Adult Clinical Trials

Melanoma and other skin cancers

If you need additional information about any of the trials listed or would like to inquire about other open trials, please contact Melanoma Clinical Trials Office at 919.684.8239.

11 trials identified.

Proleukin Observational Registry to Evaluate the Treatment Patterns and Clincal Response in Malignancy
Phase: N/A
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: Michael Morse
Contact: Melanoma Clinical Trials Research Office
Phone: 919.613.0400
Reference Number: 00032008

AN OPEN-LABEL, MULTICENTER, DOSE-ESCALATION, PHASE 1B/2 STUDY OF THE SAFETY, EFFICACY, PHARMACODYNAMICS, AND PHARMACOKINETICS OF RTA 408 IN COMBINATION WITH IPILIMUMAB OR NIVOLUMAB IN THE TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA
Phase: Phase I
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: April Salama
Contact: Melanoma Clinical Trials Research Office
Phone: 919.613.0400
Purpose: Malignant melanoma is a leading cause of death from cutaneous malignancies, accounting for approximately three-fourths of all skin cancer deaths. For metastatic or unresectable melanomas, standard treatment options include immune checkpoint inhibitors (e.g., ipilimumab and nivolumab) and other therapies, however, approved therapies are rarely curative. It is now well accepted that tumors are able to evade detection and eradication by the immune system, even though many tumor types, particularly melanoma, are capable of eliciting a strong immune response (Swann, 2007). Substantial mechanistic work in recent years has revealed the key role of myeloid-derived suppressor cells (MDSCs) in masking cancer cells from the immune system, promoting both tumor progression and resistance to cancer immunotherapy. The immune-suppressive effect of MDSCs is dependent on the production of reactive oxygen species (ROS) and reactive nitrogen species (RNS). High levels of these reactive molecules and their by-products, such as nitrotyrosine, have been correlated with poor clinical outcomes in melanoma. Currently available melanoma therapies do not target MDSCs. In animals, RTA 408 significantly reduces tumor nitrotyrosine burden, inhibits the activity of MDSCs, and augments T-cell anticancer activity at relevant doses. Thus, through inhibition of MDSC activity and suppression of tumor ROS/RNS, RTA 408 may work in combination with T-cell-activating therapeutics such as ipilimumab to enhance the natural immune anticancer response. RTA 408 also has direct anticancer effects via inhibition of NF-kappa B. Chronic activation of NF-kappa B is associated with tumor progression, metastasis, and resistance to therapy. This proposed study is designed to assess the safety, efficacy, pharmacodynamics, and pharmacokinetics of omaveloxolone (RTA 408) in combination with ipilimumab or nivolumab in patients with unresectable or metastatic melanoma. In this open-label, multicenter, dose-escalation, Phase 1b/2 study, patients who qualify will receive omaveloxolone (RTA 408) at the assigned dose level in combination with ipilimumab or nivolumab. Patients will receive omaveloxolone (RTA 408) orally once daily for 1 week prior to initiation of ipilimumab or nivolumab. For patients treated with ipilimumab , the run-in period will be followed by omaveloxolone (RTA 408) orally once daily in combination with ipilimumab administered at Weeks 1, 4, 7, and 10. After Week 10, patients will receive maintenance treatment with omaveloxolone (RTA 408) alone once daily. For patients treated with nivolumab, the run-in period will be followed by omaveloxolone (RTA 408) orally once daily in combination with nivolumab administered approximately every two weeks as clinically indicated. Each patient will continue at the assigned omaveloxolone (RTA 408) dose level until disease progression occurs, toxicity requiring discontinuation from study drug (i.e., RTA 408) is experienced, the patient has completed approximately 72 weeks of treatment, the patient is discontinued from the study drug for another reason, or the patient withdraws consent. Patients will return 4 weeks after omaveloxolone (RTA 408) treatment completion for a follow-up visit. The starting omaveloxolone (RTA 408) dose level for the first dose-escalation cohort in this study has been selected based on available safety and pharmacodynamic data from a Phase 1 study of RTA 408 (NCT02029729). Subsequent cohorts will be enrolled at dose levels based on available safety and PD data from this study, but they will not be greater than 2-fold above the prior dose level. Phase 1b (dose-escalation): In the phase 1b/2 portion of this study, 12 patients will be enrolled in each dose cohort, with six patients administered omaveloxolone (RTA 408) plus ipilimumab and the remaining six administered rTA 408 plus nivolumab. Subsequent cohorts will assess escalating the doses of omaveloxolone (RTA 408) administered in combination with ipilimumab or nivolumab. Dose escalation decisions will be based on ongoing review of all available safety information for enrolled patients. Phase 2: The Phase 2 portion of the study may include separate expansion cohorts consisting of patients treated with either of the combination therapies. Each expansion cohort will include an additional 24 patients enrolled at the selected Phase 2 dose level to achieve a total of 30 patients at that omaveloxolone (RTA 408) dose in combination with ipilimumab or nivolumab.
Reference Number: 00059068
View this trial at ClinicalTrials.gov

