Phase 2 Completed N=26 Treatment

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.

Source: ClinicalTrials.gov NCT02678741 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2024

Primary outcomePrimary: Graded Standard Systemic Toxicities (Using CTCAE Graded Toxicity Scale) by Patient — 12 participants

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Graded Standard Systemic Toxicities (Using CTCAE Graded Toxicity Scale) by Patient	12	—
PRIMARY Graded Standard Systemic Toxicities (Using CTCAE Graded Toxicity Scale) by Number of AEs	12; 79; 0	—
SECONDARY Tumor Response to Treatment Using Response Evaluation Criteria in Solid Tumors (RECIST) Criteria	2; 10; 2; 2	—

Eligibility Criteria

Inclusion Criteria

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:
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)

Exclusion Criteria

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
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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02678741). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.