Trial Outcomes & Findings for Phase IIB TL + YCWP + DC in Melanoma (NCT NCT02301611)
NCT ID: NCT02301611
Last Updated: 2024-11-29
Results Overview
The primary outcome measure of the trial is assessing disease free survival (DFS) at 24 months compared between the vaccinated and control groups after the final enrolled patient completes two years of follow-up. An interim analysis will be performed six months after the final patient is enrolled. This analysis will compare median DFS between vaccinated and control groups.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
187 participants
Primary outcome timeframe
24 months
Results posted on
2024-11-29
Participant Flow
Patients 18 years of age or older with stage III/IV melanoma capable of being disease free after surgery were recruited at the individual study sites. Enrollment start was January 2015. Patients were first randomized 2:1 to receive either the TLPLDC vaccine or placebo (n=124), and then randomization transitioned to 2:1 TLPO or TLPLDC vaccine for 63 more patients. This resulted placebo (n=41), TLPO (n=43), and TLPLDC (n=103) formulations.
Participant milestones
| Measure |
Treatment TLPLDC
autologous TLPLDC (active vaccine)
TLPLDC: Autologous tumor lysate, particle-loaded dendritic cell vaccine
|
Placebo
unloaded YCWP + autologous DC (control)
Placebo
|
Treatment TLPO
Tumor Lysate Particle Only (TLPO)
|
Treatment TLPLDC-G
autologous TLPLDC - pre-treated with G-CSF
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
47
|
41
|
43
|
56
|
|
Overall Study
COMPLETED
|
19
|
8
|
1
|
8
|
|
Overall Study
NOT COMPLETED
|
28
|
33
|
42
|
48
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Based on stratification
Baseline characteristics by cohort
| Measure |
Treatment TLPLDC-G
n=56 Participants
autologous TLPLDC - pre-treated with G-CSF
|
Total
n=187 Participants
Total of all reporting groups
|
Treatment TLPLDC
n=47 Participants
autologous TLPLDC (active vaccine)
TLPLDC: Autologous tumor lysate, particle-loaded dendritic cell vaccine
|
Placebo
n=41 Participants
unloaded YCWP + autologous DC (control)
Placebo
|
Treatment TLPO
n=43 Participants
Tumor Lysate Particle Only (TLPO)
|
|---|---|---|---|---|---|
|
Age, Customized
Age
|
61.7 years
STANDARD_DEVIATION .07 • n=4 Participants • Based on stratification
|
60.2 years
STANDARD_DEVIATION .07 • n=21 Participants • Based on stratification
|
69.5 years
STANDARD_DEVIATION .07 • n=5 Participants • Based on stratification
|
58.7 years
STANDARD_DEVIATION .07 • n=7 Participants • Based on stratification
|
63.6 years
STANDARD_DEVIATION .07 • n=5 Participants • Based on stratification
|
|
Sex: Female, Male
Female
|
16 Participants
n=4 Participants • Based on stratification
|
62 Participants
n=21 Participants • Based on stratification
|
16 Participants
n=5 Participants • Based on stratification
|
14 Participants
n=7 Participants • Based on stratification
|
16 Participants
n=5 Participants • Based on stratification
|
|
Sex: Female, Male
Male
|
40 Participants
n=4 Participants • Based on stratification
|
125 Participants
n=21 Participants • Based on stratification
|
31 Participants
n=5 Participants • Based on stratification
|
27 Participants
n=7 Participants • Based on stratification
|
27 Participants
n=5 Participants • Based on stratification
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=4 Participants • Based on stratification
|
1 Participants
n=21 Participants • Based on stratification
|
0 Participants
n=5 Participants • Based on stratification
|
0 Participants
n=7 Participants • Based on stratification
|
0 Participants
n=5 Participants • Based on stratification
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=4 Participants • Based on stratification
|
1 Participants
n=21 Participants • Based on stratification
|
0 Participants
n=5 Participants • Based on stratification
|
1 Participants
n=7 Participants • Based on stratification
|
0 Participants
n=5 Participants • Based on stratification
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=4 Participants • Based on stratification
|
0 Participants
n=21 Participants • Based on stratification
|
0 Participants
n=5 Participants • Based on stratification
|
0 Participants
n=7 Participants • Based on stratification
|
0 Participants
n=5 Participants • Based on stratification
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=4 Participants • Based on stratification
|
2 Participants
n=21 Participants • Based on stratification
|
0 Participants
n=5 Participants • Based on stratification
|
1 Participants
n=7 Participants • Based on stratification
|
1 Participants
n=5 Participants • Based on stratification
|
|
Race (NIH/OMB)
White
|
52 Participants
n=4 Participants • Based on stratification
|
177 Participants
n=21 Participants • Based on stratification
|
46 Participants
n=5 Participants • Based on stratification
|
38 Participants
n=7 Participants • Based on stratification
|
41 Participants
n=5 Participants • Based on stratification
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=4 Participants • Based on stratification
|
0 Participants
n=21 Participants • Based on stratification
|
0 Participants
n=5 Participants • Based on stratification
|
0 Participants
n=7 Participants • Based on stratification
|
0 Participants
n=5 Participants • Based on stratification
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=4 Participants • Based on stratification
|
6 Participants
n=21 Participants • Based on stratification
|
1 Participants
n=5 Participants • Based on stratification
|
1 Participants
n=7 Participants • Based on stratification
|
1 Participants
n=5 Participants • Based on stratification
|
|
Region of Enrollment
United States
|
56 participants
n=4 Participants • based on stratification factors.