A Multi-Center Phase 2 Open-Label Study to Evaluate Safety and Efficacy in Subjects with Melanoma Metastatic to the Brain treated with Nivolumab in Combination with Ipilimumab followed by Nivolumab Monotherapy
Phase: Phase II
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: April Salama
Contact: Melanoma Clinical Trials Research Office
Phone: 919.613.0400
Purpose: This is an open-label, multi-site Phase 2 study of Nivolumab combined with Ipilimumab followed by Nivolumab monotherapy for the treatment of subjects with Melanoma metastatic to the brain. Patients with histologically confirmed Malignant melanoma and asymptomatic brain metastases are eligible for the study.
Reference Number: 00059334
View this trial at ClinicalTrials.gov

Understanding Immunotherapy Resistance Mechanisms in Advanced Melanoma
Phase: N/A
Sponsor: Internal Investigator Initiated Non-therapeutic/Non-interventional
Principal Investigator: Brent Hanks
Contact: Melanoma Clinical Trials Research Office
Phone: 919.613.0400
Reference Number: 00059349

A Phase II Study of Glembatumumab Vedotin, an Anti-gpNMB Antibody -Drug Conjugate, as Monotherapy or in Combination with Varlilumab in Patients with Advanced Melanoma
Phase: Phase II
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: April Salama
Contact: Melanoma Clinical Trials Research Office
Phone: 919.613.0400
Purpose: This study will examine the effectiveness and safety of glembatumumab vedotin as monotherapy or in combination with immunotherapies in patients with advanced melanoma.
Reference Number: 00065547
View this trial at ClinicalTrials.gov

A Phase Ib/II Open-label, Multi-center Study of the Safety and Efficacy of IMCgp100 in Combination with Durvalumab (MEDI4736) or Tremelimumab or the Combination of Durvalumab and Tremelimumab Compared to IMCgp100 Alone in Patients with Advanced Melanoma
Phase: Phase I
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: April Salama
Contact: Melanoma Clinical Trials Research Office
Phone: 919 .613.0400
Purpose: This study is a Phase Ib/II, multi-center, open-label study of IMCgp100 as a single agent and in combination with durvalumab (MEDI4736) and/or tremelimumab in metastatic cutaneous melanoma. The purpose of this study is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and anti-tumor activity of IMCgp100 in combination with durvalumab (MEDI4736, programmed death-ligand 1 [PD-L1] inhibitor), tremelimumab (CLTA-4 inhibitor), and the combination of durvalumab with tremelimumab compared to single-agent IMCgp100 alone. The study will enroll patients who have metastatic melanoma that is refractory to treatment with an anti-PD-1 inhibitor as well as patients naive to therapy in the metastatic setting. Recent biologic evidence indicates that optimal responses to programmed cell death-1 (PD-1) directed therapy require the presence of CD8+ T cells in the tumor microenvironment and thus therapies such as IMCgp100 that recruit these effector cells to the tumor may overcome pre-existing resistance to checkpoint blockade. This emerging biology of checkpoint inhibitor resistance suggests the combination of IMCgp100 with checkpoint inhibition may have enhanced activity in patients with pre-existing resistance.
Reference Number: 00067271
View this trial at ClinicalTrials.gov

