Modified Melanoma Vaccine for High Risk or Low Residual D... | NCT01861938

Studies
Modified Melanoma Vaccine for High Risk or Low Residual Disease Patients

NCT01861938

Sponsor

Hadassah Medical Organization

Status

Withdrawn

Last Update Posted

Oct 2, 2025Actual

Enrollment

0Actual

Phase

Phase 2Phase 3

Conditions

High Risk HLA-A2+ Melanoma
Metastatic Disease

Interventions

Melanoma vaccine modified to express HLA A2/4-1BB ligand

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The study was withdrawn because no participants enrolled

Expanded Access Info

Start Date

Mar 2017Estimated

Primary Completion Date

Mar 2019Estimated

Completion Date

Mar 2019Estimated

First Submitted Date

Dec 20, 2012

First Submission Date that Met QC Criteria

May 23, 2013

First Posted Date

May 24, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 29, 2025

Last Update Posted Date

Oct 2, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study is based on the hypothesis that stimulation of the immune response against the tumor can help destroy residual tumor in melanoma patients with very high risk for disease recurrence and in patients with relatively low tumor burden who already got first line treatment for their disease.

Ongoing clinical trials in the Hadassah Hospital have shown that vaccination of patients with a cell line of tumor cells from the patient himself, or with a combination of three cell lines that partially match the patient's cell characteristics, could improve the immune response against the tumor, was associated with improved disease-free and overall survival.

In this study, the investigators will evaluate the efficacy of a modified tumor cell vaccine, in terms of immune response,improved disease-free and overall survival. The vaccine consists of a cell line that has a high expression level of melanoma molecules, and has been genetically modified to induce a strong immune response.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Melanoma vaccine	Experimental		Biological: Melanoma vaccine modified to express HLA A2/4-1BB ligand

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Melanoma vaccine modified to express HLA A2/4-1BB ligand	Biological	This study is designed for patients who had malignant melanoma and, following tumor removal, are now free of disease, or have only very minor residual disease, and are at a very high risk of disease recurrence. These patients will be treated with the A2/4-1BBL melanoma vaccine, a compatible melanoma cell line that has been engineered to express a molecule termed 4-1BBL, which enhances the chances of the cell line to be recognized by the patient's immune system, and to induce its stimulation. The hypothesis that drives the study states that the immune response against the cell line will also be effective against the residual tumor that may still be present in the body.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of adverse effects		For 20 weeks from the start of treatment

Secondary Outcomes

Measure	Description	Time Frame
Overall and disease free survival		For at least five years

Other Outcomes

Measure	Description	Time Frame
Emergence of anti-tumor T cell reactivity		To be measured one month after the last vaccine was admininstered, on average 18-20 weeks after treatment start

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients included in this protocol must carry one or more of the following tissue typing alleles: HLA-A2, -A24, -A33, -B35, -B49, -CW04/12(04/08). We estimate that 50% of melanoma patients will be eligible.
Cutaneous malignant melanoma AJCC stage IIb (over 4 mm) or IIc (ulcerated melanoma over 4mm).
Metastatic melanoma AJCC stage III (nodal involvement, N1-3a,b) post surgical removal of lymph nodes.
Metastatic melanoma AJCC stage IV, completely resected.
Non cutaneous malignant melanoma of respective stages including uveal and mucosal melanoma.
Melanoma can be of either mutant or wild-type B-RAF.
Karnofsky performance status over 80 (Normal activity with effort).
No active cardio-respiratory disease.
Hematocrit over 25% and WBC over 3000.
Informed consent of the patient.

Exclusion Criteria:

Administration of cytotoxic drugs or extensive radiotherapy less than 28 days prior to protocol administration.
Active brain metastases requiring cortico-steroids.
Concurrent malignancy (other than skin cancer, carcinoma in situ of cervix and early stage prostate cancer).
Active serious infection.
Allergy to penicillin.
Patient's wish to withdraw from the study at any stage.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009362	Neoplasm Metastasis
D008545	Melanoma

Ancestor Terms

ID	Term
D009385	Neoplastic Processes
D009369	Neoplasms
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided