Select Clinical Trials Currently Enrolling Patients with Melanoma

June 2017, Vol 7, No 6 - Clinical Trials Tracker


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

1 Immune Checkpoint Inhibitors Alone or in Combination with Dorgenmeltucel-L for Stage IV Melanoma

The objective of this randomized, open-label, single-group assignment, phase 2 clinical trial is to examine the 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. Men and women aged ≥18 years with an Eastern Cooperative Oncology Group (ECOG) performance status score of ≤1 and with serum albumin ≥3.0 g/dL may be eligible for enrollment if other criteria are met. Patients will 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 the clinical response rate. The secondary outcome measures include clinical activity, antitumor immune response, immune activation, and antitumor mechanism. This study plans to enroll 100 patients in Illinois, Iowa, North Carolina, and Tennessee. For more information, contact NewLink Genetics at 515-296-5555. The NLM Identifier is NCT02054520.

2 PDR001 plus Dabrafenib and Trametinib in Advanced Melanoma

This randomized, parallel-assignment, double-blind, placebo-controlled, phase 3 clinical trial evaluates the safety and efficacy of the combination of an anti–PD-1 antibody (PDR001), a BRAF inhibitor (dabrafenib), and a MEK inhibitor (trametinib) in unresectable or metastatic BRAF V600 mutation–positive melanoma. Men and women aged ≥18 years with an ECOG performance status score of ≤1 may be eligible for enrollment if other criteria are met. This is a 3-part study: part 1 will include a safety cohort, part 2 will include a biomarker cohort, and part 3 will include a randomized patient cohort. In part 3, eligible patients will receive PDR001 plus dabrafenib and trametinib or placebo plus dabrafenib and trametinib.

The primary outcome measures are the incidence of dose-limiting toxicities, immune microenvironment and biomarker modulation, and PFS. The secondary outcome measures are OS, overall response rate, duration of response, disease control rate, global health status, quality of life, PFS by PD-L1 expression, and OS by PD-L1 expression. This study plans to enroll 538 patients at multiple locations abroad. For more information, contact Novartis Pharmaceuticals at 888-669-6682 or trialandresults.registries@novartis.com. The NLM Identifier is NCT02967692.

3 Nivolumab plus Ipilimumab versus Nivolumab Monotherapy for Stage IV Melanoma with No Evidence of Disease

This randomized, crossover-assignment, double-blind, phase 2 clinical trial is assessing the efficacy and safety of adjuvant immunotherapy with nivolumab plus ipilimumab or nivolumab monotherapy as a postsurgical or postradiation treatment for patients with stage IV melanoma with no evidence of disease. Men and women aged ≥18 years with stage IV melanoma, an ECOG performance status score of 0 or 1, and a known BRAF mutation status may be eligible for enrollment if other criteria are met. The participants will receive nivolumab plus placebo, nivolumab plus ipilimumab, or double placebo control.

The primary outcome measure is PFS. The secondary outcome measure is OS, and another outcome measure is safety. This study expects to enroll 312 patients at multiple locations in Germany. For more information, contact Dirk Schadendorf at Dirk.Schadendorf@uk-essen.de, or Jürgen C. Becker at j.becker@dkfz-heidelberg.de. The NLM Identifier is NCT02523313.

4 Glembatumumab Vedotin as Monotherapy or in Combination with Immunotherapies in Patients with Advanced Melanoma

This nonrandomized, single-group assignment, phase 2 clinical trial examines the effectiveness and safety of glembatumumab vedotin as monotherapy or in combination with immunotherapies in patients with advanced melanoma. Men and women aged ≥18 years with unresectable, histologically confirmed advanced-stage melanoma and with no more than 1 previous chemotherapy-containing regimen for advanced disease may be eligible for enrollment if other criteria are met. Eligible patients will receive glembatumumab vedotin, glembatumumab vedotin and varlimumab, or glembatumumab vedotin plus nivolumab or pembrolizumab.

The primary outcome measure is objective response rate. The secondary outcome measures are duration of response, PFS, OS, the correlation of activity to gpNMP expression, and adverse events. This study plans to enroll 120 patients across the United States. For more information, contact Celldex Therapeutics at info@celldex.com. The NLM Identifier is NCT02302339.

5 Dendritic-Cell Vaccine plus Dasatinib for Metastatic Melanoma

This randomized, parallel-assignment, open-label, phase 2 clinical trial will assess the safety and immune effects of dasatinib given in combination with an autologous type-1 polarized dendritic-cell vaccine. Men and women aged ≥18 years with an ECOG performance status score of <2 who did not previously receive dasatinib may be eligible for enrollment if other criteria are met. Patients will start the dendritic-cell vaccine on cycle 1, day 1 and dasatinib on cycle 2, day 1, or patients will start the dendritic-cell vaccine on cycle 1, day 1 and dasat­inib on cycle 1, day 1.

The primary outcome measure is an increase in the CD8+ T-cell response from the addition of dasatinib. The secondary outcome measures include the number of participants with adverse events, tumor response, the number of CD8+ T-cell–infiltrating melanoma lesions, the number of suppressor-cell populations and blood vessels in melanoma tumor biopsies, the number of suppressor-cell populations in patients’ peripheral blood, the level of EphA2 protein expression in tumor biopsies, and the serum concentration of the T-cell–recruiting chemokine CXCL10/IP-10. This study expects to enroll 28 patients at the Hillman Cancer Center in Pittsburgh, PA. For more information, contact Ahmad Tarhini, MD, at 412-647-6370 or tarhiniaa@upmc.edu, or Carrie Muniz, RN, BSN, at 412-623-6121 or munizca@upmc.edu. The NLM Identifier is NCT01876212.

6 Cellular Adoptive Immunotherapy Using Autologous CD8+ Antigen-Specific T-Cells and Anti-CTLA4 for Metastatic Melanoma

The purpose of this single-group assignment, open-label, phase 2 clinical trial is to assess the safety and efficacy of administering CD8+ T-cells with ipilimumab, cyclophosphamide, and interleukin (IL-2; aldesleukin) in patients with metastatic melanoma. Men and women aged ≥18 years with histopathologic documentation of melanoma concurrent with the diagnosis of metastatic disease and with an ECOG performance status score of 0 to 2 may be eligible for enrollment if other criteria are met. Eligible patients will receive CD8+ T-cells, cyclophosphamide, IL-2, and ipilimumab.

The primary outcome measure is overall response. This study plans to enroll 30 patients at the University of Texas M.D. Anderson Cancer Center. For more information, contact Adi Diab, MD, at 713-792-2921. The NLM Identifier is NCT02027935.

7 Sequential Approach with Ipilimumab and Nivolu­mab and Combination Target Therapy in Patients with BRAF Mutation–Positive Metastatic Melanoma

The purpose of this randomized, parallel-assignment, phase 2 clinical trial is to evaluate the best sequencing approach with the combination of target agents (LGX818 plus MEK162) and the combination of immunomodulatory antibodies (ipilimumab plus nivolumab) in patients with BRAF V600 mutation–positive metastatic melanoma. Men and women aged ≥18 years with histologically confirmed BRAF mutation–positive stage III or IV melanoma and with an ECOG performance status score of 0 or 1 may be eligible for enrollment if other criteria are met. Patients will be randomized to receive LGX818 plus MEK162 until disease progression, followed by ipilimumab every 3 weeks and nivolumab every 2 weeks; nivolumab plus ipilimumab every 3 weeks and then nivolumab every 2 weeks until disease progression, followed by LGX818 plus MEK162 until disease progression; or LGX818 450 mg plus MEK162 for 8 weeks, followed by nivolumab plus ipilimumab every 3 weeks, and then nivolumab every 2 weeks until disease progression, followed by LGX818 plus MEK162 until disease progression.

The primary outcome measure is OS. The secondary outcome measures include total PFS, the percentage of patients who are alive at 2 and 3 years, best overall response rate, duration of response, toxicity, quality of life and general health, and the 3-year PFS rate. This study plans to enroll 230 patients at multiple locations abroad. For more information, contact Marcello Curvietto, MD, at curvietto.ma@gmail.com, or Elena Abrami at elena.abrami@cr-technology.com. The NLM Identifier is NCT02631447.