Study of a Melanoma Vaccine in Stage IIb, IIc, and III Melanoma Patients
NCT01546571 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 504
Last updated 2025-10-24
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.
Conditions
Interventions
- BIOLOGICAL
-
POL-103A
POL-103A is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
- BIOLOGICAL
-
POL-103A without API
Placebo is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
Sponsors & Collaborators
-
Polynoma LLC
lead INDUSTRY
Principal Investigators
-
Craig Slingluff, M.D. · University of Virginia Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-05-01
- Primary Completion
- 2021-04-29
- Completion
- 2021-06-30
Countries
- United States
- Canada
Study Locations
More Related Trials
-
Monoclonal Antibody and Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma That Has Been Removed During Surgery
NCT00025181 ·Status: COMPLETED ·Phase: PHASE1
-
Study of gp75 Vaccine in Patients With Stage III and IV Melanoma
NCT00034554 ·Status: COMPLETED ·Phase: PHASE1
-
Vaccine Therapy for Patients With Stage III Melanoma
NCT00052130 ·Status: UNKNOWN ·Phase: PHASE3
-
Peptide Vaccination for Patients at High Risk for Recurrent Melanoma
NCT00059475 ·Status: COMPLETED ·Phase: PHASE2
-
Vaccine Therapy in Treating Patients With Stage IIC-IV Melanoma
NCT00085189 ·Status: COMPLETED ·Phase: PHASE2
-
Study of Vaccination With Poly-ICLC and Peptide-pulsed Dendritic Cells
NCT01783431 ·Status: TERMINATED ·Phase: PHASE1
-
Vaccine Therapy Followed by Biological Therapy in Treating Patients With Stage III or Stage IV Melanoma
NCT00006113 ·Status: TERMINATED ·Phase: PHASE2
-
Vaccine Therapy in Treating Patients With Melanoma
NCT00020358 ·Status: COMPLETED ·Phase: PHASE2
-
Sargramostim, Vaccine Therapy, or Sargramostim and Vaccine Therapy in Preventing Disease Recurrence in Patients With Melanoma That Has Been Removed By Surgery
NCT01989572 ·Status: COMPLETED ·Phase: PHASE3
-
QUILT-3.046: NANT Melanoma Vaccine: Combination Immunotherapy in Subjects With Melanoma Who Have Progressed On or After Chemotherapy and PD-1/PD-L1 Therapy
NCT03167177 ·Status: WITHDRAWN ·Phase: PHASE1/PHASE2
-
Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma
NCT00005841 ·Status: TERMINATED ·Phase: PHASE1
-
Vaccine Therapy in Treating Patients With Stage II Melanoma That Can Be Removed by Surgery
NCT00003274 ·Status: COMPLETED ·Phase: PHASE2
-
Vaccine Therapy in Treating Patients With Advanced Stage III-IV Melanoma
NCT01744171 ·Status: TERMINATED ·Phase: PHASE1
-
Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma
NCT00005633 ·Status: COMPLETED ·Phase: PHASE1
-
Monoclonal Antibody Therapy and Vaccine Therapy in Treating Patients With Resected Stage III or Stage IV Melanoma
NCT00084656 ·Status: COMPLETED ·Phase: PHASE2
-
Safety Study of a Helper Peptide Vaccine Plus Adjuvant Combinations for the Treatment of Melanoma
NCT02425306 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
Vaccine Therapy in Treating Patients With Recurrent Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery
NCT00471471 ·Status: COMPLETED ·Phase: PHASE1
-
Vaccine Therapy and Monoclonal Antibody Therapy in Treating Patients With Stage IV Melanoma
NCT00032045 ·Status: COMPLETED ·Phase: PHASE2
-
Vaccine Therapy in Treating Patients With Stage IIB, Stage IIC, Stage III, or Stage IV Melanoma
NCT00104845 ·Status: COMPLETED ·Phase: PHASE1
-
Vaccination of Melanoma Patients With Total or CD25-depleted Peripheral Blood Mononuclear Cell (PBMC)
NCT00961376 ·Status: TERMINATED ·Phase: PHASE2
-
Vaccine Therapy With or Without Recombinant Interleukin-12 Followed by Daclizumab in Treating Patients With Metastatic Melanoma
NCT01307618 ·Status: TERMINATED ·Phase: PHASE2
-
A Phase II/III Trial of Nivolumab, Ipilimumab, and GM-CSF in Patients With Advanced Melanoma
NCT02339571 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2/PHASE3
-
Safety and Immunogenicity of a Melan-A VLP Vaccine in Advanced Stage Melanoma Patients
NCT00306514 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Monoclonal Antibody Therapy in Treating Patients With Stage III or Stage IV Melanoma
NCT00004184 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Vaccine Therapy in Treating HLA-A2 Positive Patients With Melanoma
NCT00003895 ·Status: COMPLETED ·Phase: PHASE2