Phase IIB TL + YCWP + DC in Melanoma

NCT02301611 | Completed Phase 2 Results DMC

• 1 other identifier: 20141932
• Study Type: interventional
• Target: 187
• Locations: 1 country
• Sites: 18

Brief Summary

The majority of melanoma vaccines tested to date have been antigen-specific vaccines targeting melanoma-specific or associated antigens and utilizing a variety of delivery systems and immune-adjuvants. As opposed to testing an "off the shelf" vaccine that might be able to treat a subset of patients, our approach has been personalized to the patient and applicable to all patients. Our vaccine approach consists of harnessing the most potent antigen presenting cell in the body - the dendritic cell (DC) - together with the full repertoire of tumor antigens from an individual's cancer. We have conducted phase I and II studies using an autologous DC-tumor cell fusion technique that has now been simplified into a DC-tumor cell lysate vaccine. The autologous tumor lysate (TL) is loaded into yeast cell wall particles (YCWP) that are naturally and efficiently taken up into the patient's DC. These autologous tumor lysate, particle-loaded, DC (TLPLDC) are injected intradermally (ID) monthly x 3 followed by boosters at 6, 12, and 18 months.

Conditions

Melanoma

Outcome Measures

Primary Outcomes (1)

• Disease Free Survival Assessment

  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.

  24 months

Study Arms (2)

Treatment

EXPERIMENTAL

autologous TLPLDC (active vaccine)

Drug: TLPLDC

Placebo

PLACEBO COMPARATOR

unloaded YCWP + autologous DC (control)

Drug: Placebo

Interventions

TLPLDC DRUG

Autologous tumor lysate, particle-loaded dendritic cell vaccine

Treatment

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 99 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 0,1 (Appendix D)
• AJCC stage III or IV completely resectable melanoma identified before surgery
• Approximately 1 mg (1 cm3) of accessible and dispensable tumor that will not interfere with pathologic staging
• Clinically disease-free after surgery
• Completing SoC adjuvant therapy per NCCN guidelines to include chemotherapy, radiation therapy, and/or biologic therapy as clinically indicated. (Consent #2 should be signed as close to completion of SoC as possible but may overlap completion by up to one month.)
• Vaccinations initiated between 3 weeks and 3 months from completion of SoC multi-modality cancer care
• 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%
• 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:

• Evidence of residual disease after surgery and SoC adjuvant therapies
• Insufficient tumor available to produce vaccine
• ECOG \>2 performance status (Appendix D)
• Immune deficiency disease or known history of HIV, HBV, HCV
• Receiving immunosuppressive therapy including chronic steroids, 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 (18)

University of Alabama Birmingham (UAB) Comprehensive Cancer Center

Birmingham, Alabama, 35243, United States

Location

Mayo Clinic - Cancer Clinical Research Office

Phoenix, Arizona, 85054, United States

Location

The University of Arizona Cancer Center

Tucson, Arizona, 85724, United States

Location

The Angeles Clinic and Research Institute A Cedars-Sinai Affiliate

Los Angeles, California, 90025, United States

Location

John Wayne Cancer Institute

Santa Monica, California, 90404, United States

Location

Mount Sinai Cancer Research Program

Miami Beach, Florida, 33140, United States

Location

Northside Hospital Cancer Institute

Atlanta, Georgia, 30341, United States

Location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Memorial Hospital of South Bend

South Bend, Indiana, 46601, United States

Location

Mayo Clinic, Rochester

Rochester, Minnesota, 55905, United States

Location

New Mexico Cancer Care Alliance

Albuquerque, New Mexico, 87102, United States

Location

Laura and Isaac Permutter Cancer Center @ NYU Langone

New York, New York, 10016, United States

Location

University of Cincinnati Cancer Institute

Cincinnati, Ohio, 45267, United States

Location

The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43202, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

St. Francis Hospital Cancer Center

Greenville, South Carolina, 29607, United States

Location

Huntsman Cancer Institute/The University of Utah

Salt Lake City, Utah, 84112, United States

Location

Providence Regional Medical Center Everett

Everett, Washington, 98201, United States

Location

Related Publications (2)

• Carpenter EL, Van Decar S, Adams AM, O'Shea AE, McCarthy P, Chick RC, Clifton GT, Vreeland T, Valdera FA, Tiwari A, Hale D, Kemp Bohan P, Hickerson A, Smolinsky T, Thomas K, Cindass J, Hyngstrom J, Berger AC, Jakub J, Sussman JJ, Shaheen MF, Yu X, Wagner TE, Faries M, Peoples GE. Prospective, randomized, double-blind phase 2B trial of the TLPO and TLPLDC vaccines to prevent recurrence of resected stage III/IV melanoma: a prespecified 36-month analysis. J Immunother Cancer. 2023 Aug;11(8):e006665. doi: 10.1136/jitc-2023-006665.

  PMID: 37536936 DERIVED

• Vreeland TJ, Clifton GT, Hale DF, Chick RC, Hickerson AT, Cindass JL, Adams AM, Bohan PMK, Andtbacka RHI, Berger AC, Jakub JW, Sussman JJ, Terando AM, Wagner T, Peoples GE, Faries MB. A Phase IIb Randomized Controlled Trial of the TLPLDC Vaccine as Adjuvant Therapy After Surgical Resection of Stage III/IV Melanoma: A Primary Analysis. Ann Surg Oncol. 2021 Oct;28(11):6126-6137. doi: 10.1245/s10434-021-09709-1. Epub 2021 Feb 27.

  PMID: 33641012 DERIVED

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: Marsha Greene
• Organization: Lumabridge, LLC

mgreene@lumabridge.com

(484) 319-1117

Study Officials

• George E Peoples, MD

  LumaBridge

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2014
• First Posted: November 26, 2014
• Study Start: January 1, 2015
• Primary Completion: May 11, 2022
• Study Completion: May 11, 2022
• Last Updated: November 29, 2024
• Results First Posted: November 29, 2024

Record last verified: 2024-11

Locations

US (18)