|
187 participants
n=21 Participants • based on stratification factors.
|
47 participants
n=5 Participants • based on stratification factors.
|
41 participants
n=7 Participants • based on stratification factors.
|
43 participants
n=5 Participants • based on stratification factors.
|
PRIMARY outcome
Timeframe: 24 monthsPopulation: Number of participants remaining at displayed timepoints
The primary outcome measure of the trial is assessing disease free survival (DFS) at 24 months compared between the vaccinated and control groups after the final enrolled patient completes two years of follow-up. An interim analysis will be performed six months after the final patient is enrolled. This analysis will compare median DFS between vaccinated and control groups.
Outcome measures
| Measure |
Treatment TLPLDC
n=47 Participants
autologous TLPLDC (active vaccine) Survival Table - remaining cases
|
Placebo
n=41 Participants
unloaded YCWP + autologous DC (control) Placebo
|
Treatment TLPO
n=43 Participants
Tumor Lysate Particle Only (TLPO)
|
Treatment TLPLDC-G
n=56 Participants
autologous TLPLDC - pre-treated with G-CSF
|
|---|---|---|---|---|
|
Disease Free Survival Assessment
Survival 6 months
|
32 Participants
|
30 Participants
|
31 Participants
|
30 Participants
|
|
Disease Free Survival Assessment
Survival 12 months
|
26 Participants
|
20 Participants
|
29 Participants
|
20 Participants
|
|
Disease Free Survival Assessment
Survival 18 months
|
23 Participants
|
12 Participants
|
20 Participants
|
17 Participants
|
|
Disease Free Survival Assessment
Survival 24 months
|
19 Participants
|
7 Participants
|
10 Participants
|
9 Participants
|
Adverse Events
Treatment TLPLDC
Serious events: 4 serious events
Other events: 24 other events
Deaths: 14 deaths
Placebo
Serious events: 6 serious events
Other events: 14 other events
Deaths: 6 deaths
Treatment TLPO
Serious events: 7 serious events
Other events: 15 other events
Deaths: 6 deaths
Treatment TLPLDC-G
Serious events: 6 serious events
Other events: 13 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Treatment TLPLDC
n=47 participants at risk
autologous TLPLDC (active vaccine) Survival Table - remaining cases
|
Placebo
n=41 participants at risk
unloaded YCWP + autologous DC (control) Placebo
|
Treatment TLPO
n=43 participants at risk
Tumor Lysate Particle Only (TLPO)
|
Treatment TLPLDC-G
n=56 participants at risk
autologous TLPLDC - pre-treated with G-CSF
|
|---|---|---|---|---|
|
Infections and infestations
Sepsis
|
6.4%
3/47 • Number of events 3 • 36 months
|
0.00%
0/41 • 36 months
|
0.00%
0/43 • 36 months
|
0.00%
0/56 • 36 months
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/47 • 36 months
|
0.00%
0/41 • 36 months
|
0.00%
0/43 • 36 months
|
1.8%
1/56 • Number of events 2 • 36 months
|
|
Gastrointestinal disorders
Colitis
|
2.1%
1/47 • Number of events 1 • 36 months
|
0.00%
0/41 • 36 months
|
2.3%
1/43 • Number of events 1 • 36 months
|
0.00%
0/56 • 36 months
|
|
Nervous system disorders
Stroke
|
2.1%
1/47 • Number of events 3 • 36 months
|
0.00%
0/41 • 36 months
|
0.00%
0/43 • 36 months
|
0.00%
0/56 • 36 months
|
|
General disorders
Fever
|
2.1%
1/47 • Number of events 1 • 36 months
|
0.00%
0/41 • 36 months
|
2.3%
1/43 • Number of events 1 • 36 months
|
0.00%
0/56 • 36 months
|
|
Cardiac disorders
Congestive heart failure
|
0.00%
0/47 • 36 months
|
0.00%
0/41 • 36 months
|
0.00%
0/43 • 36 months
|
1.8%
1/56 • Number of events 1 • 36 months
