Dendritic Cell Vaccines + Dasatinib for Metastatic Melanoma

• Sponsor: Walter J. Storkus (Other)
• Overall Status: Completed
• CT.gov ID: NCT01876212
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 15
• Location: 1
• Arms: 2
• Actual Duration (Months): 62.5
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

Current therapeutic approaches available for patients with advanced-stage melanoma remain inadequate, and existing approaches including those involving immunotherapy with cytokines and/or targeted strategies have resulted in disappointingly low rates of durable and complete responses. Correcting immune dysfunction in advanced-stage melanoma patients using tyrosine-kinase inhibitor (TKI) such as dasatinib is proposed to relicense the patient's immune system to respond optimally to specific immunization. The integration of antigens expressed by tumor-associated blood vessel cells provides a means to selectively target the genetically-/antigenically-heterogeneous population of tumor cells in the advanced-stage melanoma patient.

This is a single-center, prospective randomized Phase 2 trial evaluating the activity, safety and immune effects of dasatinib given in combination with an autologous type-1 polarized Dendritic Cell (αDC1) vaccine. The current trial represents a randomized Phase 2 study to determine the activity and safety of intradermal (id) administration of αDC1s loaded with a mixture of six TBVA-derived peptides at the time of, or immediately after, an initial therapy cycle with the TKI dasatinib.

Dasatinib will be administered at the standard dose and schedule recommended by the FDA (70 mg BID). The autologous type-I DC vaccine will be administered either prior to, or concomitant with, the initiation of dasatinib administration. All patients will receive dasatinib at a starting dose of 70 mg twice daily by mouth in the outpatient setting approximately every 12 hours, at the same time each day.

The DC vaccine will be administered by a single intradermal injection of approximately 10e7 cells, with all the DCs being administered on days 1 and 15 of every cycle on an outpatient basis in the University of Pittsburgh Clinical and Translational Research Center (UPCI-CTRC).

Patients on Arm A will start dasatinib administration on cycle 2, day 1 (week 5), while those patients in Arm B will start dasatinib administration on cycle 1, day 1 (week 1).

Men and women at least 18 years of age must be HLA-A2+ and have histologically confirmed melanoma that is metastatic (Stage IV) or unresectable Stage IIIB/C and for which standard curative or palliative measures do not exist or are no longer effective.

Note: The outcome measures and time frames (previously) described in the PRS protocol record have been revised and articulated in the results section, to more accurately describe and represent the stated per-protocol investigations and endpoints, quantitatively.

Condition or Disease	Intervention/Treatment	Phase
Metastatic Melanoma	Biological: DC vaccine; Drug: Dasatinib	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 15 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized Phase 2 Pilot Study of Type I-Polarized Autologous Dendritic Cell Vaccines Incorporating Tumor Blood Vessel Antigen (TBVA)-Derived Peptides in Combination With Dasatinib in Patients With Metastatic Melanoma
• Actual Study Start Date: May 16, 2014
• Actual Primary Completion Date: Jul 11, 2018
• Actual Study Completion Date: Jul 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Vaccine + dasatinib Patients will start vaccine on cycle 1, day 1 and dasatinib on cycle 2, day 1 (week 5). All patients will receive dasatinib at a starting dose of 70 mg twice daily by mouth in the outpatient setting. Dasatinib will be supplied as 50 mg and 20 mg tablets. Patients will take 1 of the 50 mg tablets and 1 of the 20 mg tablets twice daily, approximately every 12 hours, at the same time each day. The DC vaccine will be administered by a single intradermal injection of approximately 10e7 cells, with all the DCs being administered on days 1 and 15 of each cycle. The intradermal administration will be in the vicinity of the four nodal drainage groups of the four extremities.	Biological: DC vaccine; Other Names: Type 1-polarized, autologous, DC vaccines incorporating tumor blood vessel antigen (TBVA)-derived peptides ; Drug: Dasatinib; Other Names: BMS-354825 Sprycel
Experimental: Vaccine + dasatinib from cycle 1 Patients will start vaccine on cycle 1, day 1 and dasatinib on cycle 1, day 1. All patients will receive dasatinib at a starting dose of 70 mg twice daily by mouth in the outpatient setting. Dasatinib will be supplied as 50 mg and 20 mg tablets. Patients will take 1 of the 50 mg tablets and 1 of the 20 mg tablets twice daily, approximately every 12 hours, at the same time each day. The DC vaccine will be administered by a single intradermal injection of approximately 10e7 cells, with all the DCs being administered on days 1 and 15 of each cycle. The intradermal administration will be in the vicinity of the four nodal drainage groups of the four extremities.	Biological: DC vaccine; Other Names: Type 1-polarized, autologous, DC vaccines incorporating tumor blood vessel antigen (TBVA)-derived peptides ; Drug: Dasatinib; Other Names: BMS-354825 Sprycel

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. 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.

3. Worst Grade of Any Toxicity [Up to 2 years]

   Number of participants and severity grades for treatment-relatedness scores of possibly, probably, or definitely.

4. 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.

5. Overall Survival (OS) [Up to 30 months]

   The length of time from the start of study treatment, that patients remain alive.

6. 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.

7. 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.

8. 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.

9. 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.

10. 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.

11. 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.

12. 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.

13. 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.

