Clinical trial NCT01546571: Study of a Melanoma Vaccine in Stage IIb, IIc, and III Melanoma Patients
Official title: A Multicenter, Double-blind, Placebo-controlled, Adaptive Phase 3 Trial of POL-103A Polyvalent Melanoma Vaccine in Post-resection Melanoma Patients With a High Risk of Recurrence
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Melanoma
Lead sponsor: Polynoma LLC
Sponsor class: INDUSTRY
First posted: 2012-03-07
Enrollment: 504
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine how safe and how well POL-103A works in preventing the relapse of melanoma after patients who have undergone surgery.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed Stage IIb, IIc, III melanoma
* Surgical resection within 90 days of first dosing
* Persons with positive sentinel nodes must have a complete lymphadenectomy
* ECOG performance status 0 or 1

Exclusion Criteria:

* Any prior melanoma treatment other than surgery or regional irradiation
* Use of biologic response modifiers within 60 days of first dosing
* Subjects with history of other malignancy within past 5 years (with exceptions)

Primary outcomes:
measure: Recurrence Free Survival (RFS)
timeFrame: 436 events or approximately 4 years
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: 432 events or approximately 10 years
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Ironwood Cancer and Research Centers
state: Arizona
city: Tucson
country: United States
facility: University of Arizona Cancer Center
state: Arizona
city: Fayetteville
country: United States
facility: Highlands Oncology Group
state: Arkansas
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
city: Beverly Hills
country: United States
facility: Beverly Hills Cancer Center
state: California
city: Duarte
country: United States
facility: City of Hope National Medical Center
state: California
city: Los Angeles
country: United States
facility: The Angeles Clinic and Research Institute
state: California
city: Los Angeles
country: United States
facility: UCLA Hematology & Oncology Clinic
state: California
city: Oxnard
country: United States
facility: Ventura County Hematology Oncology Specialists
state: California
city: Sacramento
country: United States
facility: Sutter Cancer Center
state: California
city: San Francisco
country: United States
facility: St. Mary's Hospital & Medical Center Department of Pathology
state: California
city: Aurora
country: United States
facility: Anschutz Cancer Pavilion
state: Colorado
city: Washington
country: United States
facility: The Melanoma Center at the Washington Cancer Institute
state: District of Columbia
city: Jacksonville
country: United States
facility: GenesisCare USA of Florida
state: Florida
city: Jacksonville
country: United States
facility: Cancer Specialists of North Florida
state: Florida
city: Miami Beach
country: United States
facility: Mount Sinai Medical Center
state: Florida
city: Orlando
country: United States
facility: MD Anderson Cancer Center-Orlando
state: Florida
city: Ormond Beach
country: United States
facility: Ameriderm Research
state: Florida
city: Niles
country: United States
facility: Advocate Medical Group
state: Illinois
city: Springfield
country: United States
facility: Southern Illinois University School of Medicine
state: Illinois
city: Indianapolis
country: United States
facility: Investigative Clinical Research of Indiana
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Lexington
country: United States
facility: Baptist Health Lexington
state: Kentucky
city: Lexington
country: United States
facility: Central Kentucky Research Associates
state: Kentucky
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Baltimore
country: United States
facility: Harry & Jeanette Weinberg Cancer Institute @ Franklin Square
state: Maryland
city: Southfield
country: United States
facility: Ascension Providence Hospital
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota Masonic Cancer Institute
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic Cancer Center, Mayo Clinic Rochester
state: Minnesota
city: Kansas City
country: United States
facility: Center for Pharmaceutical Research
state: Missouri
city: Saint Joseph
country: United States
facility: MediSearch Clinical Trials
state: Missouri
city: Saint Louis
country: United States
facility: St. Louis University Hospital
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Lebanon
country: United States
facility: Norris Cotton Cancer Center / Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Hackensack
country: United States
facility: John Theurer Cancer Center/ Hackensack Medical Center
state: New Jersey
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of NJ
state: New Jersey
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: Greenville
country: United States
facility: East Carolina University
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University School of Medicine, Comprehensive Cancer Center
state: North Carolina
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Dayton
country: United States
facility: Premier Health Partners Clinical Trials Research Alliance
state: Ohio
city: Independence
country: United States
facility: Independence Family Health Center (Cleveland Clinic)
state: Ohio
city: Mayfield Heights
country: United States
facility: Hillcrest Hospital (Cleveland Clinic)
state: Ohio
city: Bend
country: United States
facility: Bend Memorial Clinic
state: Oregon
city: Portland
country: United States
facility: Providence Portland Medical Center
state: Oregon
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Philadelphia
country: United States
facility: Thomas Jefferson Medical Oncology
state: Pennsylvania
city: West Reading
country: United States
facility: McGlinn Cancer Institute, Reading Hospital
state: Pennsylvania
city: Germantown
country: United States
facility: The West Clinic P.C. d/b/a West Cancer Center
state: Tennessee
city: Knoxville
country: United States
facility: University of Tennessee Medical Center
state: Tennessee
city: Dallas
country: United States
facility: Cancer Solutions
state: Texas
city: Dallas
country: United States
facility: Baylor Research Institute
state: Texas
city: Houston
country: United States
facility: Center for Clinical Studies
state: Texas
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: Salt Lake City
country: United States
facility: The Huntsman Cancer Institute, University of Utah Health Care
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia Hospital
state: Virginia
city: Fairfax
country: United States
facility: Inova Schar Cancer Center
state: Virginia
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Tacoma
country: United States
facility: Multicare Institute for Research & Innovation
state: Washington
city: Victoria
country: Canada
facility: BCCA Vancouver Island Cancer Centre
state: British Columbia
city: Oshawa
country: Canada
facility: Durham Regional Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Hospital, Department of Medical Oncology
state: Ontario
city: Greenfield Park
country: Canada
facility: CISSS de la Montérégie - Centre
state: Quebec
city: Montreal
country: Canada
facility: Royal Victoria Hospital
state: Quebec
city: Quebec
country: Canada
facility: CHU de Quebec-L'Hotel-Dieu de Quebec
Study officials:
affiliation: University of Virginia Hospital
name: Craig Slingluff, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Slingluff CL, Lewis KD, Andtbacka R, Hyngstrom J, Milhem M, Markovic SN, Bowles T, Hamid O, Hernandez-Aya L, Claveau J, Jang S, Philips P, Holtan SG, Shaheen MF, Curti B, Schmidt W, Butler MO, Paramo J, Lutzky J, Padmanabhan A, Thomas S, Milton D, Pecora A, Sato T, Hsueh E, Badarinath S, Keech J, Kalmadi S, Kumar P, Weber R, Levine E, Berger A, Bar A, Beck JT, Travers JB, Mihalcioiu C, Gastman B, Beitsch P, Rapisuwon S, Glaspy J, McCarron EC, Gupta V, Behl D, Blumenstein B, Peterkin JJ. Multicenter, double-blind, placebo-controlled trial of seviprotimut-L polyvalent melanoma vaccine in patients with post-resection melanoma at high risk of recurrence. J Immunother Cancer. 2021 Oct;9(10):e003272. doi: 10.1136/jitc-2021-003272.