Stage IV Skin Melanoma Clinical Trial
Official title:
Peptide Vaccine With Glucopyranosyl Lipid A - Stable Oil-in-Water Emulsion (GLA-SE) for Patients With Resected Melanoma: A Pilot Study
This randomized pilot clinical trial studies melanoma antigen recognized by T-cells 1 (MART-1) antigen with or without toll-like receptor 4 (TLR4) agonist glucopyranosyl lipid A-stable oil-in-water emulsion (GLA-SE) in treating patients with stage II-IV melanoma that has been removed by surgery. Vaccines made from MART-1a peptide or antigen may help the body build an effective immune response to kill tumor cells. Giving TLR4 agonist GLA-SE with MART-1 antigen may help increase the immune response to MART-1a antigen.
PRIMARY OBJECTIVES:
I. Evaluate the immune response of each immunization regimen to determine an optimal regimen
in terms of immune response to recommend for phase II testing.
SECONDARY OBJECTIVES:
I. Evaluate the adverse events profile of each immunization regimen.
TERTIARY OBJECTIVES:
I. Describe the immunological efficacy of the vaccine preparations as measured by the
frequency and interferon (IFN) gamma production of peptide-specific cytotoxic T lymphocytes
(CTL).
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive MART-1 antigen and TLR4 antagonist GLA-SE intramuscularly (IM) on day
1. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression
or unacceptable toxicity.
ARM II: Patients receive MART-1 antigen IM on day 1. Treatment repeats every 21 days for up
to 3 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, stage II patients are followed up at 10 weeks and then
at 6, 12, 18, and 24 months and stage III-IV patients are followed up at 3, 6, 9, 12, 15, 18,
21, and 24 months.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01886235 -
Intravital Microscopy for Identifying Tumor Vessels in Patients With Stage IA-IV Melanoma That is Being Removed by Surgery
|
N/A | |
Completed |
NCT01961115 -
Epacadostat and Vaccine Therapy in Treating Patients With Stage III-IV Melanoma
|
Phase 2 | |
Completed |
NCT02858869 -
Pembrolizumab and Stereotactic Radiosurgery for Melanoma or Non-Small Cell Lung Cancer Brain Metastases
|
Phase 1 | |
Completed |
NCT03229278 -
Trigriluzole With Nivolumab and Pembrolizumab in Treating Patients With Metastatic or Unresectable Solid Malignancies or Lymphoma
|
Phase 1 | |
Completed |
NCT01989559 -
Booster Vaccination in Preventing Disease Recurrence in Previously Vaccinated Patients With Melanoma That Has Been Removed By Surgery
|
Phase 1 | |
Withdrawn |
NCT02812693 -
Pembrolizumab and Imatinib in Patients With Locally Advanced/Metastatic Melanoma With c-KIT Mutation/Amplification
|
Phase 1/Phase 2 | |
Completed |
NCT00026221 -
Bevacizumab With or Without Interferon Alfa in Treating Patients With Metastatic Malignant Melanoma
|
Phase 2 | |
Active, not recruiting |
NCT02876068 -
Cediranib Maleate and Selumetinib in Treating Patients With Solid Malignancies
|
Phase 1 | |
Completed |
NCT01131234 -
Gamma-Secretase Inhibitor RO4929097 and Cediranib Maleate in Treating Patients With Advanced Solid Tumors
|
Phase 1 | |
Completed |
NCT00397982 -
Temsirolimus and Bevacizumab in Treating Patients With Stage III or Stage IV Malignant Melanoma
|
Phase 2 | |
Terminated |
NCT01744171 -
Vaccine Therapy in Treating Patients With Advanced Stage III-IV Melanoma
|
Phase 1 | |
Terminated |
NCT02748564 -
Aldesleukin and Pembrolizumab in Treating Patients With Stage III-IV Melanoma
|
Phase 2 | |
Completed |
NCT02941744 -
A Clinical Trial: Adjuvant Low-dose Ipilimumab + Nivolumab After Resection of Melanoma Macrometastases
|
Phase 1/Phase 2 | |
Terminated |
NCT01970527 -
Phase II Trial of Stereotactic Body Radiotherapy Followed by Ipilimumab in Treating Patients With Stage IV Melanoma
|
Phase 2 | |
Completed |
NCT01789827 -
Aldesleukin Imaging in Viewing Tumor Growth in Patients With Stage IV Melanoma Receiving Ipilimumab or Pembrolizumab Therapy
|
Early Phase 1 | |
Active, not recruiting |
NCT02654821 -
Study With T-cel Receptor Gene Therapy in Metastatic Melanoma
|
Phase 1/Phase 2 | |
Completed |
NCT01522820 -
Vaccine Therapy With or Without Sirolimus in Treating Patients With NY-ESO-1 Expressing Solid Tumors
|
Phase 1 | |
Completed |
NCT00866177 -
MEK Inhibitor AZD6244 in Treating Patients With Stage III or Stage IV Melanoma
|
Phase 2 | |
Active, not recruiting |
NCT03719131 -
Rituximab and Hyaluronidase Human in Patients With Advanced Melanoma Undergoing Nivolumab and Ipilimumab Therapy
|
Phase 2 | |
Completed |
NCT02716948 -
SRS and Nivolumab in Treating Patients With Newly Diagnosed Melanoma Metastases in the Brain or Spine
|
Phase 1 |