Trial Outcomes & Findings for Multi-center Phase I/IIa Trial of an Autologous Tumor Lysate (TL) + Yeast Cell Wall Particles (YCWP) + Dendritic Cells (DC) Vaccine in Addition to Standard of Care Checkpoint Inhibitor of Choice in Metastatic Melanoma Patients With Measurable Disease. (NCT NCT02678741)
NCT ID: NCT02678741
Last Updated: 2024-03-12
Results Overview
Safety of adding the TLPLDC vaccine to SoC CPI monotherapy
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
26 participants
Primary outcome timeframe
12 months (1 year)
Results posted on
2024-03-12
Participant Flow
All enrollees evaluated across all arms.
Participant milestones
| Measure |
Treatment Group
TLPLDC Vaccine: Tumor Lysate, Particle Loaded, Dendritic Cell Vaccine
|
|---|---|
|
Overall Study
STARTED
|
26
|
|
Overall Study
No Clinical Response
|
3
|
|
Overall Study
Stable Disease
|
2
|
|
Overall Study
Progressive Disease
|
10
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
20
|
Reasons for withdrawal
| Measure |
Treatment Group
TLPLDC Vaccine: Tumor Lysate, Particle Loaded, Dendritic Cell Vaccine
|
|---|---|
|
Overall Study
Death
|
4
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
ineligible
|
3
|
|
Overall Study
Not RECIST Measurable
|
2
|
|
Overall Study
Lack of Efficacy
|
10
|
Baseline Characteristics
Multi-center Phase I/IIa Trial of an Autologous Tumor Lysate (TL) + Yeast Cell Wall Particles (YCWP) + Dendritic Cells (DC) Vaccine in Addition to Standard of Care Checkpoint Inhibitor of Choice in Metastatic Melanoma Patients With Measurable Disease.
Baseline characteristics by cohort
| Measure |
Treatment
n=26 Participants
TLPLDC Vaccine: Tumor Lysate, Particle Loaded, Dendritic Cell Vaccine
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 months (1 year)Population: The safety evaluation of TLPLDC was the primary endpoint of this phase 1 trial. There were 26 patients enrolled, and 16 received at least one dose of vaccine. The population used for the safety analysis included these 16 patients. Toxicity was graded per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03. A total of 60 inoculations of TLPLDC were given to 16 patients, with the median of 3.5 inoculations.
Safety of adding the TLPLDC vaccine to SoC CPI monotherapy
Outcome measures
| Measure |
Treatment Group
n=16 Participants
TLPLDC Vaccine: Tumor Lysate, Particle Loaded, Dendritic Cell Vaccine
|
|---|---|
|
Graded Standard Systemic Toxicities (Using CTCAE Graded Toxicity Scale) by Patient
|
12 participants
|
PRIMARY outcome
Timeframe: 12 months (1 year)Safety of adding the TLPLDC vaccine to SoC CPI monotherapy
Outcome measures
| Measure |
Treatment Group
n=16 Participants
TLPLDC Vaccine: Tumor Lysate, Particle Loaded, Dendritic Cell Vaccine
|
|---|---|
|
Graded Standard Systemic Toxicities (Using CTCAE Graded Toxicity Scale) by Number of AEs
AEs related to TLPLDC
|
12 events
|
|
Graded Standard Systemic Toxicities (Using CTCAE Graded Toxicity Scale) by Number of AEs
Total AEs
|
79 events
|
|
Graded Standard Systemic Toxicities (Using CTCAE Graded Toxicity Scale) by Number of AEs
Serious AEs or Deaths
|
0 events
|
SECONDARY outcome
Timeframe: 12 months (1 year)Population: Of 26 patients enrolled, 16 received at least one inoculation with the TLPLDC vaccine; The 16 patients who received at least one inoculation were included in the efficacy analysis
RECIST criteria is used for assessing tumor response in the addition of TLPLDC vaccine. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Treatment Group
n=16 Participants
TLPLDC Vaccine: Tumor Lysate, Particle Loaded, Dendritic Cell Vaccine
|
|---|---|
|
Tumor Response to Treatment Using Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
No Clinical Response
|
2 Participants
|
|
Tumor Response to Treatment Using Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
Progressive Disease
|
10 Participants
|
|
Tumor Response to Treatment Using Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
Stable Disease
|
2 Participants
|
|
Tumor Response to Treatment Using Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
Not RECIST evaluable
|
2 Participants
|
Adverse Events
Treatment Group
Serious events: 0 serious events
Other events: 12 other events
Deaths: 4 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment Group
n=16 participants at risk
TLPLDC Vaccine: Tumor Lysate, Particle Loaded, Dendritic Cell Vaccine
|
|---|---|
|
Cardiac disorders
Syncope
|
18.8%
3/16 • Number of events 3 • Safety data was collected on local and systemic toxicities, graded and reported per the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.03 (Appendix C) (7). Patients followed up at their respective sites for evaluation of metastatic disease per NCCN guidelines (2)]. Patients underwent imaging to monitor disease approximately every 3 months for 1 year.
