Trial · NCT01437605
Phase II Study to Assess the Safety and Immunogenicity of recMAGE-A3+AS15 ASCI With or Without Poly IC:LC
NCT01437605, Phase 2, Terminated, H. Lee Moffitt Cancer Center and Research Institute; results first posted 2019-12-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase II Study to Assess the Safety and Immunogenicity of recMAGE-A3+AS15 ASCI With or Without Poly IC:LC. Trials, record NCT01437605. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01437605
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase II Study to Assess the Safety and Immunogenicity of recMAGE-A3+AS15 ASCI With or Without Poly IC:LC
- NCT number
- NCT01437605
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 14 participants, actual
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Conditions
- Melanoma
- Interventions
- MAGE-A3 ASCI injections without Poly IC:LC, MAGE-A3 ASCI injections with Poly IC:LC
- First posted
- 2011-09-21
- Last updated
- 2019-12-20
- Results first posted
- 2019-12-20
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events Related to Study Treatment | Beginning of Treatment to End of Follow Up - up to 5 years per participant | Number of participants with adverse events after receiving one dose of recMAGE-A3 + AS15 ASCI or recMAGEA3 + AS15 ASCI in combination with Poly IC:LC |
| Secondary | Immunogenicity Per Treatment Arm | Beginning of Treatment to End of Follow Up - up to 5 years per participant | Laboratory Endpoint: Assessment of the immunogenicity of the two regimens. Serum antibodies (such as Anti-MAGE-A3) seropositivity status (a seropositive patient is a patient whose titre is greater than or equal to the cut-off value) will be the primary immune endpoints assessed. Seropositivity will be assessed at baseline, after 2, 4, 6, 7 and 9 administrations, post-treatment (i.e., at concluding visit) and one year after concluding visit (i.e., at follow-up visit 2). |
| Secondary | Percentage of Participants With Relapse-Free Survival (RFS) | Beginning of Treatment to End of Follow Up - up to 2 years per participant | RFS, defined as the time from randomization to the date of first relapse of melanoma or of death, whichever comes first. Percentage of participants with RFS, assessed up to 2 years is reported |
| Secondary | Median Overall Survival (OS) | At 5 years | OS defined as the interval from randomization to the date of death, irrespective of the cause of death; patients still alive will be censored at the date of the last assessment. The primary analysis will be based on the adjusted Cox regression model. |
| Other | Immunogenicity as Measured by T Cell Responses | Beginning of Treatment to End of Follow Up - up to 5 years per participant | Immunogenicity as measured by T cell responses directed against MAGE-A3 antigen. |
| Other | Correlation Between Gene Expression Profile and Treatment Clinical Activity | Beginning of Treatment to End of Follow Up - up to 5 years per participant | A potential correlation between gene expression profile and treatment clinical activity (RFS) in both study arms (recMAGE-A3 + AS15 ASCI and recMAGE-A3 + AS15 ASCI in combination with Poly IC:LC). |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Events Related to Study Treatment | Beginning of Treatment to End of Follow Up - up to 5 years per participant | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Immunogenicity Per Treatment Arm | Beginning of Treatment to End of Follow Up - up to 5 years per participant | Data not collected (likely futility from low numbers enrolled when the protocol was closed to accrual) | ||
| SECONDARY | Percentage of Participants With Relapse-Free Survival (RFS) | Beginning of Treatment to End of Follow Up - up to 2 years per participant | percentage of participants | NUMBER | |
| SECONDARY | Median Overall Survival (OS) | At 5 years | Data not collected (likely futility from low numbers enrolled when the protocol was closed to accrual) | ||
