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.

NCT02678741 | Completed Phase 1 Results DMC

• 1 other identifier: 20152397
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Metastatic Melanoma

Outcome Measures

Primary Outcomes (2)

• Graded Standard Systemic Toxicities (Using CTCAE Graded Toxicity Scale) by Patient

  Safety of adding the TLPLDC vaccine to SoC CPI monotherapy

  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

  12 months (1 year)

Secondary Outcomes (1)

• Tumor Response to Treatment Using Response Evaluation Criteria in Solid Tumors (RECIST) Criteria

  12 months (1 year)

Study Arms (3)

No clinical response

ACTIVE COMPARATOR

No clinical response (PD de novo) after a minimum of 3 months on CPI monotherapy

Drug: TLPLDC Vaccine

Develop PD

ACTIVE COMPARATOR

Develop PD after initial clinical response to CPI monotherapy

Drug: TLPLDC Vaccine

Stable Disease

ACTIVE COMPARATOR

Stable disease for at least 6 months on CPI monotherapy

Drug: TLPLDC Vaccine

Interventions

TLPLDC Vaccine DRUG

Tumor Lysate, Particle Loaded, Dendritic Cell Vaccine

Develop PD; No clinical response; Stable Disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Elios Therapeutics, LLC: lead
• LumaBridge: collaborator

Study Sites (7)

University of Alabama Birmingham Comprehensive Cancer Center

Birmingham, Alabama, 35243, United States

Location

John Wayne Cancer Institute/Providence Saint John's Health Center

Santa Monica, California, 90404, United States

Location

Mount Sinai Comprehensive Cancer Center

Miami Beach, Florida, 33140, United States

Location

Northside Hospital

Atlanta, Georgia, 30342, United States

Location

University of Cincinnati Cancer Institute

Cincinnati, Ohio, 45267, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Providence Regional Medical Center

Everett, Washington, 98201, United States

Location

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Timothy Vreeland, MD
• Organization: LumaBridge

tvreeland@lumabridge.com

6363465458

Study Officials

• George Peoples, MD

  LumaBridge

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2016
• First Posted: February 10, 2016
• Study Start: February 1, 2016
• Primary Completion: October 30, 2019
• Study Completion: November 13, 2019
• Last Updated: March 12, 2024
• Results First Posted: March 12, 2024

Record last verified: 2024-03

Locations

US (7)