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Melanoma clinical trials

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NCT ID: NCT05940311 Recruiting - Melanoma (Skin) Clinical Trials

Versatile Ampification Single-Molecule Detection in Liquid Biopsy

VerSiLiB
Start date: April 12, 2022
Phase:
Study type: Observational [Patient Registry]

Robust detection of single molecules in complex biological fluids is the ultimate goal in the field of disease biomarker analysis. Conventionally, to enable the quantitative analysis of individual molecules in macroscopic volumes, analyte pre-concentration and sample partitioning into fL-nL compartments has been combined with the amplification of the specific recognition events. In these setups, the positive or negative detection of fluorescence signal is triggered by enzymatic reactions occurring in each compartment. Binary readout based on Poisson statistics quantifies ultra-low concentrations of analyte molecules. This approach has been adopted for nucleic acids analysis in current digital PCR, and is also available for proteins in a technique coined as digital ELISA. The objective of VerSiLiB is to develop an enzyme-free amplification strategy for the analysis of both protein and nucleic acid analytes with the single digital platform that offers means to access additional information on target analytes not achievable with current technologies. Method is based on novel affinity-mediated-transport amplification, where affinity interaction of target analyte with a specific ligand attached to a magnetic nanoparticle transporter is accompanied with rapid shuttling of fluorescent tracers that serve as reporters. By applying external magnetic field, tracers are transported from the tracer storage side (where they are dark) to tracer active side (where they become bright) only if target analyte is present in the small reaction compartment. Tailored plasmonic nanostructures will be prepared at the storage and active sides of the compartment to render the tracer either dark or bright. The aim is to perform technology validation for the novel VerSiLiB proteogenomics amplification platform in cancer management using biobanked liquid biopsy samples.

NCT ID: NCT05933577 Recruiting - Melanoma Clinical Trials

A Clinical Study of V940 Plus Pembrolizumab in People With High-Risk Melanoma (V940-001)

Start date: July 19, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to learn if V940 which is an individualized neoantigen therapy (INT; formerly, called messenger ribonucleic acid [mRNA]-4157) with pembrolizumab (MK-3475) is safe and prevents cancer from returning in people with high-risk melanoma. Researchers want to know if V940 with pembrolizumab is better than receiving pembrolizumab alone at preventing the cancer from returning.

NCT ID: NCT05926960 Recruiting - Melanoma Clinical Trials

A Study Comparing 3 Study Medicines (Encorafenib, Binimetinib, Pembrolizumab) to 2 Study Medicines (Ipilimumab and Nivolumab) in Patients With Advanced Melanoma

PORTSIDE
Start date: June 13, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to learn about the effects of 3 study medicines (encorafenib, binimetinib, pembrolizumab) compared to 2 study medicines (ipilimumab and nivolumab) given for the treatment of melanoma. Melanoma is a type of cancer that starts in the cells that give color to your skin. The study is seeking participants who: - have advanced or metastatic melanoma (has spread to other parts of the body); - have a certain abnormal gene called "BRAF". - have taken nivolumab or pembrolizumab treatment before this study. Participants will either receive: - pembrolizumab given by intravenous infusion (directly into a vein) every 3 weeks at the study clinic. Participants will also receive encorafenib and binimetinib by mouth every day at home, - or will receive ipilimumab and nivolumab given by intravenous infusion (directly into a vein) every 3 weeks at the study clinic 4 times. This will be followed by nivolumab given by intravenous infusion every 4 weeks at the study clinic. Both pembrolizumab and nivolumab will be given for a maximum of around 2 years. However, there is no time limit for encorafenib and binimetinib treatment. The study team will see how each participant is doing after receiving the study treatments during regular visits to the study clinic.

NCT ID: NCT05913388 Recruiting - Clinical trials for Head and Neck Squamous Cell Carcinoma

GB1211 and Pembrolizumab Versus Pembrolizumab and Placebo in Patients With Metastatic Melanoma and Head and Neck Squamous Cell Carcinoma

Start date: February 29, 2024
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the objective response of GB1211 and pembrolizumab versus pembrolizumab and placebo in patients with advance metastatic melanoma or head and neck squamous cell carcinoma.