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/47 • 36 months
|
0.00%
0/41 • 36 months
|
0.00%
0/43 • 36 months
|
1.8%
1/56 • Number of events 1 • 36 months
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/47 • 36 months
|
4.9%
2/41 • Number of events 2 • 36 months
|
0.00%
0/43 • 36 months
|
0.00%
0/56 • 36 months
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/47 • 36 months
|
0.00%
0/41 • 36 months
|
0.00%
0/43 • 36 months
|
1.8%
1/56 • Number of events 1 • 36 months
|
|
Investigations
Weight loss
|
2.1%
1/47 • Number of events 1 • 36 months
|
0.00%
0/41 • 36 months
|
0.00%
0/43 • 36 months
|
0.00%
0/56 • 36 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/47 • 36 months
|
0.00%
0/41 • 36 months
|
0.00%
0/43 • 36 months
|
1.8%
1/56 • Number of events 1 • 36 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
0.00%
0/47 • 36 months
|
2.4%
1/41 • Number of events 1 • 36 months
|
0.00%
0/43 • 36 months
|
0.00%
0/56 • 36 months
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/47 • 36 months
|
0.00%
0/41 • 36 months
|
0.00%
0/43 • 36 months
|
1.8%
1/56 • Number of events 1 • 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.3%
2/47 • Number of events 2 • 36 months
|
0.00%
0/41 • 36 months
|
0.00%
0/43 • 36 months
|
0.00%
0/56 • 36 months
|
|
Vascular disorders
Hypertension
|
2.1%
1/47 • Number of events 1 • 36 months
|
0.00%
0/41 • 36 months
|
0.00%
0/43 • 36 months
|
1.8%
1/56 • Number of events 1 • 36 months
|
|
Infections and infestations
Wound infection
|
0.00%
0/47 • 36 months
|
4.9%
2/41 • Number of events 2 • 36 months
|
0.00%
0/43 • 36 months
|
0.00%
0/56 • 36 months
|
|
Infections and infestations
Lung infection
|
2.1%
1/47 • Number of events 1 • 36 months
|
0.00%
0/41 • 36 months
|
0.00%
0/43 • 36 months
|
0.00%
0/56 • 36 months
|
|
Infections and infestations
Skin infection
|
0.00%
0/47 • 36 months
|
0.00%
0/41 • 36 months
|
2.3%
1/43 • Number of events 1 • 36 months
|
0.00%
0/56 • 36 months
|
|
Infections and infestations
Enterocolitis infectious
|
2.1%
1/47 • Number of events 1 • 36 months
|
0.00%
0/41 • 36 months
|
0.00%
0/43 • 36 months
|
0.00%
0/56 • 36 months
|
|
Infections and infestations
Bladder infection
|
2.1%
1/47 • Number of events 1 • 36 months
|
0.00%
0/41 • 36 months
|
0.00%
0/43 • 36 months
|
0.00%
0/56 • 36 months
|
|
Infections and infestations
Bacteremia
|
0.00%
0/47 • 36 months
|
0.00%
0/41 • 36 months
|
2.3%
1/43 • Number of events 1 • 36 months
|
0.00%
0/56 • 36 months
|
|
Infections and infestations
Acute appendicitis
|
0.00%
0/47 • 36 months
|
0.00%
0/41 • 36 months
|
2.3%
1/43 • Number of events 1 • 36 months
|
0.00%
0/56 • 36 months
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/47 • 36 months
|
2.4%
1/41 • Number of events 1 • 36 months
|
0.00%
0/43 • 36 months
|
0.00%
0/56 • 36 months
|
|
Gastrointestinal disorders
Norovirus
|
0.00%
0/47 • 36 months
|
0.00%
0/41 • 36 months
|
2.3%
1/43 • Number of events 1 • 36 months
|
0.00%
0/56 • 36 months
|
|
Gastrointestinal disorders
Protein calorie malnutrition
|
2.1%
1/47 • Number of events 1 • 36 months
|
0.00%
0/41 • 36 months
|
0.00%
0/43 • 36 months
|
0.00%
0/56 • 36 months
|
|
Nervous system disorders
Syncope
|
2.1%
1/47 • Number of events 1 • 36 months
|
0.00%
0/41 • 36 months
|
0.00%
0/43 • 36 months
|
0.00%
0/56 • 36 months
|
|
Nervous system disorders
Intracranial hemorrhage
|
4.3%
2/47 • Number of events 2 • 36 months
|
0.00%
0/41 • 36 months
|
0.00%