14. 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.

15. 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.

16. 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.

17. EphA2 Protein Expression in Tumor Biopsies [Up to 6 months]

    Level of EphA2 protein expression in tumor tissue biopsies.

18. 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.

19. CD8+ T Cells Infiltration [Up to 6 months]

    Percentage of CD8+ T cells infiltrating into melanoma lesions (tumor tissues).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients must be HLA-A2+ and have histologically confirmed melanoma that is metastatic (Stage IV) or unresectable Stage IIIB/C and for which standard curative or palliative measures do not exist or are no longer effective.

• Patients must have measurable disease by RECIST 1.1, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥ 20 mm with conventional techniques or as ≥ 10 mm with spiral CT scan, MRI, or calipers by clinical exam. See Section 11 for the evaluation of measurable disease.

• Patients should have at least 2 subcutaneous, intracutaneous, and accessible tumor deposits, lymph node or other site available for biopsy purposes. Patients that have one biopsiable site that can be amenable to 2 biopsies (pre- and post-) will be considered eligible.

• Prior chemotherapy, immunotherapy, or targeted therapy is allowed as long as it did not include dasatinib.

• Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of dasatinib in patients < 18 years of age, children are excluded from this study, but will be eligible for future pediatric trials.

• ECOG performance status ≤ 2 (Karnofsky ≥ 60%, see Appendix A).

• Life expectancy of greater than 12 weeks.

• Patients must have normal organ and marrow function as defined below:

• Leukocytes ≥ 3,000/µL

• absolute neutrophil count ≥ 1,500/µL

• absolute lymphocyte count ≥ 500/µL

• platelets ≥ 100,000/µL

• total bilirubin within normal institutional limits

• AST(SGOT)/ALT(SGPT) ≤ 2.5 X institutional upper limit of normal

• Creatinine ≤ 2.0 X institutional upper limit of normal

• Serum magnesium, potassium and adjusted (or ionized) calcium ≥ the institutional lower limit of normal. (Supplementation of electrolytes prior to screening is allowed).

• Sexually active women and men of childbearing potential must agree to use an effective method of birth control during the course of the study and for up to 3 months following the last dose of the study drug, in a manner such that risk of pregnancy is minimized. Surgical sterilization, intrauterine device or barrier method (e.g. condom and/or diaphragm with spermicidal agents) are acceptable forms of birth control. Women of childbearing potential must have a negative pregnancy test (serum) within 7 days prior to treatment. A pregnancy test is not required for registration. Women who have not menstruated for more than 2 years will be considered postmenopausal, thus not of childbearing potential.

• Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

• Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.

• Patients with documented c-KIT mutations.

• Patients who are receiving any other investigational agents.

• Patients with known active brain metastases should be excluded. Patients with treated brain metastases with documented stability for 4 weeks are eligible.

• History of allergic reactions attributed to compounds of similar chemical or biologic composition to dasatinib or any of the components of the vaccine being administered as part of this study.

• Women who are pregnant or nursing/breastfeeding.

• History of significant bleeding disorder unrelated to cancer, including:

• Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease)

• Diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies)

• Patients currently taking medications that inhibit platelet function (i.e., aspirin, dipyridamole, epoprostenol, eptifibatide, clopidogrel, cilostazol, abciximab, ticlopidine, and any non-steroidal anti-inflammatory drug) because of a potential increased risk of bleeding from dasatinib.

• Patients currently taking anticoagulants (warfarin, heparin/low molecular weight heparin [e.g., danaparoid, dalteparin, tinzaparin, enoxaparin]) because of a potential increased risk of bleeding from dasatinib.

• Diagnosis of unstable angina or myocardial infarction within 6 months of study entry.

• Patients currently taking one or more of the following drugs that are generally accepted to have a risk of causing Torsades de Pointes:

• quinidine, procainamide, disopyramide

• amiodarone, sotalol, ibutilide, dofetilide

• erythromycins, clarithromycin

• chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide

• cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazine.

• Diagnosed or suspected congenital long QT syndrome.

• Prolonged QTc interval on pre-entry electrocardiogram (> 450 msec) within 30 days prior to study registration.

• Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes)

• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

• HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with dasatinib. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hillman Cancer Center	Pittsburgh	Pennsylvania	United States	15232

Sponsors and Collaborators

• Walter J. Storkus
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: John Kirkwood, MD, University of Pittsburgh Cancer Institute (UPCI)

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 14, 2017

More Information

Publications

None provided.

• Responsible Party: Walter J. Storkus, Associate Professor of Medicine, Clinical & Translational Science, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT01876212
• Other Study ID Numbers: 12-048; R01CA169118; UPCI 12-048
• First Posted: Jun 12, 2013
• Last Update Posted: Aug 22, 2019
• Last Verified: Aug 1, 2019

• Keywords provided by Walter J. Storkus, Associate Professor of Medicine, Clinical & Translational Science, University of Pittsburgh: melanoma; metastatic; vaccine; BRAF
• Additional relevant MeSH terms: Melanoma; Dasatinib; Vaccines