A prospective, randomized, blinded, placebo-controlled, phase IIb trial of an autologous tumor lysate (TL) + yeast cell wall particles (YCWP) + dendritic cells (DC) vaccine vs unloaded YCWP + DC in stage III and stage IV (resected) melanoma to prevent recurrence
Phase: Phase II
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: John Stewart
Contact: Melanoma Clinical Trials Research Office
Phone: 919.613.0400
Purpose: The majority of melanoma vaccines tested to date have been antigen-specific vaccines targeting melanoma-specific or associated antigens and utilizing a variety of delivery systems and immune-adjuvants. As opposed to testing an off the shelf vaccine that might be able to treat a subset of patients, our approach has been personalized to the patient and applicable to all patients. Our vaccine approach consists of harnessing the most potent antigen presenting cell in the body - the dendritic cell (DC) - together with the full repertoire of tumor antigens from an individual's cancer. We have conducted phase I and II studies using an autologous DC-tumor cell fusion technique that has now been simplified into a DC-tumor cell lysate vaccine. The autologous tumor lysate (TL) is loaded into yeast cell wall particles (YCWP) that are naturally and efficiently taken up into the patient's DC. These autologous tumor lysate, particle-loaded, DC (TLPLDC) are injected intradermally (ID) monthly x 3 followed by boosters at 6, 12, and 18 months.
Reference Number: 00068598
View this trial at ClinicalTrials.gov

A US Multi-Site Observational Study in Patients with Unresectable and Metastatic Melanoma: The OPTIMIzE Study
Phase: N/A
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: April Salama
Contact: MELANOMA ONCOLOGY CLINICAL TRIALS OFFICE
Phone: 919.613.0400
Reference Number: 00068641

A Randomized, Controlled, Phase 3 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Melphalan/HDS Treatment in Patients with Hepatic-Dominant Ocular Melanoma
Phase: Phase III
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: Dan Blazer
Contact: Melanoma Clinical Trials Research Office
Phone: 919.613.0400
Purpose: This study will evaluate two groups of patients who have melanoma that has spread from the eye to the liver: one group (50%) will get high-dose chemotherapy delivered specifically to the liver, while the other group (50%) will get one of 4 standard best alternative care treatments. Patients in each group will get repeating cycles of treatment until the cancer in the liver advances and will be followed until death. This study will evaluate the effect of the treatments on how long patients live and how long it takes for the cancer to advance or respond to the treatment.
Reference Number: 00069107
View this trial at ClinicalTrials.gov

A Phase II Study of MK-3475 in Patients with Advanced Merkel Cell Carcinoma (MCC)
Phase: Phase II
Sponsor: Cooperative Group Initiated
Principal Investigator: Brent Hanks
Contact: Melanoma Clinical Trials Research Office
Phone: 919.613.0400
Purpose: This phase II trial studies how well pembrolizumab works in treating patients with Merkel cell cancer that cannot be removed by surgery or controlled with treatment, or has spread to other parts of the body. Pembrolizumab may stimulate the immune system to identify and destroy cancer cells.
Reference Number: 00071314
View this trial at ClinicalTrials.gov

SWOG S1404: A Phase III Randomized Trial Comparing Physician/Patient Choice of Either High Dose Interferon or Ipilimumab to MK-3475 (Pembrolizumab) in Patients with High Risk Resected Melanoma
Phase: Phase III
Sponsor: Cooperative Group Initiated
Principal Investigator: Jeffrey Crawford
Contact: Melanoma Clinical Trials Research Office
Phone: 919.613.0400
Purpose: This randomized phase III trial studies how well high-dose recombinant interferon alfa-2B or ipilimumab works compared with pembrolizumab in treating patients with stage III-IV melanoma that has been removed by surgery but is likely to come back or spread. High-dose recombinant interferon alfa-2B may help shrink or slow the growth of melanoma. Monoclonal antibodies, such as ipilimumab and pembrolizumab, may block tumor growth in different ways by targeting certain cells. It is not yet known whether high-dose recombinant interferon alfa-2B or ipilimumab is more effective than pembrolizumab in treating patients with melanoma.
Reference Number: 00072069
View this trial at ClinicalTrials.gov