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Melanoma clinical trials

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NCT ID: NCT04657991 Active, not recruiting - Melanoma Clinical Trials

A Clinical Trial of Three Study Medicines (Encorafenib, Binimetinib, and Pembrolizumab) in Patients With Advanced or Metastatic Melanoma

Start date: January 15, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to learn about the effects of three study medicines (encorafenib, binimetinib, and pembrolizumab) given together for the treatment of melanoma that: - is advanced or metastatic (spread to other parts of the body); - has a certain type of abnormal gene called "BRAF"; and - has not received prior treatment. All participants in this study will receive pembrolizumab at the study clinic once every 3 weeks as an intravenous (IV) infusion (given directly into a vein). In addition, half of the participants will take encorafenib and binimetinib orally (by mouth) at home every day. Participants may receive pembrolizumab for up to two years. Those participants taking encorafenib and binimetinib can continue until their melanoma is no longer responding. The study team will monitor how each participant is doing with the study treatment during regular visits at the study clinic.

NCT ID: NCT04655157 Terminated - Melanoma Clinical Trials

Safety and Efficacy in Participants With Metastatic BRAF-mutant Melanoma Treated With Encorafenib With and Without Binimetinib in Combination With Nivolumab and Low-dose Ipilimuma

QUAD01
Start date: May 28, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

Patients with unresectable or metastatic BRAF-mutant melanoma high-risk patients will be given 450 mg orally (PO) daily (QD) plus binimetinib 45 mg PO twice daily (BID) together with nivolumab administered intravenously (IV) at 3mg/kg and ipilimumab administered IV at 1 mg/kg every 3 weeks for 4 doses, followed by nivolumab administered IV at 480mg every 4 weeks until progression or discontinuation due to toxicity. Concurrently, a triple therapy arm will be explored with encorafenib 300 mg PO QD together with ipilimumab administered IV at 1mg/kg and nivolumab 3mg/kg IV every 3 weeks for 4 doses, followed by nivolumab administered at 480mg every 4 weeks until progression or discontinuation due to toxicity. Tolerability of the two arms will be compared, and a recommended phase 2 dose (RP2D) will be determined. After determination of treatment schedule, expansion cohorts will further explore the preliminary efficacy and further describe the toxicity profile of the triplet or quadruplet regimen in high-risk cohorts including symptomatic brain metastases or liver metastases with elevated lactate dehydrogenase (LDH) or bulky systemic disease burden.

NCT ID: NCT04653038 Terminated - Clinical trials for Untreated Mucosal or Acral Lentiginous Melanoma

A Study to Evaluate the Safety and Efficacy of MGD013 in Patients With Melanoma

Start date: October 29, 2020
Phase: Phase 1
Study type: Interventional

This is an open-label, multi-cohort, multi-center Phase I clinical trial to evaluate the efficacy and safety of MGD013 in ① Cohort 1: patients with unresectable, recurrent or metastatic melanoma who have failed prior immune checkpoint inhibitor therapy; ② Cohort 2: patients with untreated, unresectable recurrent or metastatic, mucosal or acral lentiginous melanoma.

NCT ID: NCT04648163 Completed - Malignant Melanoma Clinical Trials

Suction Drain in Axillary Lymph Node Dissection for Malignant Melanoma

Start date: December 1, 2017
Phase:
Study type: Observational

Postoperative complications like seroma formation and wound site infection readily occur following completion axillary lymph node dissection (ALND) for malignant melanoma. We analyzed the impact of time-to-drain removal and drainage volume on seroma formation after ALND.

NCT ID: NCT04645680 Recruiting - Metastatic Melanoma Clinical Trials

Effect of Diet on the Immune System in Patients With Stage III-IV Melanoma Receiving Immunotherapy, DIET Study

DIET
Start date: June 24, 2020
Phase: Phase 2
Study type: Interventional

This phase II trial investigates the possible immune effects of two different diets targeting the gut microbiome in patients with stage III-IV melanoma that has been removed by surgery (resectable), has spread to other places in the body (metastatic), or is unable to be removed by surgery (unresectable), and who are being treated with the immunotherapy drugs pembrolizumab or nivolumab as part of their standard of care. Both diets are whole foods diets that meet the American Cancer Society recommendations for cancer patients, but they will vary in fiber content. The purpose of this trial is to learn about the effects of dietary interventions on the structure and function of the gut microbiome in patients with melanoma being treated with standard of care immunotherapy (pembrolizumab or nivolumab).

NCT ID: NCT04644315 Terminated - Melanoma Clinical Trials

A Home-Based Approach Study to Evaluate the Efficacy and Safety of Alectinib in Locally-Advanced or Metastatic ALK-Positive Solid Tumors

ALpha-T
Start date: May 24, 2021
Phase: Phase 2
Study type: Interventional

This study will evaluate the efficacy and safety of alectinib in participants with Anaplastic Lymphoma Kinase (ALK)-positive locally advanced or metastatic solid tumors other than lung cancer.

NCT ID: NCT04640545 Recruiting - Advanced Melanoma Clinical Trials

A Study to Assess LBL-007 in Combination With Toripalimab and Axitinib Tablets Subjects With Advanced Melanoma

Start date: May 12, 2020
Phase: Phase 1
Study type: Interventional

A phase I clinical study evaluating LBL-007 in the treatment of subjects with advanced solid tumors

NCT ID: NCT04633902 Recruiting - Metastatic Melanoma Clinical Trials

Phase II Study of Olaparib and Pembrolizumab in Advanced Melanoma With Homologous Recombination (HR) Mutation

Start date: March 3, 2021
Phase: Phase 2
Study type: Interventional

This open-label phase II trial studies how well olaparib in combination with pembrolizumab works in treating patients with advanced, metastatic melanoma with the homologous recombination (HR) pathway gene mutation / alteration. Olaparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth, and potentially augment an anti-tumor immune response to pembrolizumab. The trial is designed to assess the efficacy and safety of olaparib in combination with pembrolizumab in patients with HR mutation/ alteration whose disease progressed on prior immunotherapy and/or BRAF-targeting therapy

NCT ID: NCT04631731 Recruiting - Clinical trials for Hepatocellular Carcinoma

Risk Factors of Immune-ChEckpoint Inhibitors MEdiated Liver, Gastrointestinal, Endocrine and Skin Toxicity

ICEMELT
Start date: December 15, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

"Risk factors of Immune-ChEckpoint inhibitor MEdiated Liver, gastrointestinal, endocrine and skin Toxicity" (ICEMELT) study is a prospective multicenter cohort study, enrolling patients who are scheduled to receive (1) single agent PD1/L1 inhibitor; (2) PD1/L1 inhibitor plus CTLA4 inhibitor; (3) platinum-based chemotherapy + PD1/L1 inhibitor; (4) PD1/L1 inhibitor and tyrosine kinase inhibitor and (5) PD1/L1 inhibitor and vascular endothelial growth factor (VEGF) inhibitor.

NCT ID: NCT04629339 Terminated - Clinical trials for Hepatocellular Carcinoma

Study of INCB086550 in Select Solid Tumors

Start date: September 2, 2021
Phase: Phase 2
Study type: Interventional

An open-label, nonrandomized study to evaluate the efficacy and safety of INCB086550, a first-in-class oral inhibitor of PD-L1, as initial immune checkpoint inhibitor therapy in participants with select solid tumors