Metastatic MelanomaPhase 1/2NCT02678741
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.
A Phase 1/2 study testing TLPLDC Vaccine in people with Metastatic Melanoma, run by Elios Therapeutics, LLC at 7 sites in United States.
Trial summary
Assess the safety and tumor response of utilizing an autologous tumor lysate, particle-loaded, dendritic cell (TLPLDC) vaccine given in combination with standard of care (SoC) checkpoint inhibitors (CPI) in patients with stage IV melanoma with measurable disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Melanoma
- What is being tested?
- TLPLDC Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 7 sitesUnited States
- Study dates
- Feb 2016to 13 Nov 2019
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 (Appendix A)
- Metastatic melanoma eligible for {or currently on} standard of care CPI therapy (treating physician's choice) with measurable disease.
- Approximately 1 cm3 preferred but 1 mg minimum of accessible and dispensable tumor (minimum of 3 passes with a core needle)
- Able to tolerate CPI treatment regimen {if already started}
- Adequate organ function as determined by the following laboratory values:
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- ANC ≥ 1,000/μL
- Platelets ≥ 75,000/μL
- Hgb ≥ 9 g/dL
- Creatinine ≤ 1.5 x upper limit of normal (ULN) or Creatinine clearance ≥ 50% of lower limit of normal (LLN)
- Total bilirubin ≤ 1.5 ULN
- ALT and AST ≤ 1.5 ULN
- For women of child-bearing potential, agreement to use adequate birth control (abstinence, hysterectomy, bilateral oophorectomy, bilateral tubal ligation, oral contraception, IUD, or use of condoms or diaphragms)
Who cannot join
- Inability to tolerate CPI therapy {if already started}
- Rapidly progressing multi-focal metastatic melanoma
- Insufficient tumor available to produce vaccine
- ECOG >2 performance status (Appendix A)
- Immune deficiency disease or known history of HIV, HBV, HCV
- Receiving immunosuppressive therapy including chronic steroids (except physiologic maintenance doses), methotrexate, or other known immunosuppressive agents
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- Pregnancy (assessed by urine HCG)
- Breast feeding
- Active pulmonary disease requiring medication to include multiple inhalers (>2 inhalers and one containing steroids)
- Involved in other experimental protocols (except with permission of the other study PI)
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Northside Hospital
Atlanta, Georgia, 30342
University of Alabama Birmingham Comprehensive Cancer Center
Birmingham, Alabama, 35243
University of Cincinnati Cancer Institute
Cincinnati, Ohio, 45267
Providence Regional Medical Center
Everett, Washington, 98201
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, 33140
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
John Wayne Cancer Institute/Providence Saint John's Health Center
Santa Monica, California, 90404
About this study
Assess the safety and tumor response of utilizing an autologous tumor lysate, particle-loaded, dendritic cell (TLPLDC) vaccine given in combination with standard of care (SoC) checkpoint inhibitors (CPI) in patients with stage IV melanoma with measurable disease.
Read the detailed description
Metastatic melanoma patients eligible for (or currently on) CPI therapy per SoC will be identified and screened for inclusion/exclusion criteria. Eligible patients will be counseled and consented for tissue procurement. They will undergo excisional or core needle biopsy as clinically indicated and this tissue will be shipped in liquid nitrogen shippers through FedEx to our central facility in Greenville, SC.The tumor will be stored frozen until vaccine preparation. Vaccine development requires 48 hours for preparation. Upon verification that adequate tissue was obtained, these patients will then be counseled and consented for participation in the trial.
The patients who qualify for participation in this trial will continue their treatment of CPI. Once consented, patients will receive a single injection of Neupogen (G-CSF) 300 μg SQ 24-48 hrs prior to having 70 mL of blood collected and sent to our central facility for DC isolation and preparation. Those who cannot tolerate Neupogen or refuse it will have 120 mL of blood drawn and sent. Additional blood may be drawn if additional vaccine doses need to be made or re-made for any reason. Vaccines will be prepared by producing TL through freeze/thaw cycling and then loaded into pre-prepared YCWP. The TL-loaded YCWP will be introduced to the DC for phagocytosis thus creating the TLPLDC vaccine, which will be frozen in single dose vials. Each vial will contain 1 x 106 TLPLDC and will be labeled with the patient's unique study number.
The frozen autologous TLPLDC will be sent back to the site with a total of 6 single dose vials after the vaccine has completed QA/QC testing and lot-release (usually 3 weeks). The primary vaccination series will include monthly inoculations at 0, 1, 2, 3 months followed by boosters at 6 and 9 months in the same lymph node draining area (preferably the anterior thigh). Once received, the first inoculation should occur within 4 weeks.
Safety data will be collected on local and systemic toxicities and graded and reported per the Common Terminology Criteria for Adverse Events (CTCAE) v4.03.
Patients will follow-up at their respective sites for evaluation of metastatic disease per SoC. They will under imaging, CT/PET-CT, to meet Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1 and iRECIST to monitor disease.
Blood (50 mL) will be collected from all patients prior to each inoculation and at 12 months from enrollment for a total of 7 time points or a total of 350 mL of blood over 1 year. The collected blood will be sent to our central facility for immunologic testing of T-cell responses.
- Conditions
- Metastatic Melanoma
- Being tested
- TLPLDC Vaccine
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TLPLDC VaccineDrug
Tumor Lysate, Particle Loaded, Dendritic Cell Vaccine
| Study group | Role | What they receive |
|---|---|---|
| No clinical response | Active comparator | No clinical response (PD de novo) after a minimum of 3 months on CPI monotherapy Receives: Drug: TLPLDC Vaccine |
| Develop PD | Active comparator | Develop PD after initial clinical response to CPI monotherapy Receives: Drug: TLPLDC Vaccine |
| Stable Disease | Active comparator | Stable disease for at least 6 months on CPI monotherapy Receives: Drug: TLPLDC Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Graded Standard Systemic Toxicities (Using CTCAE Graded Toxicity Scale) by Patient
Safety of adding the TLPLDC vaccine to SoC CPI monotherapy
Measured: 12 months (1 year)
Graded Standard Systemic Toxicities (Using CTCAE Graded Toxicity Scale) by Number of AEs
Safety of adding the TLPLDC vaccine to SoC CPI monotherapy
Measured: 12 months (1 year)
Secondary outcomes (1)
Tumor Response to Treatment Using Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
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.
Measured: 12 months (1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completion30 Oct 2019
- Study completion13 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metastatic MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elios Therapeutics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- LumaBridge
- Responsible party
- Sponsor
- Investigators
- George Peoples, MD, Study director, LumaBridge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02678741
- Sponsor's protocol ID
- 20152397
- Status last verified
- Mar 2024
- First submitted
- 4 Feb 2016
- Last updated
- 12 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT02678741
- Acronym / sponsor ID
- 20152397
- Conditions
- Metastatic Melanoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Elios Therapeutics, LLCIndustry (pharma, biotech, devices)
- Collaborators
- LumaBridge
- Study start
- Feb 2016
- Primary completion
- 30 Oct 2019 (actual)
- Study completion
- 13 Nov 2019 (actual)
- First posted
- 10 Feb 2016 (estimated)
- Results
- Posted 12 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Assess the safety and tumor response of utilizing an autologous tumor lysate, particle-loaded, dendritic cell (TLPLDC) vaccine given in combination with standard of care (SoC) checkpoint inhibitors (CPI) in patients with stage IV melanoma with measurable disease.
Detailed description
Metastatic melanoma patients eligible for (or currently on) CPI therapy per SoC will be identified and screened for inclusion/exclusion criteria. Eligible patients will be counseled and consented for tissue procurement. They will undergo excisional or core needle biopsy as clinically indicated and this tissue will be shipped in liquid nitrogen shippers through FedEx to our central facility in Greenville, SC.The tumor will be stored frozen until vaccine preparation. Vaccine development requires 48 hours for preparation. Upon verification that adequate tissue was obtained, these patients will then be counseled and consented for participation in the trial.
