Trial Outcomes & Findings for RV001V, a RhoC Anticancer Vaccine, Against Metastasis From Solid Tumours (NCT NCT03199872)

NCT ID: NCT03199872

Last Updated: 2020-06-09

Results Overview

Proportions of participants with treatment-related adverse events as assessed by CTCAE v4.0

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 22 participants
• Primary outcome timeframe: 8 month
• Results posted on: 2020-06-09

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	22
Overall Study COMPLETED	22
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

RV001V, a RhoC Anticancer Vaccine, Against Metastasis From Solid Tumours

Baseline characteristics by cohort

Measure	Experimental: RV001V n=22 Participants RV001 Vaccine 0.1 mg/mL (RV001V). RV001V consists of the peptide RV001 and the adjuvant Montanide ISA 51. RV001V: Sc injection
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants
Age, Categorical >=65 years	17 Participants n=5 Participants
Age, Continuous	67.6 years STANDARD_DEVIATION 6.1 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	22 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Denmark	22 Participants n=5 Participants

PRIMARY outcome

Timeframe: 8 month

Proportions of participants with treatment-related adverse events as assessed by CTCAE v4.0

Outcome measures

Measure	Experimental: RV001V n=22 Participants RV001 Vaccine 0.1 mg/mL (RV001V). RV001V consists of the peptide RV001 and the adjuvant Montanide ISA 51. RV001V: Sc injection
Proportions of Participants With Treatment-related Adverse Events	22 Participants

SECONDARY outcome

Timeframe: 12 months

RV001-specific immunological response after treatment from baseline to each treatment and follow-up

Outcome measures

Measure	Experimental: RV001V n=21 Participants RV001 Vaccine 0.1 mg/mL (RV001V). RV001V consists of the peptide RV001 and the adjuvant Montanide ISA 51. RV001V: Sc injection
Immunological Response	18 Participants

Adverse Events

Experimental: RV001V

Serious events: 4 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Measure	Experimental: RV001V n=22 participants at risk RV001 Vaccine 0.1 mg/mL (RV001V). RV001V consists of the peptide RV001 and the adjuvant Montanide ISA 51. RV001V: Sc injection
General disorders Impaired healing	4.5% 1/22 • Number of events 1 • 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.
Infections and infestations Pneumonia	4.5% 1/22 • Number of events 1 • 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.
Musculoskeletal and connective tissue disorders Arthralgia	9.1% 2/22 • Number of events 2 • 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.

Other adverse events

Measure	Experimental: RV001V n=22 participants at risk RV001 Vaccine 0.1 mg/mL (RV001V). RV001V consists of the peptide RV001 and the adjuvant Montanide ISA 51. RV001V: Sc injection
General disorders Injection site reaction	100.0% 22/22 • Number of events 22 • 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.

Additional Information

Steven Glazer, MD

RhoVac ApS

Phone: +4525674434

Email: sgl@rhovac.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place