Vaccine Therapy for Patients With Stage IV Melanoma
A Phase III Randomized Double-Blind Pivotal Trial of Immunotherapy With a Polyvalent Melanoma Vaccine, CancerVax™ Vaccine Plus BCG Versus Placebo Plus BCG as a Post-Surgical Treatment for Stage IV Melanoma
2 other identifiers
interventional
670
13 countries
77
Brief Summary
This is a Phase III study in patients with melanoma that has spread to the lymph nodes and/or a distant organ, and who have had all of their cancer surgically removed. The purpose of this study is to evaluate the ability of the CancerVax™ vaccine to prevent or slow the recurrence of melanoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
77 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 23, 2003
CompletedFirst Posted
Study publicly available on registry
January 24, 2003
CompletedJune 24, 2005
April 1, 2005
January 23, 2003
June 23, 2005
Conditions
Interventions
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
Study Sites (77)
Arizona Cancer Center
Tucson, Arizona, 85724, United States
Central Arkansas Veterans Healthcare System
Little Rock, Arkansas, 72205, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
Kaiser Permanente Medical Group
Anaheim, California, United States
Cedars Sinai Comprehensive Cancer Center
Los Angeles, California, United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92658, United States
Comprehensive Cancer Center at DRMC
Palm Springs, California, 92262, United States
Kaiser Permanente Medical Group
Riverside, California, United States
Kaiser Permanente Medical Group
San Diego, California, 92120, United States
Sharp Hospital
San Diego, California, 92123, United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94143-0128, United States
University of Colorado Cancer Center
Aurora, Colorado, United States
Lakeland Regional Cancer Center
Lakeland, Florida, 33805, United States
Mt. Sinai Comprehensive Cancer Center
Miami, Florida, United States
University of Miami
Miami, Florida, United States
Florida Hospital Cancer Institute
Orlando, Florida, 32804, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612-9497, United States
The Cancer Institute at Good Samaritan Medical Center
West Palm Beach, Florida, 33401, United States
Loyola University Medical Center
Maywood, Illinois, United States
OSF Saint Francis Medica Center
Peoria, Illinois, 61637, United States
Wagner and Associates
Indianapolis, Indiana, 46256, United States
James Graham Brown Cancer Center
Louisville, Kentucky, 40202, United States
St. Agnes Healthcare
Baltimore, Maryland, 21229, United States
Franklin Square Hospital Center
Baltimore, Maryland, 21237, United States
Sidney Kimmel Comprehensive Cancer Center
Lutherville, Maryland, United States
Boston Medical Center
Boston, Massachusetts, 02118-2393, United States
Spectrum Health - Butterworth Campus
Grand Rapids, Michigan, 49546, United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, 65203, United States
St. Louis University Health Sciences Center
St Louis, Missouri, 63110-0250, United States
The Cancer Cener at Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Medical Center of Princeton
Princeton, New Jersey, 08540, United States
Millard Fillmore Hospital
Buffalo, New York, 14209, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001, United States
Columbia Presbyterian Medical Center
New York, New York, 10032, United States
Suny Health Science Center at Syracuse
Syracuse, New York, 13210, United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295, United States
Wake Forest University
Winston-Salem, North Carolina, United States
Christ Hospital
Cincinnati, Ohio, 45219, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240, United States
Dayton Clinical Oncology Group
Dayton, Ohio, 45409, United States
St. Lukes Hospital Cancer Center
Bethlehem, Pennsylvania, 18015, United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104-4283, United States
Lankenau Hospital
Wynnewood, Pennsylvania, 19096, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838, United States
UT Southwest Medical Center- Dallas
Dallas, Texas, 75235-9154, United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009, United States
Intermountain Health Care- Mckay-Dee Hospital
Ogden, Utah, 84403, United States
Intermountain Health Care-LDS Hospital
Salt Lake City, Utah, 84143, United States
University of Washington
Seattle, Washington, 98109, United States
Northwest Medical Specialties
Tacoma, Washington, 98405, United States
Royal Prince Alfred Hospital, Sydney
Sydney, New South Wales, 2050, Australia
NSW Breast Cancer Institute
Westmead, New South Wales, 2145, Australia
Princess Alexandra Hospital
Brisbane, Queensland, 4102, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
Peter MacCallum Cancer Center
Melbourne, Victoria, 3002, Australia
The Alfred Hospital
Melbourne, Victoria, 3181, Australia
INCA (National Cancer Institute)
Rio de Janeiro, 20230, Brazil
Hospital Sirio Lebanes
São Paulo, 01308-050, Brazil
McGill University
Montreal, Quebec, Canada
CHU Pitie-Salpetriere
Paris, 75651, France
Klinikum Augsburg
Augsburg, Germany
Charite- University Medicine
Berlin, Germany
University of Jena
Jena, 07740, Germany
University Hospial of Mannheim
Mannheim, Germany
University of Tuebingen
Tübingen, Germany
University of Ulm
Ulm, Germany
University Hospital Wuerzburg
Würzburg, Germany
Cork University
Cork, Ireland
Tel-Aviv Medical Center
Tel Aviv, 62995, Israel
Istituto Nazionale Tumori di Milano
Milan, Milan, 20133, Italy
Instituto Eurepeo di Oncologia
Milan, Milan, 20141, Italy
Istituto Nazionale dei Tumori
Naples, 80132, Italy
University Hospital of Groningen
Groningen, Netherlands
North Shore Hospital
Auckland, Auckland, 92024, New Zealand
University of Zurich
Zurich, Switzerland
Harley Street Clinic
London, England, SW17 ORE, United Kingdom
Related Publications (2)
Faries MB, Mozzillo N, Kashani-Sabet M, Thompson JF, Kelley MC, DeConti RC, Lee JE, Huth JF, Wagner J, Dalgleish A, Pertschuk D, Nardo C, Stern S, Elashoff R, Gammon G, Morton DL; MMAIT-IV Clinical Trial Group. Long-Term Survival after Complete Surgical Resection and Adjuvant Immunotherapy for Distant Melanoma Metastases. Ann Surg Oncol. 2017 Dec;24(13):3991-4000. doi: 10.1245/s10434-017-6072-3. Epub 2017 Oct 10.
PMID: 29019177DERIVEDHoshimoto S, Faries MB, Morton DL, Shingai T, Kuo C, Wang HJ, Elashoff R, Mozzillo N, Kelley MC, Thompson JF, Lee JE, Hoon DS. Assessment of prognostic circulating tumor cells in a phase III trial of adjuvant immunotherapy after complete resection of stage IV melanoma. Ann Surg. 2012 Feb;255(2):357-62. doi: 10.1097/SLA.0b013e3182380f56.
PMID: 22202581DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 23, 2003
First Posted
January 24, 2003
Last Updated
June 24, 2005
Record last verified: 2005-04