A Phase 1/2 interventional study of RV001V in Prostate Cancer, sponsored by RhoVac APS. Completed at 1 site in Denmark. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-06-09.
Sponsored by RhoVac APS · Phase 1/2, Interventional, and Treatment
The study will evaluate safety and immunological response to RhoC peptide vaccine in patients with prostate cancer
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 22 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →RhoVac APS is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
RV001 Vaccine 0.1 mg/mL (RV001V). RV001V consists of the peptide RV001 and the adjuvant Montanide ISA 51.
Biological: RV001V
Sc injection
Proportions of Participants With Treatment-related Adverse Events
Proportions of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 8 month
Immunological Response
RV001-specific immunological response after treatment from baseline to each treatment and follow-up
Time frame: 12 months
| Milestone | Experimental: RV001V |
|---|---|
| Started | 22 |
| Completed | 22 |
| Not completed | 0 |
Proportions of participants with treatment-related adverse events as assessed by CTCAE v4.0
| Participants | Experimental: RV001V |
|---|---|
| Proportions of Participants With Treatment-related Adverse Events | 22 |
RV001-specific immunological response after treatment from baseline to each treatment and follow-up
| Participants | Experimental: RV001V |
|---|---|
| Immunological Response | 18 |
Collected over 20 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Experimental: RV001V | 0/22 (0%) | 4/22 (18.2%) | 22/22 (100%) |
| Event | Experimental: RV001V |
|---|---|
| ArthralgiaMusculoskeletal and connective tissue disorders | 2/22 |
| Impaired healingGeneral disorders | 1/22 |
| PneumoniaInfections and infestations | 1/22 |
| Event | Experimental: RV001V |
|---|---|
| Injection site reactionGeneral disorders | 22/22 |
| Age, Categorical(Participants) | Experimental: RV001V |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 5 |
| >=65 years | 17 |
| Age, Continuous(years) | Experimental: RV001V |
|---|---|
| Mean | 67.6 ± 6.1 |
| Sex: Female, Male(Participants) | Experimental: RV001V |
|---|---|
| Female | 0 |
| Male | 22 |
| Race (NIH/OMB)(Participants) | Experimental: RV001V |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 22 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | Experimental: RV001V |
|---|---|
| Denmark | 22 |
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Plan to share: No
This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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RhoVac APS