0/43 • 36 months
|
0.00%
0/56 • 36 months
|
|
Nervous system disorders
Transient ischemic attack
|
2.1%
1/47 • Number of events 1 • 36 months
|
0.00%
0/41 • 36 months
|
0.00%
0/43 • 36 months
|
0.00%
0/56 • 36 months
|
|
Nervous system disorders
Dizziness
|
0.00%
0/47 • 36 months
|
0.00%
0/41 • 36 months
|
0.00%
0/43 • 36 months
|
1.8%
1/56 • Number of events 1 • 36 months
|
|
Nervous system disorders
Depressed level of conciousness
|
2.1%
1/47 • Number of events 1 • 36 months
|
0.00%
0/41 • 36 months
|
0.00%
0/43 • 36 months
|
0.00%
0/56 • 36 months
|
|
Nervous system disorders
Cerebral edema
|
0.00%
0/47 • 36 months
|
2.4%
1/41 • Number of events 1 • 36 months
|
0.00%
0/43 • 36 months
|
0.00%
0/56 • 36 months
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/47 • 36 months
|
2.4%
1/41 • Number of events 1 • 36 months
|
0.00%
0/43 • 36 months
|
0.00%
0/56 • 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/47 • 36 months
|
0.00%
0/41 • 36 months
|
2.3%
1/43 • Number of events 1 • 36 months
|
0.00%
0/56 • 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Lung infection
|
2.1%
1/47 • Number of events 1 • 36 months
|
0.00%
0/41 • 36 months
|
0.00%
0/43 • 36 months
|
0.00%
0/56 • 36 months
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/47 • 36 months
|
0.00%
0/41 • 36 months
|
2.3%
1/43 • Number of events 1 • 36 months
|
0.00%
0/56 • 36 months
|
Other adverse events
| Measure |
Treatment TLPLDC
n=47 participants at risk
autologous TLPLDC (active vaccine) Survival Table - remaining cases
|
Placebo
n=41 participants at risk
unloaded YCWP + autologous DC (control) Placebo
|
Treatment TLPO
n=43 participants at risk
Tumor Lysate Particle Only (TLPO)
|
Treatment TLPLDC-G
n=56 participants at risk
autologous TLPLDC - pre-treated with G-CSF
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
2.1%
1/47 • Number of events 1 • 36 months
|
2.4%
1/41 • Number of events 1 • 36 months
|
0.00%
0/43 • 36 months
|
1.8%
1/56 • Number of events 1 • 36 months
|
|
Ear and labyrinth disorders
Vestibular disorder
|
0.00%
0/47 • 36 months
|
0.00%
0/41 • 36 months
|
0.00%
0/43 • 36 months
|
1.8%
1/56 • Number of events 1 • 36 months
|
|
Endocrine disorders
Endocrine disorder
|
0.00%
0/47 • 36 months
|
0.00%
0/41 • 36 months
|
2.3%
1/43 • Number of events 1 • 36 months
|
0.00%
0/56 • 36 months
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/47 • 36 months
|
0.00%
0/41 • 36 months
|
2.3%
1/43 • Number of events 1 • 36 months
|
0.00%
0/56 • 36 months
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/47 • 36 months
|
0.00%
0/41 • 36 months
|
0.00%
0/43 • 36 months
|
3.6%
2/56 • Number of events 2 • 36 months
|
|
Gastrointestinal disorders
Diarrhea
|
2.1%
1/47 • Number of events 1 • 36 months
|
0.00%
0/41 • 36 months
|
2.3%
1/43 • Number of events 1 • 36 months
|
3.6%
2/56 • Number of events 2 • 36 months
|
|
General disorders
Fatigue
|
0.00%
0/47 • 36 months
|
4.9%
2/41 • Number of events 2 • 36 months
|
7.0%
3/43 • Number of events 3 • 36 months
|
7.1%
4/56 • Number of events 10 • 36 months
|
|
General disorders
Fever
|
0.00%
0/47 • 36 months
|
2.4%
1/41 • Number of events 1 • 36 months
|
0.00%
0/43 • 36 months
|
1.8%
1/56 • Number of events 4 • 36 months
|
|
Musculoskeletal and connective tissue disorders
General muscle weakness
|
4.3%
2/47 • Number of events 2 • 36 months
|
0.00%
0/41 • 36 months
|
0.00%
0/43 • 36 months
|
0.00%
0/56 • 36 months
|
|
Musculoskeletal and connective tissue disorders
