Clinical Trials Actively Recruiting Patients With Melanoma

Study Type: Phase I pilot/interventional/parallel assignment

Study Title: A Pilot Study of Ipilimumab and Radiation in Poor Prognosis Melanoma

Study Sponsor and Collaborators: Duke University

Purpose: To assess the safety of the combination of ipilimumab administered concurrently with radiotherapy for patients with locally advanced or unresectable melanoma and patients at high risk for recurrence after resection

Primary Outcome Measures: Compare the off-line spectral analyses of saline and alcohol skin swabs of normal control, melanoma-negative and melanoma-positive skin biopsies [time frame: 1 day]

Principal Investigator: Nikolaus Gravenstein, MD, University of Florida; 352-494-4938, ngravenstein@anest.ufl.edu

ClinicalTrials.gov Identifier: NCT02393001

Study Title: A Phase I Trial of a Recombinant Human hsp110-gp100 Chaperone Complex Vaccine for Advanced Stage IIIB/C or IV Melanoma

Study Sponsor and Collaborators: Roswell Park Cancer Institute, National Cancer Institute (NCI)

Purpose: To study the side effects and best dose of vaccine therapy in treating patients with stage III-IV advanced melanoma

Primary Outcome Measures: Maximum tolerated dose of recombinant human hsp110-gp100 chaperone complex melanoma vaccine based on the probability of dose-limiting toxicity (DLT), graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4 [time frame: up to 30 days after the last vaccine dose]

Principal Investigator: John Kane, MD, FACS, Roswell Park Cancer Institute; 877-275-7724, ASKRPCI@roswellpark.org

ClinicalTrials.gov Identifier: NCT01744171

Study Title: A Phase I Trial With a Personalized Neoantigen Cancer Vaccine in Melanoma

Study Sponsor and Collaborators: Dana-Farber Cancer Institute

Purpose: To determine if it is possible to make and administer safely a vaccine against melanoma by using information gained from specific characteristics of the participant’s own melanoma

Primary Outcome Measures:

Number of participants experiencing clinical and laboratory adverse events [time frame: 7 weeks from first study drug administration]

Number of participants for whom sequencing and analysis leads to identification of at least 10 actionable peptides to initiate vaccine production [time frame: 12 weeks]

Principal Investigator: Patrick Ott, MD, PhD, Brigham and Women’s Hospital/Dana-Farber Cancer Institute; 617-582-5030, Patrick_Ott@dfci.harvard.edu

ClinicalTrials.gov Identifier: NCT01970358

Study Type: Phase I/II/interventional/single-group assignment

Study Title: A Phase I/II Trial to Evaluate the Safety, Immunogenicity, and Clinical Activity of a Helper Peptide Vaccine Plus CTLA-4 Blockade in Advanced Melanoma (Mel62; 6PAC)

Study Sponsor and Collaborators: Craig L. Slingluff Jr, MD, University of Virginia

Purpose: To evaluate whether it is safe to administer a peptide vaccine with ipilimumab, and to evaluate the effects of the combination of the peptide vaccine and ipilimumab on the immune system

Primary Outcome Measures: Safety (Adverse event profile) [time frame: 30 days after the last vaccination]

Principal Investigator: Elizabeth Gaughan, MD, University of Virginia; contact Emily Allred, PhD; 434-982-1902, eh4m@virginia.edu

ClinicalTrials.gov Identifier: NCT02385669

Study Title: A Phase I/II Trial of Vemurafenib and Metformin to Unresectable Stage IIIC and Stage IV BRAF V600E+ Melanoma Patients

Study Sponsor and Collaborators: James Graham Brown Cancer Center, University of Louisville

Purpose: To evaluate the safety of Vemurafenib in combination with Metformin in melanoma patients

Primary Outcome Measures: Observation of CTCAE grade 4 or higher adverse events in six patients [time frame: Duration of phase I portion, approximately 6 months]

Principal Investigator: Jason A. Chesney, MD, PhD, James Graham Brown Cancer Center-University of Louisville; 502-562-3429, jason.chesney@louisville.edu

ClinicalTrials.gov Identifier: NCT01638676

 Phase II

Study Type: Phase II/interventional/parallel assignment

Study Title: A Phase II, Open-Label, Multicenter, Randomized Study of CDX-1401, a Dendritic Cell Targeting NY-ESO-1 Vaccine, in Patients With Malignant Melanoma Pre-treated With Recombinant CDX-301, a Recombinant Human Flt3 Ligand

Study Sponsor and Collaborators: National Cancer Institute (NCI)

Purpose: To study how well DEC-205/NY-ESO-1 fusion protein CDX-1401 (CDX-1401) and neoantigen-based melanoma-poly-ICLC vaccine (poly-ICLC) vaccine therapy work when given with or without recombinant flt3 ligand (CDX-301) in treating patients with stage IIB-IV melanoma

Primary Outcome Measures: Immune T-cell response to NY-ESO-1 [time frame: Up to 12 weeks after final vaccination]

Principal Investigator: Nina Bhardwaj, MD, PhD, Cancer Immunotherapy Trials Network; contact desired location (multiple trial sites listed on cancer.gov)

ClinicalTrials.gov Identifier: NCT02129075

Study Title: A Pilot Study of the Administration of Young Tumor Infiltrating Lymphocytes Following a Non-Myelo­ablative Lymphocyte Depleting Chemotherapy Regimen in Metastatic Melanoma

Study Sponsor and Collaborators: National Cancer Institute (NCI), National Institutes of Health Clinical Center

Purpose: To study if chemotherapy and white blood cell therapy without aldesleukin is a safe and effective treatment for metastatic melanoma

Primary Outcome Measures: Determine whether objective responses can be mediated in patients with metastatic melanoma [time frame: Approximately 2 years]

Principal Investigator: Steven A. Rosenberg, MD, NCI; 301-496-4164, sar@mail.nih.gov

ClinicalTrials.gov Identifier: NCT01468818

 Phase III

Study Type: Phase III/interventional/parallel assignment

Study Title: A Phase III Randomized Study of Adjuvant Ipilimumab Anti-­CTLA4 Therapy Versus High-Dose Interferon a-2b for Resected High Risk Melanoma

Study Sponsor and Collaborators: National Cancer Institute (NCI)

Purpose: To study ipilimumab to see how well it works compared to high-dose interferon alfa-2b in treating patients with high-risk stage III-IV melanoma that has been removed by surgery

Primary Outcome Measures: Overall survival and recurrence-free survival [time frame: From randomization to the time of disease recurrence or death from any cause, assessed up to 20 years]

Principal Investigator: Ahmad Tarhini, MD, PhD, ECOG-ARIN Cancer Research Group; contact desired location (multiple trial sites listed on cancer.gov)

ClinicalTrials.gov Identifier: NCT01274338  ■