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TENDU Vaccine in Patients With Relapse After Primary Radical Prostatectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04701021
Recruitment Status : Active, not recruiting
First Posted : January 8, 2021
Last Update Posted : November 29, 2023
Sponsor:
Information provided by (Responsible Party):
Ultimovacs ASA

Tracking Information
First Submitted Date  ICMJE January 5, 2021
First Posted Date  ICMJE January 8, 2021
Last Update Posted Date November 29, 2023
Actual Study Start Date  ICMJE February 17, 2021
Actual Primary Completion Date August 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 7, 2021)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 7, 2021)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 7, 2021)
  • 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)
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE TENDU Vaccine in Patients With Relapse After Primary Radical Prostatectomy
Official Title  ICMJE Safety and Effect of Different Doses of TENDU Vaccine, a Therapeutic Peptide Conjugate Vaccine, in Patients With Relapse After Primary Radical Prostatectomy
Brief Summary This is a phase I, dose selection study of safety and effect of different doses of TENDU vaccine, a therapeutic peptide conjugate vaccine, in patients with relapse after primary radical prostatectomy.
Detailed Description

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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE Biological: TENDU
The vaccine is administrated by subcutaneous injections, one injection per drug substance (four separate injections) consecutively.
Study Arms  ICMJE Experimental: TENDU
Three different doses of the TENDU vaccine are to be investigated: 40, 400 and 960μg.
Intervention: Biological: TENDU
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 17, 2023)
12
Original Estimated Enrollment  ICMJE
 (submitted: January 7, 2021)
18
Estimated Study Completion Date  ICMJE December 31, 2023
Actual Primary Completion Date August 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Males ≥18 years of age
  2. PSA rise >0.2 ng/mL less than 18 months following radical prostatectomy (RP) and pathological ISUP Grade 4-5 (Gleason score >7), or persisting PSA >0.1 ng/mL six weeks after RP and short PSA-DT, eligible for salvage radiotherapy and short term androgen deprivation therapy
  3. ECOG performance status 0 or 1
  4. Adequate organ function as indicated by the following laboratory values:

    • White blood cell count ≥ 2,500/μL
    • Absolute neutrophil count ≥ 1,000/μL
    • Platelets ≥ 100,000/μL
    • Haemoglobin ≥ 9 g/dL or ≥ 5.6 mmol/L
    • Serum creatinine ≤ 1.5 x upper limit of normal (ULN)
    • Serum total bilirubin ≤ 1.5 x ULN or direct bilirubin ≤ ULN for patients with total bilirubin levels > 1.5 ULN
    • AST and ALT ≤ 2.5 x ULN
  5. Patients with potential to father children must use an acceptable contraceptive method
  6. Written informed consent prior to any study-specific evaluations

Exclusion Criteria:

  1. History of hematologic or primary solid tumor malignancy other than prostate cancer with remission less than 3 years prior study enrolment.
  2. Metastatic disease assessed by PSMA PET/CT
  3. Hypersensitivity to the active substance or any of its excipients
  4. Current use of androgen deprivation therapy or radiotherapy to the pelvis
  5. Known history or any evidence of active, non-infectious pneumonitis
  6. History of New York Heart Association class 3-4 congestive heart failure or history of myocardial infarction within 6 months of starting study treatment
  7. Active autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Patients with vitiligo or resolved childhood asthma/atopy would be an exception to this rule.
  8. Active infection requiring systemic therapy
  9. Diagnosis of immunodeficiency
  10. Any use of immunosuppressive (cytotoxic chemotherapy, systemic steroids) or immunomodulating agents within 8 weeks of study entry.
  11. Hepatitis B or Hepatitis C or Human Immunodeficiency Virus positive
  12. Expected to require any other form of systemic or localized antineoplastic therapy during the study
  13. Received any other investigational therapy within 4 weeks of the first dose of study treatment
  14. Any medical, psychological, social or neurological condition that would make it difficult for the patient to participate in the study and comply with the study procedures, restrictions, and requirements
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04701021
Other Study ID Numbers  ICMJE TENDU-101
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Ultimovacs ASA
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Ultimovacs ASA
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Wolfgang Lilleby, MD PhD Oslo universitetssykehus HF
PRS Account Ultimovacs ASA
Verification Date November 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP