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Metastatic Melanoma - ClinicalTrials.gov

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Last Updated: 22 June 2022

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An Open-label, Phase I Study of NEO-PTC-01 in Patients With Advanced or Metastatic Melanoma

NEO-PTC-01 is an autologous personalized T cell therapy system for adoptive cell therapy that is made in vivo and targets neoantigens found on the patient's tumor and the tumour microenvironment. The dose expansion portion of the research will determine the safety in an expanded population of patients to better define the risk.

Source link: https://clinicaltrials.gov/ct2/show/NCT04625205


Phase II Trial of Combination Anti-PD-1 and Aldesleukin for Metastatic Melanoma and Renal Cell Carcinoma

History: The FDA has approved high-dose interleukin-2 for the treatment of metastatic melanoma and renal cell carcinoma with a 5-12% response rate. Participants with limited therapeutic options can be impacted by non-specific activation of the immune system with both positive stimulation and the unveiling of negative legislation, according to the hypothesis under scrutiny. Objectives: Primary: To determine the objective response rate in participants with melanoma refractory to anti-PD-1 therapy and treatment-refractory renal cell carcinoma, seeking a fetal diagram and laboratory correlations of response. Objects: Objectives: To determine the toxicity profile of this treatment program. The participant must be able to determine the response rate as determined by RECIST 1. 1 criteria, as well as chronic tumor and/or cancer in patients with advanced mela re Cohort 2: Metastatic renal cell carcinoma refractory to at least one line of PD1/PDL1-based therapy. Penetolizumab infusion in Course 1 on the morning of Day 1 with the aldesleukin administration will begin later that day. If clinically appropriate, participants with no onset of progressive disease will receive a second course of pembrolizumab alone. Participants with stable disease will be monitored until disease progression increases to one year.

Source link: https://clinicaltrials.gov/ct2/show/NCT05155033


Phase 1 Study of E6201 Plus Dabrafenib for the Treatment of Central Nervous System (CNS) Metastases From BRAF V600-Mutated Metastatic Melanoma

To find the maximum tolerated dose of MEK-1/MEKK-1 inhibitor E6201 in combination with dabrafenib in patients with central nervous system metastases from BRAF V600-mutated metastatic melanoma, see Figure. With a BRAF V600 mutation treated with E6201+ dabrafenib, we'll determine the time to first progression in subjects with CNS metastases due to metastatic melanoma. With a BRAF V600 mutation treated with E6201 + dabrafenib, it's likely that overall survival in subjects with CNS metastases due to metastatic melanoma. With a BRAF V600 mutation treated with E6201 + dabrafenib, we can assess the adverse events profile of E6201 in combination with dabrafenib in patients with CNS metastases due to metastatic melanoma. To determine the relationship of BRAF mutational status in archival tissue with clinical outcome. Patients are treated with MEK-1/MEKK-1 inhibitor E6201 intravenously over 2 hours on days 1, 4, 8, 11, 15, and 18, with dabrafenib administered daily on days 1-28.

Source link: https://clinicaltrials.gov/ct2/show/NCT05388877


Pilot Study to Test the Feasibility of IV Injected Tc-99m-tilmanocept for Imaging of M2-like Tumour Associated Macrophages in Metastatic Melanoma

According to the Swiss Federal Statistical Office, cancer is the leading cause of death in Switzerland for men aged 45 to 84, as well as women aged 25 to 84. However, it has been reported that also PD-L1 negative tumours respond to PD1/PD-L1 blockade. One possible explanation could be the heterogeneity of intra-tumoural PD-L1 expression or the heterogeneity among varying tumor sites in melanoma patients. Tumor-associated macrophages seem to be of particular importance in the tumour microenvironment's immune modulation. The evolution of the macrophage compartment aided in the creation of new treatment plans as CSFR-1-directed antibodies, resulting in promising synergizing results with PD-1-directed therapy and a reversal resistance to checkpoint inhibitor therapy. Most recent trials have investigated Tc-99m Tilmanocept as an intravenous injection in patients with Rheumatoid Arthritis. Tc-99m-tilmanocept is a non-invasive marker for CD206+ TAMs in melanoma lesions. This research is intended to investigate the safety and effectiveness of Tc-99m-tilmanocept as a marker for CD206+ M2-like TAMs in lesions in melanoma patients. The finding of a correlation between M2-like TAMs presence in the outcomes of patients receiving anti-PD1 immunotherapy may lead to new ways to predict ICH treatment responses. We therefore want to take the first step with this pilot study to determine the safety of Tc-99m-tilmanocept as a marker for imaging M2-like TAMs in melanoma metastasis. This Project is in risk category C. Intravenous Injection has been successfully tested in a Phase I dose escalation trial in people with active rheumatoid arthritis. Patients will be questioned by the government about recent hypersensitivity reactions to dextran and modified forms of dextran. The results of the survey may help provide a better understanding of immunotherapy's variety and may help to predict the response of a melanoma patient to immunotherapy in the future. The scans will be compared to immunohistochemistry results from biopsy staining for TAMs and M2-like TAMs, as well as retrospectively with the immunotherapy to see if there is any correlation between M2-like TAMs and treatment response, as well as reaction to the immunotherapy to determine any correlation between M2-like TAMs and treatment response. In Tilmanocept's Tilmanocept SPECT/CT, the lesion size and FDG will be determined to determine any correlation between CD206-related uptake and treatment response, as well as Tilmanocept SPECT/CT.

