Trial · NCT00796445
A Phase III Study to Test the Benefit of a New Kind of Anti-cancer Treatment in Patients With Melanoma, After Surgical Removal of Their Tumor
NCT00796445, Phase 3, Terminated, GlaxoSmithKline; results first posted 2019-03-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Phase III Study to Test the Benefit of a New Kind of Anti-cancer Treatment in Patients With Melanoma, After Surgical Removal of Their Tumor. Trials, record NCT00796445. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00796445
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase III Study to Test the Benefit of a New Kind of Anti-cancer Treatment in Patients With Melanoma, After Surgical Removal of Their Tumor
- NCT number
- NCT00796445
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 1,351 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Melanoma
- Interventions
- GSK 2132231A, Placebo
- First posted
- 2008-11-24
- Last updated
- 2021-03-05
- Other registries' IDs
- eudract:2008-002447-16
- Results first posted
- 2019-03-19
- Limitations and caveats
- The study was terminated early on 08 Sep 2015 following assessment of the two co-primary endpoints showed the lack of efficacy of the study product.
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Disease Free Survival (DFS) | At Final analysis (Month 30 = Year 2.5) | DFS = time to event from randomization to the date of first disease recurrence (as assessed by investigator) or the date of death (whatever cause), whichever occurred first. DFS was expressed as the person-year rate i.e. the number of patients with at least one event (n) over the sum of the follow-up periods in years (T), until the first occurrence of a recurrence/death. Types of recurrence to be considered as an event included loco-regional and distant metastases. Any death occurring without prior documentation of tumor recurrence was considered as an event (not censored in the stat. analysis) as this approach was less prone to introduce bias. If no event occurred by the time of analysis, then the time to event was censored at the last assessment date (tumor assessment/visit) of the patient. Any new primary cancer at another site, including second primary melanoma, was not considered as a recurrence and had to be reported as a Serious Adverse Event (SAE). |
| Primary | Disease Free Survival (DFS) | At follow-up analysis (up to Year 5) | DFS = time to event from randomization to the date of first disease recurrence (as assessed by investigator) or the date of death (whatever cause), whichever occurred first. DFS was expressed as the person-year rate i.e. the number of patients with at least one event (n) over the sum of the follow-up periods in years (T), until the first occurrence of a recurrence/death. Types of recurrence to be considered as an event included loco-regional and distant metastases. Any death occurring without prior documentation of tumor recurrence was considered as an event (not censored in the stat. analysis) as this approach was less prone to introduce bias. If no event occurred by the time of analysis, then the time to event was censored at the last assessment date (tumor assessment/visit) of the patient. Any new primary cancer at another site, including second primary melanoma, was not considered as a recurrence and had to be reported as a Serious Adverse Event (SAE). |
| Secondary | Overall Survival (OS) | At Final analysis (Month 30 = Year 2.5) and at follow-up analysis (up to Year 5) | Overall Survival (OS) was defined as the time to event from randomization to the date of death, irrespective of the cause of death. OS was expressed as the person-year rate i.e. the number of patients with death (n) over the sum of the follow-up periods in years (T). Patients alive at the time of the analysis were censored on the date last known to be alive. |
| Secondary | Disease-free Specific Survival (DFSS) | At Final analysis (Month 30 = Year 2.5) | Disease Free Specific Survival (DFSS) was defined as the time to event from randomization to the date of first recurrence of disease or date of death due to melanoma (cause as assessed by investigator), whichever occurred first. DFSS was expressed as the person-year rate i.e. the number of patients with at least one event (n) over the sum of the follow-up periods in years (T), until the first occurrence of a recurrence/death. Patients who died due to a cause other than the disease under study and patients alive at the time of analysis were censored on the date of last assessment (visit or tumor assessment). |
| Secondary | Distant Metastasis-free Survival (DMFS) | At Final analysis (Month 30 = Year 2.5) | Distant Metastasis Free Survival (DMFS) was defined as the time to event from randomization to the date of first distant metastasis or date of death, whichever occurred first. DMFS was expressed as the person-year rate i.e. the number of patients with at least one event (n) over the sum of the follow-up periods in years (T), until the first occurrence of distant metastasis/death. Patients alive and without distant metastases were censored at the date of last assessment (visit or tumor assessment, or date of last tumor assessment as documented during the yearly contact follow-up period). |
