Trial · NCT01876212
Dendritic Cell Vaccines + Dasatinib for Metastatic Melanoma
NCT01876212, Phase 2, Completed, Walter J. Storkus; results first posted 2019-08-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Dendritic Cell Vaccines + Dasatinib for Metastatic Melanoma. Trials, record NCT01876212. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01876212
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dendritic Cell Vaccines + Dasatinib for Metastatic Melanoma
- NCT number
- NCT01876212
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 15 participants, actual
- Lead sponsor
- Walter J. Storkus
- Conditions
- Metastatic Melanoma
- Interventions
- DC vaccine, Dasatinib
- First posted
- 2013-06-12
- Last updated
- 2019-08-22
- Results first posted
- 2019-08-06
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Immune Response Rate | Up to 13 months | Patients that received at least one cycle of study treatment. | proportion of participants | NUMBER |
| SECONDARY | Best Clinical Response | Up to 13 months | Patients that received at least once cycle of study treatment who were evaluable for response using tumor measurements via radiologic evaluation. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Objective Response Rate (ORR) | Up to 13 months | Patients that received at least once cycle of study treatment who were evaluable for response using tumor measurements via radiologic evaluation. | proportion of participants | NUMBER |
| SECONDARY | Worst Grade of Any Toxicity | Up to 2 years | Patients that received at least one dose of study treatment who experienced a treatment-related toxicity . | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Progression-free Survival (PFS) | Up to 15 months | Patients that received at least once cycle of study treatment who were evaluable for response using tumor measurements via radiologic evaluation. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Up to 30 months | All patients enrolled in the study. | months | MEDIAN |
| SECONDARY | T Cell-recruiting Chemokine CXCL10/IP-10 | At baseline (prior to treatment) | Patients that received Vaccine (Cycle 1, Day 1) + dasatinib (Cycle 2, D1) or Vaccine + dasatinib (both agents beginning Cycle 1, D1) for which there was an analyzable PBMC sample. | pg/mL | MEAN |
| SECONDARY | T Cell-recruiting Chemokine CXCL10/IP-10 | At between 5 and 7 weeks, post treatment | Patients that received Vaccine (Cycle 1, Day 1) + dasatinib (Cycle 2, D1) or Vaccine + dasatinib (both agents beginning Cycle 1, D1) for which there was an analyzable PBMC sample. | pg/mL | MEAN |
| SECONDARY | Treg CD4FoxP3 Suppressor Cells | At baseline (prior to treatment) | Patients that received Vaccine (Cycle 1, Day 1) + dasatinib (Cycle 2, D1) or Vaccine + dasatinib (both agents beginning Cycle 1, D1) for which there was an analyzable PBMC sample. | percentage of cells | MEAN |
| SECONDARY | Treg CD4FoxP3 Suppressor Cells | At between 4 and 6 weeks, post treatment | Patients that received Vaccine (Cycle 1, Day 1) + dasatinib (Cycle 2, D1) or Vaccine + dasatinib (both agents beginning Cycle 1, D1) for which there was an analyzable PBMC sample. | percentage of cells | MEAN |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group46
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Immune Response Rate | Vaccine (Cycle 1, Day 1) + Dasatinib (Cycle 2, D1) | 0.29 | 95% Confidence Interval 0.04 to 0.71 | proportion of participants | |
| Immune Response Rate | Vaccine + Dasatinib (Cycle 1, D1) | 0.67 | 95% Confidence Interval 0.22 to 0.96 | proportion of participants | |
| Best Clinical Response | Vaccine (Cycle 1, Day 1) + Dasatinib (Cycle 2, D1) | Partial Response | 0 | Participants | |
| Best Clinical Response | Vaccine + Dasatinib (Cycle 1, D1) | Partial Response | 4 | Participants | |
