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Select Ongoing Trials Currently Enrolling Patients with Melanoma

June 2016, Vol 6, No 6

The following clinical trials represent a selection of key clinical trials that are currently recruiting patients with melanoma for inclusion in investigations of new therapies and new regimens of available therapies for patients with melanoma. Each clinical trial description includes the NLM Identifier to be used as a reference with ClinicalTrials.gov. The information below can help oncology practice managers and providers direct their eligible patients to one of these clinical trials.

1 Pembrolizumab with/without Talimogene Laherparepvec in Unresected Melanoma

This randomized, open-label, multicenter, double-blind, parallel-assignment phase 3 clinical trial compares the safety and efficacy of pembrolizumab plus talimogene laherparepvec versus pembrolizumab plus placebo. Men and women aged 18 to 95 years with histologically confirmed stage IIIB to stage IVM1c melanoma for whom surgery is not recommended may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive pembrolizumab plus talim­ogene laherparepvec or pembroliz­umab plus placebo.

The primary outcome measures are progression-free survival (PFS) and overall survival (OS). This study plans to enroll 660 patients at multiple locations across the United States. For more information, contact the Amgen Call Center at 866-572-6436. The NLM Identifier is NCT02263508.

2 High-Dose Interferon Alfa-2b or Pembrolizumab in Patients with Stage III/IV High-Risk Melanoma That Was Removed by Surgery

This phase 3, randomized, parallel-assignment, double-blind clinical trial will assess the efficacy of high-dose recombinant interferon alfa-2b compared with pembrolizumab in patients with stage III to stage IV melanoma that has been removed by surgery but is likely to come back or to spread. Men and women aged ≥18 years with stage IIIA (N2a), IIIB, IIIC, or stage IV melanoma and with multiple regional nodal basin involvement may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive high-dose recombinant interferon alfa-2b or pembrolizumab.

The primary outcome measures are OS, PD ligand 1 (PD-L1) status, and relapse-free survival (RFS). Some of the secondary outcome measures include long-term survival, change in quality of life, and incidence of toxicity. This study expects to enroll 1378 patients at multiple locations across the United States and Canada. For more information, contact Kenneth Grossmann, MD, PhD, at 801-585-0206. The NLM Identifier is NCT02506153.

3 Ipilimumab or High-Dose Interferon Alfa-2b for High-Risk Stage III/IV Melanoma That Was Surgically Removed

This phase 3, randomized, open-label, parallel-assignment clinical trial is assessing the efficacy of ipilimu­mab versus high-dose interferon alfa-2b in treating patients with high-risk stage III to stage IV melanoma that has been surgically removed. Males and females (aged ≥12 years) with primary cutaneous melanoma, and patients with disease recurrence after adequate surgical excision of the original primary cutaneous or unknown primary melanoma may be eligible for enrollment if other criteria are met. Eligible patients aged 12 to 17 years will receive high-dose ipilimumab, recombinant interferon alfa-2b, or low-dose ipilimumab; patients aged ≥18 years will receive high-dose ipilimumab, recombinant interferon alfa-2b, or low-dose ipilimumab. The primary outcome measures are OS and RFS. The secondary outcome measures are change in global quality of life (assessed via the Functional Assessment of Cancer Therapy-General questionnaire), change in health-related domains of quality of life (assessed via symptom and functioning subscales), and incidence of toxicity.

This study plans to enroll 1545 patients at multiple locations across the United States and Canada. For more information, contact Ahmad Tarhini, MD, PhD, at 412-648-6575. The NLM Identifier is NCT01274338.

4 Dabrafenib plus Trametinib Followed by Ipilimumab plus Nivolumab or Ipilimumab plus Nivolumab Followed by Da­brafenib and Trametinib in Stage III/IV BRAF V600 Melanoma

This phase 3, randomized, crossover-assignment, open-label clinical trial will assess how well initial treatment with ipilimumab and nivolumab followed by dabrafenib and trametinib works compared with initial treatment with da­brafenib and trametinib followed by ipilimumab and nivolumab in patients with BRAF V600 stage III to stage IV melanoma that cannot be removed by surgery. Men and women aged ≥18 years with Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive dabrafenib and trametinib followed by ipilimumab and nivolumab or ipilimumab and nivolumab followed by dabrafenib and trametinib.

The primary outcome measure is OS. The secondary outcome measures include PFS, response rate, toxicity rate for categorized adverse events (AEs), toxicity rate for individual AEs, and toxicity rate for worst-degree AEs. This study plans to enroll 300 patients across multiple locations in the United States. For more information, contact Michael Atkins, MD, at 202-444-4971. The NLM Identifier is NCT02224781.

