View clinical trials related to Melanoma Stage III.
Filter by:Background: Standard treatment for stage III melanoma with lymph node metastases involves complete lymph node dissection, which is a radical surgical procedure aimed at the removal of the entire regional lymph node basin. Conservative surgery for low-burden nodal metastasis involves removal of the metastatic lymph node or nodes ("node-picking"), leaving uninvolved nodes within the regional basin. This is expected to provide adequate regional control of the disease with no negative impact on patient survival and a lower rate of surgical complications. Aims: The MelConSurg Cohort will provide the first data on conservative surgery for patients with stage III melanoma with nodal metastases detected clinically or by imaging. Methods: A multicentre, single-arm prospective cohort study. Inclusion criteria: Patients with melanoma aged between 18 and 90 years, Eastern Cooperative Oncology Group performance status 0-1, non-matted regional lymph node metastasis (N1b or N2b) in a single regional basin detected clinically or by imaging (ultrasound, CT scan, PET scan). Study period: A 3-year recruitment period and a 3-year follow-up phase. Intervention: Patients will undergo conservative nodal surgery using conventional surgery, radio-guided surgery, or imaging guided surgery. Outcome measures: 3-year nodal relapse-free survival, 3-year disease-free survival, 3-year melanoma-specific survival, rate of surgical complications, and quality of life (SF-36 questionnaire). Sample size & Statistics: the estimated sample size to be recruited is 68 patients. Survival outcomes will be analysed through the Kaplan-Meier method, with the log-rank test. Conclusions: This Project is expected to provide unique evidence regarding a less radical nodal surgery for patients with melanoma. If favourable results are obtained, controlled studies could be conducted and changes in current clinical practice could be considered.
Prospective non-interventional study of clinical outcomes and biomarkers in patients with stage 0-IV skin melanoma in real clinical practice
There are in total 3 cohorts. Cohort A: 16 patients will receive a daily dose of 80mg regorafenib up until progressive disease, unacceptable toxicity or withdrawal of consent. Dose can be escalated intra-patient up to 120 mg if no AE with a grad >1 at 28 days. Patients get a baseline evaluation and have a consultation every 2 weeks for evaluation during treatment. This evaluation consists out of lab tests, PET/CT (not bi-weekly), MRI (not bi-weekly) and physical evaluation. Primary endpoint is the anti-tumor activity, secondary endpoints are the Overall Survival Rate, Progression Free Survival and the incidence and severity of AE and Health-Related Quality of Life. Cohort-B: 16 patients who are being treated with BRAF-/MEK- inhibitors will receive additional daily regorafenib in combination with BRAF-/MEK inhibitors. Approved BRAF-/MEK- inhibitor combinations include dabrafenib/trametinib and encorafenib/binimetinib. An interruption of BRAF-/MEK-inhibitors dosing of maximum 4 weeks is allowed between the documentation of progression of disease on this therapy and the initiation of regorafenib study treatment. Dose of regorafenib is 40mg. Cohort-C: 16 patients in Cohort-C will have interrupted treatment with any BRAF- /MEK - inhibitor combination for at least 12 weeks prior to initiating study therapy with regorafenib. At the time of initiating regorafenib study treatment at 40mg, patients will also resume treatment with encorafenib/binimetinib at its standard dosing regimen. The first 6 patients enrolled in each Cohort (B, and -C) will be considered as a safety lead-in study population. If two or more serious treatment-related adverse events are observed among the first 6 patients, enrollment will be suspended (if applicable). The risk/benefit for continuing enrollment will be evaluated and an interim safety report will be provided to the Medical Ethics Committee of the UZ Brussel. If less than two serious treatment-related adverse events are observed, enrollment will be continued without interruption to complete the phase II objective.
The purpose of this single arm, multi-national clinical trial in patients with metastatic or unresectable melanoma is to evaluate the BOR and compare it to historical data on patients on anti-PD1 treatment with pembrolizumab alone.
Combination treatment with nivolumab and ipilimumab before surgery may help people with melanoma because the drugs are designed to help the immune system target and destroy cancer cells (immunotherapy), which may shrink the cancer and prevent recurrence after surgery. Treatment given before surgery is called neoadjuvant therapy. The purpose of this study is to find out whether neoadjuvant therapy with nivolumab and ipilimumab can kill melanoma tumors before surgery and prevent disease from coming back after surgery. This study also explores a new, experimental PET scan that images the immune system to see if it is related to treatment outcomes.
In this study the aim is to investigate whether transfer of the microbiota of either responder or non-responder patients via fecal microbiotica transplantation (FMT) can convert the response to immunotherapy in immune checkpoint inhibitors (ICI) refractory metastatic melanoma patients. This is a randomized double-blind intervention phase Ib/IIa trial in ICI refractory metastatic melanoma patients receiving either FMT of an ICI responding or FMT from an ICI non-responding donor, in combination with ICI. Following randomization, patients will receive vancomycin 250 mg, four times daily for 4 days (day -5 up until day -2), and undergo bowel clearance on day -1 (in total 1L MoviPrep). The FMT, either derived from donor group R (who showed a good response on anti-PD-1 therapy) or donor group NR (who showed progression on anti-PD-1 therapy), will be performed by a gastroenterologist using esophagogastroduodenoscopy. A total amount of 198mL (containing a total of 60 gram feces) will be used for transplantation. Anti-PD-1 treatment will be continued according to the patient's regular treatment schedule. Evaluation of safety and response to treatment will be performed.
Prospective evaluation of clinical outcomes in patients with resectable or metastatic BRAF+ melanoma treated with dabrafenib and trametinib in real practice
The purpose of this study is to assess rate of disease relapse and hazard rate of disease relapse after neoadjuvant therapy based on the statuses of pathologic complete response or non-pathologic complete response, and postoperative adjuvant therapy.
This phase II trial studies how well binimetinib and imatinib work in treating patients with stage III-IV KIT-mutant melanoma that cannot be removed by surgery (unresectable). Binimetinib and imatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving binimetinib and imatinib may help treat patients with KIT-mutant melanoma.
The purpose of this study is to find out if the administration of Interleukin-2 concurrently with ipilimumab followed by Nivolumab will result in improved anti-cancer activity and if it is effective for advanced melanoma.