| Best Clinical Response | Vaccine (Cycle 1, Day 1) + Dasatinib (Cycle 2, D1) | Progressed Disease | 4 | Participants | |
| Best Clinical Response | Vaccine + Dasatinib (Cycle 1, D1) | Progressed Disease | 2 | Participants | |
| Best Clinical Response | Vaccine (Cycle 1, Day 1) + Dasatinib (Cycle 2, D1) | Stable Disease | 3 | Participants | |
| Best Clinical Response | Vaccine + Dasatinib (Cycle 1, D1) | Stable Disease | 0 | Participants | |
| Objective Response Rate (ORR) | Vaccine (Cycle 1, Day 1) + Dasatinib (Cycle 2, D1) | 0 | 95% Confidence Interval 0 to 0.4096 | proportion of participants | |
| Objective Response Rate (ORR) | Vaccine + Dasatinib (Cycle 1, D1) | 0.6667 | 95% Confidence Interval 0.2228 to 0.9567 | proportion of participants |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Vaccine (Cycle 1, Day 1) + Dasatinib (Cycle 2, D1) | 9 | |
| Overall Study | STARTED | Vaccine + Dasatinib (Cycle 1, D1) | 6 | |
| Overall Study | COMPLETED | Vaccine (Cycle 1, Day 1) + Dasatinib (Cycle 2, D1) | 9 | |
| Overall Study | COMPLETED | Vaccine + Dasatinib (Cycle 1, D1) | 6 | |
| Overall Study | NOT COMPLETED | Vaccine (Cycle 1, Day 1) + Dasatinib (Cycle 2, D1) | 0 | |
| Overall Study | NOT COMPLETED | Vaccine + Dasatinib (Cycle 1, D1) | 0 |
Source ClinicalTrials.gov
Adverse events242
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 | Vaccine (Cycle 1, Day 1) + Dasatinib (Cycle 2, D1) | 5 | 9 | |
| other | Anemia | Blood and lymphatic system disorders | Vaccine + Dasatinib (Cycle 1, D1) | 3 | 6 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Vaccine (Cycle 1, Day 1) + Dasatinib (Cycle 2, D1) | 0 | 9 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Vaccine + Dasatinib (Cycle 1, D1) | 1 | 6 | |
| other | Palpitations | Cardiac disorders | Vaccine (Cycle 1, Day 1) + Dasatinib (Cycle 2, D1) | 1 | 9 | |
| other | Palpitations | Cardiac disorders | Vaccine + Dasatinib (Cycle 1, D1) | 0 | 6 | |
| other | Sinus tachycardia | Cardiac disorders | Vaccine (Cycle 1, Day 1) + Dasatinib (Cycle 2, D1) | 1 | 9 | |
| other | Sinus tachycardia | Cardiac disorders | Vaccine + Dasatinib (Cycle 1, D1) | 1 | 6 | |
| other | Ear pain | Ear and labyrinth disorders | Vaccine (Cycle 1, Day 1) + Dasatinib (Cycle 2, D1) | 0 | 9 | |
| other | Ear pain | Ear and labyrinth disorders | Vaccine + Dasatinib (Cycle 1, D1) | 1 | 6 |
1 to 10 of 242Source ClinicalTrials.gov
See all 242 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vaccine (Cycle 1, Day 1) + Dasatinib (Cycle 2, D1) | 8 | 9 |
| Total, all-cause mortality | Vaccine + Dasatinib (Cycle 1, D1) | 5 | 6 |
| Total, other adverse events | Vaccine (Cycle 1, Day 1) + Dasatinib (Cycle 2, D1) | 8 | 9 |
| Total, other adverse events | Vaccine + Dasatinib (Cycle 1, D1) | 6 | 6 |
| Total, serious adverse events | Vaccine (Cycle 1, Day 1) + Dasatinib (Cycle 2, D1) | 7 | 9 |
| Total, serious adverse events | Vaccine + Dasatinib (Cycle 1, D1) | 4 | 6 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34782430 | DERIVED |
Source PubMed
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01CA169118 | Combinational Immunotherapy Targeting the Melanoma-Associated Vasculature | STORKUS, WALTER J. | UNIVERSITY OF PITTSBURGH AT PITTSBURGH | NATIONAL CANCER INSTITUTE | 2012 to 2016 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Vaccine (Cycle 1, Day 1) + Dasatinib (Cycle 2, D1) vs Vaccine + Dasatinib (Cycle 1, D1): deaths from any cause | Trial comparisons |
| Vaccine (Cycle 1, Day 1) + Dasatinib (Cycle 2, D1) vs Vaccine + Dasatinib (Cycle 1, D1): 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.
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GET https://conductscience.org/api/trials/v1/NCT01876212/results?page=2