| Secondary | Health-related Quality of Life | At Weeks 0, 6, 12 [on the day of and the day after treatment administration (TA)], at Month 6, 9, 12, 24, at the Concluding visit (Month 30) + 6 months and +12 Months and at disease recurrence | The assessment of health-related quality of life was restricted to patients who consented to study participation after Protocol Amendment 1 became effective at their study site, and for whom a validated version of the Euro Quality of Life-5D (EQ-5D) questionnaire was available in their native language. The EQ-5D comprises a 5-dimensional descriptive system (mobility, self-care, usual activities, pain/discomfort and anxiety/depression), where each item has 3 levels and together they define 243 possible health states. For each health state, a value (utility) was determined by using an additive algorithm. These utility scores were calculated for each patient at each timepoint at which an EQ-5D questionnaire was completed. The score had a maximum value of 1.0 corresponding to full health level, while lower scores, down to a minimum value of 0.0 reflected degradation in the health-related quality of life. |
| Secondary | Number of Subjects With Anti-MAGE-A3 Antibody Concentrations Above the Cut-off Value | At Weeks 0, 6, 12, 36, 48 72, 120 (Concluding visit) and at Week 120 + 6 months | The cut-off value was 27 Enzyme-Linked Immunosorbent Assay (ELISA) units per milliliter (EL.U/mL). |
| Secondary | Anti-MAGE-A3 Antibody Geometric Mean Concentrations | At Weeks 0, 6, 12, 36, 48 72, 120 (Concluding visit) and at Month 120 + 6 months | Anti-MAGE-A3 antibody concentrations were presented as geometric mean concentrations (GMC) and expressed in EL.U/mL. |
| Secondary | Number of Subjects With Anti-MAGE-A3 Antibody Response | At Weeks 6, 12, 36, 48 72, 120 (Concluding visit) and at Month 120 + 6 months | Treatment response defined as: - For initially seronegative patients: post-treatment antibody concentration ≥ 27 EL.U/mL; - For initially seropositive patients: post-treatment antibody concentration ≥ 2 fold the pre-treatment antibody concentration. |
| Secondary | Number of Subjects With Abnormal Haematological and Biochemical Parameters | Within the 31-day (Days 0-30) post-treatment period | Laboratory abnormalities belong to hematological and biochemical parameters such as: alanine aminotransferase \[ALT\], asparatate aminostransferase \[AST\], alkaline phoshatase \[AP\], bilirubin \[BIL\], creatinine \[CREA\], hemoglobin \[HGB\], leukocytes \[LEU\], lymphopenia \[LYMPH\], neutrophils \[NEU\], platelets \[PLA\]. Parameter grades (Grade \[G\] 0, 1, 2, 3, 4, Unknown) were compared to each baseline parameter grade (G Unknown, 0, 1, 2, 3), as defined by the Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 of August 9, 2006. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Disease Free Survival (DFS) | At Final analysis (Month 30 = Year 2.5) | The analysis was performed on the Total Treated population - as randomized, which included patients in the treatment groups as allocated by the randomization system at the start of the study. | First events per person-year | NUMBER |
| PRIMARY | Disease Free Survival (DFS) | At follow-up analysis (up to Year 5) | The analysis was performed on the Total Treated population - as randomized, which included patients in the treatment groups as allocated by the randomization system at the start of the study. Between the final and follow-up analyses, 1 patient was found to have an invalid ICF and was not included in the follow-up analysis. | First events per person-year | NUMBER |
| SECONDARY | Overall Survival (OS) | At Final analysis (Month 30 = Year 2.5) and at follow-up analysis (up to Year 5) | The analysis was performed on the Total Treated population - as randomized, which included patients in the treatment groups as allocated by the randomization system at the start of the study. Between the final and follow-up analyses, 1 patient was found to have an invalid ICF and was not included in the follow-up analysis. | Events per person-year | NUMBER |
| SECONDARY | Disease-free Specific Survival (DFSS) | At Final analysis (Month 30 = Year 2.5) | The analysis was performed on the Total Treated population - as randomized, which included patients in the treatment groups as allocated by the randomization system at the start of the study. | First events per person-year | NUMBER |
| SECONDARY | Distant Metastasis-free Survival (DMFS) | At Final analysis (Month 30 = Year 2.5) | The analysis was performed on the Total Treated population - as randomized, which included patients in the treatment groups as allocated by the randomization system at the start of the study. | First events per person-year | NUMBER |
| SECONDARY | Health-related Quality of Life | At Weeks 0, 6, 12 [on the day of and the day after treatment administration (TA)], at Month 6, 9, 12, 24, at the Concluding visit (Month 30) + 6 months and +12 Months and at disease recurrence | The analysis was performed on subjects with valid EQ-5D data from the Total Treated population - as randomized, which included patients in the treatment groups as allocated by the randomization system at the start of the study. | Units on a scale | MEAN |