Source link: https://clinicaltrials.gov/ct2/show/NCT04663126


A Phase II Study of the TRIplet Combination of Dabrafenib, Nivolumab, and Trametinib in Patients With Metastatic Melanoma (TRIDeNT) or Binimetinib, EnCorafenib, and NivolumAb (TRIBECA)

Patients with BRAF-mutated metastatic melanoma must be evaluated for safety, tolerability, and efficacy of nivolumab in combination with dabrafenib, trametinib and trametinib or encorafenib and binimetinib in combination with dabrafenib and trametinib. Efficacy of the combination as determined by the severity and time of responses by RECIST 1. 1 and modified RECIST 1. Patients are nivolumab intravenously over 30 minutes on day 1, dabrafenib orally twice a day on days 1-28, and trametinib PO once a day on days 1-28. Patients get nivolumab IV over 30 minutes on day 1 and 15, as well as trametinib PO QD on days 1-28. Patients are given nivolumab IV for over 30 minutes on day 1 and 15, encorafenib PO QD on days 1-28, and binimetinib PO BID on days 1-28. Patients are followed up at 30 days after completion of study and then every 3 months for up to three years.

Source link: https://clinicaltrials.gov/ct2/show/NCT02910700


Phase 1/2 Study of an EZH2 Inhibitor (Tazemetostat) in Combination With Dual BRAF/MEK Inhibition in Patients With BRAF- Mutated Metastatic Melanoma Who Progressed on Prior BRAF/MEK Inhibitor Therapy

When used in combination with dual BRAF inhibitor and MEK inhibitor therapy in BRAF/MEK inhibitor-resistant, BRAF-mutated metastatic melanoma, it's easy to determine a maximum tolerated dose for the EZH2 inhibitor, tazemetostat hydrobromide. To determine if the addition of the EZH2 inhibitor, tazemetostat, to BRAF and MEK inhibitor therapy can promotes progression-free survival in patients with BRAF/MEK inhibitor-resistant, BRAF-mutated melanomas harboring an EZH2 genotype, sees a BRAF/MEK inhibitor-resistant, BRAF/MEK inhibitor-resistant BRAF/MEK inhibitor-resistant BRAF/MEK inhibitor-resistant BRAF/BRAF/Mo ta BRAF/IK inhibitor therapy, tazemetotazemetostat, BRAF/MEK inhibitor therapy improves BRAF and MEK inhibitor therapy in patients with BRAF/MEK inhibitor-mutated BRAF/MIK inhibitor-mutation of BRAF/MEK inhibitor-mutated BRAF/V600-mutated BRAF/MEK inhibitor-mutated BRAF/MEK inhibitor-mutated BRAF/MEK inhibitor-mutation, BRAF/MEK inhibitor-mutated BRAF/MEK inhibitor-Ma-mutated BRAF/MEK inhibitor-mut In patients with BRAF/MEK inhibitor-resistant BRAF/MEK inhibitor-resistant BRAF melanomas harboring an EZH2 alteration, the average response rate of single-agent EZH2 inhibitor, BRAF inhibitor, and MEK inhibitor therapy is determined. Patients in the phase I trial receive the same care as in Arm II. Patients may return to Arm II after completion of radiation therapy at the time of progression. ARM II: Patients receive tazemetostat PO BID, dabrafenib PO BID, and trametinib PO BID every day on days 1-28.

Source link: https://clinicaltrials.gov/ct2/show/NCT04557956


A Prospective Randomized and Phase II Trial for Metastatic Melanoma Using Adoptive Cell Therapy With Tumor-Infiltrating Lymphocytes Plus IL-2 Either Alone or Following the Administration of Pembrolizumab

low PD-1 levels were found on TIL in vivo, but PD-1 can be re-expressed on TIL in vivo following TIL injection In pre-clinical studies, the administration of an anti-PD1 antibody raises the anti-tumor activity of transferred T-cells. Following the cell infusion, patients receiving pepolizumab-pep are expected to get their pegongolizumab right away before TIL administration and go on for an additional three cycles.

Source link: https://clinicaltrials.gov/ct2/show/NCT02621021


A Phase II Study for Metastatic Melanoma Using High-Dose Chemotherapy Preparative Regimen Followed by Cell Transfer Therapy Using Tumor-Infiltrating Lymphocytes Plus IL-2 With the Administration of Pembrolizumab in the Retreatment Arm

According to measurements using RECIST criteria, 44 percent, 52%, and 72% were found in a string of consecutive trials using this chemotherapy preparation regimen alone or with 2 Gy or 12 Gy total body irradiation objective response rates using RECIST criteria. Patients with metastatic melanoma lesion in the preparation of TIL resection are expected to have lesions, and following TIL growth, patients with Til plus aldesleukin therapy will be notified.

Source link: https://clinicaltrials.gov/ct2/show/NCT01993719

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions