Phase I/Ila Study of RNActive®-derived therapeutic vaccine in metastatic hormone refractory prostate cancer

Short Title: RNActive®-derived therapeutic vaccine

Synopsis:
This is a Phase I/Ila open, uncontrolled, prospective study, to be conducted in an out-patient setting. CV9103 is an mRNA-based vaccine for the treatment of human prostate cancer that is based on CureVac's RNActiveo technology. CV9 103 encodes for 4 prostate specific antigens (PSA, PSMA, PSCA and STEAP). Because these antigens are present in prostate cancer cells, they are appropriate targets for intervention. These antigens have been shown to correlate frequently with the progression of prostate cancer, and are known to be immunogenic in humans, where they induce antigen specific T-cell or B cell expansion.

As an RNA-based vaccine, CV9I103 features several advantages over other approaches: it is highly specific, there is no restriction to the patient's MHC genotype, and it does not need to cross the nuclear membrane to be active. Finally, in the absence of reverse transcriptase, RNA can not be integrated into the genome.

The vaccine will be applied intradermally over a period of 7 weeks in Phase I (weeks 1, 3 and 7), and over 23 weeks in Phase Ila, beginning in week 1, followed by weeks 3, 7, 15 and 23; subjects from Phase I may receive the 4th and 5th vaccinations at weeks 15 and 23 if they did not experience DLT during the first three vaccinations and if approved by the Cohort Review Committee of safety data and FDA notification and consultation.

Subjects will be followed up for survival until week 52. Thus individual patient participation is one year.

Sponsor:
CureVac GmbH

This study is currently recruiting participants.

For more information, go to: http://clinicaltrials.gov

Study Coordinator:
Judy King, RN, CCRP
Tel: (352) 265-8285
Email: Judy.King@urology.ufl.edu

Principal Investigator:
Johannes Vieweg, MD
Tel: (352) 273-7895
Email: j.vieweg@urology.ufl.edu

Synopsis:
This is a prospective, multicenter, multinational, randomized (1:1), doubled-blind, placebo-controlled, parallel-arm study comparing the efficacy of aflibercept (Arm A) versus placebo (Arm B) in terms of OS in patients treated with docetaxel/prednisone or prednisolone for MAIPC.

The combination regimen of docetaxel/prednisone is the standard of care for the treatment of MAIPC.  Therefore, the present randomized placebo-controlled study has been designed to evaluate the efficacy and safety of the addition of aflibercept to the doses of docetaxel/prednisone in the first-line treatment of patients with MAIPC.

Sponsor:
sanofi aventis

This study is currently recruiting participants.

For more information, go to: http://clinicaltrials.gov

Study Contact:
Judy King
Tel: (352) 265-8285

Principal Investigator:
Dr. Robert Marsh

CHAARTED: ChemoHormonal Therapy versus Androgen Ablation Randomized Trial for Extensive Disease in Prostate Cancer

Synopsis:
This is a randomized trial in men 18 years of age or greater with metastatic prostate cancer.

The purpose of this study is to determine whether instituting chemotherapy when starting hormonal therapy can delay the time to progression to a clinically meaningful degree without affected quality of life in men with extensive disease.

The subjects will return for every 2 week clinic visits during the intervention period.  After the intervention period subjects will be followed for 10 years.

Sponsor:
The Eastern Cooperative Oncology Group (ECOG)

This study is currently recruiting participants.

For more information, go to: http://clinicaltrials.gov

Study Contact:
Judy King, RN
Tel: (352) 265-8285

Principal Investigator:
Dr. Robert Marsh