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Metastatic Cutaneous Melanoma - ClinicalTrials.gov

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Last Updated: 03 May 2022

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Phase I/II Study of Immunization With Multiple Peptides Mixed With the Immunological Adjuvant CpG 7909 or Montanide ISA51 in HLA-A2 Patients With Metastatic Cutaneous Melanoma

Patients were given six sequential immunizations with 8 peptides developed by HLA-A2 and mixed with either CpG 7909 or Montanide ISA51 at 2-week intervals. Each peptide was mixed with 4 mg CpG 7909 or 0. 5 million ml of Montanide ISA51. Before beginning the therapy, Peripheral Blood Lymphocytes collections were performed, and Peripheral Blood Lymphocytes samples were collected at weeks 3, 7, and 13. The pre-immune tumor biopsy's PCR results must be available at week 13 for week 13. Patients without tumor progression requiring another therapy will be referred to patients without tumor progression requiring additional cycles of immunization, ONLY with the peptides expressed by the tumor mixed with Montanide ISA51. Starting at month 11, a second cycle of 3 injections at 6-week intervals will begin at week 17, followed by a third cycle of 12 injections at 3-month intervals, beginning at week 17. The immune response may well be a limiting factor in the vaccine's therapeutic success.

Source link: https://clinicaltrials.gov/ct2/show/NCT00145158


A Phase II Trial of SCH 727965 (NSC 747135) in Patients With Stage IV Melanoma

To determine the 1-year overall survival rate in patients with stage IV melanoma treated with dinaciclib. To determine the response rate in the subset of patients with measurable disease. To determine the safety and tolerability of dinaciclib given to patients with stage IV melanoma. On day 1, patients are treated to dinaciclib IV for over two hours.

Source link: https://clinicaltrials.gov/ct2/show/NCT00937937


Phase I Clinical Trial of Tremelimumab Plus MEDI3617 in Patients With Unresectable Stage III or Stage IV Melanoma

The investigators are looking for the highest dose of the combination of study drugs that can be administered safely without having severe or unmanageable side effects in participants with melanoma, but not everyone who participates in this research study will be given the same dose of the study drug.

Source link: https://clinicaltrials.gov/ct2/show/NCT02141542


Randomized Phase II/III Study of Nivolumab Plus Ipilimumab Plus Sargramostim Versus Nivolumab Plus Ipilimumab in Patients With Unresectable Stage III or Stage IV Melanoma

vs. nivolumab/ipilimumab/GM-CSF versus nivolumab/ipilimumab is a measure of progress-free survival of patients treated with nivolumab/ipilimumab/cg on a nivolumab/ipilimumab/ipilimumab/ipilimumab/ipipipipipulmab/ilimumab/ilimumab/ilimumab/imab/itimab/ilimumab/ilimumab/ipipipipolitilimumab/ilimumab/ilimumab/ipipilimumab/ilimumab/ilimumab/ipilimumab/ipipilimumab/ipilimumab/ilimumab/ipilimab/ To determine the effects of nicotine use on patient-reported physical signs and psychological signs, we need to know the effects of nicotine use on patient-reported physical signs and psychological signs. ARM A: THERAPY: Patients are given nivolumab intravenously over 30 minutes on day 1, ipilimumab IV over 30 minutes on day 1, and sargramostim subcutaneously on days 1-14. Patients with partial response, stable disease, or complete response at 24 weeks can continue maintenance therapy for up to two years in the absence of disease progression or unacceptable toxicity. Patients in Arm I receive nivolumab and ipilimumab. Patients are treated with nivolumab as a part of induction therapy, according to MAINTENANCE THERAPY: Patients are treated with nivolumab. Patients with PR, SD, or CR at 24 weeks may continue maintenance therapy for up to two years if disease progression or unacceptable toxicity is present.

Source link: https://clinicaltrials.gov/ct2/show/NCT02339571


A Phase II Study of the Interleukin-6 Receptor Inhibitor Tocilizumab in Combination With Ipilimumab and Nivolumab in Patients With Unresectable Stage III or Stage IV Melanoma

The study will consist of an investigation into the safety and tolerability of tocilizumab, administered in combination with ipilimumab and nivolumab for four induction doses every 6 weeks for four weeks until week 12, and maintenance nivolumab alone up to one year to patients with advanced melanoma.

Source link: https://clinicaltrials.gov/ct2/show/NCT03999749


A Phase II Study of High Dose Bolus IL2 in Combination With Low Dose Ipilimumab Followed Sequentially by Nivolumab in Patients With Inoperable Stage III or Stage IV Melanoma Who Have Failed Prior Anti-PD1 Immunotherapy

This is a Phase II study of high dose bolus interleukin-2 in combination with low dose ipilimumab and nivolumab in patients with acute inoperable stage III or stage IV melanoma who have previously failed prior anti-PD1 immunotherapy. During week 1 of the 2 first cycles or each course, HD IL2 will be offered. On Day 1 of the 2 initial cycles of each course for up to two doses total, the Ipilimumab will be administered in a single dose of 1 mg/kg concurrently at a low dose of 1 mg/kg.

Source link: https://clinicaltrials.gov/ct2/show/NCT04562129


An Extended Dosing, Two-phase Study of MDX-010 as Monotherapy or in Combination With Tyrosinase/gp100/MART-1 Peptides Emulsified With Montanide ISA 51 VG in the Treatment of Subjects With Resected Stage III or Stage IV Melanoma

On day 1 of weeks 1, 3, 5, 6, 9, 20, 21, 22, 33, 41, and 53, patients were treated with anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody IV over 90 minutes, emulsified in Montanide ISA-51 subcutaneously, including tyrosinase, gp100 antigen, and MART-1 antigen-4 monoclone globular antibody IV, 21, 23, 43,.

Source link: https://clinicaltrials.gov/ct2/show/NCT00084656


Randomized Phase II Neoadjuvant Study of PD-1 Inhibitor Dostarlimab (TSR-042) vs. Combination of Tim-3 Inhibitor Cobolimab (TSR-022) and PD-1 Inhibitor Dostarlimab (TSR-042) in Resectable Stage III or Oligometastatic Stage IV Melanoma (Neo-MEL-T)

This is a randomized phase II study comparing neoadjuvant therapy with PD-1 inhibitor Dostarlimab to the PD-1/TIM-3 inhibitor combination Dostarlimab/TSR-022 in patients with resectable regionally advanced or oligometastatic melanoma. Patients with stage III B/C/D or oligometastatic stage IV A melanoma with lymph node and/or in-transit and/or oligometastatic disease with oligometastatic disease who have yet to have elective surgery are eligible to enroll.

Source link: https://clinicaltrials.gov/ct2/show/NCT04139902

* 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