Study Results

Participant Flow

Arm/Group Title	Vaccine (Cycle 1, Day 1) + Dasatinib (Cycle 2, D1)	Vaccine + Dasatinib (Cycle 1, D1)
Arm/Group Description	Patients received vaccine on treatment Cycle 1, Day 1, and dasatinib beginning on treatment Cycle 2, Day 1 (week 5). All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours). The DC vaccine was administered by a single intradermal injection of approximately 10^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle.	Patients received both vaccine and dasatinib beginning on treatment Cycle 1, Day 1. All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours). The DC vaccine was administered by a single intradermal injection of approximately 10^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle.
Period Title: Overall Study
STARTED	9	6
COMPLETED	9	6
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Vaccine (Cycle 1, Day 1) + Dasatinib (Cycle 2, D1)	Vaccine + Dasatinib (Cycle 1, D1)	Total
Arm/Group Description	Patients received vaccine on treatment Cycle 1, Day 1, and dasatinib beginning on treatment Cycle 2, Day 1 (week 5). All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours). The DC vaccine was administered by a single intradermal injection of approximately 10^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle.	Patients received both vaccine and dasatinib beginning on treatment Cycle 1, Day 1. All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours). The DC vaccine was administered by a single intradermal injection of approximately 10^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle.	Total of all reporting groups
Overall Participants	9	6	15
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	67.2	64.7	66.2
Sex: Female, Male (Count of Participants)
Female	4 44.4%	3 50%	7 46.7%
Male	5 55.6%	3 50%	8 53.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	9 100%	6 100%	15 100%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Stage of Disease (Count of Participants)
Stage IIC	0 0%	1 16.7%	1 6.7%
Stage IV	8 88.9%	5 83.3%	13 86.7%
Not evaluable	1 11.1%	0 0%	1 6.7%

Outcome Measures

1. Primary Outcome

Title	Immune Response Rate
Description	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.
Time Frame	Up to 13 months

Outcome Measure Data

Analysis Population Description

Patients that received at least one cycle of study treatment.

Arm/Group Title	Vaccine (Cycle 1, Day 1) + Dasatinib (Cycle 2, D1)	Vaccine + Dasatinib (Cycle 1, D1)
Arm/Group Description	Patients received vaccine on treatment Cycle 1, Day 1, and dasatinib beginning on treatment Cycle 2, Day 1 (week 5). All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours). The DC vaccine was administered by a single intradermal injection of approximately 10^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle.	Patients received both vaccine and dasatinib beginning on treatment Cycle 1, Day 1. All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours). The DC vaccine was administered by a single intradermal injection of approximately 10^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle.
Measure Participants	7	6
Number (95% Confidence Interval) [proportion of participants]	0.29 3.2%	0.67 11.2%

2. Secondary Outcome

Title	Best Clinical Response
Description	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.
Time Frame	Up to 13 months

Outcome Measure Data

Analysis Population Description

Patients that received at least once cycle of study treatment who were evaluable for response using tumor measurements via radiologic evaluation.

Arm/Group Title	Vaccine (Cycle 1, Day 1) + Dasatinib (Cycle 2, D1)	Vaccine + Dasatinib (Cycle 1, D1)
Arm/Group Description	Patients received vaccine on treatment Cycle 1, Day 1, and dasatinib beginning on treatment Cycle 2, Day 1 (week 5). All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours). The DC vaccine was administered by a single intradermal injection of approximately 10^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle.	Patients received both vaccine and dasatinib beginning on treatment Cycle 1, Day 1. All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours). The DC vaccine was administered by a single intradermal injection of approximately 10^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle.
Measure Participants	7	6
Partial Response	0 0%	4 66.7%
Progressed Disease	4 44.4%	2 33.3%
Stable Disease	3 33.3%	0 0%

3. Secondary Outcome

Title	Objective Response Rate (ORR)
Description	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.
Time Frame	Up to 13 months

Outcome Measure Data

Analysis Population Description

Patients that received at least once cycle of study treatment who were evaluable for response using tumor measurements via radiologic evaluation.

Arm/Group Title	Vaccine (Cycle 1, Day 1) + Dasatinib (Cycle 2, D1)	Vaccine + Dasatinib (Cycle 1, D1)
Arm/Group Description	Patients received vaccine on treatment Cycle 1, Day 1, and dasatinib beginning on treatment Cycle 2, Day 1 (week 5). All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours). The DC vaccine was administered by a single intradermal injection of approximately 10^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle.	Patients received both vaccine and dasatinib beginning on treatment Cycle 1, Day 1. All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours). The DC vaccine was administered by a single intradermal injection of approximately 10^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle.
Measure Participants	7	6
Number (95% Confidence Interval) [proportion of participants]	0 0%	0.6667 11.1%

4. Secondary Outcome

Title	Worst Grade of Any Toxicity
Description	Number of participants and severity grades for treatment-relatedness scores of possibly, probably, or definitely.
Time Frame	Up to 2 years

Outcome Measure Data

Analysis Population Description

Patients that received at least one dose of study treatment who experienced a treatment-related toxicity .

