A phase III randomised, double-blind trial of immunotherapy with a polyvalent melanoma vaccine (C-VAX) plus bacille Calmette-Guerin (BCG) versus placebo plus BCG as a post surgical treatment for stage IV melanoma
| ISRCTN | ISRCTN72807124 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN72807124 |
| Protocol serial number | N0436044028 |
| Sponsor | Department of Health (UK) |
| Funder | Leeds Teaching Hospitals NHS Trust (UK) |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 05/03/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr PM Patel
Scientific
Scientific
Medical Oncology
Cancer Studies
ICRF Research Building
St James's University Hospital
Beckett Street
Leeds
LS9 7TF
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A phase III randomised, double-blind trial of immunotherapy with a polyvalent melanoma vaccine (C-VAX) plus bacille Calmette-Guerin (BCG) versus placebo plus BCG as a post surgical treatment for stage IV melanoma |
| Study objectives | To establish whether adjuvant C-VAX plus BCG will prolong disease free and overall survival compared to placebo plus BCG in stage IV melanoma patients who have no evidence of disease post-surgery. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Stage IV melanoma |
| Intervention | Randomised controlled trial. |
| Intervention type | Biological/Vaccine |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | C-VAX, BCG |
| Primary outcome measure(s) |
Progression free survival. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/08/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Key inclusion criteria | Patients with resected stage IV melanoma. |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 01/04/1999 |
| Date of final enrolment | 01/08/2003 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
St James's University Hospital
Leeds
LS9 7TF
United Kingdom
LS9 7TF
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
05/03/2019: Internal review.