NCT ID: NCT05912244 Recruiting - Melanoma Clinical Trials

A Study of IO102/IO103, Nivolumab, and Relatlimab in People With Melanoma

Start date: June 9, 2023
Phase: Phase 2
Study type: Interventional

The researchers are doing this study to find out whether the study vaccines, IO102/IO103, given in combination with the standard-of-care drug combination, nivolumab and relatlimab, is a safe and effective treatment for people with untreated, unresectable melanoma.

NCT ID: NCT05909995 Recruiting - Melanoma Clinical Trials

Interventional Study of INCB 99280 With Ipilimumab in Participants With Select Solid Tumors

Start date: August 29, 2023
Phase: Phase 1
Study type: Interventional

The purpose of this study is to characterize the safety, tolerability, PK, and efficacy of INCB 99280 in combination with ipilimumab in participants with select solid tumors.

NCT ID: NCT05909618 Recruiting - Clinical trials for MGMT-Unmethylated Glioblastoma

Crizanlizumab Alone or in Combination With Nivolumab for Glioblastoma and Melanoma With Brain Metastases

14
Start date: July 11, 2023
Phase: Phase 2
Study type: Interventional

A single-center, open-label, non-randomized phase I/II study to evaluate the efficacy, safety and tolerance of crizanlizumab monotherapy and in combination with nivolumab in patients with advanced glioblastoma (GB) who exhausted standard of care (SOC) therapy, patients with metastatic brain melanoma (MBM) and patients with newly diagnosed unmethylated GB. Subjects will be screened for up to 28 days prior to treatment initiation. Eligible subjects will be allocated to one of 3 cohorts: Cohort 1: Patients with metastatic melanoma with primarily diagnosed or newly progressing brain metastases who failed immunotherapy. Cohort 2: Patients with recurrent or progressing GB following primary radiation therapy and temozolomide. Patients may have failed up to 2 prior systemic treatment lines (including temozolomide as adjuvant therapy) and are candidates for further treatment. Cohort 3: Patients with newly diagnosed GB who were evaluated for methylguanine-DNA methyltransferase(MGMT) methylation status and have un-methylated MGMT promotor-therefore, they are not candidates for maintenance temozolomide therapy.

NCT ID: NCT05907954 Recruiting - Uveal Melanoma Clinical Trials

(Neo)Adjuvant IDE196 (Darovasertib) in Patients With Localized Ocular Melanoma

Start date: July 3, 2023
Phase: Phase 2
Study type: Interventional

Neoadjuvant/adjuvant IDE196 (darovasertib) in patients with primary uveal melanoma

NCT ID: NCT05907512 Recruiting - Clinical trials for Clinical Stage IV Cutaneous Melanoma AJCC v8

Endostar Plus Toripalimab as Adjuvant Therapy for Resectable Stage III-Oligometastatic Stage IV Cutaneous Melanoma

Start date: April 1, 2020
Phase: Phase 2
Study type: Interventional

The goal of this clinical trial is to evaluate the efficacy and safety of Endostar combined with Toripalimab in the adjuvant treatment of resectable stage III-oligometastatic stage IV melanoma, and to find effective biomarkers of efficacy based on tumor paraffin tissue specimens and peripheral blood. The main questions it aims to answer are: - The efficacy and safety of the combination treatment regimen; - Finding suitable biomarkers can refine the patients with effective treatment After a series of evaluation, if the participants meet the inclusion and exclusion criteria and are evaluated by the investigator, they will formally enter the study observation period and receive the following treatments Endostar: The dose of 210 mg (14 vials) is administered by intravenous pump from Day 1 to Day 3 of each course, every 4 weeks as a cycle, until disease recurrence, metastasis or intolerable toxicity, and up to 6 courses of administration. Toripalimab: 3 mg/kg by intravenous drip every 2 weeks (Day 1 and Day 15 of each cycle) in a 4-week cycle until disease recurrence, metastasis, or intolerable toxicity for up to 1 year (about 13 cycles).

NCT ID: NCT05907122 Recruiting - Melanoma Clinical Trials

A Study to Evaluate Similarity of ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Resected Melanoma

Start date: July 26, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to investigate the pharmacokinetic (PK) similarity and efficacy, safety, and immunogenicity of ABP 206 compared with OPDIVO® (nivolumab) in subjects with resected advanced melanoma.