Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Hormones

Vaccines

CV9103 is applied intradermally into the thigh and upper arm of either side of the body at week 1, week 3, week 7, week 15, week 23

Over a period of 23 weeks 5 vaccinations with CV9103 will be administered.

CV9103

Kurt Miller, Professor

The purpose of this study is to determine the efficacy and safety of a new vaccine in hormone refractory prostate cancer

Immunotherapy of prostate cancer is a promising approach for the treatment of advanced or recurrent forms of prostate cancer. Recently, immunotherapy of prostate cancer has been facilitated by the identification of a number of prostate specific antigens that are expressed in healthy and tumor prostate tissues. For prostatectomized patients, such antigens offer ideal targets for immunotherapy as they are only present in tumor but not in healthy tissue. The use of prostate specific antigens in a cancer vaccine is one attractive option for cancer immunotherapy.

Safety and Efficacy Trial of a RNActive®-Derived Prostate Cancer Vaccine in Hormone Refractory Disease

CureVac

CV9103 will be applied intradermally on three (3) or five (5) time points. Treatment with CV9103 is administered over a period of either seven (7) or twenty-three (23) weeks.

CV9103 encodes for 4 prostate specific antigens.

Johannes Vieweg, MD FACS

This is a Phase I/IIa open, uncontrolled, prospective study, to be conducted in an out-patient setting. The present study is one of two clinical trials of the RNActive®-derived vaccine CV9103 being conducted concurrently in the US and Europe, which represent the first clinical trials conducted for this novel vaccine.

The Phase I part of the study consists of a staggered inclusion of subjects in two cohorts of 3, to confirm the safety of the intended dose (320 µg RNA per antigen), with a lower dose to be considered in case of dose-limiting toxicity (DLT) being reported in greater than or equal to 2 out of 3-6 subjects; in this way, the recommended dose (RD) for the Phase IIa part of the study will be established. In the Phase IIa part of the study, additional subjects will be included at the RD, to confirm the safety and explore the activity of that dose.

Medical Need:

At present, no curative therapy is available for subjects with advanced or metastatic prostate cancer. Approximately 1 of every 3 men present with advanced or metastatic disease; therefore, current standard therapies are ineffective and new therapeutic approaches are warranted. There is ample evidence that active immunotherapy against cancer is safe and capable of stimulating potentially therapeutic immune responses in the cancer patient. Moreover, several Phase II immunotherapy trials have suggested clinical benefit by reducing the tumor mass or prolonging time to progression in subjects with advanced prostate cancer.

Potential Benefits:

CV9103 is an mRNA-based vaccine for the treatment of human prostate cancer that is based on CureVac's RNActive® technology. CV9103 encodes for 4 prostate specific antigens. 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, CV9103 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.

CV9103 will be administered in 5 doses.

RNActive®-Derived Therapeutic Vaccine

Phase I/IIa Study of RNActive®-Derived Therapeutic Vaccine in Advanced or Metastatic Hormone Refractory Prostate Cancer

Dose Limiting Toxicity (DLT) is defined as the following treatment-related adverse events or laboratory abnormalities, graded according to NCI-CTCAE version 3.0:

1. All Categories equal or greater than grade 3
2. Allergy/autoimmunity equal or greater than grade 2
3. Dosing delay greater than 48 hours due to toxicity All adverse events will be graded and documented according to Common Terminology Criteria for Adverse Events version 3.0.

University of Florida

Age, Categorical

Age Continuous

Sex: Female, Male

United States

Region of Enrollment

This study was terminated early by decision of the Sponsor after 6 subjects had been enrolled in the Phase I part of the study. No efficacy evaluations were planned during the Phase I part of the study.

Dr. Johannes Vieweg

Phase 1 consisted of cohort 1 with 3 subjects and cohort 2 with three subjects.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety and Efficacy Trial of a RNActive®-Derived Prostate Cancer Vaccine in Hormone Refractory Disease	NCT00831467	Hormonal Refrac...	CV9103	18 Years - 75 Years	CureVac
Safety and Efficacy Trial of a RNActive®-Derived Prostate Cancer Vaccine in Hormone Refractory Disease	NCT00831467	Hormonal Refrac...	CV9103	18 Years - 75 Years	CureVac
RNActive®-Derived Therapeutic Vaccine	NCT00906243	Hormone Refract...	CV9103	18 Years - 75 Years	University of Florida
Safety and Efficacy Trial of a RNActive®-Derived Prostate Cancer Vaccine in Hormone Refractory Disease	NCT00831467	Hormonal Refrac...	CV9103	18 Years - 75 Years	CureVac
RNActive®-Derived Therapeutic Vaccine	NCT00906243	Hormone Refract...	CV9103	18 Years - 75 Years	University of Florida

Spots Global Cancer Trial Database for cv9103

Every month we try and update this database with for cv9103 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for cv9103

Every month we try and update this database with for cv9103 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for cv9103 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.