| SECONDARY | Number of Subjects With Anti-MAGE-A3 Antibody Concentrations Above the Cut-off Value | At Weeks 0, 6, 12, 36, 48 72, 120 (Concluding visit) and at Week 120 + 6 months | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all eligible subjects who have received at least the first 4 MAGE-A3 ASCI study treatment doses and have provided a result for immunogenicity measurement within the time schedule for study product administration and blood sample draw. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Anti-MAGE-A3 Antibody Geometric Mean Concentrations | At Weeks 0, 6, 12, 36, 48 72, 120 (Concluding visit) and at Month 120 + 6 months | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all eligible subjects who have received at least the first 4 MAGE-A3 ASCI study treatment doses and have provided a result for immunogenicity measurement within the time schedule for study product administration and blood sample draw. | EL.U/mL | GEOMETRIC_MEAN |
| SECONDARY | Number of Subjects With Anti-MAGE-A3 Antibody Response | At Weeks 6, 12, 36, 48 72, 120 (Concluding visit) and at Month 120 + 6 months | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all eligible subjects who have received at least the first 4 MAGE-A3 ASCI study treatment doses and have provided a result for immunogenicity measurement within the time schedule for study product administration and blood sample draw. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Abnormal Haematological and Biochemical Parameters | Within the 31-day (Days 0-30) post-treatment period | The analysis was performed on the Total Treated population - as treated, which included patients in the treatment group as per treatment actually received. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group714
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Disease Free Survival (DFS) | MAGE-A3 Group | 0.505 | First events per person-year | ||
| Disease Free Survival (DFS) | Placebo Group | 0.478 | First events per person-year | ||
| Disease Free Survival (DFS) | GS+ Mage-A3 Sub-Group | 0.500 | First events per person-year | ||
| Disease Free Survival (DFS) | GS+ Placebo Sub-Group | 0.460 | First events per person-year | ||
| Disease Free Survival (DFS) | GS- Mage-A3 Sub-Group | 0.437 | First events per person-year | ||
| Disease Free Survival (DFS) | GS- Placebo Sub-Group | 0.442 | First events per person-year | ||
| Disease Free Survival (DFS) | MAGE-A3 Group | 0.366 | First events per person-year | ||
| Disease Free Survival (DFS) | Placebo Group | 0.345 | First events per person-year | ||
| Disease Free Survival (DFS) | GS+ Mage-A3 Sub-Group | 0.345 | First events per person-year | ||
| Disease Free Survival (DFS) | GS+ Placebo Sub-Group | 0.335 | First events per person-year |
1 to 10 of 714Source ClinicalTrials.gov
See all 714 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | MAGE-A3 Group | 895 | |
| Overall Study | STARTED | Placebo Group | 450 | |
| Overall Study | COMPLETED | MAGE-A3 Group | 310 | |
| Overall Study | COMPLETED | Placebo Group | 158 | |
| Overall Study | NOT COMPLETED | MAGE-A3 Group | 585 | |
| Overall Study | NOT COMPLETED | Placebo Group | 292 |
Source ClinicalTrials.gov
Adverse events360
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | MAGE-A3 Group | 46 | 895 | 61 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo Group | 19 | 450 | 26 |
| other | Nausea | Gastrointestinal disorders | MAGE-A3 Group | 123 | 895 | 266 |
| other | Nausea | Gastrointestinal disorders | Placebo Group | 32 | 450 | 43 |
| other | Asthenia | General disorders | MAGE-A3 Group | 149 | 895 | 354 |
| other | Asthenia | General disorders | Placebo Group | 46 | 450 | 68 |
| other | Chills | General disorders | MAGE-A3 Group | 179 | 895 | 432 |
| other | Chills | General disorders | Placebo Group | 15 | 450 | 23 |
| other | Fatigue | General disorders | MAGE-A3 Group | 210 | 895 | 490 |
| other | Fatigue | General disorders | Placebo Group | 63 | 450 | 116 |
1 to 10 of 360Source ClinicalTrials.gov
See all 360 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | MAGE-A3 Group | 5 | 895 |
| Total, all-cause mortality | Placebo Group | 1 | 450 |
| Total, other adverse events | MAGE-A3 Group | 819 | 895 |
| Total, other adverse events | Placebo Group | 327 | 450 |
| Total, serious adverse events | MAGE-A3 Group | 129 | 895 |
| Total, serious adverse events | Placebo Group | 64 | 450 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| MAGE-A3 Group vs Placebo Group: Number of Subjects With Potential Immune-mediated Diseases (pIMDs) | Trial comparisons |
| MAGE-A3 Group vs Placebo Group: Number of Subjects With Any Serious Adverse Events (SAEs) | Trial comparisons |
| MAGE-A3 Group vs Placebo Group: Number of Subjects With Any Adverse Events (AEs) | Trial comparisons |
| MAGE-A3 Group vs Placebo Group: deaths from any cause | Trial comparisons |
| MAGE-A3 Group vs Placebo Group: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00796445
GET https://conductscience.org/api/trials/v1/NCT00796445/results?page=2