TENDU Vaccine in Patients With Relapse After Primary Radical Prostatectomy
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|ClinicalTrials.gov Identifier: NCT04701021|
Recruitment Status : Recruiting
First Posted : January 8, 2021
Last Update Posted : February 21, 2021
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Biological: TENDU||Phase 1|
This is a open label dose selection study to investigate the safety, tolerability, immune response and preliminary clinical effect of different doses of the TENDU vaccine. TENDU is a synthetic therapeutic peptide conjugate vaccine intended for treatment of prostate cancer.
The patients enrolled in this study is adults with documented progressive disease after radical prostatectomy and who are eligible for salvage radiotherapy and short-term (6 months) androgen deprivation therapy.
All patients taking part at the study must be vaccinated with a Boostrix vaccine (including tetanus antigen) one week prior to the first TENDU vaccine treatment.
Three different doses, 40, 400 and 960 μg of the TENDU vaccine are to be investigated.
The vaccine is administrated by subcutaneous injections with one injection per drug substance (four separate injections) consecutively. The TENDU vaccine will be given four times during a treatment period lasting for 6 weeks and followed up for 6 months after the last treatment.
In total between 12 to 18 patients will be enrolled with a 3+3 design in each dose cohort. The first patient will receive the lowest dose of the TENDU vaccine, and after the treatment is completed, a safety evaluation will be done to evaluate enrolment of the next patients in this cohort. If one patient develops a dose limiting toxicity at a specific dose, an additional three patients are to be enrolled into that same dose cohort, and on the recommended dose an addition of 3 patients will be enrolled.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Effect of Different Doses of TENDU Vaccine, a Therapeutic Peptide Conjugate Vaccine, in Patients With Relapse After Primary Radical Prostatectomy|
|Actual Study Start Date :||February 17, 2021|
|Estimated Primary Completion Date :||July 31, 2022|
|Estimated Study Completion Date :||December 31, 2022|
Three different doses of the TENDU vaccine are to be investigated: 40, 400 and 960μg.
The vaccine is administrated by subcutaneous injections, one injection per drug substance (four separate injections) consecutively.
- Assessment of safety and tolerability of TENDU vaccine [ Time Frame: Time from enrollment until 6 months after last dose ]Frequency and severity of Adverse Events (AEs) graded according to CTCAE version 5.0.
- Assessment of Immunological response [ Time Frame: Time from enrollment until 6 months after last dose ]To evaluate the immunological response against the prostate specific peptides in the patients at baseline and after TENDU vaccinations.
- Assessment of anti-tetanus protein and anti-MTTE titers [ Time Frame: Time from enrollment until 6 months after last dose ]To evaluate the preliminary anti-tumor activity of the TENDU vaccine in patients pre- and post the vaccination with Boostrix (including tetanus antigen) and the TENDU vaccinations by evaluation of anti-tetanus protein and anti-MTTE titers.
- Assessment of Anti-tumor activity [ Time Frame: Time from enrollment until 6 months after last dose ]To evaluate the preliminary anti-tumor activity of the TENDU vaccine according to changes in the PSA, PAP, PSMA and PET/CT.
- Assessment of antibody titers [ Time Frame: Time from enrollment until 6 months after last dose ]Evaluation of antibody titers against PAP and PSMA peptides epitopes presented in the TENDU vaccine.
- Assessment of possible biomarkers [ Time Frame: Time from enrollment until 6 months after last dose ]Assessment of possible biomarkers e.g. phenotyping of circulating tumor cells (CTCs)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04701021
|Contact: Wenche Rasch, PhDfirstname.lastname@example.org|
|Oslo University Hospital, The Norwegian Radium Hospital||Recruiting|
|Oslo, Norway, 0379|
|Principal Investigator:||Wolfgang Lilleby, MD PhD||Oslo universitetssykehus HF|