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

Phase 1/Phase 2
18 Years
75 Years
Not Enrolling
Hormone Refractory Prostate Cancer

Thank you

Trial Information

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

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

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.

Inclusion Criteria:

- Subjects with documented history of hormone refractory prostate cancer as evidenced
by three consecutive increases in serum PSA despite continued androgen ablative
therapy. Serum testosterone levels must be less than 50 ng/dl

- Signed informed consent in accordance with Good Clinical Practice (GCP) and local
regulatory requirements prior to trial participation

- Age greater than or equal to 18 yrs (Phase I and IIa) and less than or equal to 75
yrs (Phase IIa only)

- ECOG (Eastern Cooperative Oncology Group) Grade of 0 or 1

- Adequate Hematologic Function with:

- WBC ≥ 3000 mm3

- hemoglobin ≥ 10mg/dl

- platelets ≥ 100,000/mm3

- Adequate Renal and Hepatic Function with:

- serum creatinine ≤ 1.5 x Upper Limit of Normal

- bilirubin < 2.0 mg/dl

- Adequate Coagulation Parameters with:

- Prothrombin INR < 1.5

- Partial Thromboplastin Time < 1.5 x Institutional Upper Limit of Normal

- Subjects will be advised to use barrier contraception while enrolled in the study and
for one month after the last immunization.

- Life Expectancy > 6 month

Exclusion Criteria:

- Subjects who have received radiation therapy within 8 weeks of pretreatment
evaluation. (There must be at least 12 weeks if prior therapy included 89-Strontium
between any prior therapy and study entry.)

- Subjects who have received chemotherapy, radiation therapy or biologic regimens
within 8 weeks of pretreatment evaluation.

- Subjects treated with any investigational agent within the past 30 days are excluded.

- Subjects who have received active immunotherapy, such as Antigen Loaded Dendritic
Cells, are excluded (Phase I only). In Phase IIa, Subjects who have received an
active immunotherapy based on any of the antigens used in this study either as DNA,
RNA or a protein/peptide-based vaccines are excluded. Subjects who have received any
other active immunotherapy, such as Antigen Loaded Dendritic Cells, within 6 months
prior to study entry are also excluded.

- Subjects who have not recovered from radiation, chemotherapy, or immunotherapy

- Subjects with either previously irradiated or new CNS (central nervous system)
metastases. (Pre-enrollment head CT is not required.)

- Subjects with a history of autoimmune disease such as, but not restricted to,
inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis,
scleroderma, or multiple sclerosis.

- Subjects with serious intercurrent chronic or acute illness such as pulmonary [asthma
or chronic obstructive pulmonary disease (COPD)] or cardiac (NYHA class III or IV) or
hepatic disease or other illness considered by the P.I. to constitute an unwarranted
high risk for investigational drug treatment.

- Medical or psychological impediment to probable compliance with the protocol.

- Concurrent second malignancy other than non-melanoma skin cancer, or controlled
superficial bladder cancer. In the event of prior malignancies treated surgically,
the subject must be considered NED (no evidence of disease) for a minimum of 3 years
prior to enrollment.

- Subjects on steroid therapy (or other immunosuppressive agents such as azathioprine
or cyclosporine A) are excluded on the basis of potential immune suppression.
Subjects must have had 8 weeks of discontinuation of any steroid therapy prior to

- Presence of an active acute or chronic infection, including symptomatic urinary tract
infection, HIV (as determined by ELISA and confirmed by Western Blot) or viral
hepatitis (as determined by HBsAg and Hepatitis C serology).

- Subjects with penicillin allergies

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Phase I: Assessment of Safety and Tolerability of the Trial Regimen

Outcome Description:

Dose Limiting Toxicity (DLT) is defined as the following treatment-related adverse events or laboratory abnormalities, graded according to NCI-CTCAE version 3.0: All Categories equal or greater than grade 3 Allergy/autoimmunity equal or greater than grade 2 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.

Outcome Time Frame:

At Nine Weeks with Follow Up at One Year

Safety Issue:


Principal Investigator

Johannes Vieweg, MD FACS

Investigator Role:

Principal Investigator

Investigator Affiliation:

Univeristy of Florida, College of Medicine


United States: Food and Drug Administration

Study ID:




Start Date:

May 2009

Completion Date:

December 2010

Related Keywords:

  • Hormone Refractory Prostate Cancer
  • Prostatic Neoplasms



University of Florida, College of MedicineGainesville, Florida  32610