Arm/Group Title	Vaccine (Cycle 1, Day 1) + Dasatinib (Cycle 2, D1)	Vaccine + Dasatinib (Cycle 1, D1)
Arm/Group Description	Patients received vaccine on treatment Cycle 1, Day 1, and dasatinib beginning on treatment Cycle 2, Day 1 (week 5). All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours). The DC vaccine was administered by a single intradermal injection of approximately 10^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle.	Patients received both vaccine and dasatinib beginning on treatment Cycle 1, Day 1. All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours). The DC vaccine was administered by a single intradermal injection of approximately 10^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle.
Measure Participants	9	6
Grade 2 Toxicity	1 11.1%	2 33.3%
Grade 3 Toxicity	6 66.7%	3 50%
Grade 4 Toxicity	0 0%	1 16.7%
Grade 5 Toxicity	1 11.1%	0 0%
No >Grade 2 Toxicity	1 11.1%	0 0%

5. Secondary Outcome

Title	Progression-free Survival (PFS)
Description	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.
Time Frame	Up to 15 months

Outcome Measure Data

Analysis Population Description

Patients that received at least once cycle of study treatment who were evaluable for response using tumor measurements via radiologic evaluation.

Arm/Group Title	Vaccine (Cycle 1, Day 1) + Dasatinib (Cycle 2, D1)	Vaccine + Dasatinib (Cycle 1, D1)
Arm/Group Description	Patients received vaccine on treatment Cycle 1, Day 1, and dasatinib beginning on treatment Cycle 2, Day 1 (week 5). All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours). The DC vaccine was administered by a single intradermal injection of approximately 10^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle.	Patients received both vaccine and dasatinib beginning on treatment Cycle 1, Day 1. All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours). The DC vaccine was administered by a single intradermal injection of approximately 10^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle.
Measure Participants	9	6
Median (95% Confidence Interval) [months]	1.967	7.867

6. Secondary Outcome

Title	Overall Survival (OS)
Description	The length of time from the start of study treatment, that patients remain alive.
Time Frame	Up to 30 months

Outcome Measure Data

Analysis Population Description

All patients enrolled in the study.

Arm/Group Title	Vaccine (Cycle 1, Day 1) + Dasatinib (Cycle 2, D1)	Vaccine + Dasatinib (Cycle 1, D1)
Arm/Group Description	Patients received vaccine on treatment Cycle 1, Day 1, and dasatinib beginning on treatment Cycle 2, Day 1 (week 5). All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours). The DC vaccine was administered by a single intradermal injection of approximately 10^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle.	Patients received both vaccine and dasatinib beginning on treatment Cycle 1, Day 1. All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours). The DC vaccine was administered by a single intradermal injection of approximately 10^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle.
Measure Participants	9	6
Median (95% Confidence Interval) [months]	3.667	17.83

7. Secondary Outcome

Title	T Cell-recruiting Chemokine CXCL10/IP-10
Description	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.
Time Frame	At baseline (prior to treatment)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Vaccine (Cycle 1, Day 1) + Dasatinib (Cycle 2, D1)	Vaccine + Dasatinib (Cycle 1, D1)
Arm/Group Description	Patients received vaccine on treatment Cycle 1, Day 1, and dasatinib beginning on treatment Cycle 2, Day 1 (week 5). All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours). The DC vaccine was administered by a single intradermal injection of approximately 10^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle.	Patients received both vaccine and dasatinib beginning on treatment Cycle 1, Day 1. All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours). The DC vaccine was administered by a single intradermal injection of approximately 10^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle.
Measure Participants	7	6
Mean (Full Range) [pg/mL]	296.68	268.06

8. Secondary Outcome

Title	T Cell-recruiting Chemokine CXCL10/IP-10
Description	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.
Time Frame	At between 5 and 7 weeks, post treatment

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Vaccine (Cycle 1, Day 1) + Dasatinib (Cycle 2, D1)	Vaccine + Dasatinib (Cycle 1, D1)
Arm/Group Description	Patients received vaccine on treatment Cycle 1, Day 1, and dasatinib beginning on treatment Cycle 2, Day 1 (week 5). All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours). The DC vaccine was administered by a single intradermal injection of approximately 10^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle.	Patients received both vaccine and dasatinib beginning on treatment Cycle 1, Day 1. All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours). The DC vaccine was administered by a single intradermal injection of approximately 10^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle.
Measure Participants	7	6
Mean (Full Range) [pg/mL]	501.43	194.96

9. Secondary Outcome

Title	Treg CD4FoxP3 Suppressor Cells
Description	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.
Time Frame	At baseline (prior to treatment)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Vaccine (Cycle 1, Day 1) + Dasatinib (Cycle 2, D1)	Vaccine + Dasatinib (Cycle 1, D1)
Arm/Group Description	Patients received vaccine on treatment Cycle 1, Day 1, and dasatinib beginning on treatment Cycle 2, Day 1 (week 5). All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours). The DC vaccine was administered by a single intradermal injection of approximately 10^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle.	Patients received both vaccine and dasatinib beginning on treatment Cycle 1, Day 1. All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours). The DC vaccine was administered by a single intradermal injection of approximately 10^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle.
Measure Participants	7	6
Mean (Full Range) [percentage of cells]	6.67	8.04

10. Secondary Outcome

Title	Treg CD4FoxP3 Suppressor Cells
Description	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.
Time Frame	At between 4 and 6 weeks, post treatment