Athralgia
|
2.1%
1/47 • Number of events 1 • 36 months
|
0.00%
0/41 • 36 months
|
2.3%
1/43 • Number of events 1 • 36 months
|
0.00%
0/56 • 36 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/47 • 36 months
|
0.00%
0/41 • 36 months
|
0.00%
0/43 • 36 months
|
1.8%
1/56 • Number of events 1 • 36 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.1%
1/47 • Number of events 1 • 36 months
|
0.00%
0/41 • 36 months
|
0.00%
0/43 • 36 months
|
1.8%
1/56 • Number of events 1 • 36 months
|
|
Nervous system disorders
Headache
|
0.00%
0/47 • 36 months
|
0.00%
0/41 • 36 months
|
2.3%
1/43 • Number of events 1 • 36 months
|
10.7%
6/56 • Number of events 8 • 36 months
|
|
Nervous system disorders
Dizziness
|
2.1%
1/47 • Number of events 1 • 36 months
|
0.00%
0/41 • 36 months
|
2.3%
1/43 • Number of events 1 • 36 months
|
0.00%
0/56 • 36 months
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/47 • 36 months
|
0.00%
0/41 • 36 months
|
2.3%
1/43 • Number of events 1 • 36 months
|
0.00%
0/56 • 36 months
|
|
Psychiatric disorders
Insomnia
|
2.1%
1/47 • Number of events 1 • 36 months
|
0.00%
0/41 • 36 months
|
0.00%
0/43 • 36 months
|
0.00%
0/56 • 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/47 • 36 months
|
0.00%
0/41 • 36 months
|
4.7%
2/43 • Number of events 2 • 36 months
|
0.00%
0/56 • 36 months
|
|
Skin and subcutaneous tissue disorders
Injection site reaction
|
21.3%
10/47 • Number of events 29 • 36 months
|
12.2%
5/41 • Number of events 14 • 36 months
|
11.6%
5/43 • Number of events 6 • 36 months
|
12.5%
7/56 • Number of events 17 • 36 months
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
19.1%
9/47 • Number of events 35 • 36 months
|
9.8%
4/41 • Number of events 20 • 36 months
|
4.7%
2/43 • Number of events 4 • 36 months
|
1.8%
1/56 • Number of events 1 • 36 months
|
|
Skin and subcutaneous tissue disorders
Pain (at injection site)
|
4.3%
2/47 • Number of events 3 • 36 months
|
0.00%
0/41 • 36 months
|
9.3%
4/43 • Number of events 5 • 36 months
|
1.8%
1/56 • Number of events 1 • 36 months
|
|
Gastrointestinal disorders
Dry mouth
|
2.1%
1/47 • Number of events 1 • 36 months
|
2.4%
1/41 • Number of events 1 • 36 months
|
0.00%
0/43 • 36 months
|
0.00%
0/56 • 36 months
|
|
Gastrointestinal disorders
Oral dysesthesia
|
0.00%
0/47 • 36 months
|
2.4%
1/41 • Number of events 3 • 36 months
|
0.00%
0/43 • 36 months
|
0.00%
0/56 • 36 months
|
|
Gastrointestinal disorders
Vomiting
|
2.1%
1/47 • Number of events 1 • 36 months
|
0.00%
0/41 • 36 months
|
0.00%
0/43 • 36 months
|
0.00%
0/56 • 36 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/47 • 36 months
|
2.4%
1/41 • Number of events 1 • 36 months
|
0.00%
0/43 • 36 months
|
0.00%
0/56 • 36 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremities
|
0.00%
0/47 • 36 months
|
2.4%
1/41 • Number of events 1 • 36 months
|
0.00%
0/43 • 36 months
|
0.00%
0/56 • 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.1%
1/47 • Number of events 1 • 36 months
|
0.00%
0/41 • 36 months
|
2.3%
1/43 • Number of events 1 • 36 months
|
0.00%
0/56 • 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
2.1%
1/47 • Number of events 1 • 36 months
|
0.00%
0/41 • 36 months
|
0.00%
0/43 • 36 months
|
0.00%
0/56 • 36 months
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/47 • 36 months
|
2.4%
1/41 • Number of events 1 • 36 months
|
0.00%
0/43 • 36 months
|
0.00%
0/56 • 36 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place