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Melanoma clinical trials

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NCT ID: NCT06154668 Recruiting - Melanoma Clinical Trials

Profiling of Circulating Immune Cells to Uncover Response Signatures to Anti-PD1 Immunotherapy in Melanoma Patients

PHENOMENAL
Start date: January 17, 2024
Phase:
Study type: Observational

Despite being standard of care, there are still many medical requirements related to immune checkpoint blocker based therapies such as identify patients susceptible to respond with the less adverse events, evaluate the clinical benefit of adjuvant treatment /risk of relapse and design new strategies for non-responder patients. Thus, this project aims at understanding the impact of anti-PD1 on the immune system through investigation of the phenotypic, functional, metabolic and transcriptomic profiles of circulating DC subsets and effectors in response to anti-PD1 therapy in melanoma patients. The primary objective of the study is to identify the biomarkers of response to anti-PD1 according to the type of patient before the start of the treatment.

NCT ID: NCT06153238 Recruiting - Melanoma Clinical Trials

A PK Study to Compare GME751 (Proposed Pembrolizumab Biosimilar) and US-licensed and EU-authorized Keytruda® in Participants With Stage II and III Melanoma

Start date: May 15, 2024
Phase: Phase 1
Study type: Interventional

The purpose of this study is to investigate the pharmacokinetic (PK) similarity and efficacy, safety, and immunogenicity of GME751 compared with Keytruda® (pembrolizumab) in subjects with resected advanced melanoma requiring adjuvant treatment with pembrolizumab.

NCT ID: NCT06151847 Recruiting - Metastatic Melanoma Clinical Trials

Lifileucel With Reduced Dose Fludarabine/Cyclophosphamide Lymphodepletion and Interleukin-2 for the Treatment of Patients With Unresectable or Metastatic Melanoma

Start date: December 21, 2023
Phase: Phase 2
Study type: Interventional

This phase II trial tests how well lifileucel, with reduce dose fludarabine and cyclophosphamide for lymphodepletion and interleukin-2, work for treating patients with melanoma that cannot be removed by surgery (unresectable) or that has spread from where it first started (primary site) to other places in the body (metastatic).Lifileucel is made up of specialized immune cells called lymphocytes or T cells that are taken from a patient's tumor, grown in a manufacturing facility and infused back into the preconditioned patient to attack the tumor. Giving Lifileucel with a reduced dose of fludarabine and cyclophosphamide for lymphodepletion and interleukin -2 is being studied in patients with unresectable or metastatic melanoma.

NCT ID: NCT06150664 Recruiting - Clinical trials for Non Small Cell Lung Cancer

A Phase 1 of CTX-8371 in Patients With Advanced Malignancies

Start date: March 19, 2024
Phase: Phase 1
Study type: Interventional

This is a Phase 1, open-label, first-in-human study of CTX-8371 administered as a monotherapy in patients with metastatic or locally advanced malignancies. The study will be conducted in 2 cohorts: Dose Escalation and Dose Expansion.

NCT ID: NCT06146920 Recruiting - Clinical trials for Non-small Cell Lung Cancer

Use of Serial Plasma NGS as a New Efficacy Metric to Guide Immunotherapy Treatment Discontinuation

Start date: January 10, 2024
Phase: N/A
Study type: Interventional

The goal of this prospective study to investigate the use of circulating tumor DNA (ctDNA) to guide end of therapy decisions in patients with melanoma or non-small-cell lung cancer. The main question it aims to answer is: • Do patients with metastatic melanoma or non-small-cell lung cancer, who have received at least 12 months of immune checkpoint inhibition (monotherapy or in combination) with evidence of disease response/control on imaging and have no evidence of circulating tumor DNA, have an increased 12-month disease free survival in comparison to historical controls?

NCT ID: NCT06121180 Recruiting - Clinical trials for Metastatic Uveal Melanoma

Study of Cemiplimab Plus Ziv-Aflibercept for Subjects With Metastatic Uveal Melanoma

Start date: February 9, 2024
Phase: Phase 2
Study type: Interventional

The goal of this clinical research study is to find out if Cemiplimab plus Ziv-Aflibercept is safe and effective in treating your condition of metastatic (spread to other parts of your body) uveal melanoma. This research study will test the study drugs to see if the combination of Cemiplimab plus Ziv-Aflibercept can make tumors shrink or stop growing.

NCT ID: NCT06120712 Recruiting - Melanoma Clinical Trials

A Phase Ⅰb Study on Autologous GC101 TIL Injection for the Treatment of Advanced Melanoma (MIZAR-002)

MIZAR-002
Start date: November 8, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

20 participants are expected to be enrolled for the Phase Ib clinical trial,this trail is expected to be finished in 20 months.

NCT ID: NCT06116461 Recruiting - Melanoma Clinical Trials

Nivolumab Dose Optimization in Patients With a Complete, Partial or Stable Response

NIVOPTIMIZE
Start date: January 5, 2022
Phase: Phase 4
Study type: Interventional

Patients with advanced melanoma are, amongst others, currently treated with nivolumab monotherapy or with nivolumab and ipilimumab followed by nivolumab. Even though registration studies administered nivolumab in a 3 mg/kg 2 weekly scheme, currently, nivolumab monotherapy is either administered in a 240 mg 2-weekly scheme or in a 6 mg/kg or 480 mg 4-weekly scheme. With the current dosing regimen, steady-state is achieved after approximately 5 to 6 months, whereas a tumour response is usually observed earlier in patients with metastatic melanoma. Moreover, PD-1 receptor occupancy is almost saturated above doses of 0.3 mg/kg, or at nivolumab serum levels of 10 mg/L, which is a concentration that is achieved after one treatment cycle. In melanoma patients, the additional probability on response in patients treated with 3 mg/kg compared to 1 mg/kg seems limited. PFS and OS for 3 mg/kg were not superior to 1 mg/kg. Therefore, in this study, our aim is to investigate nivolumab trough levels and pharmacokinetic parameters after 3 reduced nivolumab doses.

NCT ID: NCT06112808 Recruiting - Advanced Melanoma Clinical Trials

A Clinical Study of the Pharmacokinetics and Safety of BCD-263 and Opdivo® as Monotherapy in Subjects With Advanced Melanoma of the Skin

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

The aim of the study BCD-263-1 is to prove the comparability of the pharmacokinetics and similarity of the safety, immunogenicity and pharmacodynamic profiles of BCD-263 and Opdivo following intravenous administration to subjects with advanced unresectable or metastatic melanoma of the skin. The study will have randomized, double-blind design with parallel assignment.

NCT ID: NCT06112314 Recruiting - Advanced Melanoma Clinical Trials

IMC-F106C Regimen Versus Nivolumab Regimens in Previously Untreated Advanced Melanoma (PRISM-MEL-301)

PRISM-MEL-301
Start date: December 18, 2023
Phase: Phase 3
Study type: Interventional

This is a phase 3, randomized, controlled study of IMC-F106C plus nivolumab compared to standard nivolumab regimens in HLA-A*02:01-positive participants with previously untreated advanced melanoma.