5 Nivolumab plus Ipilimumab Followed by Nivolumab Monotherapy as First-Line Treatment for Advanced Melanoma

The purpose of this nonrandomized, single-group assignment, open-label, phase 3 clinical trial is to determine the effects of combining nivolumab with ipilimumab followed by nivolumab monotherapy in patients with previously untreated advanced melanoma. Men and women aged ≥18 years with advanced melanoma that spread to other sites in the body and is unable to be removed by surgery may be eli­gible for enrollment if other criteria are met. Eligible patients will receive nivo­lumab plus ipilimumab followed by nivolumab monotherapy.

The primary outcome measures are the rate and frequency of high-grade, treatment-related selected AEs. Some of the secondary outcome measures include median time to the resolution of AEs, the resolution of an AE, the median time to onset of AEs, and the incidence of all high-grade, select AEs. This study expects to enroll 615 patients at multiple locations abroad. For more information, e-mail This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM Identifier is NCT02599402.

6 Adjuvant Vemurafenib Therapy in Patients with Resected Cutaneous Melanoma with BRAF Mutation

This phase 3, multicenter, randomized, parallel-assignment, double-blind clinical trial will evaluate the efficacy and safety of vemurafenib in patients with completely resected, cutaneous BRAF mutation–positive melanoma at high risk for recurrence. Men and women aged ≥18 years with histologically confirmed melanoma of cutaneous origin and with an ECOG performance status of 0 or 1 may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive oral doses of vemurafenib or matching placebo.

The primary outcome measure is disease-free survival. The secondary outcome measures include OS, distant metastases–free survival, safety, quality of life, and pharmacokinetics. This study expects to enroll 475 patients across multiple locations in the United States and abroad. For more information, contact Roche at 888-662-6728 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM Identifier is NCT01667419.

7 Ipilimumab versus Ipilimumab plus Nivolumab in Patients with Stage III/IV Melanoma That Progressed/Relapsed with PD-1 Inhibitor Therapy

The purpose of this phase 2, parallel-assignment, open-label clinical trial is to assess whether patients whose melanoma progresses after treatment with nivolumab or pembrolizumab respond to ipilimumab alone or in combination with nivolumab. Women and men aged ≥18 years with stage IV cutaneous melanoma or stage III cutaneous or acral melanoma that is judged inoperable, with a life expectancy greater than 3 months, and with an ECOG performance status of 0 or 1 may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive ipilimumab plus nivolumab or ipi­limumab monotherapy.

The primary outcome measure is objective response. This study plans to enroll 70 patients at Memorial Sloan Kettering Cancer Center in New York. For more information, contact Jedd Wolchok, MD, PhD, at 646-888-2315, or Michael Postow, MD, at 646-888-4589. The NLM Identifier is NCT02731729.

8 Trametinib for Advanced Unresectable or Distant Metastatic Cutaneous Melanoma with BRAF V600E/K Mutation

This nonrandomized, open-label, single-group assignment phase 3 clinical trial will assess the safety and efficacy of trametinib alone and in combination with dabrafenib in patients with stage III or stage IV BRAF V600E/K mutation–positive melanoma. Men and women aged ≥18 years who are able to swallow and retain oral medication and with an ECOG performance status of 0 to 2 may be eligible for enrollment if other criteria are met. Eligible patients will receive trametinib, and, where appropriate, in combination with dabrafenib.

The primary outcome measures are frequencies of AEs as a measure of safety, proportions of AEs as a measure of safety, the number of participants with serious AEs, and the response rates to treatment. This study plans to enroll 250 patients at multiple locations in France. For more information, contact the GSK Clinical Trials Call Center at 877-379-3718 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM Identifier is NCT02416232.

9 Vemurafenib and Cobimetinib in Patients with Advanced Melanoma and BRAF V600 Mutation

This phase 3, open-label, randomized, parallel-assignment clinical trial explores the immunologic effects of vemurafenib and cobimetinib, administered alone and in combination, in patients with advanced BRAF V600E/K mutation–positive melanoma. Men and women aged ≥18 years with a life expectancy of ≥12 weeks and with an ECOG performance status of ≤2 may be eligible for enrollment if other criteria are met. Eligible patients will begin vemurafenib monotherapy for 10 days and then add cobimetinib, or patients will begin cobimetinib monotherapy and then add vemurafenib.

The primary outcome measures are safety and tolerability. The secondary outcome measure is antitumor activity. This study expects to enroll 20 patients at the Sidney Kimmel Comprehensive Cancer Center in Baltimore, MD. For more information, contact Kim Palmer at 410-616-7660 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM Identifier is NCT02427893.

