Dendritic Cell Activating Scaffold in Melanoma

NCT01753089 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: 12-306
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 2

Brief Summary

This research study is a Phase I clinical trial. Phase I clinical trials test the safety of investigational melanoma vaccines. Phase I studies also try to define the appropriate dose of the investigational vaccine, in this case WDVAX, to use for further studies. "Investigational" means that the vaccine is still being studied and that research doctors are trying to find out more about it. It also means that the FDA has not yet approved WDVAX for any use in patients, including people with Melanoma. The purpose of this study is to determine if it is possible to make a vaccine against melanoma by using your own melanoma tumor cells and combining them with other proteins which activate the immune system. We hope that by combining the cells and the proteins in this way that the vaccine will cause your own immune system to react against your melanoma tumor cells. The purpose of this study is also to determine the safest way to give this vaccine with the least amount of side effects. Each vaccine will contain your own tumor cells which have been killed by a freezing and thawing process which destroys the cells but keeps the proteins from the melanoma cells. This is called a "tumor lysate" Your tumor lysate is combined with other proteins which activate the immune system. The other proteins are called GM-CSF and CpG. All of this is held together to form a "tablet" or "scaffold" which is about the size of a regular aspirin tablet. The material that holds the protein together is called PLGA. PLGA is the same material that doctors use for "dissolvable stitches" If you have ever had a problem with these types of stitches in the past, be sure to let your study doctor know about this.

Conditions

Melanoma

Keywords

Metastatic

Outcome Measures

Primary Outcomes (2)

• Feasibility of WDVAX for Metastatic Melanoma

  To determine the feasibility of preparing dendritic cells activating scaffolds (WDVAX) incorporating autologous melanoma cell lysates in patients with metastatic melanoma

  2 years

• Safety and Biologic Activity of WDVAX

  To determine the safety and biologic activity of vaccination with dendritic cell activation scaffolds (WDVAX) incorporating autologous melanoma cell lysates in patients with metastatic melanoma

  2 years

Secondary Outcomes (4)

• Immune Response

  2 years

• Tumor Response

  2 years

• Survival

  2 years

• Response to subsequent immunotherapy (E.G., anit-CTLA-4 or anti_PD-1mAbs

  2 years

Study Arms (1)

WDVAX

OTHER

Treatment

Biological: WDVAX

Interventions

WDVAX BIOLOGICAL

WDVAX

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically confirmed Stage IV melanoma
• Life expectancy of 6 months or greater
• At least four weeks since treatment
• Recovered from any acute toxicity associated with prior therapy
• At least 8 weeks since treatment with any check point blockade agent

You may not qualify if:

• Known allergy or adverse reaction to PLG
• Pregnant or breastfeeding
• Receiving other investigational study agents
• Active autoimmune disease requiring treatment for suppression of inflammation
• Uncontrolled intercurrent illness
• History of a different malignancy unless disease-free for at least 5 years or diagnosed and treated cervical cancer in situ, basal or squamous cell carcinoma of the skin
• HIV positive

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02215, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Melanoma; Neoplasm Metastasis

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; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• F. Stephen Hodi, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 17, 2012
• First Posted: December 20, 2012
• Study Start: June 1, 2013
• Primary Completion: August 4, 2025
• Study Completion: August 4, 2025
• Last Updated: September 15, 2025

Record last verified: 2025-09

Locations

US (2)