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Vaccine (Cycle 1, Day 1) + Dasatinib (Cycle 2, D1)	Vaccine + Dasatinib (Cycle 1, D1)
Arm/Group Description	Patients received vaccine on treatment Cycle 1, Day 1, and dasatinib beginning on treatment Cycle 2, Day 1 (week 5). All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours). The DC vaccine was administered by a single intradermal injection of approximately 10^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle.	Patients received both vaccine and dasatinib beginning on treatment Cycle 1, Day 1. All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours). The DC vaccine was administered by a single intradermal injection of approximately 10^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle.
Measure Participants	7	6
Mean (Full Range) [percentage of cells]	8.06	6.27

11. Secondary Outcome

Title	Treg CD4FoxP3 Suppressor Cells
Description	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.
Time Frame	At between 7 and 10 weeks, post treatment

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Vaccine (Cycle 1, Day 1) + Dasatinib (Cycle 2, D1)	Vaccine + Dasatinib (Cycle 1, D1)
Arm/Group Description	Patients received vaccine on treatment Cycle 1, Day 1, and dasatinib beginning on treatment Cycle 2, Day 1 (week 5). All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours). The DC vaccine was administered by a single intradermal injection of approximately 10^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle.	Patients received both vaccine and dasatinib beginning on treatment Cycle 1, Day 1. All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours). The DC vaccine was administered by a single intradermal injection of approximately 10^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle.
Measure Participants	7	6
Mean (Full Range) [percentage of cells]	7.38	6.6

12. Secondary Outcome

Title	Monocytic Myeloid Derived Suppressor Cells (M-MDSC)
Description	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.
Time Frame	At baseline (prior to treatment)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Vaccine (Cycle 1, Day 1) + Dasatinib (Cycle 2, D1)	Vaccine + Dasatinib (Cycle 1, D1)
Arm/Group Description	Patients received vaccine on treatment Cycle 1, Day 1, and dasatinib beginning on treatment Cycle 2, Day 1 (week 5). All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours). The DC vaccine was administered by a single intradermal injection of approximately 10^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle.	Patients received both vaccine and dasatinib beginning on treatment Cycle 1, Day 1. All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours). The DC vaccine was administered by a single intradermal injection of approximately 10^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle.
Measure Participants	7	6
Mean (Full Range) [percentage of cells]	6.23	11.65

13. Secondary Outcome

Title	Monocytic Myeloid Derived Suppressor Cells (M-MDSC)
Description	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.
Time Frame	At between 4 and 6 weeks, post treatment

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Vaccine (Cycle 1, Day 1) + Dasatinib (Cycle 2, D1)	Vaccine + Dasatinib (Cycle 1, D1)
Arm/Group Description	Patients received vaccine on treatment Cycle 1, Day 1, and dasatinib beginning on treatment Cycle 2, Day 1 (week 5). All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours). The DC vaccine was administered by a single intradermal injection of approximately 10^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle.	Patients received both vaccine and dasatinib beginning on treatment Cycle 1, Day 1. All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours). The DC vaccine was administered by a single intradermal injection of approximately 10^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle.
Measure Participants	7	6
Mean (Full Range) [percentage of cells]	8.7	8.78

14. Secondary Outcome

Title	Monocytic Myeloid Derived Suppressor Cells (M-MDSC)
Description	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.
Time Frame	At between 7 and 10 weeks, post treatment

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Vaccine (Cycle 1, Day 1) + Dasatinib (Cycle 2, D1)	Vaccine + Dasatinib (Cycle 1, D1)
Arm/Group Description	Patients received vaccine on treatment Cycle 1, Day 1, and dasatinib beginning on treatment Cycle 2, Day 1 (week 5). All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours). The DC vaccine was administered by a single intradermal injection of approximately 10^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle.	Patients received both vaccine and dasatinib beginning on treatment Cycle 1, Day 1. All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours). The DC vaccine was administered by a single intradermal injection of approximately 10^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle.
Measure Participants	7	6
Mean (Full Range) [percentage of cells]	9.32	8.32

15. Secondary Outcome

Title	Polymorphonucler Myeloid-derived Suppressor Cells (PMN-MDSC)
Description	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.
Time Frame	At baseline (prior to treatment)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Vaccine (Cycle 1, Day 1) + Dasatinib (Cycle 2, D1)	Vaccine + Dasatinib (Cycle 1, D1)
Arm/Group Description	Patients received vaccine on treatment Cycle 1, Day 1, and dasatinib beginning on treatment Cycle 2, Day 1 (week 5). All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours). The DC vaccine was administered by a single intradermal injection of approximately 10^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle.	Patients received both vaccine and dasatinib beginning on treatment Cycle 1, Day 1. All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours). The DC vaccine was administered by a single intradermal injection of approximately 10^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle.
Measure Participants	7	6
Mean (Full Range) [percentage of cells]	12.36	11.59

16. Secondary Outcome

Title	Polymorphonucler Myeloid-derived Suppressor Cells (PMN-MDSC)
Description	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.
Time Frame	At between 4 and 6 weeks, post treatment

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Vaccine (Cycle 1, Day 1) + Dasatinib (Cycle 2, D1)	Vaccine + Dasatinib (Cycle 1, D1)
Arm/Group Description	Patients received vaccine on treatment Cycle 1, Day 1, and dasatinib beginning on treatment Cycle 2, Day 1 (week 5). All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours). The DC vaccine was administered by a single intradermal injection of approximately 10^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle.	Patients received both vaccine and dasatinib beginning on treatment Cycle 1, Day 1. All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours). The DC vaccine was administered by a single intradermal injection of approximately 10^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle.
Measure Participants	7	6
Mean (Full Range) [percentage of cells]	10.14	14.61