| OTHER_PRE_SPECIFIED | Immunogenicity as Measured by T Cell Responses | Beginning of Treatment to End of Follow Up - up to 5 years per participant | Participants not analyzed due to low number of patients accrued to this study before closure for likely futility from other negative trials of MAGE-A3 | ||
| OTHER_PRE_SPECIFIED | Correlation Between Gene Expression Profile and Treatment Clinical Activity | Beginning of Treatment to End of Follow Up - up to 5 years per participant | Participants not analyzed due to low number of patients accrued to this study before closure for likely futility from other negative trials of MAGE-A3 |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events Related to Study Treatment | A: recMAGE-A3 + AS15 | 9 | Participants | ||
| Number of Participants With Adverse Events Related to Study Treatment | B: recMAGE-A3 + AS15 + Poly IC:LC | 5 | Participants | ||
| Percentage of Participants With Relapse-Free Survival (RFS) | A: recMAGE-A3 + AS15 | 1 Year RFS | 56 | 95% Confidence Interval 20 to 80 | percentage of participants |
| Percentage of Participants With Relapse-Free Survival (RFS) | B: recMAGE-A3 + AS15 + Poly IC:LC | 1 Year RFS | 40 | 95% Confidence Interval 5 to 75 | percentage of participants |
| Percentage of Participants With Relapse-Free Survival (RFS) | A: recMAGE-A3 + AS15 | 2 Year RFS | 33 | 95% Confidence Interval 8 to 62 | percentage of participants |
| Percentage of Participants With Relapse-Free Survival (RFS) | B: recMAGE-A3 + AS15 + Poly IC:LC | 2 Year RFS | 40 | 95% Confidence Interval 5 to 75 | percentage of participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | A: recMAGE-A3 + AS15 | 9 | |
| Overall Study | STARTED | B: recMAGE-A3 + AS15 + Poly IC:LC | 5 | |
| Overall Study | COMPLETED | A: recMAGE-A3 + AS15 | 9 | |
| Overall Study | COMPLETED | B: recMAGE-A3 + AS15 + Poly IC:LC | 5 | |
| Overall Study | NOT COMPLETED | A: recMAGE-A3 + AS15 | 0 | |
| Overall Study | NOT COMPLETED | B: recMAGE-A3 + AS15 + Poly IC:LC | 0 |
Source ClinicalTrials.gov
Adverse events156
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 | Anemia | Blood and lymphatic system disorders | A: recMAGE-A3 + AS15 | 1 | 9 | 1 |
| other | Anemia | Blood and lymphatic system disorders | B: recMAGE-A3 + AS15 + Poly IC:LC | 0 | 5 | 0 |
| other | Atrial Fibrillation | Cardiac disorders | A: recMAGE-A3 + AS15 | 0 | 9 | 0 |
| other | Atrial Fibrillation | Cardiac disorders | B: recMAGE-A3 + AS15 + Poly IC:LC | 1 | 5 | 2 |
| other | Atrial Flutter | Cardiac disorders | A: recMAGE-A3 + AS15 | 0 | 9 | 0 |
| other | Atrial Flutter | Cardiac disorders | B: recMAGE-A3 + AS15 + Poly IC:LC | 1 | 5 | 1 |
| other | Cushingoid | Endocrine disorders | A: recMAGE-A3 + AS15 | 1 | 9 | 1 |
| other | Cushingoid | Endocrine disorders | B: recMAGE-A3 + AS15 + Poly IC:LC | 0 | 5 | 0 |
| other | Endocrine Disorders - Other, Specify | Endocrine disorders | A: recMAGE-A3 + AS15 | 0 | 9 | 0 |
| other | Endocrine Disorders - Other, Specify | Endocrine disorders | B: recMAGE-A3 + AS15 + Poly IC:LC | 1 | 5 | 2 |
1 to 10 of 156Source ClinicalTrials.gov
See all 156 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | A: recMAGE-A3 + AS15 | 4 | 9 |
| Total, all-cause mortality | B: recMAGE-A3 + AS15 + Poly IC:LC | 2 | 5 |
| Total, other adverse events | A: recMAGE-A3 + AS15 | 9 | 9 |
| Total, other adverse events | B: recMAGE-A3 + AS15 + Poly IC:LC | 5 | 5 |
| Total, serious adverse events | A: recMAGE-A3 + AS15 | 3 | 9 |
| Total, serious adverse events | B: recMAGE-A3 + AS15 + Poly IC:LC | 1 | 5 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| A: recMAGE-A3 + AS15 vs B: recMAGE-A3 + AS15 + Poly IC:LC: Number of Participants With Adverse Events Related to Study Treatment | Trial comparisons |
| A: recMAGE-A3 + AS15 vs B: recMAGE-A3 + AS15 + Poly IC:LC: deaths from any cause | Trial comparisons |
| A: recMAGE-A3 + AS15 vs B: recMAGE-A3 + AS15 + Poly IC:LC: 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/NCT01437605
GET https://conductscience.org/api/trials/v1/NCT01437605/events?page=2