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TENDU Vaccine in Patients With Relapse After Primary Radical Prostatectomy

Primary Purpose

Prostate Cancer

Status

Active

Phase

Phase 1

Locations

Norway

Study Type

Interventional

Intervention

TENDU

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring prostate, vaccine, cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

Males ≥18 years of age
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
ECOG performance status 0 or 1
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
Patients with potential to father children must use an acceptable contraceptive method
Written informed consent prior to any study-specific evaluations

Exclusion Criteria:

History of hematologic or primary solid tumor malignancy other than prostate cancer with remission less than 3 years prior study enrolment.
Metastatic disease assessed by PSMA PET/CT
Hypersensitivity to the active substance or any of its excipients
Current use of androgen deprivation therapy or radiotherapy to the pelvis
Known history or any evidence of active, non-infectious pneumonitis
History of New York Heart Association class 3-4 congestive heart failure or history of myocardial infarction within 6 months of starting study treatment
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.
Active infection requiring systemic therapy
Diagnosis of immunodeficiency
Any use of immunosuppressive (cytotoxic chemotherapy, systemic steroids) or immunomodulating agents within 8 weeks of study entry.
Hepatitis B or Hepatitis C or Human Immunodeficiency Virus positive
Expected to require any other form of systemic or localized antineoplastic therapy during the study
Received any other investigational therapy within 4 weeks of the first dose of study treatment
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

Sites / Locations

Oslo University Hospital, The Norwegian Radium Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TENDU

Arm Description

Three different doses of the TENDU vaccine are to be investigated: 40, 400 and 960μg.

Outcomes

Primary Outcome Measures

Assessment of safety and tolerability of TENDU vaccine

Frequency and severity of Adverse Events (AEs) graded according to CTCAE version 5.0.

Secondary Outcome Measures

Assessment of Immunological response

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

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

To evaluate the preliminary anti-tumor activity of the TENDU vaccine according to changes in the PSA, PAP, PSMA and PET/CT.

Full Information

NCT ID

NCT04701021

First Posted

January 5, 2021

Last Updated

April 17, 2023

Sponsor

Ultimovacs ASA

1. Study Identification

Unique Protocol Identification Number

NCT04701021

Brief Title

TENDU Vaccine in Patients With Relapse After Primary Radical Prostatectomy

Official Title

Safety and Effect of Different Doses of TENDU Vaccine, a Therapeutic Peptide Conjugate Vaccine, in Patients With Relapse After Primary Radical Prostatectomy

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

February 17, 2021 (Actual)

Primary Completion Date

July 31, 2023 (Anticipated)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ultimovacs ASA

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

prostate, vaccine, cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

TENDU

Arm Type

Experimental

Arm Description

Three different doses of the TENDU vaccine are to be investigated: 40, 400 and 960μg.

Intervention Type

Biological

Intervention Name(s)

TENDU

Intervention Description

The vaccine is administrated by subcutaneous injections, one injection per drug substance (four separate injections) consecutively.

Primary Outcome Measure Information:

Title

Assessment of safety and tolerability of TENDU vaccine

Description

Frequency and severity of Adverse Events (AEs) graded according to CTCAE version 5.0.

Time Frame

Time from enrollment until 6 months after last dose

Secondary Outcome Measure Information:

Title

Assessment of Immunological response

Description

To evaluate the immunological response against the prostate specific peptides in the patients at baseline and after TENDU vaccinations.

Time Frame

Time from enrollment until 6 months after last dose

Title

Assessment of anti-tetanus protein and anti-MTTE titers

Description

Time Frame

Time from enrollment until 6 months after last dose

Title

Assessment of Anti-tumor activity

Description

To evaluate the preliminary anti-tumor activity of the TENDU vaccine according to changes in the PSA, PAP, PSMA and PET/CT.

Time Frame

Time from enrollment until 6 months after last dose

Other Pre-specified Outcome Measures:

Title

Assessment of antibody titers

Description

Evaluation of antibody titers against PAP and PSMA peptides epitopes presented in the TENDU vaccine.

Time Frame

Time from enrollment until 6 months after last dose

Title

Assessment of possible biomarkers

Description

Assessment of possible biomarkers e.g. phenotyping of circulating tumor cells (CTCs)

Time Frame

Time from enrollment until 6 months after last dose

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Males ≥18 years of age 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 ECOG performance status 0 or 1 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 Patients with potential to father children must use an acceptable contraceptive method Written informed consent prior to any study-specific evaluations Exclusion Criteria: History of hematologic or primary solid tumor malignancy other than prostate cancer with remission less than 3 years prior study enrolment. Metastatic disease assessed by PSMA PET/CT Hypersensitivity to the active substance or any of its excipients Current use of androgen deprivation therapy or radiotherapy to the pelvis Known history or any evidence of active, non-infectious pneumonitis History of New York Heart Association class 3-4 congestive heart failure or history of myocardial infarction within 6 months of starting study treatment 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. Active infection requiring systemic therapy Diagnosis of immunodeficiency Any use of immunosuppressive (cytotoxic chemotherapy, systemic steroids) or immunomodulating agents within 8 weeks of study entry. Hepatitis B or Hepatitis C or Human Immunodeficiency Virus positive Expected to require any other form of systemic or localized antineoplastic therapy during the study Received any other investigational therapy within 4 weeks of the first dose of study treatment 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wolfgang Lilleby, MD PhD

Organizational Affiliation

Oslo universitetssykehus HF

Official's Role

Principal Investigator

Facility Information:

Facility Name

Oslo University Hospital, The Norwegian Radium Hospital

City

Oslo

ZIP/Postal Code

0379

Country

Norway

12. IPD Sharing Statement

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TENDU Vaccine in Patients With Relapse After Primary Radical Prostatectomy

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