17. Secondary Outcome

Title	Polymorphonucler Myeloid-derived Suppressor Cells (PMN-MDSC)
Description	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.
Time Frame	At between 7 and 10 weeks, post treatment

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Vaccine (Cycle 1, Day 1) + Dasatinib (Cycle 2, D1)	Vaccine + Dasatinib (Cycle 1, D1)
Arm/Group Description	Patients received vaccine on treatment Cycle 1, Day 1, and dasatinib beginning on treatment Cycle 2, Day 1 (week 5). All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours). The DC vaccine was administered by a single intradermal injection of approximately 10^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle.	Patients received both vaccine and dasatinib beginning on treatment Cycle 1, Day 1. All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours). The DC vaccine was administered by a single intradermal injection of approximately 10^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle.
Measure Participants	7	6
Mean (Full Range) [percentage of cells]	9.41	12.45

18. Secondary Outcome

Title	EphA2 Protein Expression in Tumor Biopsies
Description	Level of EphA2 protein expression in tumor tissue biopsies.
Time Frame	Up to 6 months

Outcome Measure Data

Analysis Population Description

Results not achievable due to insufficient patient biopsy material for the assays required for this endpoint.

Arm/Group Title	Vaccine (Cycle 1, Day 1) + Dasatinib (Cycle 2, D1)	Vaccine + Dasatinib (Cycle 1, D1)
Arm/Group Description	Patients received vaccine on treatment Cycle 1, Day 1, and dasatinib beginning on treatment Cycle 2, Day 1 (week 5). All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours). The DC vaccine was administered by a single intradermal injection of approximately 10^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle.	Patients received both vaccine and dasatinib beginning on treatment Cycle 1, Day 1. All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours). The DC vaccine was administered by a single intradermal injection of approximately 10^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle.
Measure Participants	0	0

19. Secondary Outcome

Title	Suppressor Cell Populations and Blood Vessels in Melanoma Tumor Biopsies
Description	Percentage of suppressor cell populations and blood vessels in melanoma tumor biopsies.
Time Frame	Up to 6 months

Outcome Measure Data

Analysis Population Description

Results not achievable due to insufficient patient biopsy material for the assays required for this endpoint.

Arm/Group Title	Vaccine (Cycle 1, Day 1) + Dasatinib (Cycle 2, D1)	Vaccine + Dasatinib (Cycle 1, D1)
Arm/Group Description	Patients received vaccine on treatment Cycle 1, Day 1, and dasatinib beginning on treatment Cycle 2, Day 1 (week 5). All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours). The DC vaccine was administered by a single intradermal injection of approximately 10^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle.	Patients received both vaccine and dasatinib beginning on treatment Cycle 1, Day 1. All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours). The DC vaccine was administered by a single intradermal injection of approximately 10^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle.
Measure Participants	0	0

20. Secondary Outcome

Title	CD8+ T Cells Infiltration
Description	Percentage of CD8+ T cells infiltrating into melanoma lesions (tumor tissues).
Time Frame	Up to 6 months

Outcome Measure Data

Analysis Population Description

Results not achievable due to insufficient patient biopsy material for the assays required for this endpoint.

Arm/Group Title	Vaccine (Cycle 1, Day 1) + Dasatinib (Cycle 2, D1)	Vaccine + Dasatinib (Cycle 1, D1)
Arm/Group Description	Patients received vaccine on treatment Cycle 1, Day 1, and dasatinib beginning on treatment Cycle 2, Day 1 (week 5). All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours). The DC vaccine was administered by a single intradermal injection of approximately 10^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle.	Patients received both vaccine and dasatinib beginning on treatment Cycle 1, Day 1. All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours). The DC vaccine was administered by a single intradermal injection of approximately 10^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle.
Measure Participants	0	0