The patients who qualify for participation in this trial will continue their treatment of CPI. Once consented, patients will receive a single injection of Neupogen (G-CSF) 300 μg SQ 24-48 hrs prior to having 70 mL of blood collected and sent to our central facility for DC isolation and preparation. Those who cannot tolerate Neupogen or refuse it will have 120 mL of blood drawn and sent. Additional blood may be drawn if additional vaccine doses need to be made or re-made for any reason. Vaccines will be prepared by producing TL through freeze/thaw cycling and then loaded into pre-prepared YCWP. The TL-loaded YCWP will be introduced to the DC for phagocytosis thus creating the TLPLDC vaccine, which will be frozen in single dose vials. Each vial will contain 1 x 106 TLPLDC and will be labeled with the patient's unique study number.
The frozen autologous TLPLDC will be sent back to the site with a total of 6 single dose vials after the vaccine has completed QA/QC testing and lot-release (usually 3 weeks). The primary vaccination series will include monthly inoculations at 0, 1, 2, 3 months followed by boosters at 6 and 9 months in the same lymph node draining area (preferably the anterior thigh). Once received, the first inoculation should occur within 4 weeks.
Safety data will be collected on local and systemic toxicities and graded and reported per the Common Terminology Criteria for Adverse Events (CTCAE) v4.03.
Patients will follow-up at their respective sites for evaluation of metastatic disease per SoC. They will under imaging, CT/PET-CT, to meet Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1 and iRECIST to monitor disease.
Blood (50 mL) will be collected from all patients prior to each inoculation and at 12 months from enrollment for a total of 7 time points or a total of 350 mL of blood over 1 year. The collected blood will be sent to our central facility for immunologic testing of T-cell responses.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No clinical response | Active comparator | Drug: TLPLDC VaccineNo clinical response (PD de novo) after a minimum of 3 months on CPI monotherapy |
| Develop PD | Active comparator | Drug: TLPLDC VaccineDevelop PD after initial clinical response to CPI monotherapy |
| Stable Disease | Active comparator | Drug: TLPLDC VaccineStable disease for at least 6 months on CPI monotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 (Appendix A)
- Metastatic melanoma eligible for {or currently on} standard of care CPI therapy (treating physician's choice) with measurable disease.
- Approximately 1 cm3 preferred but 1 mg minimum of accessible and dispensable tumor (minimum of 3 passes with a core needle)
- Able to tolerate CPI treatment regimen {if already started}
Key exclusion criteria (10 listed)
- Inability to tolerate CPI therapy {if already started}
- Rapidly progressing multi-focal metastatic melanoma
- Insufficient tumor available to produce vaccine
- ECOG >2 performance status (Appendix A)
- Immune deficiency disease or known history of HIV, HBV, HCV
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TLPLDC VaccineTumor Lysate, Particle Loaded, Dendritic Cell Vaccine | Drug | Develop PD, No clinical response, Stable Disease |
Primary outcome
Graded Standard Systemic Toxicities (Using CTCAE Graded Toxicity Scale) by Patient
Time frame: 12 months (1 year)
Safety of adding the TLPLDC vaccine to SoC CPI monotherapy
Graded Standard Systemic Toxicities (Using CTCAE Graded Toxicity Scale) by Number of AEs
Time frame: 12 months (1 year)
Safety of adding the TLPLDC vaccine to SoC CPI monotherapy
1 secondary outcome
Tumor Response to Treatment Using Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
Time frame: 12 months (1 year)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George Peoples, MD study director
LumaBridge
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TLPLDC Vaccine in people with Metastatic Melanoma, run by Elios Therapeutics, LLC at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Graded Standard Systemic Toxicities (Using CTCAE Graded Toxicity Scale) by Patient (time frame: 12 months (1 year)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.