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| Name | Class |
|---|---|
| Dantrials Aps | INDUSTRY |
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The study will evaluate safety and immunological response to RhoC peptide vaccine in patients with prostate cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RV001V | Experimental | RV001 Vaccine 0.1 mg/mL (RV001V). RV001V consists of the peptide RV001 and the adjuvant Montanide ISA 51. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RV001V | Biological | Sc injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportions of Participants With Treatment-related Adverse Events | Proportions of participants with treatment-related adverse events as assessed by CTCAE v4.0 | 8 month |
| Measure | Description | Time Frame |
|---|---|---|
| Immunological Response | RV001-specific immunological response after treatment from baseline to each treatment and follow-up | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jesper Sonne, MD, PhD | Dantrials Aps | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet | Copenhagen | 2400 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33184050 | Derived | Schuhmacher J, Heidu S, Balchen T, Richardson JR, Schmeltz C, Sonne J, Schweiker J, Rammensee HG, Thor Straten P, Roder MA, Brasso K, Gouttefangeas C. Vaccination against RhoC induces long-lasting immune responses in patients with prostate cancer: results from a phase I/II clinical trial. J Immunother Cancer. 2020 Nov;8(2):e001157. doi: 10.1136/jitc-2020-001157. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental: RV001V | RV001 Vaccine 0.1 mg/mL (RV001V). RV001V consists of the peptide RV001 and the adjuvant Montanide ISA 51. RV001V: A total of 11 s.c.injection with RV001V. The first 6 injections were given every 2 weeks, whereas the remaining 5 vaccinations were administered with 4 weeks between each injection. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental: RV001V | RV001 Vaccine 0.1 mg/mL (RV001V). RV001V consists of the peptide RV001 and the adjuvant Montanide ISA 51. RV001V: Sc injection |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportions of Participants With Treatment-related Adverse Events | Proportions of participants with treatment-related adverse events as assessed by CTCAE v4.0 | Posted | Count of Participants | Participants | 8 month |
|
|
20 months
Non-TEAEs (Treatment Emergent Adverse Events) took place before the first vaccination.
TEAEs took place after first vaccination and up to start of follow up phase (Visit 13). Only related AEs and SAEs are to be captured in the follow up period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Experimental: RV001V | RV001 Vaccine 0.1 mg/mL (RV001V). RV001V consists of the peptide RV001 and the adjuvant Montanide ISA 51. RV001V: Sc injection |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Impaired healing | General disorders | MedDRA (10.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site reaction | General disorders | MedDRA (10.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steven Glazer, MD | RhoVac ApS | +4525674434 | sgl@rhovac.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 7, 2017 | Feb 10, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
| Secondary | Immunological Response | RV001-specific immunological response after treatment from baseline to each treatment and follow-up | Posted | Count of Participants | Participants | 12 months |
|
|
|
| 0 |
| 22 |
| 4 |
| 22 |
| 22 |
| 22 |
| Pneumonia | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |