New Clinical Trials Under Way

The following clinical trials are currently recruiting patients with melanoma for inclusion in several investigations. Each trial description includes the NLM Identifier to use as reference with Clinical Trials.gov.

1 Carboplatin, Paclitaxel, and Bevacizumab with or without Everolimus in Patients with Metastatic Malignant Melanoma

The objective of this phase 2 trial is to determine whether the addition of everolimus to combination therapy with carboplatin, pac­litaxel, and bevacizumab offers
sufficient promise of an impact on progression-free survival in patients with metastatic malignant melanoma so that further testing will be recommended. Tumor response rate, overall survival time, and safety profile are among other objectives that will be studied.

Patients who are aged ?18 years with histologically confirmed stage IV disease may be eligible to participate if additional criteria are met. The study will be conducted at 310 sites in the United States. For more information, contact Study Chair­man Robert McWilliams, MD, at 507-538-7623. The NLM Identifier is NCT00976573.

2 Comparing Com­bination of LGX818 plus MEK162 and LGX818 Monotherapy versus Vemurafenib in Patients with BRAF- Mutated Melanoma (COLUMBUS)

The purpose of this prospective, randomized, open-label, multicenter, parallel-group, phase 3 study is to compare the efficacy and safety of LGX818 plus MEK162 combination therapy and LGX818 monotherapy versus vemurafenib in patients with locally advanced unresectable or metastatic melanoma with a BRAF V600 mutation. Approximately 900 patients will be randomized 1:1:1 to 1 of the 3 treatment arms.

Patients aged ?18 years with American Joint Committee on Cancer stage IIIB, IIIC, or IV locally advanced, unresectable, or metastatic cutaneous melanoma and evidence of at least 1 measurable lesion as detected by radiograph or photograph may be eligible for inclusion
if several other criteria are met. Additional inclusion and exclusion criteria can be found at ClinicalTrials.gov using NLM Identifier NCT-01909453. The study will be conducted at 209 sites internationally and in the United States. For more information, contact Novartis Pharmaceuticals at 888-669-6682.

3 Utility of Novel BRAF Test for Melanoma

The objective of this observational study is to obtain blood samples from patients with stage II/III and unresectable stage IIIC/stage IV malignant melanoma. Tissue and/or blood samples will be compared and analyzed to help researchers better understand the BRAF V600 mutation, with the hope that this knowledge will further an understanding of melanoma and help plan future treatment options for patients at each stage of this disease. Approximately 220 patients will be separated into 2 groups, one for patients with stage IIIC/IV melanoma (Group 1), and another for patients with stage II/III disease (Group 2).

Depending on their assigned group, patients will have 1 blood draw or ongoing blood draws for 1 to 2 years; samples will be taken during regularly scheduled blood draws that are part of patients’ standard melanoma care. Patients aged ?18 years who are being treated at Massachusetts General Hospital, Dana-Farber Cancer Institute, or Beth Israel Deaconess Medical Center may be eligible to participate if certain other criteria are met. For more information, contact Ryan Sullivan, MD, at 617-643-3614 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM Identifier is NCT01840527.

4 A Multinational, Prospective, Observational Study in Patients with Unresectable or Metastatic Melanoma (IMAGE)

This study will examine the safety of ipilimumab and patterns of use in the treatment of unresectable or metastatic melanoma in the postapproval setting. Patients will be separated into 2 cohorts: The first cohort will comprise 1000 ipilimumab-treated patients who will be identified and followed prospectively, and the second cohort will comprise 800 non–ipilimumab-treated patients. Of the patients in the second cohort, 600 will be identified and followed prospectively, and 200 will be identified and followed retrospectively.

Patients aged ?18 years will be selected from approximately 200 US and international medical practice sites. To be eligible for inclusion, patients must have been diagnosed with unresectable or me­­tastatic melanoma, should have received at least 1 previous therapy for their diagnosis, and must meet additional inclusion and exclusion criteria. For more information, visit www.BMSStudyConnect.com. The NLM Identifier is NCT01511913.

5 Vorinostat for the Treatment of Patients with Metastatic Melanoma of the Eye

This phase 2 trial examines how well vorinostat works in treating patients with metastatic uveal melanoma who harbor a GNAQ or GNA11 mutation. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Overall objective response rate, overall survival, progression-free survival, and tolerability will be evaluated.

The study will be conducted at Memorial Sloan-Kettering Cancer Center in New York and is open to patients aged ?18 years with a confirmed diagnosis of metastatic uveal melanoma. An estimated 40 pa­tients will be enrolled. For more information and a full list of inclusion criteria, contact Richard D. Carvajal, MD, at 646-888-4161 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM Identifier is NCT01587352.

6 Evaluation of a New Anti­cancer Immunotherapy in Patients with Nonoperable and Progressing Metastatic Cutaneous Melanoma

This phase 1 study investigates the safety, immunogenicity, and clinical activity of GSK2241658A antigen-specific cancer immunotherapeutic, a biologic therapy for the treatment of patients with nonoperable and progressing metastatic cutaneous melanoma. Primary outcome measures include the occurrence of severe toxicities, as well as the induction of objective clinical response at various time points.

Patients who are aged ?18 years with histologically proven, measurable metastatic cutaneous melanoma, and who meet all inclusion and exclusion criteria may be eligible to participate. The study will enroll approximately 34 patients, and will take place in the United States, Australia, and several European countries. For more information, contact the US Glaxo-SmithKline Clinical Trials Call Center at 877-379-3718 or GSK This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM Identifier is NCT01213472.

7 Trial of Vemurafenib with or without Bevacizumab in Patients with BRAF V600 Mutation Melanoma

This phase 2 randomized, open-label study will help researchers determine the effectiveness of using vemurafenib and bevacizumab together compared with vemurafenib alone. Researchers will investigate whether using both drugs lengthens the amount of time before a patient’s melanoma progresses, increases the number of patients whose melanoma responds to treatment, and impacts the occurrence of side effects versus the use of each drug separately.

Eligible patients will be aged ?18 years and have metastatic or unresectable stage IIIC, clearly progressive melanoma with a BRAF V600E or BRAF V600K mutation; measurable disease; Eastern Cooperative Oncology Group performance status of 0, 1, or 2; and no more than 2 previous systemic treatment regimens for metastatic disease (certain previous therapies are permitted). The study will be conducted in Massachusetts and the District of Columbia. For more information, contact Michael B. Atkins, MD, at 617-632-9250 or F. Stephen Hodi, MD, at 617-632-5053. The NLM Identifier is NCT01495988.

8 Ipilimumab or High-Dose Interferon Alfa-2b for Patients with High-Risk Stage III-IV Melanoma that Has Been Removed by Surgery

The objective of this study is to evaluate recurrence-free survival among patients randomized to receive postoperative high-dose or low-dose ipilimumab versus those randomized to receive high-dose interferon alfa-2b. Patients aged ?18 years with recurrent melanoma or stage IIIB, IIIC, or IV disease that has been completely surgically resected may be eligible to participate if other criteria are met. Overall survival, safety, tolerability, and quality of life will also be studied.
The study will take place at 712 sites in the United States and 7 sites in Canada. For more information, contact Principal Investigator Ahmad A. Tarhini, MD, PhD, at 412-647-8073. The NLM Identifier is NCT01274338.

9 Ipilimumab with or without Dabrafenib, and/or Trametinib for Patients with Metastatic or Unresectable Melanoma

In this randomized phase 1 trial, investigators will evaluate the safety and tolerability of ipilimumab after lead-in BRAF and MEK inhibitors, alone or in combination, in patients with metastatic or unresectable melanoma with a BRAF V600 mutation. Treatment arms include ipilimumab with a 25-day lead-in of dabrafenib and trametinib, ipilimumab with a 25-day lead-in of trametinib alone, ipilimumab with a 25-day lead-in of da­-brafenib alone, and ipilimumab without a lead-in therapy. Response rates, as well as safety and tolerability, will also be studied.

Patients aged ?18 years with confirmed unresectable or metastatic malignant melanoma harboring a confirmed BRAF V600 mutation may be eligible to participate if other criteria are met. The study will be conducted in Boston, MA, at the Dana-Farber Cancer Institute and Brigham and Women’s Hospital. For more information, contact Principal Investigator Jason J. Luke, MD, at 617-632-4715 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM Identifier is NCT01940809.

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