Adverse Events

Time Frame	Up to 3 years
Adverse Event Reporting Description	This study will use the CTCAE (Common Terminology Criteria for Adverse Events) version 4.0. for toxicity and serious adverse event reporting. Adverse Events will be evaluated and data collected from Week 1 through Week 8 during treatment, up to and during the off study treatment visit.
Arm/Group Title	Vaccine (Cycle 1, Day 1) + Dasatinib (Cycle 2, D1)		Vaccine + Dasatinib (Cycle 1, D1)
Arm/Group Description	Patients received vaccine on treatment Cycle 1, Day 1, and dasatinib beginning on treatment Cycle 2, Day 1 (week 5). All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours). The DC vaccine was administered by a single intradermal injection of approximately 10^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle.		Patients received both vaccine and dasatinib beginning on treatment Cycle 1, Day 1. All patients received dasatinib at a starting oral dose of 70 mg twice daily, and dasatinib as (1) 50 mg and (1) 20 mg tablets twice daily (each 12 hours). The DC vaccine was administered by a single intradermal injection of approximately 10^7 cells (in the vicinity of the four nodal drainage groups of the four extremities) , on days 1 and 15 of each cycle.
All Cause Mortality
	Vaccine (Cycle 1, Day 1) + Dasatinib (Cycle 2, D1)		Vaccine + Dasatinib (Cycle 1, D1)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	8/9 (88.9%)		5/6 (83.3%)
Serious Adverse Events
	Vaccine (Cycle 1, Day 1) + Dasatinib (Cycle 2, D1)		Vaccine + Dasatinib (Cycle 1, D1)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/9 (77.8%)		4/6 (66.7%)
Blood and lymphatic system disorders
Anemia	1/9 (11.1%)		2/6 (33.3%)
Cardiac disorders
Cardiac disorders - Other, specify	0/9 (0%)		1/6 (16.7%)
Endocrine disorders
Adrenal insufficiency	0/9 (0%)		1/6 (16.7%)
Gastrointestinal disorders
Abdominal pain	2/9 (22.2%)		0/6 (0%)
Constipation	1/9 (11.1%)		0/6 (0%)
Gastrointestinal disorders - Other, specify	0/9 (0%)		1/6 (16.7%)
Nausea	1/9 (11.1%)		0/6 (0%)
Vomiting	1/9 (11.1%)		0/6 (0%)
General disorders
Fatigue	1/9 (11.1%)		0/6 (0%)
Gait disturbance	0/9 (0%)		1/6 (16.7%)
Non-cardiac chest pain	1/9 (11.1%)		0/6 (0%)
Infections and infestations
Urinary tract infection	1/9 (11.1%)		1/6 (16.7%)
Investigations
Investigations - Other, specify	1/9 (11.1%)		0/6 (0%)
Lymphocyte count decreased	2/9 (22.2%)		0/6 (0%)
Urine output decreased	0/9 (0%)		1/6 (16.7%)
Metabolism and nutrition disorders
Anorexia	0/9 (0%)		1/6 (16.7%)
Hyperuricemia	1/9 (11.1%)		0/6 (0%)
Hypophosphatemia	0/9 (0%)		2/6 (33.3%)
Musculoskeletal and connective tissue disorders
Arthralgia	0/9 (0%)		1/6 (16.7%)
Back pain	1/9 (11.1%)		0/6 (0%)
Myalgia	0/9 (0%)		1/6 (16.7%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	1/9 (11.1%)		1/6 (16.7%)
Nervous system disorders
Encephalopathy	0/9 (0%)		1/6 (16.7%)
Psychiatric disorders
Confusion	1/9 (11.1%)		1/6 (16.7%)
Respiratory, thoracic and mediastinal disorders
Aspiration	0/9 (0%)		1/6 (16.7%)
Dyspnea	2/9 (22.2%)		0/6 (0%)
Hypoxia	1/9 (11.1%)		0/6 (0%)
Pulmonary edema	0/9 (0%)		1/6 (16.7%)
Respiratory, thoracic and mediastinal disorders - Other, specify	1/9 (11.1%)		0/6 (0%)
Skin and subcutaneous tissue disorders
Rash maculo-papular	1/9 (11.1%)		0/6 (0%)
Vascular disorders
Hypotension	0/9 (0%)		1/6 (16.7%)
Other (Not Including Serious) Adverse Events
	Vaccine (Cycle 1, Day 1) + Dasatinib (Cycle 2, D1)		Vaccine + Dasatinib (Cycle 1, D1)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	8/9 (88.9%)		6/6 (100%)
Blood and lymphatic system disorders
Anemia	5/9 (55.6%)		3/6 (50%)
Leukocytosis	0/9 (0%)		1/6 (16.7%)
Cardiac disorders
Palpitations	1/9 (11.1%)		0/6 (0%)
Sinus tachycardia	1/9 (11.1%)		1/6 (16.7%)
Ear and labyrinth disorders
Ear pain	0/9 (0%)		1/6 (16.7%)
Endocrine disorders
Endocrine disorders - Other, specify	0/9 (0%)		1/6 (16.7%)
Hypoparathyroidism	0/9 (0%)		1/6 (16.7%)
Hypothyroidism	0/9 (0%)		2/6 (33.3%)
Eye disorders
