The information contained in this Clinical Trials Resource Guide includes actively recruiting clinical studies in melanoma. These studies focus on assessing response to checkpoint inhibitors; T-cell immunotherapy; combination therapies; adoptive cell therapy; combination therapy development; and more. All of the studies are listed on the National Institutes of Health website at ClinicalTrials.gov.
PHASE I
Study Title: Early Assessment of Response to Dual Checkpoint Inhibitor Therapy in Patients With Advanced Melanoma Using 18F-Fluorothymidine (FLT) Positron-Emission Tomography (PET)/Computed Tomography (CT) and PET/Magnetic Resonance
Study Type: Phase I
Study Sponsor and Collaborators: Washington University School of Medicine
Purpose: To utilize advanced PET/CT and PET/MR imaging methods to validate the hypothesis that melanoma patients receiving dual immune checkpoint blockade therapy who ultimately achieve clinical benefit will have an increase, or “flare,” in tumor FLT and/or fludeoxyglucose (FDG) uptake from baseline, as seen after one cycle of treatment, and that after two cycles of treatment, responders will have a decline in FLT and FDG uptake, in comparison to the patients classified as nonresponders
Primary Outcome Measures: Mean difference in FLT uptake between responders and nonresponders [time frame: baseline and week 3]; mean difference in FLT uptake between responders and nonresponders [time frame: baseline and week 6]
Principal Investigator: Richard L. Wahl, MD, Washington University School of Medicine; (314) 362-7100, rwahl@wustl.edu
ClinicalTrials.gov Identifier: NCT02891616
PHASE I/II
Study Title: A Phase I/II Trial of Dabrafenib, Trametinib, and Metformin Administered to Unresectable Stage IIIC and Stage IV BRAF V600E–Positive Melanoma Patients
Study Type: Phase I/II
Study Sponsor and Collaborators: James Graham Brown Cancer Center, University of Louisville
Purpose: To evaluate the clinical response, safety, and survival of dabrafenib and trametinib in combination with metformin in patients with stage IIIC and stage IV BRAF V600E mutation–positive melanoma
Primary Outcome Measures: Observation of two CTCAE drug-related grade 4 toxicities in six patients [time frame: duration of phase I portion, approximately 6 months]; clinical response rate [time frame: 6 years]
Principal Investigator: Jason A. Chesney, MD, PhD, James Graham Brown Cancer Center; contact Stacy Baum, BSN, (502) 562-2280, msbaum02@louisville.edu
ClinicalTrials.gov Identifier: NCT02143050
PHASE II
Study Title: A Prospective Randomized and Phase II Trial for Metastatic Melanoma Using Adoptive Cell Therapy With Tumor-Infiltrating Lymphocytes Plus Interleukin-2 Either Alone or Following the Administration of Pembrolizumab
Study Type: Phase II
Study Sponsor and Collaborators: NCI
Purpose: To evaluate whether adding pembrolizumab to cell therapy is safe and effective in the treatment of melanoma
Primary Outcome Measures: Response rates [time frame: 6 and 12 weeks after cell infusion, then every 3 months x3, then every 6 months x5 years, then at primary investigator’s discretion]
Principal Investigator: Steven A. Rosenberg, MD, NCI; contact Abigail R. Johnson, RN, (866) 820-4505, ncisbirc@mail.nih.gov
ClinicalTrials.gov Identifier: NCT02621021
Study Title: A Phase II Study Assessing the Effect of Pembrolizumab-Induced Changes to the NK Cell–Exhaustion Phenotype on the Efficacy of PD-1 Targeted Treatment in Patients With Unresectable Stage III or IV Melanoma
Study Type: Phase II
Study Sponsor and Collaborators: Icahn School of Medicine at Mount Sinai
Purpose: To better understand how NK cell function and exhaustion interplays with programmed cell death protein 1 (PD-1) function and activity and potentially develop more efficacious combination therapies
Primary Outcome Measures: Percent of LAMP-1–positive cells; percent of positive cell for interferon-gamma; percent of proliferating cells [time frame: up to 3 years]
Principal Investigator: Nina Bhardwaj, MD, PhD, Icahn School of Medicine; contact Simona Podgrabinska, PhD, (212) 824-8448, simona.podgrabinska@mssm.edu
ClinicalTrials.gov Identifier: NCT03241927
PHASE III
Study Title: A Randomized Phase III Trial of Dabrafenib + Trametinib Followed by Ipilimumab + Nivolumab at Progression vs Ipilimumab + Nivolumab Followed by Dabrafenib + Trametinib at Progression in Patients With Advanced BRAF V600–Mutant Melanoma
Study Type: Phase III
Study Sponsor and Collaborators: NCI
Purpose: To study how well initial treatment with ipilimumab and nivolumab followed by dabrafenib and trametinib works, and compare it with initial treatment with dabrafenib and trametinib followed by ipilimumab and nivolumab in treating patients with stage III–IV melanoma that contains a BRAF V600 mutation and cannot be removed by surgery
Primary Outcome Measures: Overall survival rate, defined as the proportion of patients alive after 2 years of follow-up [time frame: time from randomization to death from any cause, assessed for up to 2 years]
Principal Investigator: Michael B. Atkins, MD, ECOG-ACRIN Cancer Research Group; visit clinicaltrials.gov for all study locations
ClinicalTrials.gov Identifier: NCT02224781 ■
Editor’s Note: The clinical trials presented here do not represent all the trials listed on ClinicalTrials.gov. For the complete list, go to ClinicalTrials.gov.
