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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


Phase 3
18 Years
75 Years
Open (Enrolling)
Both
Melanoma

Thank you

Trial Information

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


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

- Diagnosis of non-cutaneous melanoma or melanoma with unknown primary origin

- Use of biologic response modifiers within 60 days of first dosing

- Subjects with history of other malignancy within past 5 years (with exceptions)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Recurrence Free Survival (RFS)

Outcome Time Frame:

362 events

Safety Issue:

Yes

Principal Investigator

Craig Slingluff, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Martha Jefferson Hospital, University of Virginia

Authority:

United States: Food and Drug Administration

Study ID:

103A-301

NCT ID:

NCT01546571

Start Date:

April 2012

Completion Date:

October 2018

Related Keywords:

  • Melanoma
  • Melanoma

Name

Location

University of Iowa Hospitals and ClinicsIowa City, Iowa  52242
Washington University School of MedicineSaint Louis, Missouri  63110
Mount Sinai School of MedicineNew York, New York  10029
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Central Baptist HospitalLexington, Kentucky  40503
City of HopeDuarte, California  91010
Mount Sinai Medical CenterMiami Beach, Florida  33140
Research Across AmericaCarrollton, Texas  75010
University of Arizona Cancer CenterTucson, Arizona  85724
Anschutz Cancer PavilionAurora, Colorado  
The Angeles Clinic and Research InstituteLos Angeles, California  90025
Investigative Clinical Research of IndianaIndianapolis, Indiana  46254
Wake Research AssociatesRaleigh, North Carolina  27612
St. Louis HospitalSt. Louis, Missouri  63110
Intermountain Medical CenterMurray, Utah  84157
Dallas Surgical GroupDallas, Texas  75235
Norris Cotton Cancer Center / Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756
Clinical Research Associates of TidewaterNorfolk, Virginia  23507
John Theurer Cancer CenterHackensack, New Jersey  07601
MD Anderson Cancer Center-OrlandoOrlando, Florida  32806
Ameriderm ResearchJacksonville, Florida  32216
Northern California Melanoma Center/ St. Mary's Medical CenterSan Francisco, California  94117
The Melanoma Center at the Washington Cancer InstituteWashington, District of Columbia  20010
Oncology Specialists, SC (OSSC)Niles, Illinois  60714
Central Kentucky Research AssociatesLexington, Kentucky  40509
Center for Pharmaceutical ResearchKansas City, Missouri  64114
Wake Forest University School of Medicine, Comprehensive Cancer CenterWinston-Salem, North Carolina  27157
Kimmel Cancer Center at Thomas Jefferson Univ.Philadelphia, Pennsylvania  19107
The Huntsman Cancer Institute, University of UtahSalt Lake City, Utah  84112-5550
Arizona Clinical ResearchTucson, Arizona  85715
Pacific Dermatology InstituteTemecula, California  92592
University of Minnesota Masonic Cancer InstituteMinneapolis, Minnesota  55455
Mayo Clinic Cancer Center, Mayo Clinic RochesterRochester, Minnesota  55905
Cancer Center of NJNew Brunswick, New Jersey  08901
University of Virginia HospitalCharlottesville, Virginia  22908