Eyelid function disorder	0/9 (0%)		1/6 (16.7%)
Gastrointestinal disorders
Abdominal pain	1/9 (11.1%)		2/6 (33.3%)
Constipation	1/9 (11.1%)		0/6 (0%)
Diarrhea	2/9 (22.2%)		3/6 (50%)
Dry mouth	0/9 (0%)		1/6 (16.7%)
Dyspepsia	0/9 (0%)		2/6 (33.3%)
Dysphagia	0/9 (0%)		1/6 (16.7%)
Nausea	1/9 (11.1%)		5/6 (83.3%)
Vomiting	0/9 (0%)		4/6 (66.7%)
General disorders
Chills	2/9 (22.2%)		1/6 (16.7%)
Edema limbs	0/9 (0%)		1/6 (16.7%)
Fatigue	5/9 (55.6%)		5/6 (83.3%)
Fever	2/9 (22.2%)		2/6 (33.3%)
Malaise	1/9 (11.1%)		0/6 (0%)
General disorders and administration site conditions - Other, specify	0/9 (0%)		3/6 (50%)
Non-cardiac chest pain	0/9 (0%)		1/6 (16.7%)
Pain	3/9 (33.3%)		2/6 (33.3%)
Infections and infestations
Eye infection	0/9 (0%)		1/6 (16.7%)
Infections and infestations - Other, specify	0/9 (0%)		2/6 (33.3%)
Lung infection	1/9 (11.1%)		0/6 (0%)
Lymph gland infection	0/9 (0%)		1/6 (16.7%)
Phlebitis infective	0/9 (0%)		1/6 (16.7%)
Skin infection	1/9 (11.1%)		0/6 (0%)
Upper respiratory infection	1/9 (11.1%)		1/6 (16.7%)
Urinary tract infection	1/9 (11.1%)		0/6 (0%)
Injury, poisoning and procedural complications
Bruising	0/9 (0%)		1/6 (16.7%)
Investigations
Activated partial thromboplastin time prolonged	0/9 (0%)		1/6 (16.7%)
Alkaline phosphatase increased	3/9 (33.3%)		1/6 (16.7%)
Aspartate aminotransferase increased	2/9 (22.2%)		3/6 (50%)
Cardiac troponin I increased	0/9 (0%)		1/6 (16.7%)
Creatinine increased	0/9 (0%)		2/6 (33.3%)
Investigations - Other, specify	0/9 (0%)		3/6 (50%)
Investigations - Other, specify	3/9 (33.3%)		0/6 (0%)
Lymphocyte count decreased	2/9 (22.2%)		3/6 (50%)
Neutrophil count decreased	2/9 (22.2%)		4/6 (66.7%)
Platelet count decreased	2/9 (22.2%)		3/6 (50%)
Weight loss	1/9 (11.1%)		1/6 (16.7%)
White blood cell decreased	1/9 (11.1%)		2/6 (33.3%)
Metabolism and nutrition disorders
Anorexia	3/9 (33.3%)		1/6 (16.7%)
Dehydration	0/9 (0%)		1/6 (16.7%)
Hyperglycemia	0/9 (0%)		2/6 (33.3%)
Hypermagnesemia	0/9 (0%)		1/6 (16.7%)
Hypoalbuminemia	4/9 (44.4%)		4/6 (66.7%)
Hypocalcemia	2/9 (22.2%)		2/6 (33.3%)
Hypoglycemia	0/9 (0%)		2/6 (33.3%)
Hypokalemia	1/9 (11.1%)		2/6 (33.3%)
Hypomagnesemia	1/9 (11.1%)		0/6 (0%)
Hyponatremia	5/9 (55.6%)		5/6 (83.3%)
Hypophosphatemia	2/9 (22.2%)		2/6 (33.3%)
Metabolism and nutrition disorders - Other, specify	2/9 (22.2%)		1/6 (16.7%)
Musculoskeletal and connective tissue disorders
Back pain	0/9 (0%)		1/6 (16.7%)
Flank pain	1/9 (11.1%)		0/6 (0%)
Generalized muscle weakness	1/9 (11.1%)		0/6 (0%)
Musculoskeletal and connective tissue disorder - Other, specify	1/9 (11.1%)		1/6 (16.7%)
Neck pain	1/9 (11.1%)		1/6 (16.7%)
Pain in extremity	1/9 (11.1%)		3/6 (50%)
Nervous system disorders
Dizziness	3/9 (33.3%)		2/6 (33.3%)
Dysarthria	0/9 (0%)		1/6 (16.7%)
Headache	1/9 (11.1%)		4/6 (66.7%)
Psychiatric disorders
Hallucinations	1/9 (11.1%)		1/6 (16.7%)
Insomnia	0/9 (0%)		3/6 (50%)
Psychiatric disorders - Other, specify	0/9 (0%)		1/6 (16.7%)
Renal and urinary disorders
Acute kidney injury	1/9 (11.1%)		0/6 (0%)
Bladder spasm	1/9 (11.1%)		1/6 (16.7%)
Reproductive system and breast disorders
Uterine hemorrhage	0/9 (0%)		1/6 (16.7%)
Respiratory, thoracic and mediastinal disorders
Cough	2/9 (22.2%)		1/6 (16.7%)
Dyspnea	2/9 (22.2%)		2/6 (33.3%)
Hoarseness	0/9 (0%)		1/6 (16.7%)
Hypoxia	0/9 (0%)		1/6 (16.7%)
Nasal congestion	1/9 (11.1%)		0/6 (0%)
Pleural effusion	1/9 (11.1%)		0/6 (0%)
Productive cough	0/9 (0%)		1/6 (16.7%)
Respiratory, thoracic and mediastinal disorders - Other, specify	0/9 (0%)		2/6 (33.3%)
Skin and subcutaneous tissue disorders
Dry skin	0/9 (0%)		2/6 (33.3%)
Erythema multiforme	1/9 (11.1%)		1/6 (16.7%)
Pruritus	0/9 (0%)		2/6 (33.3%)
Rash maculo-papular	0/9 (0%)		3/6 (50%)
Skin and subcutaneous tissue disorders - Other, specify	1/9 (11.1%)		2/6 (33.3%)
Urticaria	0/9 (0%)		1/6 (16.7%)
Vascular disorders
Hot flashes	1/9 (11.1%)		0/6 (0%)
Hypertension	0/9 (0%)		1/6 (16.7%)
Lymphedema	1/9 (11.1%)		0/6 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.