints

Primary

Relative change in PSA-specific T-cell precursors (CD8)Day 85

Secondary

Safety of regimens
Clinical activity of regimens
CD4 T-cell responses to the vaccine

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