Clinical Trials Actively Recruiting Patients With Melanoma


Get Permission

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.


Advertisement

Advertisement



Advertisement