Trial · NCT01876212
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Immune Response Rate | Up to 13 months | Immune Response is defined as improved peripheral blood CD8+ T cell responses against 3 or more peptide epitopes after active vaccination with Type I-polarized autologous dendritic cell (αDC1) vaccine incorporating 6 tumor blood vessel-associated antigen (TBVA)-derived peptides. The measure of Immune Response for this study is expressed as a proportion of responders: The number of HLA-A2+ melanoma patients with improved peripheral blood CD8+ T cell responses (responders) divided by the total number of evaluable patients. |
| Secondary | Best Clinical Response | Up to 13 months | The number of treated patients by best clinical response achieved (tumor measurements via radiologic evaluation) using RECIST 1.1. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (target or non-target) with reduction in short axis to \<10 mm. Partial Response (PR): ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Progressive Disease (PD):≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression. |
| Secondary | Objective Response Rate (ORR) | Up to 13 months | The proportion of evaluable patients that achieved either partial or complete responses. Calculation: The number of patients who experienced a Partial Response (PR) + the number of patients who experienced a Complete Response (CR) / total number of response-evaluable patients. Per RECIST v1.1, Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
| Secondary | Worst Grade of Any Toxicity | Up to 2 years | Number of participants and severity grades for treatment-relatedness scores of possibly, probably, or definitely. |
| Secondary | Progression-free Survival (PFS) | Up to 15 months | The length of time after study treatment that a patient lives with disease but the disease does not progress. Patients were followed for 1 year after removal from study treatment or until death, whichever occurs first. Per RECIST 1.1, Progressive Disease is defined as a ≥ 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression. |
| Secondary | Overall Survival (OS) | Up to 30 months | The length of time from the start of study treatment, that patients remain alive. |
| Secondary | T Cell-recruiting Chemokine CXCL10/IP-10 | At baseline (prior to treatment) | Circulating serum concentration (levels) of T cell-recruiting chemokine CXCL10/IP-10 analyzed via ELISA assay. Higher levels of T cell-recruiting chemokine CXCL10/IP-1 correlate with patients exhibiting objective clinical response immunotherapy. |
| Secondary | T Cell-recruiting Chemokine CXCL10/IP-10 | At between 5 and 7 weeks, post treatment | Circulating serum concentration (levels) of T cell-recruiting chemokine CXCL10/IP-10 analyzed via ELISA assay. Higher levels of T cell-recruiting chemokine CXCL10/IP-1 correlate with patients exhibiting objective clinical response immunotherapy. |
| Secondary | Treg CD4FoxP3 Suppressor Cells | At baseline (prior to treatment) | Percentage of Treg CD4FoxP3 suppressor cells in patients' peripheral blood. The accumulation of Treg CD4FoxP3 suppressor cell populations correlates with tumor progression (disease progression) and negative prognosis. |
| Secondary | Treg CD4FoxP3 Suppressor Cells | At between 4 and 6 weeks, post treatment | Percentage of Treg CD4FoxP3 suppressor cells in patients' peripheral blood. The accumulation of Treg CD4FoxP3 suppressor cell populations correlates with tumor progression (disease progression) and negative prognosis. |
| Secondary | Treg CD4FoxP3 Suppressor Cells | At between 7 and 10 weeks, post treatment | Percentage of Treg CD4FoxP3 suppressor cells in patients' peripheral blood. The accumulation of Treg CD4FoxP3 suppressor cell populations correlates with tumor progression (disease progression) and negative prognosis. |
| Secondary | Monocytic Myeloid Derived Suppressor Cells (M-MDSC) | At baseline (prior to treatment) | Percentage of Monocytic Myeloid Derived Suppressor Cells (M-MDSC) present in patients' peripheral blood. The accumulation of M-MDSC populations correlates with tumor progression (disease progression) and negative prognosis. |
| Secondary | Monocytic Myeloid Derived Suppressor Cells (M-MDSC) | At between 4 and 6 weeks, post treatment | Percentage of Monocytic Myeloid Derived Suppressor Cells (M-MDSC) present in patients' peripheral blood. The accumulation of M-MDSC populations correlates with tumor progression (disease progression) and negative prognosis. |
| Secondary | Monocytic Myeloid Derived Suppressor Cells (M-MDSC) | At between 7 and 10 weeks, post treatment | Percentage of Monocytic Myeloid Derived Suppressor Cells (M-MDSC) present in patients' peripheral blood. The accumulation of M-MDSC populations correlates with tumor progression (disease progression) and negative prognosis. |
| Secondary | Polymorphonucler Myeloid-derived Suppressor Cells (PMN-MDSC) | At baseline (prior to treatment) | Percentage of Polymorphonucler myeloid-derived suppressor cells (PMN-MDSC) present in patients' peripheral blood. The accumulation/increase of M-MDSC populations correlates with tumor progression (disease progression) and negative prognosis. |
| Secondary | Polymorphonucler Myeloid-derived Suppressor Cells (PMN-MDSC) | At between 4 and 6 weeks, post treatment | Percentage of Polymorphonucler myeloid-derived suppressor cells (PMN-MDSC) present in patients' peripheral blood. The accumulation/increase of M-MDSC populations correlates with tumor progression (disease progression) and negative prognosis. |
| Secondary | Polymorphonucler Myeloid-derived Suppressor Cells (PMN-MDSC) | At between 7 and 10 weeks, post treatment | Percentage of Polymorphonucler myeloid-derived suppressor cells (PMN-MDSC) present in patients' peripheral blood. The accumulation/increase of M-MDSC populations correlates with tumor progression (disease progression) and negative prognosis. |
| Secondary | EphA2 Protein Expression in Tumor Biopsies | Up to 6 months | Level of EphA2 protein expression in tumor tissue biopsies. |
| Secondary | Suppressor Cell Populations and Blood Vessels in Melanoma Tumor Biopsies | Up to 6 months | Percentage of suppressor cell populations and blood vessels in melanoma tumor biopsies. |
| Secondary | CD8+ T Cells Infiltration | Up to 6 months | Percentage of CD8+ T cells infiltrating into melanoma lesions (tumor tissues). |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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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