10 Nivolumab plus Ipilimu­mab for Previously Untreated Metastatic Uveal Melanoma

This phase 2 single-group assignment, open-label clinical trial will assess the safety and efficacy of nivolu­mab plus ipilimumab in patients with untreated metastatic uveal melanoma. Men and women aged 18 to 99 years with a histologic diagnosis of uveal melanoma and an ECOG performance status of 0 to 1 may be eligible for enrollment if other criteria are met. Eligible patients will receive nivolumab plus ipilimumab.

The primary outcome measure is OS at 12 months. The secondary outcome measures include OS at 24 months, PFS, global PFS, objective response rate, disease control rate proportion, and duration of response. This study plans to enroll 48 patients across multiple locations in Spain. For more information, contact Federico Nepote at This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM Identifier is NCT02626962.

11 Immune Checkpoint Inhibitors Alone and in Combination with Dorgenmeltucel-L in Patients with Stage IV Melanoma

The purpose of this phase 2, randomized, open-label, single-group assignment clinical trial is to examine effectiveness of immune checkpoint inhibitors (ipilimumab, nivolumab, or pembrolizumab) given alone or in combination with the experimental immunotherapy drug, dorgenmeltucel-L, for stage IV melanoma. Women and men aged ≥18 years with a histologically or cytologically confirmed diagnosis of stage IV metastatic, progressive, refractory melanoma, and with an ECOG performance status of ≤1 may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive dorgenmeltucel-L plus ipilimumab, ipilimumab alone, nivolumab alone, pembrolizumab alone, dorgenmeltucel-L plus nivolumab, or dorgenmeltucel-L plus pembrolizumab.

The primary outcome measures are safety and clinical response rate. The secondary outcome measures include clinical activity, antitumor response rate, immune activation, and antitumor mechanism. This study plans to enroll 100 patients across multiple locations in the United States, including Illinois, Iowa, North Carolina, and Tennessee. For more information, contact NewLink Genetics at 515-296-5555. The NLM Identifier is NCT02054520.

12 Sunitinib plus Nivolumab for KIT Mutation–Positive Advanced Melanoma

This phase 2, open-label, single-group assignment clinical trial is evaluating the safety and efficacy of sunitinib plus nivolumab in patients with advanced, measurable, KIT mutation–positive metastatic melanoma. Men and women aged ≥18 years with unresectable stage III or stage IV metastatic melanoma and with a Karnofsky performance status of >60% may be eligible for enrollment if other criteria are met. Eligible patients will receive a combination of sunitinib plus nivolumab.

The primary outcome measure is objective response. The secondary outcome measures include grade 3 to 5 AEs, change in peripheral blood lymphocytes, and PFS. This study plans to enroll 18 patients at the California Pacific Medical Center Research Institute. For more information, contact Madeline Decker at 415-600-3613 or This email address is being protected from spambots. You need JavaScript enabled to view it., or Laurel Brechtel at 415-600-1654 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM Identifier is NCT02400385.

13 Ipilimumab in Children and Adolescents with Unresectable Stage III/lV Malignant Melanoma

This single-group assignment, open-label, phase 3 clinical trial is examining the safety and efficacy of ipilimumab in children and adolescents with previously treated or untreated unresectable stage III or stage IV malignant melanoma. Patients aged 12 to 17 years with a Karnofsky performance status or Lansky score of ≥50 may be eligible for enrollment if other criteria are met. Eligible patients will receive ipilimumab once every 3 weeks for 4 doses, then every 12 weeks until disease progression or unacceptable toxicity.

The primary outcome measures are the OS rate at 1 year and severe immune-mediated AEs. The secondary outcome measures include the disease control rate, PFS, and best overall response rate. This study expects to enroll 30 patients at multiple locations in the United States and abroad. For more information, e-mail Bristol-Myers Squibb at This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM Identifier is NCT01696045.

14 Stereotactic Body Radiotherapy Followed by Ipi­limumab in Patients with Stage IV Melanoma

The purpose of this open-label, single-group assignment, phase 2 clinical trial is to assess how effective stereotactic body radiotherapy and ipilimumab are in patients with stage IV melanoma. Men and women aged ≥18 years with a histologically confirmed diagnosis of melanoma and an ECOG performance status of 0 to 2 may be eligible for enrollment if other criteria are met. Eligible patients will undergo stereotactic body radiotherapy followed by treatment with ipilimumab.

The primary outcome measures are immune-related clinical response, immune-related PFS, late toxicities, and OS. This study plans to enroll 40 patients at the Fred Hutch/University of Washington Cancer Consortium in Seattle. For more information, contact Ramesh Rengan at 206-598-4110 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM Identifier is NCT01970527.

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