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Melanoma clinical trials

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NCT ID: NCT05863052 Active, not recruiting - Melanoma Clinical Trials

Analyzing Clinical Outcomes and Genomic Data of American Indian Patient Population

Start date: January 31, 2022
Phase:
Study type: Observational

The aim of this study is to describe the outcomes in American Indian patients receiving immunotherapy in a multi-institution retrospective study at several other high-volume centers that care for this patient population and to identify any healthcare disparities that can lead to future interventional studies.

NCT ID: NCT05783882 Active, not recruiting - Clinical trials for Unresectable or Metastatic Melanoma

Prolgolimab 250 mg Q3W in Patients With Unresectable or Metastatic Melanoma

FLAT
Start date: February 1, 2022
Phase: Phase 3
Study type: Interventional

Multicentre, single-arm, open-label efficacy, pharmacokinetics, and safety study to demonstrate non-inferiority of prolgolimab 250 mg every 3 weeks versus historical data for prolgolimab 1 mg/kg every 2 weeks in patients with unresectable or metastatic melanoma, as well as collecting pharmacokinetics and safety data. The study is conducted under the same conditions as the previously conducted study BCD-100-2/MIRACULUM. This means that this Study No. BCD-100-8/FLAT has identical parameters such as: - selection criteria for subjects in the study, defining the population, - research centers, - procedures for evaluating effectiveness and safety, - permitted prior and concomitant therapy of the underlying disease.

NCT ID: NCT05744076 Active, not recruiting - Melanoma Clinical Trials

Analysis of Circulating Exosomes in Melanoma Patients

EXOMEL1
Start date: March 1, 2019
Phase:
Study type: Observational

The hypothesis is that PD-L1[Programmed Death-Ligand 1] labeling in exosomes could be a biomarker of disease progression in melanoma. The rate of circulating exosomes, their size and the exosomal expression of PD-L1 could be correlated with the stage of the disease, the response to treatment and/or the prognosis of patients. In this study, blood samples (EDTA tubes taken as part of routine care at Besançon University Hospital) and associated clinical data are reused.

NCT ID: NCT05739006 Active, not recruiting - Melanoma Clinical Trials

Clinical Trial to Evaluate the PK and Safety of BCD-201 and Keytruda® in Patients With Advanced Malignancies

Start date: February 8, 2021
Phase: Phase 1
Study type: Interventional

Clinical study BCD-201-1 is a double-blind randomized study of the pharmacokinetics (PK), pharmacodynamics (PD), safety, and immunogenicity of BCD-201 versus Keytruda following intravenous administration to subjects with advanced unresectable, metastatic, or recurrent melanoma and NSCLC. The study aimed to establish the equivalence of PK and similarity of the safety, immunogenicity, and PD profiles of BCD-201 and Keytruda.

NCT ID: NCT05736523 Active, not recruiting - Melanoma Clinical Trials

Improving Early Detection of Melanoma Recurrence With Circulating Tumor DNA (ctDNA)

Start date: September 23, 2020
Phase:
Study type: Observational

This is a non-randomized experimental biomarker study evaluating ctDNA levels in patients with stage IIB/C and stage IIIB/C/D melanoma skin cancer pre and post-surgery Study participants will complete a ctDNA test within 4 weeks of their planned surgical resection of their melanoma. Within 4 weeks post-surgery another ctDNA test will be completed. During these time points stool samples and diet questionnaires will be collected for biospecimen banking.

NCT ID: NCT05704933 Active, not recruiting - Metastatic Melanoma Clinical Trials

Pilot Study of Nivolumab w/Ipilimumab or Relatlimab in Surgically Resectable Melanoma Brain Metastases

Start date: June 6, 2023
Phase: Early Phase 1
Study type: Interventional

The purpose of this pilot study is to determine the safety and feasibility of giving a single dose of Nivolumab with Ipilimumab or Relatlimab in participants with brain metastases from melanoma who can undergo surgery for removal of their brain metastases 7- 10 days after receiving the study drug.