Imaging was done with the same modality that was used for baseline measurements, to meet RECIST criteria (5) Time to the best overall response was determined from the date of first inoculation until the first day that the tumor meets RECIST criteria for a particular tumor response
|
|
General disorders
Fatigue
|
6.2%
1/16 • Number of events 1 • Safety data was collected on local and systemic toxicities, graded and reported per the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.03 (Appendix C) (7). Patients followed up at their respective sites for evaluation of metastatic disease per NCCN guidelines (2)]. Patients underwent imaging to monitor disease approximately every 3 months for 1 year.
Imaging was done with the same modality that was used for baseline measurements, to meet RECIST criteria (5) Time to the best overall response was determined from the date of first inoculation until the first day that the tumor meets RECIST criteria for a particular tumor response
|
|
General disorders
Headache
|
12.5%
2/16 • Number of events 2 • Safety data was collected on local and systemic toxicities, graded and reported per the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.03 (Appendix C) (7). Patients followed up at their respective sites for evaluation of metastatic disease per NCCN guidelines (2)]. Patients underwent imaging to monitor disease approximately every 3 months for 1 year.
Imaging was done with the same modality that was used for baseline measurements, to meet RECIST criteria (5) Time to the best overall response was determined from the date of first inoculation until the first day that the tumor meets RECIST criteria for a particular tumor response
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.5%
2/16 • Number of events 2 • Safety data was collected on local and systemic toxicities, graded and reported per the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.03 (Appendix C) (7). Patients followed up at their respective sites for evaluation of metastatic disease per NCCN guidelines (2)]. Patients underwent imaging to monitor disease approximately every 3 months for 1 year.
Imaging was done with the same modality that was used for baseline measurements, to meet RECIST criteria (5) Time to the best overall response was determined from the date of first inoculation until the first day that the tumor meets RECIST criteria for a particular tumor response
|
|
General disorders
Chills
|
6.2%
1/16 • Number of events 1 • Safety data was collected on local and systemic toxicities, graded and reported per the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.03 (Appendix C) (7). Patients followed up at their respective sites for evaluation of metastatic disease per NCCN guidelines (2)]. Patients underwent imaging to monitor disease approximately every 3 months for 1 year.
Imaging was done with the same modality that was used for baseline measurements, to meet RECIST criteria (5) Time to the best overall response was determined from the date of first inoculation until the first day that the tumor meets RECIST criteria for a particular tumor response
|
|
Gastrointestinal disorders
Nausea and Vomiting
|
6.2%
1/16 • Number of events 1 • Safety data was collected on local and systemic toxicities, graded and reported per the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.03 (Appendix C) (7). Patients followed up at their respective sites for evaluation of metastatic disease per NCCN guidelines (2)]. Patients underwent imaging to monitor disease approximately every 3 months for 1 year.
Imaging was done with the same modality that was used for baseline measurements, to meet RECIST criteria (5) Time to the best overall response was determined from the date of first inoculation until the first day that the tumor meets RECIST criteria for a particular tumor response
|
|
Skin and subcutaneous tissue disorders
Injection site rxn
|
6.2%
1/16 • Number of events 1 • Safety data was collected on local and systemic toxicities, graded and reported per the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.03 (Appendix C) (7). Patients followed up at their respective sites for evaluation of metastatic disease per NCCN guidelines (2)]. Patients underwent imaging to monitor disease approximately every 3 months for 1 year.
Imaging was done with the same modality that was used for baseline measurements, to meet RECIST criteria (5) Time to the best overall response was determined from the date of first inoculation until the first day that the tumor meets RECIST criteria for a particular tumor response
|
|
Skin and subcutaneous tissue disorders
skin hypopigmentation
|
6.2%
1/16 • Number of events 1 • Safety data was collected on local and systemic toxicities, graded and reported per the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.03 (Appendix C) (7). Patients followed up at their respective sites for evaluation of metastatic disease per NCCN guidelines (2)]. Patients underwent imaging to monitor disease approximately every 3 months for 1 year.
Imaging was done with the same modality that was used for baseline measurements, to meet RECIST criteria (5) Time to the best overall response was determined from the date of first inoculation until the first day that the tumor meets RECIST criteria for a particular tumor response
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place