Trial · NCT00849875
A Study of Safety and Clinical Activity of Immunotherapy Plus Chemotherapy in Metastatic Melanoma Patients
NCT00849875, Phase 2, Terminated, GlaxoSmithKline; results first posted 2017-03-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Safety and Clinical Activity of Immunotherapy Plus Chemotherapy in Metastatic Melanoma Patients. Trials, record NCT00849875. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00849875
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Safety and Clinical Activity of Immunotherapy Plus Chemotherapy in Metastatic Melanoma Patients
- NCT number
- NCT00849875
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 48 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Melanoma
- Interventions
- Immunotherapeutic GSK2132231A, Dacarbazine
- First posted
- 2009-02-24
- Last updated
- 2017-07-12
- Results first posted
- 2017-03-30
Source ClinicalTrials.gov
Registered outcomes38
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. | Within the 31-day (Days 0-30) post-administration period. | The assessed AEs were ASCI-related grade 3/4 adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. An unsolicited AE covers any untoward medical occurrence in a clinical investigation patient temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Related = AE assessed by the investigator as related to the treatment. |
| Primary | Number of Patients Reported With Serious Adverse Events (SAEs) | During the entire study period, up to 5 years | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Events which were part of the natural course of the disease under study (i.e., disease progression, recurrence) were captured as part of the clinical activity outcome variables in this study; therefore these did not need to be reported as SAEs. Progression/recurrence of the tumor in a patient was recorded as part of the clinical assessment data collection, and deaths due to progressive disease was recorded on a specific form, but not as an SAE. However, if the investigator considered that there was a causal relationship between treatment or protocol design/procedures and the disease progression/recurrence, then the event was reported as an SAE. Any new primary cancer (non-related to the cancer under study) was reported as an SAE. |
| Primary | Number of Seroconverted Patients for Melanoma Antigen (Anti-MAGE-A3) | Post Dose 4 at Week 13 (W13). | Seroconversion was defined as a concentration of antibodies assessed that was greater than the cut-off value for a patient whose concentration of such antibodies was below the cut-off level before the initiation of treatment. Seroconverted patients were those patients with anti-MAGE-A3 antibody concentrations ≥ 27. |
| Primary | Anti-MAGE-A3 Antibody Concentrations | Post Dose 4 at Week 13 (W13). | Anti-MAGE-A3 antibody concentrations were presented as geometric mean concentrations (GMTs) and expressed in ELISA units per millilitre (EL.U/mL) |
| Primary | Number of Patients With Treatment Response for Anti-MAGE-A3 Antibodies | Post Dose 4 at Week 13 (W13). | Treatment response defined as: For initially seronegative patients: post-administration antibody concentration ≥ 27 EL.U/mL For initially seropositive patients: post-administration antibody concentration ≥ 2 fold the pre-vaccination antibody concentration |
| Primary | Concentrations of Antibodies Against Protein D (Anti-PD) | Post Dose 4 at Week 13 (W13). | Anti-PD antibody concentrations were presented ad geometric mean concentrations (GMTs) and expressed in ELISA units per millilitre (EL.U/mL). |
| Primary | Number of Patients With Treatment Response for Anti-PD | Post Dose 4 at Week 13 (W13). | Treatment response defined as: For initially seronegative patients: post-administration antibody concentration ≥ 100 EL.U/mL For initially seropositive patients: post-administration antibody concentration ≥ 2 fold the pre-vaccination antibody concentration |
| Primary | Anti-MAGE-A3 Antibody Concentrations (CMI) | Post Dose 4 at Week 13 (W13). | Analysis of MAGE-A3 cellular response was not performed and data were not collected.. |
| Secondary | Number of Patients With Objective Tumor Response (OR) to MAGE-A3 ASCI Study Treatment | During the entire study, up to 5 years | Response assessment was done based on a set of measurable lesions (MLs) identified at baseline as target lesions (TLs), and followed up until disease progression. Up to 5 MLs per organ \& 10 in total were identified as TLs and measured at baseline, selected based on size (those with the longest diameter \[LD\]) and measurability; a sum of LDs for all TLs was calculated and reported as baseline sum LD, which was used to characterize objective tumor response (OR), OR being defined as either complete response (CR) and/or partial response (PR) post MAGE-A3 ASCI treatment. After identification, MLs and TLs were assessed as regards CR and PR definitions per Response Evaluation Criteria in Solid Tumors (RECIST) criteria: CR = Disappearance of all extranodal target lesions. All pathological lymph nodes must have decreased to \<10 mm in short axis; PR = At least a 30% decrease in the SLD of target lesions, taking as reference the baseline sum diameters. |
| Secondary | Number of Patients With Stable Disease (SD) Response to MAGE-A3 ASCI Study Treatment | During the entire study, up to 5 years | Assessment was done based on a set of MLs identified at baseline as TLs and NTLs followed up until disease progression. TLs and NTLs were assessed as regards matching or not SD-related definitions, 1) SD definitions per Response Evaluation Criteria in Solid Tumors (RECIST) criteria for TLs \>= 20 mm and TLs both \>= and \< 20 mm: a) for TLs: SD = Neither sufficient shrinkage to qualify as a PR nor sufficient increase to qualify as PD, taking as references the smallest sum LD since treatment start. and b) for NTLs: SD = Persistence of one or more NTL; 2) following below criteria for TLs \< 20mm e. a. a) for TLs: PR/SD = Neither sufficient shrinkage to qualify for CR nor sufficient increase, to qualify for PD taking as references the smallest sum LD since treatment start, and b) for NTLs: PR/SD = Persistence of one or more NTL. |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 registered outcomesOutcomes38
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. | Within the 31-day (Days 0-30) post-administration period. | The Total Treated population included all patients who have received at least one dose of the GSK2132231A product. | Patients | NUMBER |
| PRIMARY | Number of Patients Reported With Serious Adverse Events (SAEs) | During the entire study period, up to 5 years | The Total Treated population included all patients who have received at least one dose of the GSK2132231A product. | Patients | NUMBER |
| PRIMARY | Number of Seroconverted Patients for Melanoma Antigen (Anti-MAGE-A3) | Post Dose 4 at Week 13 (W13). | The Total Treated population included all patients who have received at least one dose of the GSK2132231A product. | Patients | NUMBER |
| PRIMARY | Anti-MAGE-A3 Antibody Concentrations | Post Dose 4 at Week 13 (W13). | The ATP population for Immunogenecity included all eligible patients, who have received at least the first 4 GSK2132231A doses concomitantly to the standard chemotherapy regimen and provided a valid result for immunogenecity measurement within the 4 weeks following the 4th dose. | EL.U/mL | GEOMETRIC_MEAN |
| PRIMARY | Number of Patients With Treatment Response for Anti-MAGE-A3 Antibodies | Post Dose 4 at Week 13 (W13). | The ATP population for Immunogenecity included all eligible patients, who have received at least the first 4 GSK2132231A doses concomitantly to the standard chemotherapy regimen and provided a valid result for immunogenecity measurement within the 4 weeks following the 4th dose. | Patients | NUMBER |
| PRIMARY | Concentrations of Antibodies Against Protein D (Anti-PD) | Post Dose 4 at Week 13 (W13). | The ATP population for Immunogenecity included all eligible patients, who have received at least the first 4 GSK2132231A doses concomitantly to the standard chemotherapy regimen and provided a valid result for immunogenecity measurement within the 4 weeks following the 4th dose. | EL.U/mL | GEOMETRIC_MEAN |
| PRIMARY | Number of Patients With Treatment Response for Anti-PD | Post Dose 4 at Week 13 (W13). | The ATP population for Immunogenecity included all eligible patients, who have received at least the first 4 GSK2132231A doses concomitantly to the standard chemotherapy regimen and provided a valid result for immunogenecity measurement within the 4 weeks following the 4th dose. | Patients | NUMBER |
| PRIMARY | Anti-MAGE-A3 Antibody Concentrations (CMI) | Post Dose 4 at Week 13 (W13). | |||
| SECONDARY | Number of Patients With Objective Tumor Response (OR) to MAGE-A3 ASCI Study Treatment | During the entire study, up to 5 years | The Total Treated population included all patients who have received at least one dose of the GSK2132231A product. | patients | NUMBER |
| SECONDARY | Number of Patients With Stable Disease (SD) Response to MAGE-A3 ASCI Study Treatment | During the entire study, up to 5 years | The Total Treated population included all patients who have received at least one dose of the GSK2132231A product. | patients | NUMBER |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 outcomesResults by group433
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. | GSK2132231A GROUP | Any event, Grade 3 | 3 | Patients | |
| Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. | GSK2132231A GROUP | Any event, Grade 4 | 1 | Patients | |
| Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. | GSK2132231A GROUP | Any Blood and lymphatic system disorders, Grade 3 | 1 | Patients | |
| Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. | GSK2132231A GROUP | Any Blood and lymphatic system disorders, Grade 4 | 1 | Patients | |
| Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. | GSK2132231A GROUP | Anaemia, Grade 3 | 0 | Patients | |
| Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. | GSK2132231A GROUP | Anaemia, Grade 4 | 0 | Patients | |
| Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. | GSK2132231A GROUP | Lymphopenia, Grade 3 | 0 | Patients | |
| Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. | GSK2132231A GROUP | Lymphopenia, Grade 4 | 0 | Patients | |
| Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. | GSK2132231A GROUP | Neutropenia, Grade 3 | 1 | Patients | |
| Number of Patients Reported With Unsolicited Adverse Events (AEs) That Were Causally Related to Treatment Administration by Maximum Grade. | GSK2132231A GROUP | Neutropenia, Grade 4 | 1 | Patients |
1 to 10 of 433Source ClinicalTrials.gov
See all 433 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | GSK2132231A GROUP | 48 | |
| Overall Study | COMPLETED | GSK2132231A GROUP | 1 | |
| Overall Study | NOT COMPLETED | GSK2132231A GROUP | 47 |
Source ClinicalTrials.gov
Adverse events25
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 | Asthenia | General disorders | GSK2132231A GROUP | 25 | 48 | 25 |
| other | Injection site pain | General disorders | GSK2132231A GROUP | 18 | 48 | 18 |
| other | Pyrexia | General disorders | GSK2132231A GROUP | 14 | 48 | 14 |
| other | Injection site reaction | General disorders | GSK2132231A GROUP | 9 | 48 | 9 |
| other | Influenza like illness | General disorders | GSK2132231A GROUP | 9 | 48 | 9 |
| other | Fatigue | General disorders | GSK2132231A GROUP | 9 | 48 | 9 |
| other | Nausea | Gastrointestinal disorders | GSK2132231A GROUP | 22 | 48 | 22 |
| other | Constipation | Gastrointestinal disorders | GSK2132231A GROUP | 14 | 48 | 14 |
| other | Vomiting | Gastrointestinal disorders | GSK2132231A GROUP | 13 | 48 | 13 |
| other | Decreased appetite | Metabolism and nutrition disorders | GSK2132231A GROUP | 11 | 48 | 11 |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | GSK2132231A GROUP | ||
| Total, other adverse events | GSK2132231A GROUP | 48 | 48 |
| Total, serious adverse events | GSK2132231A GROUP | 10 | 48 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 29177094 | DERIVED |
Source PubMed
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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