NCT ID: NCT05704647 Active, not recruiting - Melanoma (Skin) Clinical Trials

Phase II Study of Nivolumab in Combination With Relatlimab in Patients With Active Melanoma Brain Metastases

Start date: February 23, 2023
Phase: Phase 2
Study type: Interventional

To learn if giving nivolumab in combination with relatlimab can help to control melanoma that has spread to the brain (melanoma with brain metastases). The safety and side effects of the study drug combination will also be studied.

NCT ID: NCT05695898 Active, not recruiting - Metastatic Melanoma Clinical Trials

XmAb23104 (PD1 X ICOS) and XmAb22841 (CTLA-4 X LAG3) in Treating Melanoma Prior Immune Checkpoint Inhibitor Therapy

Start date: February 28, 2023
Phase: Phase 1
Study type: Interventional

This is a first-in-human, multi-center, multi-cohort, open-label, phase Ib/II study of XmAb22841 (CTLA-4 X LAG3) administered in combination with XmAb23104 (PD1 X ICOS) in participants with a histologically or cytologically confirmed diagnosis of an advanced/metastatic melanoma. XmAb22841 (CTLA-4 X LAG3) is a bi-specific antibody targeting two different T cell membrane proteins responsible for regulation of T cell activity. It offers potential immunologic and safety advantages over existing therapies. XmAb22841 (CTLA-4 X LAG3) is being evaluated in this clinical study designed to assess the safety, tolerability, PK, and PD of escalating doses of XmAb22841 (CTLA-4 X LAG3) administered in combination with XmAb23104 (PD1 X ICOS) The study will be conducted through the University of California Melanoma Consortium (UCMC).

NCT ID: NCT05640193 Active, not recruiting - Metastatic Melanoma Clinical Trials

A Study of LN-144 in People With Metastatic Melanoma to the Brain

Start date: November 25, 2022
Phase: Phase 1
Study type: Interventional

This is an open label study evaluating lifileucel (LN-144) in patients with melanoma brain metastases.

NCT ID: NCT05551117 Active, not recruiting - Clinical trials for Non-small Cell Lung Cancer

A Study of Vobramitamab Duocarmazine in Participants With Metastatic Castration Resistant Prostate Cancer and Other Solid Tumors

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

Study CP-MGC018-03 is an open-label, two-part, Phase 2 study. Part 1 of the study will enroll participants with metastatic castration-resistant prostate cancer (mCRPC) previously treated with one prior androgen receptor axis-targeted therapy (ARAT). ARAT includes abiraterone, enzalutamide, or apalutamide. Participants may have received up to 1 prior docetaxel-containing regimen, but no other chemotherapy agents. This part of the study will assess the efficacy and tolerability of vobramitamab duocarmazine (MGC018) in two experimental arms (2.0 mg/kg every 4 weeks [Q4W] and 2.7 mg/kg Q4W) . Approximately 100 participants will be randomized 1:1. Part 2 of the study will enroll participants with locally advanced or metastatic squamous cell carcinoma (SCC) of the anus, melanoma, head and neck squamous cell carcinoma (HNSCC), squamous non-small cell lung carcinoma (NSCLC), and small cell lung carcinoma (SCLC). Participants must have progressive following at least 1 prior line of standard chemotherapy for advanced or metastatic disease. Participants will receive vobramitamab docarmazine at a dose of 2.7 mg/kg every 4 weeks. Up to 200 participants may be enrolled in Part 2. In both parts, vobramitamab duocarmazine will be administered intravenously (IV) in clinic on Day 1 of each 4-week cycle. Vobramitamab duocarmazine will be administered for up to 26 cycles, approximately 2 years, until criteria for treatment discontinuation are met. Participants will undergo regular testing for signs of disease progression using computed tomography (CT) scans, magnetic resonance imaging (MRI), bone scans, and prostate-specific antigen (PSA) blood tests. Routine examinations and blood tests will be performed and evaluated by the study doctor.