NL-OMON35662
Completed
Not Applicable
A phase I-II open label clinical trial, evaluating the efficacy and safety of administration of the therapeutic vaccine PEP-223/CoVaccine HT, to hormone treatment naive, immunocompetent subjects with T1-3, N0-1/x, M0 prostate cancer, eligible for hormone therapy. - PEP223-NL-701
Pepscan Therapeutics B.V.0 sites12 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Pepscan Therapeutics B.V.
- Enrollment
- 12
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1 pathological confirmed prostatic adenocarcinoma, clinical
- •stage (c) cT1\-3, cN0\-1/x, cM0;
- •2 baseline testosterone levels of \> 4 nmol/l;
- •3 baseline PSA level of \> 10 µg/l;
- •4 eligible for hormone therapy;
- •5 willingness to comply with the protocol conditions and procedures;
- •6 willing and able to give informed consent.
Exclusion Criteria
- •1 clinical evidence of distant metastases;
- •2 previous (within 3 years before enrolment into the present study)hormonal therapy administered specifically for prostatic carcinoma;
- •3 development of another invasive neoplastic disease during the previous 5 years, or concomitant presence of another invasive neoplastic disease, except basal cell carcinoma or squamous cell carcinoma of the skin;
- •4 primary or secondary immunodeficiency, including immunosuppressive disease or use of corticosteroids or other immunosuppressive medications;
- •5 concomitant administration \-or administration during the 12 weeks preceding study inclusion\- of immune enhancing medication or testosterone supplements;
- •6 presence of bacterial prostatitis causing a PSA increase during the 8 weeks preceding study inclusion;
- •7 simultaneous participation in another clinical trial or participation in a clinical trial involving investigational drugs within 3 months before enrolment into the present study;
- •8 BMI \> 30 kg/m2;
- •9 a previous serious reaction to a vaccine such as angioedema or anaphylaxis.
Outcomes
Primary Outcomes
Not specified
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